Latest / The Eye Believe Podcast / 📚 Understanding Clinical Drug Trials: A Doctor’s Perspective for Uveal Melanoma Patients

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📚 Understanding Clinical Drug Trials: A Doctor’s Perspective for Uveal Melanoma Patients · The Eye Believe Podcast

0:00
we have
0:00
Doctor
0:01
moser of
0:01
course,
0:02
here
0:02
hosting.
0:02
And he
0:03
brought
0:03
on Doctor
0:04
Meredith
0:04
McKean,
0:05
who
0:05
I believe
0:06
Doctor
0:06
moser
0:07
Did
0:07
you guys
0:07
attend
0:07
school
0:08
together?
0:09
Med
0:09
school.
0:09
Okay,
0:10
so
0:10
they've
0:10
attended
0:10
med
0:11
school
0:11
together.
0:11
They're
0:11
good
0:11
friends.
0:12
they talk
0:12
a lot
0:13
together.
0:13
I've had them
0:14
on
0:14
the podcast
0:14
webinars.
0:15
They are
0:16
an excellent
0:17
team and
0:17
we are
0:17
glad to
0:18
have them
0:18
here.
0:19
And then
0:19
we also
0:20
have
0:20
Doctor
0:20
mehmi,
0:20
who
0:20
I just
0:21
have had
0:21
the
0:21
fortune
0:21
of
0:21
meeting
0:22
today,
0:23
and
0:24
we are
0:24
so glad
0:25
to have
0:25
you here.
0:26
I'm going
0:26
to go
0:26
ahead
0:26
and
0:26
welcome
0:27
our speakers
0:27
up on
0:27
stage
0:28
as I
0:28
introduce
0:28
you guys.
0:29
So
0:30
just
0:30
by way
0:30
of
0:30
introduction,
0:31
Doctor
0:31
moser
0:31
is
0:32
a medical
0:33
oncologist
0:33
here in
0:33
Scottsdale
0:34
at Honor
0:35
Health
0:35
Research
0:35
Institute.
0:36
And
0:37
he is,
0:37
of
0:37
course,
0:37
our
0:38
hosting
0:38
doctor
0:38
here
0:38
from
0:39
Honor
0:39
Health.
0:40
And he's
0:40
currently,
0:41
actively
0:41
developing
0:42
new
0:42
clinical
0:42
trials
0:43
and
0:43
treatment
0:43
options
0:43
for
0:44
patients
0:44
with
0:44
uveal
0:45
melanoma.
0:46
Doctor
0:46
McKean,
0:46
hailing
0:47
from a
0:47
one way
0:48
flight
0:48
and a one
0:49
way out
0:49
later
0:50
from
0:50
Nashville,
0:51
she is our main
0:52
Midwest
0:53
Board
0:53
certified
0:54
medical
0:54
oncologist,
0:55
the director
0:56
of the
0:56
the
0:56
melanoma
0:57
and Skin
0:57
Cancer
0:58
Research
0:58
for Sarah
0:59
Cannon's
0:59
Research
0:59
Institute
1:00
at
1:00
Tennessee
1:01
Oncology.
1:02
And so
1:02
we're
1:02
so glad
1:03
to
1:03
have her
1:03
here
1:03
with us.
1:04
And then
1:05
Doctor
1:05
mehmi is
1:06
a
1:06
hematologist
1:07
oncologist
1:07
from
1:08
Santa
1:08
Monica
1:08
in
1:09
California
1:09
with over
1:10
16 years
1:11
of
1:11
experience
1:11
in the
1:11
medical
1:12
field.
1:12
So
1:12
hematologist,
1:13
which
1:13
I didn't
1:14
know this
1:14
phrase
1:14
until
1:15
maybe two
1:15
years
1:16
ago.
1:16
That's a
1:16
blood
1:17
doctor.
1:18
Like a
1:18
blood and
1:19
blood
1:19
doctor
1:20
of some
1:20
kind,
1:20
right?
1:21
No.
1:21
Am
1:21
I wrong?
1:22
I'm
1:22
probably
1:22
wrong.
1:23
And
1:23
what am
1:23
I?
1:24
Okay,
1:24
hematology.
1:25
He's
1:26
going to
1:26
explain.
1:27
I have it
1:28
wrong.
1:29
So let's
1:29
go ahead
1:29
and
1:30
welcome
1:30
our
1:30
speakers
1:30
to the
1:30
stage.
1:36
I think
1:36
really
1:37
the goal
1:38
of this
1:38
session,
1:38
every
1:39
session,
1:39
is
1:39
to be
1:40
able to,
1:41
you know,
1:41
offer
1:42
information.
1:42
But
1:42
really
1:43
use this
1:43
as a
1:43
platform
1:44
for you
1:44
to be
1:44
able
1:44
to ask
1:44
any questions.
1:46
So
1:46
I think
1:46
I'm
1:46
kicking
1:47
us off,
1:47
but,
1:48
there may be
1:48
a little
1:48
bit
1:49
of overlap
1:49
so my
1:50
colleagues
1:50
can
1:51
feel free
1:51
to chime
1:52
in.
1:52
So
1:52
our session
1:53
is really
1:53
just how
1:54
to make
1:54
sense of
1:54
it all.
1:56
And I
1:57
wanted
1:57
to start
1:58
and just
1:58
kind
1:58
of lay
1:59
a,
1:59
a
1:59
framework
2:00
of what
2:01
drug
2:01
development
2:02
looks like.
2:03
Because
2:03
I think
2:04
for
2:04
patients
2:05
you're
2:06
getting
2:06
involved
2:07
at kind
2:07
of any,
2:08
any place
2:09
within
2:09
that
2:10
blue box.
2:11
But I
2:11
think
2:11
just to
2:11
be able
2:12
to see
2:13
the
2:13
entire
2:14
spectrum
2:14
of the
2:15
process,
2:16
that
2:16
before we
2:17
even
2:17
offer
2:18
a
2:18
patient,
2:19
drug on a
2:20
clinical
2:20
trial,
2:21
it is
2:21
generally
2:22
undergone
2:23
years
2:23
of basic
2:24
research,
2:25
drug
2:25
discovery,
2:26
pre-clinical
2:27
work,
2:27
and
2:28
animal
2:28
models,
2:28
sometimes
2:29
healthy
2:29
volunteers.
2:30
That has
2:30
all led
2:31
to an
2:32
application
2:32
to
2:32
the FDA
2:33
to prove
2:34
why we're
2:35
researching
2:36
it, that
2:37
this looks
2:38
like,
2:38
we have some
2:39
idea of
2:39
the
2:39
potential
2:40
side
2:40
effects,
2:41
and this
2:41
looks,
2:41
very
2:42
manageable.
2:43
And then,
2:44
starting
2:44
phase one
2:45
through
2:45
phase
2:45
three
2:46
clinical
2:46
trials,
2:47
I think,
2:48
as we'll
2:48
discuss
2:48
today,
2:49
even what
2:50
a phase
2:51
one
2:51
clinical
2:52
trial
2:52
means has
2:53
changed
2:53
a lot.
2:55
Because
2:56
the goal
2:57
has
2:57
really
2:57
been
2:58
if
2:58
there's a
2:59
successful,
3:00
you know,
3:00
a
3:00
beneficial
3:01
drug out
3:01
there,
3:02
we want to
3:03
try to
3:03
move it
3:04
through
3:05
the drug
3:05
development
3:06
process
3:06
as
3:06
quickly
3:07
as we
3:07
can.
3:08
So more
3:08
patients
3:09
benefit.
3:10
And
3:10
you can
3:10
see that
3:11
the
3:11
median
3:11
time
3:12
from
3:12
patent
3:13
filing
3:13
to
3:13
product
3:14
launch
3:14
has has
3:15
dropped,
3:16
over the
3:16
last
3:17
decade,
3:17
with
3:17
the goal
3:18
of just
3:18
trying
3:19
to,
3:19
trying
3:20
to get
3:20
these
3:20
drugs
3:21
to patients
3:22
and
3:22
so this
3:23
just
3:23
outlines,
3:24
you know,
3:24
phase
3:24
one, in
3:25
general,
3:26
the goals
3:26
are
3:26
looking
3:27
at safety
3:28
and
3:28
understanding,
3:29
what dose
3:29
we'd
3:29
want to
3:30
move
3:30
forward
3:30
with,
3:31
phase two
3:32
historically
3:33
has meant
3:33
you've
3:33
decided
3:34
on your
3:34
dose,
3:34
you
3:35
decide
3:35
on your
3:35
patient
3:35
population
3:36
and
3:36
you're
3:36
further
3:37
exploring
3:37
that.
3:38
But as
3:38
we'll
3:38
discuss
3:39
today,
3:39
that's
3:39
actually
3:40
getting
3:40
tucked
3:41
into
3:41
phase
3:42
one
3:42
studies
3:42
now,
3:43
with more
3:44
so as
3:44
a phase
3:45
one B
3:46
and a lot
3:46
of that
3:47
can
3:47
just be
3:47
speed
3:48
and,
3:48
and just
3:49
being able
3:49
to hear
3:50
if
3:50
we have
3:50
a signal,
3:50
especially
3:51
for uveal
3:51
melanoma
3:52
patients,
3:52
we don't
3:53
need to
3:53
close
3:53
down
3:54
our study
3:54
to reopen
3:55
necessarily
3:55
as
3:56
a phase
3:56
two, but
3:56
try
3:57
to explore
3:57
this
3:58
within
3:58
the phase
3:58
one.
4:00
And
4:00
then a
4:00
phase
4:00
three is
4:01
is your,
4:02
more
4:03
historical
4:03
randomized
4:04
clinical
4:04
trial,
4:05
that
4:05
patients
4:06
are
4:06
randomized
4:06
either
4:07
to
4:07
receive,
4:08
therapy
4:09
versus
4:09
a standard
4:10
of care.
4:11
This is
4:11
then
4:11
reviewed
4:12
by
4:12
the FDA
4:12
and then
4:13
into
4:13
phase
4:14
four
4:14
studies.
4:15
Even once
4:15
a drug
4:15
is
4:16
approved,
4:16
the FDA is
4:17
still
4:17
monitoring
4:18
any
4:18
safety
4:19
events
4:19
and
4:19
looking to
4:20
see
4:20
are there
4:20
any other
4:21
long term
4:21
outcomes?
4:24
Of this
4:24
slide
4:24
was
4:25
interesting.
4:25
A lot of patients,
4:26
when
4:26
you're
4:26
trying
4:27
to decide
4:27
whether
4:27
or not
4:28
to
4:28
participate
4:28
in a
4:29
clinical trial.
4:30
What this
4:30
demonstrates
4:31
is
4:31
the change
4:32
that
4:32
I think
4:33
we see
4:33
as
4:33
investigators
4:34
and maybe
4:35
patients
4:35
see
4:36
when they come in
4:36
and
4:37
they'll
4:37
say,
4:37
well,
4:38
wait
4:38
a minute,
4:38
I haven't
4:38
heard of
4:39
this
4:39
company
4:39
before.
4:40
I,
4:40
you know,
4:41
I tried
4:41
googling
4:41
this
4:42
and what
4:43
this is
4:43
showing
4:44
there's
4:44
some
4:45
acronyms
4:45
here
4:46
is that
4:46
more and
4:47
more
4:47
development
4:47
is
4:48
getting
4:48
done by
4:48
smaller,
4:49
biotech
4:50
and
4:50
biopharma
4:51
companies.
4:52
And
4:52
then oftentimes
4:53
either
4:53
they're able
4:54
to take
4:54
that drug
4:55
all
4:55
the way
4:55
through,
4:56
or
4:56
they're
4:56
then
4:57
partnering
4:58
with a
4:58
larger
4:58
company
4:59
that has
4:59
maybe
5:00
been
5:00
around
5:01
longer
5:01
or, has
5:02
maybe
5:02
more
5:02
of the
5:03
funding
5:03
and
5:03
resources.
5:04
And so
5:05
I always
5:06
just
5:06
try to
5:06
tell
5:06
patients
5:07
that,
5:08
you know,
5:08
this
5:08
is just
5:09
kind of
5:09
how drug
5:10
development
5:10
is
5:10
changing,
5:11
that
5:11
we're
5:11
just
5:11
seeing
5:12
more
5:12
and more
5:12
of these
5:13
kind of
5:13
smaller
5:13
biotech
5:14
companies.
5:14
And I
5:15
think
5:15
and uveal
5:15
that's
5:16
so important
5:16
because
5:17
sometimes
5:18
these are
5:18
the
5:18
companies
5:19
that are
5:19
really
5:20
willing
5:20
to dive
5:21
into rare
5:22
diseases,
5:23
and
5:23
really
5:23
try to
5:24
help
5:24
us with
5:24
patient
5:25
outcomes.
5:27
So just
5:28
kind of
5:29
going
5:29
back
5:29
through
5:29
that
5:29
process
5:30
a little bit.
5:30
So these
5:31
pre-clinical
5:32
studies,
5:32
so
5:33
the idea
5:33
here
5:34
with,
5:34
you know,
5:35
some of
5:35
the
5:35
animal
5:35
models
5:36
is
5:36
determining
5:37
the optimal
5:37
formulation.
5:38
Is this
5:38
going to be
5:39
a pills
5:39
is going
5:40
to be
5:40
IVs is
5:41
going
5:41
to be
5:41
a subcu
5:41
injection.
5:42
Try to
5:42
decide
5:43
the
5:43
initial
5:44
safe
5:44
starting
5:44
dose
5:45
for phase
5:46
one
5:46
clinical
5:46
trials.
5:47
Oftentimes
5:47
we we
5:48
well,
5:49
not
5:49
oftentimes
5:49
we always
5:50
start
5:50
at doses
5:51
lower
5:51
than
5:51
where
5:52
we think
5:52
the exact
5:53
the target
5:53
is to
5:54
make sure
5:55
that
5:55
we're
5:55
starting
5:56
at a safe
5:56
level.
5:58
And so
5:58
that's
5:59
decided
6:00
based
6:00
on the
6:00
drug
6:01
levels,
6:01
in those
6:02
preclinical studies
6:04
and then
6:04
looking
6:05
at toxicity
6:05
so we can
6:06
understand,
6:07
hey,
6:07
based
6:07
on this
6:08
mechanism
6:08
of
6:08
action,
6:09
these
6:09
patients
6:10
may
6:10
patients
6:11
may have
6:11
a risk
6:12
of high
6:13
toxicity.
6:13
So
6:14
we need
6:14
to make
6:14
sure
6:14
we're
6:14
doing eye
6:15
exams on
6:16
this study.
6:16
There
6:17
may be a
6:17
risk of
6:18
cardiac
6:19
toxicity.
6:19
So
6:20
we need
6:20
to do
6:20
ekos at
6:21
baseline
6:21
or
6:22
on study.
6:22
And so
6:23
that's
6:23
where
6:23
that the
6:24
the
6:24
preclinical
6:25
studies
6:26
help us
6:26
to
6:26
be able
6:26
to keep
6:27
patients,
6:27
monitored
6:28
as
6:28
closely
6:29
as
6:29
possible
6:29
while
6:30
on study.
6:31
And so
6:31
then
6:32
that
6:32
kind of
6:32
falls
6:32
into then
6:33
the
6:33
clinical
6:34
monitoring,
6:34
whether
6:35
that's
6:35
EKGs,
6:36
echos,
6:37
eye
6:37
exams,
6:38
and such.
6:40
And I
6:41
always
6:41
have to
6:42
remind,
6:42
patients
6:43
that,
6:44
know any
6:45
clinical
6:46
trial,
6:46
phase one
6:47
through
6:47
phase
6:47
three has
6:47
had to
6:48
go
6:48
through
6:48
FDA
6:48
clearance.
6:49
So this
6:49
is,
6:50
submission
6:51
of all
6:52
the
6:52
rationale
6:53
based
6:53
on
6:54
mechanism
6:54
of
6:54
action,
6:55
potential
6:55
side
6:55
effects.
6:56
That is
6:56
then
6:57
given
6:57
the okay,
6:58
by
6:58
the FDA
6:59
to move
6:59
forward.
7:00
And
7:00
that's
7:01
always
7:01
important.
7:04
So
7:04
then once
7:05
a phase
7:05
one
7:05
study,
7:06
initiates,
7:07
we could
7:08
the
7:08
three of
7:08
us could
7:09
probably
7:09
talk
7:09
all day
7:09
about
7:10
just the
7:10
different
7:10
designs
7:11
of a
7:11
phase one
7:11
dose
7:12
escalation.
7:12
But
7:13
this is
7:13
just an
7:13
example
7:14
of what
7:14
it looks
7:15
like
7:15
to go,
7:16
kind of
7:16
slowly up
7:17
in dose.
7:18
And,
7:19
any of
7:19
these
7:19
clinical
7:20
trials
7:20
can be
7:20
further,
7:21
expanded
7:22
once
7:22
we've
7:22
decided
7:23
kind of
7:23
what dose
7:24
to
7:24
proceed
7:25
with.
7:27
And one
7:27
example
7:28
of
7:29
a phase
7:29
one
7:29
clinical
7:30
trial.
7:31
This was
7:31
the
7:31
initial,
7:32
clinical
7:32
trial
7:33
for
7:33
pembrolizumab
7:34
or
7:34
Keytruda.
7:35
And
7:36
you can
7:36
see here
7:37
that,
7:38
basically
7:38
within
7:39
a phase
7:40
one
7:40
clinical
7:41
trial,
7:41
the first in
7:42
human
7:42
was
7:42
initiated
7:43
back in
7:43
January
7:44
2011,
7:45
got
7:45
breakthrough
7:46
therapy
7:46
designation.
7:47
There
7:48
was a
7:48
melanoma
7:48
approval
7:48
in
7:49
September
7:49
2014
7:50
and, lung
7:51
cancer
7:51
in 2015.
7:52
This is a
7:53
good example
7:53
of how
7:54
you can,
7:54
if a drug
7:55
looks
7:55
really
7:55
successful.
7:56
You know,
7:57
historically
7:57
this
7:57
would
7:57
have
7:58
taken
7:58
like a
7:59
decade
7:59
to get
7:59
through,
8:00
but
8:00
just
8:00
trying
8:00
to get
8:01
as much
8:02
information
8:02
in a phase
8:03
one
8:03
trial.
8:03
And
8:03
you can
8:04
see how
8:04
complex
8:04
this is
8:05
and
8:05
how many
8:05
patients
8:06
were
8:06
treated
8:06
in a
8:06
phase
8:07
one
8:07
trial.
8:08
So
8:08
a phase
8:09
one trial
8:09
doesn't
8:10
always
8:10
mean,
8:11
and I
8:12
think
8:12
we're all
8:12
very
8:13
straightforward
8:13
with
8:13
patients
8:13
if you're
8:14
the first
8:14
patient
8:15
treated
8:15
or if
8:15
you're
8:16
within
8:16
the first
8:16
ten
8:16
patients,
8:17
it can be
8:17
a
8:17
thousand
8:18
patients,
8:18
treated
8:20
on that
8:20
clinical
8:21
trial.
8:22
And then
8:23
my last
8:23
slide, is
8:24
just,
8:24
helping
8:25
patients
8:25
understand
8:26
when,
8:26
for phase
8:27
one
8:27
clinical
8:28
trials,
8:28
we do
8:29
a lot
8:29
of extra
8:30
blood
8:30
draws.
8:31
And
8:31
this is
8:31
for
8:32
pharmacokinetics.
8:33
And so
8:33
the idea
8:33
is, is
8:34
you can
8:35
kind
8:35
of see
8:35
in this,
8:36
this
8:36
image,
8:37
we're
8:37
really
8:37
trying to
8:38
understand
8:38
and how
8:40
what is
8:40
the
8:40
absorption,
8:41
the metabolism,
8:42
where is it
8:43
distributing.
8:44
And so
8:44
this is
8:45
why it
8:45
is
8:45
important
8:46
for us
8:46
to be
8:46
collecting,
8:47
serial
8:48
blood,
8:49
blood
8:49
testing
8:49
over the
8:50
course of
8:50
maybe
8:50
the day
8:51
patients
8:51
have to
8:51
come back
8:52
in
8:52
potentially
8:52
the
8:53
next day
8:53
or two
8:53
days
8:54
later,
8:54
because
8:54
we're
8:55
really
8:55
trying
8:55
to
8:55
understand
8:56
how
8:56
long does
8:56
that drug
8:57
last
8:57
in the
8:58
in the
8:58
patient
8:58
system,
8:59
and
8:59
how does
8:59
that
9:00
affect
9:00
dosing
9:01
and
9:01
potential
9:01
side
9:02
effects?
9:02
So
9:03
I think
9:03
those
9:03
are just
9:03
a few
9:04
slides
9:04
for food
9:04
for
9:05
thought.
9:05
And I'll
9:05
hand it
9:06
over to
9:06
my
9:06
colleagues.
9:08
Answers
9:08
any
9:09
questions?
9:09
Hi.
9:10
Good morning,
9:10
everybody.
9:11
Justin.
9:11
Thank you
9:11
for
9:12
having me
9:12
here.
9:13
I it's
9:13
it's a
9:14
really
9:15
great
9:15
time
9:16
to be
9:16
part of
9:16
this
9:17
process.
9:18
And
9:18
Meredith
9:18
set me up
9:19
really
9:19
nicely.
9:20
For what?
9:21
By ten,
9:22
20 slides
9:22
that I
9:23
have.
9:23
And I
9:24
wanted to
9:24
talk
9:25
about,
9:26
you know,
9:26
what's
9:26
available
9:27
out
9:27
there.
9:28
Now that
9:28
Meredith
9:29
talk
9:29
about,
9:30
you know,
9:30
what the
9:30
clinical
9:31
trial
9:31
process
9:31
is and
9:32
what our
9:32
different
9:33
phases of
9:33
clinical trials
9:34
and
9:34
how do we move
9:35
from one
9:35
face to
9:36
another?
9:37
Does
9:37
every
9:37
trial
9:38
move to
9:38
the next
9:39
phase
9:39
or not?
9:40
So
9:40
I think,
9:41
so
9:41
these are
9:42
some of
9:42
my disclosures.
9:43
Why did you talk
9:44
about,
9:45
you know,
9:45
some
9:45
of the
9:46
different
9:47
targets
9:48
in uveal
9:48
melanoma
9:49
in
9:49
particular,
9:50
that
9:50
we're
9:50
trying
9:50
to use
9:51
to come
9:51
to the
9:51
next,
9:52
therapeutic
9:53
option.
9:53
So I was
9:54
going
9:54
to talk
9:54
about
9:55
this sort
9:56
of
9:56
surface
9:57
marker on
9:57
the usual
9:58
melanoma
9:58
cells
9:58
called
9:59
prame
9:59
And
10:00
how can
10:00
we target
10:01
that for
10:02
benefit?
10:03
Also, I
10:05
think
10:05
some
10:05
of this
10:05
talk
10:06
already
10:06
happened,
10:07
you know,
10:07
trying to
10:08
get to
10:08
the
10:08
metastatic
10:09
uveal
10:09
melanoma,
10:10
these masses
10:11
that are
10:11
sitting
10:12
either
10:12
in the
10:12
liver or
10:12
somewhere
10:13
else,
10:13
can we
10:14
inject
10:14
those
10:14
with
10:15
different
10:15
drugs
10:15
to get
10:16
a response?
10:17
And
10:17
there are
10:17
a couple
10:17
of
10:18
different
10:18
trials
10:18
that have
10:18
looked
10:19
very
10:19
exciting.
10:20
And also
10:21
targeted
10:21
therapy,
10:21
you know,
10:22
target
10:22
therapy
10:23
in the
10:23
other
10:24
cancer
10:24
world,
10:24
in
10:25
non-small
10:26
cell lung
10:26
cancer,
10:27
breast
10:27
cancer,
10:28
melanoma,
10:29
it's
10:30
quite
10:30
well
10:30
known.
10:31
I mean,
10:31
the first
10:32
targeted
10:32
therapy
10:32
was
10:33
for CML
10:34
with
10:34
imatinib
10:35
or
10:35
Gleevec.
10:35
And
10:35
that's
10:36
been
10:37
the dream
10:37
in every
10:38
other cancer.
10:39
Is there
10:39
a silver
10:40
bullet
10:40
for a
10:40
mutation?
10:41
That's
10:41
present?
10:42
And so,
10:42
again,
10:43
we're
10:43
looking
10:43
at that
10:44
for uveal
10:44
as well.
10:45
And then
10:46
also in
10:46
the last
10:46
is in
10:47
the last
10:47
five,
10:48
I say
10:48
about
10:49
five
10:49
years,
10:49
even
10:50
though
10:50
the cell
10:50
therapy
10:51
is as old
10:51
as you
10:52
know.
10:53
Gosh,
10:54
before
10:54
I was
10:54
born,
10:55
but in,
10:56
in
10:56
melanoma
10:57
and uveal
10:58
melanoma,
10:58
it's a
10:58
quite
10:59
new
10:59
concept
11:00
and,
11:01
and
11:01
it's in,
11:02
especially
11:02
in,
11:04
cutaneous
11:05
melanoma.
11:05
It's
11:05
an FDA
11:06
approved
11:06
therapy.
11:07
So
11:08
is this
11:09
a viable
11:09
option in
11:11
metastatic
11:11
uveal
11:11
melanoma
11:11
as well?
11:13
So
11:13
I don't know
11:14
if I can.
11:17
This is
11:17
a
11:17
hyperlink
11:18
I don't know
11:18
if I can
11:19
get to
11:19
that
11:19
or not.
11:19
But this
11:21
hyperlink
11:21
essentially
11:22
was for
11:22
clinicaltrials.gov.
11:24
And
11:25
if you
11:25
select
11:26
certain
11:26
parameters
11:27
you can come up
11:28
with
11:28
a list
11:29
of
11:29
clinical
11:29
trials.
11:31
And
11:31
it could
11:32
be quite
11:32
cumbersome
11:33
to know
11:33
which
11:34
trials
11:34
are,
11:36
recruiting
11:37
are
11:37
close,
11:38
ongoing.
11:39
So when
11:41
I put in
11:41
for
11:42
metastatic
11:42
uveal
11:43
melanoma
11:44
actively
11:44
accruing,
11:46
there are only
11:46
about 23,
11:47
24
11:48
trials.
11:49
So again,
11:50
space is
11:51
small.
11:52
And but,
11:53
you know,
11:54
in
11:54
metastatic
11:55
setting,
11:56
there's
11:56
still not
11:56
that many
11:57
trials
11:57
that are
11:57
going on.
11:58
Okay.
12:00
So we're
12:00
going to
12:00
start off
12:01
with the
12:01
phase
12:01
one
12:01
study,
12:02
from
12:03
immunocore,
12:04
of this
12:04
drug
12:04
called
12:05
IMC f
12:06
106 C.
12:07
I think
12:08
my colleagues
12:08
know this
12:09
really
12:09
well.
12:10
It was
12:10
presented
12:11
by my
12:11
senior
12:11
partner,
12:12
Doctor
12:12
Hamid,
12:12
in Europe
12:14
a couple
12:14
of years
12:14
back,
12:15
where we
12:15
looked
12:15
at all
12:16
different
12:16
solid
12:17
malignancies
12:18
that
12:18
express
12:19
prame
12:19
And
12:19
they were
12:20
of
12:20
particular
12:21
HLA
12:21
subtype,
12:22
the white
12:22
blood
12:22
cell sort
12:23
of marker
12:24
that,
12:24
Doctor
12:24
Moser
12:25
talked
12:25
about
12:25
a little bit
12:25
earlier.
12:26
And when
12:27
these
12:27
and
12:27
some of
12:28
these
12:28
patients
12:28
that were
12:28
treated,
12:29
they were
12:29
they had
12:31
uveal
12:32
melanoma
12:32
as well.
12:33
Either
12:33
they had
12:33
previously
12:34
treated
12:34
or not.
12:36
And
12:36
we see
12:36
some
12:37
signal
12:37
there.
12:37
So
12:37
this is
12:38
one of the,
12:39
you know,
12:40
possible
12:40
options
12:41
moving
12:41
forward.
12:42
And and
12:43
it's up
12:44
to us
12:46
as,
12:46
advocates
12:47
for our
12:48
patients
12:48
and the
12:49
patient
12:49
advocacy
12:49
groups
12:50
to push
12:51
these
12:51
companies
12:52
to
12:52
consider
12:52
these
12:52
trials
12:53
further,
12:53
because I
12:53
don't
12:54
know
12:54
where the
12:54
immunocore
12:55
folks
12:55
are going
12:56
with the
12:56
same
12:56
targeting
12:57
and uveal
12:58
melanoma,
13:00
but
13:00
this is
13:00
one
13:01
of the options.
13:01
And I've
13:02
treated,
13:02
more than
13:03
a few
13:03
patients
13:03
on this
13:04
study.
13:04
I think
13:05
it
13:05
potentially
13:06
is a
13:06
reasonable
13:07
option
13:07
moving
13:07
forward.
13:08
I'm not
13:08
going
13:09
to go to
13:09
too much
13:09
about
13:10
the
13:10
response
13:10
rate,
13:10
the rate.
13:11
So
13:11
there are
13:12
benefits.
13:12
I think
13:13
we could
13:13
talk
13:14
about
13:14
that
13:14
on on
13:14
a separate
13:15
day, but
13:16
just
13:16
wanted to
13:16
show you
13:17
that
13:17
there are
13:18
some
13:18
options
13:19
targeting
13:19
different,
13:20
of these.
13:20
And then
13:21
immunocore
13:23
drug is
13:23
is a
13:24
bispecific
13:25
antibody
13:26
a different
13:26
option
13:27
to target
13:27
the prane
13:28
and it
13:28
attracts
13:29
the T
13:29
cells,
13:30
the effective
13:31
T cells
13:32
that
13:32
we want
13:32
to
13:32
generate
13:33
antitumor
13:33
activity
13:34
and other
13:35
ways to,
13:35
to
13:36
generate
13:36
a
13:37
lymphocyte
13:38
that can
13:38
target
13:39
prame
13:40
you know,
13:40
similar
13:40
mechanism,
13:41
but using
13:42
a different
13:42
way
13:43
to do it.
13:44
Again,
13:45
it
13:45
appears
13:46
that this
13:47
is a
13:47
viable
13:47
option
13:48
for
13:48
metastatic
13:48
uveal
13:49
melanoma
13:50
because
13:50
this
13:51
is one of
13:51
the plume
13:52
trials
13:52
that's
13:52
looking
13:53
at that.
13:53
Again,
13:54
these are
13:55
HLA 0201
13:56
negative
13:56
and
13:56
positive
13:57
patients
13:57
that will
13:58
be
13:58
screened.
13:59
And
13:59
some of
13:59
these
14:00
are
14:00
treated
14:00
with
14:00
kimmtrac
14:01
and
14:01
some are not.
14:02
And
14:02
they will be
14:03
then
14:04
looked at
14:05
with
14:06
pembrolizumab
14:06
with
14:07
lenvatinib.
14:07
So one of
14:08
the other
14:08
studies
14:08
that's
14:09
going
14:09
on from
14:09
target is
14:10
standpoint.
14:11
This is one of the drugs
14:12
that was
14:12
a part of
14:13
when
14:14
I came
14:14
out of
14:14
my fellowship
14:15
and
14:15
we looked
14:16
at
14:16
cutaneous
14:17
melanoma
14:17
that
14:17
wasn't,
14:18
responding
14:18
to
14:19
immunotherapy
14:20
or had
14:20
neck
14:20
cancers
14:21
that
14:21
weren't
14:21
responding
14:22
to,
14:22
immunotherapy.
14:24
And this
14:24
molecule,
14:25
SD 101
14:26
is, sort
14:26
of a
14:26
short,
14:27
piece
14:28
of DNA
14:29
that is
14:29
not
14:30
methylated.
14:31
And
14:31
our body
14:32
recognizes
14:33
unmethylated
14:34
DNA as
14:34
foreign
14:35
as a
14:35
bacterial
14:36
component.
14:37
And
14:38
because
14:38
of that,
14:39
it mounts
14:39
an immune
14:40
response
14:40
to that.
14:41
So when
14:41
we
14:42
injected
14:42
these
14:43
short
14:43
pieces
14:43
of DNA
14:44
into
14:44
the tumor,
14:45
it
14:45
created
14:46
an immune
14:47
response
14:47
to that
14:48
tumor
14:49
so that
14:50
this data
14:50
is
14:50
already
14:51
published.
14:51
And in,
14:52
head
14:52
and neck
14:53
and
14:53
cutaneous
14:53
melanoma,
14:54
but and
14:55
then the
14:55
company
14:55
was
14:55
small.
14:56
And
14:56
one of
14:56
the
14:56
things
14:56
Meredith
14:57
was
14:57
talking
14:57
about
14:57
did
14:58
a lot of
14:58
these
14:58
companies
14:59
that are
15:00
doing
15:00
this
15:01
early
15:01
research
15:01
are
15:02
small.
15:02
And
15:02
sometimes,
15:04
you know,
15:04
those
15:04
companies
15:06
can't be
15:06
viable.
15:07
So this
15:08
company
15:08
originally
15:09
went down
15:10
and
15:11
it was
15:11
the
15:11
molecule
15:12
was
15:12
acquired
15:12
by a
15:13
different,
15:14
biopharma
15:14
now.
15:15
And
15:15
they're
15:16
taking it
15:16
through,
15:17
uveal
15:18
melanoma
15:18
space.
15:19
And
15:19
what they're doing
15:20
is
15:20
they've
15:21
sort of.
15:24
When I
15:25
was doing
15:25
this,
15:25
this,
15:26
cutaneous
15:26
melanoma,
15:27
work,
15:27
we
15:28
injected
15:28
the tumor.
15:29
Now, what
15:29
we're
15:29
doing
15:30
in this
15:30
particular,
15:31
trial
15:32
is
15:32
exposing
15:33
the liver
15:34
under
15:35
pressure
15:35
with
15:36
this drug
15:37
and not.
15:38
And
15:38
that's
15:38
been
15:39
really
15:39
helpful
15:40
in
15:40
providing
15:41
higher
15:42
doses
15:42
of this
15:43
drug to
15:44
that area
15:45
and see
15:45
if we can
15:46
improve
15:46
the
15:46
outcomes.
15:49
Okay.
15:50
And
15:51
this is
15:51
one of
15:51
the
15:51
one of
15:52
the reasons
15:52
we think
15:52
it works
15:53
is
15:53
because
15:53
it
15:53
suppresses
15:54
the,
15:55
so it's
15:55
kind of
15:55
like a
15:55
double
15:56
negative
15:56
suppresses
15:57
the
15:57
suppressive
15:58
activity
15:58
of immune
15:59
cells,
15:59
immune
16:00
system
16:00
on
16:00
itself.
16:01
So it's
16:01
sort of
16:02
there are
16:02
accelerators
16:03
for our
16:03
immune
16:03
system,
16:04
and then
16:04
there are
16:04
breaks
16:05
for our
16:05
immune
16:05
systems.
16:06
So
16:06
this is
16:07
kind of
16:07
breaking
16:08
the
16:08
break.
16:08
So these
16:09
myeloid
16:10
deprived,
16:11
derived
16:11
suppressor
16:12
cells
16:12
are the
16:12
breaks
16:13
for our
16:13
immune
16:13
system.
16:14
They don't
16:14
allow
16:14
anti-tumor
16:15
activity
16:16
that
16:16
we want.
16:17
So trying
16:18
to
16:18
regulate
16:19
them,
16:19
trying
16:19
to
16:19
decrease
16:20
their
16:20
numbers,
16:20
trying
16:20
to
16:21
decrease
16:21
their
16:21
activity,
16:22
hopefully
16:22
will
16:23
improve
16:23
the
16:23
anti-tumor
16:24
activity.
16:26
So one of
16:26
the options
16:27
that's
16:27
available
16:28
is
16:28
a trial
16:28
design.
16:32
And
16:33
again,
16:33
another
16:33
way to
16:34
sort of
16:34
activate
16:35
the immune
16:36
system is
16:37
trying to
16:37
inject it
16:38
with the PV
16:38
-10
16:39
which is
16:39
a
16:39
molecule
16:40
called
16:40
rose
16:41
Bengal
16:41
disodium,
16:42
and it's
16:42
an
16:43
oncolytic
16:44
intralesional
16:45
therapy
16:45
for the
16:45
liver
16:46
metastases
16:47
that again
16:48
activist
16:48
immune
16:49
system
16:49
in turn.
16:50
And
16:50
you can
16:51
see
16:51
in the
16:51
waterfall
16:51
plot
16:52
that
16:52
there's
16:52
a nice
16:53
responsive,
16:53
responses
16:54
in
16:54
most of
16:55
and very
16:56
good
16:56
number of
16:56
patients.
16:58
And then
16:59
I talked
16:59
about the
16:59
targeted
17:00
therapy,
17:00
you know,
17:01
Gleevec
17:01
came out
17:02
and
17:02
everybody
17:02
was
17:03
dreaming
17:03
that
17:03
there's
17:03
got to be
17:04
a Gleevec
17:04
similar
17:05
for all
17:06
cancers.
17:07
And
17:08
in some
17:08
we did
17:09
and some
17:09
we
17:09
didn't.
17:10
And more
17:11
recently,
17:12
we know
17:12
that
17:13
uveal
17:14
melanoma
17:14
has some,
17:15
you know,
17:16
mutations
17:17
that
17:17
perhaps
17:17
are
17:17
activating,
17:18
11.GNAQ
17:20
is,
17:20
Doctor
17:20
moser
17:21
talked
17:21
about a
17:21
little
17:21
bit
17:22
earlier
17:22
in the
17:22
NGS,
17:23
talk.
17:24
It
17:24
subsequently
17:25
activates
17:26
the protein
17:27
kinase C
17:27
pathway.
17:28
And
17:29
we know
17:30
that
17:30
protein
17:30
kinase C
17:31
pathway
17:31
is
17:32
is more
17:33
than
17:33
reasonable
17:34
target
17:35
for
17:36
for
17:36
disease
17:37
control
17:37
or cancer
17:38
control.
17:39
But
17:40
by itself
17:41
it may
17:41
not be
17:41
sufficient.
17:42
So
17:42
he needs
17:42
another
17:43
partner.
17:43
Just like
17:44
in skin
17:45
melanoma,
17:45
you have,
17:46
Braf
17:47
mutations
17:48
that
17:48
takes
17:48
two drugs
17:49
for
17:49
better
17:49
control
17:50
than one.
17:51
Similarly
17:51
here
17:53
the drove
17:53
assertive
17:54
drug is
17:54
being
17:54
combined
17:55
with
17:55
crizotinib
17:56
to get
17:57
a better
17:57
control
17:57
over
17:58
disease.
17:58
And the
17:58
data
17:59
looks
17:59
very
17:59
promising.
18:00
Early
18:00
data has
18:01
now led
18:02
to phase
18:02
three
18:03
studies
18:03
that
18:03
are open
18:04
at
18:04
multiple
18:04
sites,
18:05
including
18:05
ours.
18:06
Some of my colleagues
18:07
here
18:07
are been
18:08
at the
18:08
forefront
18:09
for
18:09
development
18:09
of this
18:10
drug.
18:13
Okay.
18:16
Again,
18:16
safety
18:17
and
18:17
efficacy.
18:17
You know,
18:18
whenever
18:18
you're
18:18
combining,
18:19
like
18:19
Doctor
18:19
moser was
18:19
saying
18:20
earlier,
18:21
you know,
18:21
we like
18:22
more
18:22
drugs.
18:23
To be
18:23
sort of
18:24
you know,
18:24
to
18:24
give us
18:25
a better
18:25
control,
18:26
of cancer,
18:27
but
18:27
that also
18:27
leads to
18:28
some toxicity.
18:29
So
18:29
there are
18:29
a number
18:30
of,
18:30
you know,
18:30
safety
18:31
concerns
18:31
with
18:31
darovasertib
18:32
crizotinib
18:33
combination.
18:34
But
18:34
most of
18:35
that more
18:36
most of
18:36
those
18:36
issues
18:37
are
18:38
fairly
18:38
easy to
18:38
manage.
18:42
And
18:42
the last thing
18:42
that I
18:43
didn't
18:43
talk
18:43
about
18:43
is tumor
18:44
infusion
18:44
lymphocyte.
18:45
And a
18:45
little bit
18:46
about
18:46
that is
18:46
what is
18:47
til So
18:48
all
18:49
tumors
18:49
have
18:49
these
18:50
immune
18:50
cells
18:51
or most
18:53
maybe not
18:53
so much
18:54
uveal
18:54
melanoma,
18:55
but
18:55
most of
18:56
the tumor
18:57
have.
18:58
It's
18:58
not just
18:59
cancer
18:59
alone.
19:00
It
19:00
has other
19:01
components,
19:02
other
19:02
cellular
19:03
components
19:04
that could be
19:04
immune
19:04
cells,
19:05
fibroblasts,
19:06
other
19:06
supportive
19:07
cells.
19:07
They are
19:08
either
19:08
helping
19:08
or
19:09
hurting
19:09
the
19:09
cancer
19:10
one way
19:10
or
19:10
another.
19:11
So in,
19:12
in, skin
19:14
melanomas,
19:15
we know
19:15
that
19:15
there's a
19:15
huge
19:16
component
19:16
within
19:17
the tumor
19:17
itself of
19:18
immune
19:18
cells.
19:19
And for
19:20
one
19:20
reason
19:20
or
19:20
another,
19:21
they're
19:21
stuck.
19:22
They're not
19:22
acting
19:23
towards
19:23
the cancer.
19:24
So
19:24
one of the ways
19:25
we can
19:25
sort of,
19:26
improve
19:27
that
19:27
process
19:27
is can
19:28
we
19:28
increase
19:29
the number
19:29
of these
19:30
tumor
19:30
infiltrating
19:31
lymphocytes
19:33
and
19:33
give it
19:33
back
19:33
to the patient
19:34
and see
19:35
if we can
19:35
control
19:35
the disease?
19:36
And in
19:37
cantaneous
19:37
melanoma
19:38
patients
19:38
who
19:38
failed
19:39
front
19:39
line,
19:40
Keytruda,
19:41
is
19:41
opdivio
19:42
or the
19:42
combination
19:42
drugs
19:43
they
19:44
they are
19:44
candidate
19:45
for this
19:45
therapy
19:46
and it's
19:46
FDA
19:46
approved
19:47
now.
19:47
Now
19:47
can we
19:48
replicate
19:49
that in
19:49
uveal
19:50
melanoma?
19:50
We know
19:51
that the
19:51
uveal
19:51
melanoma
19:52
doesn't
19:52
have the
19:53
same
19:53
kind of
19:53
mutational
19:54
status
19:55
as
19:55
cutaneous
19:55
melanoma.
19:56
But
19:57
there have
19:57
been a
19:57
number of
19:57
trials
19:58
have
19:58
looked at
19:59
is til
20:00
therapy
20:00
a viable
20:01
option
20:02
for for
20:03
metastatic
20:04
melanoma.
20:04
And we're
20:04
seeing
20:05
early
20:05
signals
20:06
that yes,
20:06
it's
20:06
possible.
20:07
And
20:09
one of
20:09
my
20:09
favorite,
20:10
uveal
20:10
melanoma
20:10
of my
20:10
oncologist,
20:11
Doctor
20:11
Patel,
20:12
has done
20:12
a lot of
20:13
work
20:13
in this
20:13
space.
20:14
Led
20:14
the work
20:14
in this
20:15
space
20:15
looking
20:16
at,
20:16
you know,
20:17
the til
20:18
therapy
20:18
that's
20:18
already
20:19
available
20:19
or
20:20
working
20:20
while she
20:20
was at MD
20:21
Anderson,
20:21
working
20:22
with the
20:22
researchers
20:23
to see
20:23
if we
20:23
can
20:23
improve
20:24
the TILs
20:25
that
20:25
we're
20:25
getting
20:26
from
20:26
these,
20:26
tumors
20:27
and
20:27
improve,
20:28
the
20:29
efficacy,
20:30
improve
20:30
the numbers
20:30
of tils
20:31
we get.
20:32
And that
20:32
could
20:32
potentially,
20:33
sort of
20:34
result
20:34
in a
20:34
better
20:35
response.
20:37
So till
20:38
1.0
20:39
verses
20:39
till 3.0,
20:41
you know,
20:42
we're
20:42
able
20:42
to get
20:43
more TILs
20:43
from the
20:44
primary
20:44
tumor,
20:45
grow them
20:46
and
20:46
perhaps,
20:47
you know,
20:48
give it
20:48
back to
20:48
the patient
20:49
and have
20:49
better
20:50
results.
20:52
I think,
20:54
again,
20:54
showing
20:54
the same
20:55
thing,
20:55
that it's
20:55
a more
20:55
than
20:55
reasonable
20:56
option
20:56
to
20:56
control
20:57
the
20:57
disease.
20:58
In, in,
21:00
and
21:00
advanced
21:01
setting.
21:02
Okay.
21:04
I'll
21:04
leave it
21:05
here.
21:05
So a lot
21:06
I didn't
21:07
want
21:07
to get to
21:07
the into
21:08
too much
21:08
nitty
21:09
gritty
21:09
of the,
21:09
of the data.
21:10
I just wanted
21:11
to,
21:11
you know,
21:11
after
21:12
marry
21:12
this talk
21:12
that
21:13
there are
21:13
options.
21:14
And the
21:16
best way
21:16
to
21:16
consider
21:17
those
21:17
options
21:17
is
21:18
talking
21:18
to your
21:18
oncologist
21:19
and see
21:19
what
21:19
makes the
21:20
most
21:20
sense.
21:23
Sorry to
21:24
in this
21:24
session,
21:24
we could
21:25
you
21:25
possibly
21:26
go back
21:26
to those
21:26
three
21:27
slides
21:27
to the
21:27
different
21:28
therapies.
21:29
One of
21:29
the
21:29
drugs,
21:30
one of
21:30
those two
21:31
therapies
21:31
is
21:31
marketed
21:32
as FDA
21:33
approval,
21:33
called
21:34
the
21:35
right.
21:35
So
21:36
that's
21:36
the
21:36
iovance
21:37
drug.
21:38
Which
21:38
one of the trials
21:39
can you
21:39
go back
21:40
one more slide.
21:40
Maybe
21:41
for me.
21:44
Yes.
21:45
Is what
21:46
I can't
21:46
pronounce
21:47
literally.
21:48
lifileucel
21:49
Which one
21:50
is it?
21:50
One of
21:51
those two
21:51
trials.
21:52
Now,
21:52
this is
21:53
not I'm
21:53
not,
21:54
focusing
21:55
particularly
21:56
lifileucel
21:56
So,
21:57
there is
21:57
an
21:57
ongoing
21:58
trial
21:58
at
21:58
Moffitt
21:59
with,
21:59
lifileucel
22:00
uveal
22:00
melanoma.
22:01
But
22:02
this is
22:02
just
22:02
looking
22:02
at
22:02
a number
22:03
of
22:03
different
22:03
til
22:04
therapies
22:04
that are
22:04
potentially
22:05
a better
22:06
position
22:07
for.
22:10
It's
22:10
a more
22:11
centralized
22:11
process,
22:12
through
22:13
through
22:13
pharmaceutical
22:13
industry.
22:17
So in
22:17
question,
22:18
lifileucel
22:18
So
22:19
lifileucel
22:20
was
22:20
actually
22:20
developed
22:21
from
22:21
the NIH,
22:21
the
22:22
national
22:22
surgical
22:22
branches,
22:23
as you
22:23
know,
22:24
and
22:24
they've
22:24
actually
22:25
they
22:25
actually
22:26
started
22:26
testing
22:27
Lifileucel
22:27
in the 80s.
22:28
So when
22:29
Doctor
22:30
mehmi
22:30
made
22:30
the comment,
22:31
this
22:31
has been
22:31
going on
22:31
before
22:32
we were
22:32
born.
22:32
He's
22:33
right.
22:33
It's
22:34
taken
22:34
almost
22:34
40 years
22:35
to get
22:35
til
22:36
therapy.
22:37
So back
22:38
at the
22:38
National
22:39
surgery
22:39
branch of
22:40
the NCI,
22:41
they did
22:41
do a
22:41
study
22:42
a couple
22:42
of years
22:42
ago of,
22:44
I think
22:45
what did
22:47
become
22:47
lifileucel
22:48
but
22:48
this was years
22:49
before it
22:49
actually
22:49
became
22:50
approved
22:50
of
22:51
looking
22:51
at this
22:51
til
22:52
therapy
22:52
in
22:52
patients
22:53
with
22:53
uveal
22:53
melanoma.
22:54
And
22:55
I want
22:55
to say
22:55
that data
22:56
showed
22:56
a 20
22:57
to 30%
22:58
response
22:58
rate.
22:58
So
22:58
there is
22:59
some data
22:59
out
23:00
there.
23:00
It's just
23:02
kind of
23:04
because
23:04
with
23:04
till you
23:05
have
23:05
the kind
23:05
of non
23:06
genetically
23:07
modified
23:07
til
23:07
which is
23:08
the life
23:08
of
23:08
lifileucel,
23:09
and
23:09
we have
23:09
a lot
23:09
of the
23:10
newer
23:10
ones
23:10
where
23:10
there
23:10
are tumor
23:11
and form
23:11
till or
23:12
genetically
23:13
modified.
23:13
And
23:13
those are
23:14
the
23:14
studies
23:14
that
23:14
Doctor
23:15
mahmi
23:15
was
23:15
highlighting
23:16
and those
23:16
I think
23:17
we have
23:17
less data
23:18
at this
23:18
point
23:18
in uveal
23:19
melanoma.
23:24
So
23:24
I think
23:24
those are
23:25
some
23:25
great
23:25
high
23:25
level
23:26
overviews
23:26
about
23:26
what is a
23:27
clinical
23:27
trial,
23:28
what
23:28
clinical
23:28
trials
23:29
are out
23:29
there.
23:30
I does
23:31
anyone
23:31
have
23:31
any questions
23:32
before
23:32
we start
23:33
asking
23:33
the questions
23:34
of,
23:34
how
23:34
do you
23:34
navigate
23:35
this
23:35
space?
23:35
Right.
23:36
We just
23:36
threw
23:36
all this
23:36
information
23:37
out
23:37
there.
23:38
How
23:38
do you
23:38
navigate it
23:39
as
23:39
a patient?
23:43
Okay.
23:43
So I'll
23:44
throw
23:44
this to
23:45
doctor
23:45
McKean
23:46
and
23:46
Doctor
23:46
mahmi
23:47
But,
23:47
you know,
23:47
so as
23:48
a patient
23:48
who's
23:48
newly
23:49
diagnosed
23:49
with
23:49
uveal
23:50
melanoma,
23:51
obviously
23:51
we have,
23:52
you know,
23:52
within
23:52
the
23:53
clinical
23:53
trials,
23:53
there's
23:54
first or
23:54
second
23:55
line
23:55
clinical
23:55
trials,
23:56
and then
23:57
there's
23:57
clinical
23:57
trials
23:58
for
23:58
patients
23:58
who are
23:59
refractory.
23:59
So
24:00
any line.
24:00
So we'll
24:01
start
24:01
kind of
24:01
earliest
24:02
in the course.
24:02
So with
24:03
frontline
24:03
trials
24:04
we obviously
24:05
have the
24:05
randomized
24:06
study
24:06
from
24:07
Ideaya
24:07
looking
24:08
at the
24:08
combination
24:09
of
24:09
darovasertib
24:09
and
24:10
crizotinib,
24:11
which is
24:12
led by
24:12
Doctor
24:12
McKean.
24:14
And soon
24:14
we'll have
24:15
the
24:15
replimune
24:16
study,
24:16
which
24:16
I believe
24:16
is second
24:17
or
24:17
first
24:18
line
24:18
for patients.
24:19
So when
24:19
we're
24:19
seeing
24:20
new
24:20
patients,
24:21
how do you
24:21
navigate,
24:22
you know,
24:23
should we go
24:24
on
24:24
a
24:24
clinical
24:24
trial
24:25
versus
24:25
a
24:25
standard
24:26
of care?
24:26
And also
24:27
how
24:27
do you
24:27
navigate
24:28
the question
24:28
that
24:28
a lot of
24:29
the first
24:29
and
24:29
second
24:29
line
24:30
trials
24:30
don't
24:30
allow
24:31
prior
24:31
liver
24:32
directed
24:32
therapy.
24:33
So when
24:33
a patient
24:34
asks you,
24:35
well,
24:35
I just have one
24:36
spot,
24:36
should I get it
24:36
radiated,
24:38
knowing
24:39
that
24:39
I cannot
24:39
go on
24:40
this
24:40
trail
24:40
in the future?
24:40
Or should
24:41
I go on
24:41
this
24:41
trial?
24:42
How do you answer
24:43
those
24:43
questions,
24:43
and
24:43
how do you start
24:44
navigating
24:44
those
24:44
situations?
24:47
Yeah, you
24:47
know,
24:47
I think
24:48
I think
24:48
first of
24:49
all, it's
24:49
great
24:50
to have
24:50
this
24:50
dilemma
24:51
now.
24:51
in uveal
24:52
melanoma.
24:52
I think,
24:53
we've
24:53
been able
24:54
to see
24:54
the field
24:54
evolve
24:55
so much
24:55
that to
24:56
have
24:56
options
24:57
and to
24:57
be able
24:58
to
24:58
kind of
24:58
think
24:58
through
24:59
what's
25:00
the best
25:00
first
25:00
step and
25:01
second
25:01
step,
25:02
shows
25:02
how much
25:03
progress
25:03
we've
25:03
been
25:03
making.
25:05
But there
25:05
still
25:06
is, more
25:07
limited
25:07
treatments
25:07
that we'd
25:08
like.
25:08
And
25:08
that's
25:08
why we
25:09
do have
25:09
to be
25:09
really
25:09
thoughtful.
25:10
So I love
25:11
this
25:11
question.
25:12
I think,
25:13
for
25:13
patients,
25:14
to me,
25:14
some of it
25:15
in the
25:15
frontline
25:15
setting
25:16
is let's
25:16
what's
25:16
the
25:16
disease
25:17
trajectory?
25:17
Where is
25:18
your
25:18
disease
25:18
located?
25:19
You know,
25:20
in
25:20
general,
25:21
most
25:21
patients
25:21
develop
25:22
metastatic
25:22
disease
25:23
in the liver.
25:24
And so
25:24
the question
25:25
is, liver
25:25
directed
25:26
therapy
25:26
now
25:27
versus
25:27
later?
25:28
Certainly
25:28
a patient
25:29
that the
25:29
disease
25:30
trajectory
25:31
is, is
25:31
pretty
25:32
rapid.
25:32
That
25:32
might be
25:33
a patient
25:33
that you
25:33
say, hey,
25:34
should
25:34
we be
25:34
looking
25:34
at liver
25:35
directed
25:35
therapies
25:36
first?
25:37
HLA
25:37
testing
25:38
is always
25:38
important
25:39
to do
25:39
upfront
25:40
both for
25:41
trial
25:42
inclusion.
25:43
Also just
25:43
to
25:43
understand
25:44
is, the
25:45
the one
25:46
FDA
25:46
approved
25:46
systemic
25:47
therapy
25:47
kimmtrac
25:48
Is that
25:48
an option
25:48
for you
25:49
or not?
25:49
Now,
25:50
I would
25:51
put
25:51
Kimmtrac
25:52
in
25:52
ipilimumab
25:53
and
25:53
nivolumab
25:54
yervoy
25:54
opdivo
25:55
in kind
25:55
of a
25:56
separate
25:56
category
25:56
because
25:57
the advantages
25:57
is
25:57
you can
25:58
do
25:58
those at
25:59
any time.
26:00
And so
26:01
you know
26:01
there's
26:01
no
26:01
restrictions
26:02
versus
26:03
several
26:03
the
26:04
clinical
26:04
trials
26:05
do limit.
26:06
Hey,
26:06
you have to
26:06
have this
26:07
in the
26:07
front
26:07
line
26:07
setting
26:08
or the
26:08
second
26:09
line
26:09
setting.
26:10
And so
26:10
then
26:10
a lot of
26:10
it
26:11
becomes
26:11
if it's
26:11
not a clear,
26:13
what's
26:14
the
26:14
trajectory
26:14
of your disease.
26:15
And do
26:15
we need
26:15
to to,
26:17
you know,
26:17
do
26:18
liver
26:18
directed
26:18
therapy
26:18
up front.
26:19
Then
26:19
it is
26:20
kind of
26:20
discussing
26:21
well,
26:21
here's
26:21
your
26:21
systemic
26:21
therapy
26:22
options.
26:23
And I
26:23
do see
26:24
clinical
26:24
trials
26:25
and
26:25
patient
26:26
participation
26:27
as,
26:27
you know,
26:27
the best
26:28
outcomes
26:28
we see is
26:30
I like
26:31
to use a
26:32
term of,
26:32
like,
26:32
best
26:32
shots
26:33
on goal.
26:33
Like,
26:33
we don't know,
26:35
I wish
26:35
I knew
26:35
exactly
26:36
which
26:37
patient
26:37
was going
26:37
to
26:38
respond
26:38
to each
26:39
treatment,
26:39
but
26:39
we don't know.
26:40
And so
26:41
the nice thing
26:42
with
26:42
clinical
26:42
trials
26:43
is being
26:43
able to
26:44
say, hey,
26:44
well,
26:45
here's
26:45
another
26:45
option
26:46
to see
26:46
if
26:46
this is
26:46
the best
26:47
option
26:48
for you.
26:48
If
26:48
this is
26:48
going
26:49
to slow
26:49
down
26:49
your cancer.
26:50
And so
26:51
especially
26:52
for
26:52
the studies
26:53
that are
26:53
front
26:53
line,
26:54
this may be
26:54
your
26:54
only chance
26:55
to get
26:56
this
26:56
drug.
26:56
And so
26:57
just
26:57
discussing
26:58
hey,
26:58
here's
26:59
what
26:59
the data
27:00
that
27:00
we do
27:00
have
27:01
here's
27:01
potential
27:01
side
27:01
effects.
27:02
Is this
27:02
something
27:03
that
27:03
you're
27:03
going to
27:03
want
27:03
to try.
27:04
Because
27:04
we may
27:05
not have
27:05
access
27:05
to it
27:06
later.
27:06
So it
27:07
it really
27:08
is, for
27:08
the
27:09
patient
27:09
in front
27:09
of you
27:10
trying to
27:10
discuss,
27:11
hey,
27:11
for your
27:11
individual
27:12
disease.
27:13
Now,
27:13
I think
27:13
the cure
27:13
in sight
27:14
does
27:14
a really
27:14
good job.
27:15
I know
27:15
Kevin's
27:15
always
27:16
summarizing
27:16
all the
27:16
trials
27:17
available
27:17
because
27:18
it is
27:18
really
27:18
hard and
27:19
can be
27:19
center
27:20
specific.
27:21
And I
27:21
do think
27:22
as
27:22
investigators,
27:23
we do
27:23
try to
27:24
kind of
27:25
collaborate
27:25
and say,
27:26
hey, what
27:26
do you have
27:27
open?
27:28
I've
27:28
got this
27:28
patient
27:29
that,
27:29
you know,
27:29
this is
27:30
kind of
27:30
what
27:30
I think
27:31
might
27:31
be the
27:31
best
27:31
option.
27:32
It
27:32
might not
27:32
be
27:32
available
27:33
here.
27:33
And
27:33
try to
27:34
direct
27:34
patients
27:35
if they're
27:35
able to,
27:36
to
27:36
where
27:36
they
27:36
might
27:37
go for
27:37
their
27:37
best
27:37
care.
27:40
I
27:40
absolutely
27:40
agree
27:41
with what
27:41
Meredith
27:41
have
27:42
said.
27:42
I think
27:44
being in
27:44
the space,
27:45
or
27:45
the area
27:46
where I
27:46
practice,
27:47
I mean,
27:47
I see
27:48
refractory
27:49
cases or
27:51
patients
27:52
who
27:52
haven't
27:52
responded
27:53
to their
27:54
previous
27:54
treatment.
27:55
That sort
27:56
of
27:56
changes
27:56
my
27:56
perspective
27:57
a little bit
27:57
when
27:57
I answer
27:58
this
27:58
question.
27:59
I favor
28:00
clinical
28:01
trials
28:01
over
28:02
any
28:03
standard
28:03
of care
28:03
therapy
28:05
if
28:06
the patient's
28:06
able
28:07
and
28:07
willing.
28:08
Right.
28:09
Because
28:09
like
28:09
Meredith
28:10
said,
28:10
you've
28:11
got
28:11
one shot
28:12
at goal,
28:12
like
28:12
some of
28:12
these
28:12
patients
28:13
that
28:13
I've seen
28:13
with
28:14
metastatic
28:14
uveal
28:14
melanoma,
28:15
if they had
28:15
gone with
28:16
liver
28:16
directed
28:17
therapy,
28:18
they would not
28:18
have had
28:19
the shot
28:19
of being
28:20
treated
28:20
with
28:21
drugs
28:22
like,
28:22
....
28:23
which is
28:23
the prame
28:24
targeting
28:24
drug.
28:25
And and
28:26
they even
28:26
had the,
28:27
the long
28:27
term
28:27
benefit
28:28
they're
28:28
having.
28:28
Right.
28:29
So
28:30
and then
28:31
even
28:31
they had
28:32
these
28:32
are the
28:33
same
28:33
patients
28:33
who are
28:34
candidate
28:34
for
28:34
Kimmtrac
28:35
as well.
28:35
Hey.
28:36
But
28:36
Kimmtrac
28:37
doesn't
28:37
give
28:37
me 100%
28:38
response
28:39
rate.
28:39
Kimmtrac
28:40
doesn't
28:40
give me,
28:41
you know,
28:41
long term
28:42
durable
28:42
control
28:43
of
28:43
these disease.
28:44
So what
28:44
can I say
28:46
based on
28:46
the data
28:47
that's
28:47
been
28:47
presented
28:48
at
28:48
different
28:48
conferences
28:49
for these
28:49
drugs,
28:50
which
28:51
gives
28:51
me the
28:51
most
28:52
confidence
28:54
So that's
28:54
sort
28:54
of the
28:55
approach
28:55
that I
28:56
take.
28:56
But
28:57
at the same
28:57
time,
28:58
I think
28:58
if we
28:58
don't
28:59
have the
28:59
courageous
29:00
patient
29:00
that are
29:00
willing
29:01
to take
29:01
part in
29:02
these
29:02
studies,
29:03
we
29:03
won't be
29:04
here
29:04
having
29:04
this
29:05
dilemma
29:05
of, hey,
29:06
these patients
29:07
aren't
29:07
able
29:07
to get
29:08
on these
29:08
trials
29:09
and this
29:09
and that,
29:10
I think
29:11
and also
29:11
talking
29:12
about,
29:13
you know,
29:13
liver
29:13
directed
29:14
therapy
29:14
itself
29:16
for
29:16
a very
29:17
small
29:17
number
29:17
of
29:18
patients,
29:18
that's
29:19
the path
29:19
to long
29:20
term
29:20
control.
29:21
That
29:22
means
29:22
majority
29:23
of
29:23
patients
29:24
will need
29:24
systemic
29:25
therapy
29:26
right.
29:27
Or
29:27
treatment
29:28
of the
29:28
whole
29:29
body.
29:29
And
29:30
and
29:30
right now
29:31
it's
29:31
tough
29:31
to tell
29:32
which
29:32
patient
29:33
is that.
29:34
You know,
29:34
the one
29:34
who is
29:34
going
29:35
to have
29:35
long term
29:35
control
29:36
with just
29:37
liver
29:37
directed
29:37
therapy
29:38
or will
29:39
they need
29:39
something
29:39
else.
29:41
So my
29:42
usually
29:42
goal is
29:43
if a
29:43
patient's
29:44
coming
29:44
in,
29:45
I got to put them
29:46
on
29:46
systemic
29:47
therapy
29:47
because
29:47
they're
29:47
going
29:47
to need it
29:48
now.
29:49
Patients
29:50
life,
29:50
patients
29:51
choices,
29:51
they
29:51
matter
29:52
immensely.
29:53
So there
29:54
that
29:54
discussion
29:54
needs to
29:55
take place.
29:55
But
29:56
my idea
29:57
is
29:58
if
29:58
I can get
29:59
a patient
29:59
on
30:00
clinical
30:00
trial,
30:02
that at
30:02
least
30:03
promises
30:03
me
30:04
benefit
30:04
as
30:05
much as,
30:05
you know
30:06
what,
30:06
we have
30:06
a
30:06
standard
30:07
of care
30:07
that
30:07
that's
30:08
usually
30:08
my goal.
30:09
And
30:09
obviously
30:09
that's a
30:10
frank
30:10
discussion
30:10
between,
30:11
you know,
30:11
in my
30:12
patient
30:13
and
30:13
myself.
30:13
So.
30:16
I think
30:17
that's
30:17
very
30:17
similar
30:17
to my
30:18
approach
30:18
as well.
30:18
You know,
30:19
I use
30:19
the analogy
30:19
of tools,
30:20
and I
30:20
think
30:21
in
30:21
general,
30:22
we don't
30:22
have
30:23
as many
30:23
tools
30:24
to treat
30:24
uveal
30:24
melanoma
30:25
as we do
30:26
other
30:27
cancers.
30:28
And so
30:28
my approach
30:29
typically
30:29
is
30:30
what is
30:31
the best
30:31
treatment
30:31
plan
30:32
that's
30:32
going
30:32
to give
30:32
you
30:32
access
30:33
to
30:33
the most tools.
30:34
So when
30:35
it comes
30:35
to the
30:35
question
30:35
of
30:36
should
30:36
I do a
30:37
liver
30:37
directed
30:37
therapy
30:38
versus
30:38
a frontline
30:39
trial,
30:40
that
30:40
would
30:40
exclude
30:41
me
30:41
in the future
30:41
if I got this?
30:42
I
30:42
typically
30:43
recommend
30:43
the trial
30:44
because
30:44
that
30:44
gives you
30:45
and they
30:45
option of
30:46
that tool
30:47
and keeps
30:47
the
30:47
toolbox
30:48
full.
30:49
Now
30:49
you have
30:50
to
30:50
balance
30:50
that with
30:51
everything
30:51
going on.
30:52
You know,
30:52
I had
30:52
a patient
30:53
the other day
30:53
where
30:54
we were
30:55
in the
30:55
discussion
30:56
of, okay,
30:57
you know,
30:57
we know
30:57
hepzato
30:58
is a
30:58
great
30:59
approved
30:59
option
30:59
for
30:59
patients
31:00
with
31:00
liver
31:00
Mets,
31:01
but
31:01
you have
31:01
to have
31:01
less than
31:02
50%
31:02
disease
31:03
in your liver.
31:03
And
31:03
we had
31:04
someone
31:04
who was
31:05
in the
31:05
40th
31:05
percentile
31:06
in terms
31:07
of the
31:07
disease
31:07
in the liver.
31:08
And
31:08
it was
31:09
do we try
31:09
this
31:09
trial
31:10
knowing
31:11
that
31:11
we may
31:11
miss
31:12
the boat
31:12
for hepzato
31:13
if it doesn't
31:13
work?
31:13
Or do
31:14
we try
31:14
hep zero
31:15
knowing
31:15
you're
31:15
not going
31:15
to be
31:15
able
31:16
to go
31:16
on this trial
31:17
and
31:17
sometimes
31:17
you're in
31:18
those
31:18
situations
31:18
and then
31:19
it's just
31:19
a really
31:19
frank
31:20
discussion
31:20
with
31:20
the patient.
31:21
But
31:22
in general,
31:22
I think
31:22
it's all
31:23
about
31:23
keeping
31:23
the
31:23
toolbox
31:24
full and
31:24
keeping
31:25
access
31:25
to the
31:25
most
31:26
available,
31:27
most
31:27
number of
31:28
available
31:28
therapies
31:29
since
31:29
they are
31:29
so
31:29
limited
31:30
for
31:30
patients.
31:30
Unfortunately.
31:32
So I have
31:33
a
31:33
question.
31:34
Yeah.
31:34
I, I,
31:36
you know,
31:36
I am a
31:36
patient
31:37
as well.
31:37
I'm
31:37
a metastatic
31:38
patient.
31:38
Just for
31:39
those of
31:39
you who
31:39
don't
31:39
know.
31:40
And one
31:40
of the
31:40
things
31:41
that I
31:41
talked to
31:42
just
31:42
a lot
31:42
of the
31:42
biotech
31:43
companies
31:43
about
31:43
is how
31:44
it can be
31:45
really
31:45
frustrating
31:45
sometimes
31:46
to say,
31:46
be in
31:47
a situation
31:47
where
31:47
maybe you
31:48
don't
31:48
need full
31:49
body
31:49
treatment,
31:50
you
31:50
only need
31:50
to treat
31:51
1 or 2,
31:52
and that
31:52
gives you
31:53
a good
31:53
duration
31:53
of time.
31:54
Is there
31:55
room
31:55
in the discussion?
31:56
I guess,
31:57
between
31:57
oncology
31:58
and
31:58
clinical
31:58
trials,
31:59
primary
31:59
investigators
32:00
to push
32:00
for
32:01
patients
32:01
to be
32:01
able to
32:02
have
32:02
access to
32:03
a trial
32:03
even if,
32:04
say,
32:04
tumor,
32:05
one
32:05
that was
32:06
singularly
32:06
treated
32:07
three
32:08
years
32:08
ago.
32:08
Let's
32:08
pretend
32:09
that's
32:09
I mean,
32:09
that'd
32:10
be ideal,
32:10
but
32:10
that doesn't
32:11
happen.
32:11
Let's
32:11
just say
32:12
it's
32:12
been a
32:12
duration
32:12
of time
32:13
they were
32:13
treated.
32:14
Now
32:14
they have new lesions
32:15
and
32:15
they want
32:16
to go on
32:16
that
32:16
trial
32:17
like is
32:17
I'm
32:18
hoping
32:18
this is
32:18
making
32:19
sense.
32:19
Like
32:19
is there
32:19
room
32:19
for that
32:20
discussion
32:20
of,
32:20
you know,
32:21
can
32:21
we push
32:21
for their
32:21
entry to
32:22
the trial
32:23
with
32:23
the new
32:23
disease
32:24
and, and
32:24
how can we like
32:26
I don't
32:26
know,
32:26
and maybe
32:26
pharma
32:27
reps,
32:27
maybe
32:27
you guys
32:28
can
32:28
answer
32:28
this a
32:28
little
32:29
better.
32:30
Yeah,
32:30
that's a
32:31
complicated
32:31
question.
32:32
I know
32:32
it's so
32:32
complicated.
32:33
And I
32:33
think
32:34
we're
32:34
starting
32:34
to see
32:35
some of
32:35
those,
32:35
I believe
32:36
the,
32:36
randomized
32:36
study
32:37
that's
32:37
coming
32:37
out with
32:38
arturo
32:38
later
32:38
this year
32:39
or early
32:39
next year
32:39
does not
32:40
exclude
32:40
patients
32:41
with
32:41
liver
32:41
directed
32:41
therapies.
32:42
I hope
32:42
I'm not
32:42
saying
32:42
that
32:43
wrong,
32:44
but
32:44
a lot of
32:44
it comes
32:45
down to
32:45
the
32:45
requirements
32:46
needed
32:47
to get
32:47
the FDA
32:48
approval,
32:49
which
32:49
Meredith
32:50
is
32:50
probably
32:50
involved
32:50
in more
32:51
of these
32:51
discussions
32:51
than I am.
32:52
But
32:52
that's
32:52
really
32:54
the
32:54
tricky
32:54
thing,
32:54
the
32:54
challenge,
32:55
right?
32:56
We can do
32:56
a trial
32:57
that
32:57
encompasses
32:57
everyone,
32:58
but
32:58
we also
32:59
need
32:59
to have
32:59
a very
32:59
clean
33:00
patient
33:00
population
33:01
to study.
33:02
Yeah.
33:02
For
33:03
the FDA
33:03
to look
33:04
and say,
33:05
is this
33:05
truly better?
33:06
Because
33:07
if you
33:07
have
33:07
a very
33:08
kind of
33:08
diverse
33:09
patient
33:09
population
33:10
and
33:10
you're
33:10
trying to
33:11
compare it
33:11
to a very
33:11
clean
33:12
patient
33:12
population,
33:13
we can't.
33:14
The data
33:14
gets
33:14
messy.
33:15
Yeah,
33:16
yeah.
33:16
Okay.
33:16
That
33:17
makes
33:17
sense.
33:17
We're
33:17
kind of
33:18
trapped.
33:18
I don't
33:18
know if
33:18
you guys
33:19
have any
33:19
other
33:19
comments
33:19
on that.
33:20
Yeah
33:20
I agree
33:21
I mean
33:21
I think
33:21
as, as
33:22
investigators
33:23
were
33:24
always
33:24
were like
33:25
the
33:25
number
33:25
one
33:25
patient
33:26
advocates
33:26
and we're
33:27
always
33:27
pushing
33:27
to
33:28
of
33:28
course,
33:28
try to,
33:29
you know,
33:30
push
33:31
the limits
33:31
on what
33:31
we,
33:32
what is allowed.
33:33
And
33:33
I think
33:34
the FDA
33:34
has
33:34
put out
33:35
several
33:35
white
33:36
papers,
33:37
you know,
33:37
trying
33:37
to say
33:38
not only
33:38
from an
33:38
inclusion
33:39
exclusion,
33:40
standpoint,
33:40
but
33:40
even just
33:41
where can
33:42
you get
33:42
safety
33:42
labs,
33:43
right?
33:43
Like
33:44
clinical
33:44
trial
33:44
participation
33:45
is still
33:45
really
33:46
limited
33:46
by
33:46
patients
33:47
having to
33:47
be able
33:47
to travel
33:48
to
33:48
major centers.
33:50
So
33:50
I think
33:51
there
33:51
there's
33:52
a lot
33:52
of push
33:53
up front.
33:54
The challenges
33:54
is once
33:55
that
33:55
protocol is
33:56
set,
33:56
we have to
33:57
abide
33:58
by it.
33:58
Yeah.
33:58
Like
33:58
there's
33:59
no
33:59
there's
34:00
no wiggle
34:00
room.
34:01
I wish there
34:01
was,
34:02
because
34:03
that's
34:03
I think
34:04
those are
34:04
the
34:04
hardest
34:05
conversations
34:05
that
34:05
we have
34:06
is when
34:06
we're
34:06
so
34:07
excited
34:07
about
34:07
a trial
34:08
for
34:08
a patient,
34:09
and
34:10
there's
34:10
just one
34:11
little
34:11
glitch
34:12
to
34:12
whatever
34:13
the
34:13
inclusion
34:13
exclusion
34:14
is.
34:14
But
34:15
that's
34:15
something
34:15
that,
34:16
like,
34:16
we've
34:16
agreed
34:16
with
34:17
the FDA
34:17
and like
34:18
there's
34:18
that's
34:19
there's
34:19
just no
34:19
wiggle
34:20
room
34:20
there.
34:20
So it
34:20
almost
34:21
I mean
34:21
it's it's
34:22
again,
34:23
still a
34:23
complicated
34:24
question,
34:24
but
34:24
it almost
34:24
sounds
34:25
like
34:25
maybe
34:25
if back
34:26
in the
34:26
inception
34:26
of the
34:27
trial
34:27
idea
34:28
that
34:28
before it
34:29
even goes
34:29
to the
34:30
okay, now
34:30
you're
34:30
ready
34:31
to go
34:31
for phase
34:32
one,
34:32
we're
34:32
ready to
34:32
do the the,
34:33
you know,
34:34
the
34:34
investigation
34:34
portion
34:35
of
34:35
the trial
34:36
that
34:36
those
34:36
trial
34:37
criteria
34:37
that
34:37
they're
34:38
submitting
34:38
to
34:38
the FDA,
34:39
if
34:39
they have
34:39
the
34:40
wiggle
34:40
room,
34:40
that's
34:40
where
34:40
they have
34:41
to say,
34:41
we
34:41
don't want
34:42
to
34:42
exclude,
34:43
if
34:43
possible,
34:44
like
34:44
that.
34:44
It would have
34:45
to start
34:45
there,
34:45
like
34:46
way back
34:46
before
34:46
the trial
34:47
becomes
34:47
a trial.
34:49
Yeah,
34:49
I'll I'll
34:50
kind of
34:50
start
34:51
that and
34:51
then pass
34:52
it on.
34:52
And I
34:52
could be
34:53
totally wrong,
34:53
but
34:54
usually
34:54
actually
34:55
usually
34:55
phase one
34:55
trials
34:56
are more
34:57
encompassing.
34:57
Right.
34:58
We
34:58
kind of
34:58
talked about
34:59
and I
34:59
know,
34:59
I was in
34:59
the FDA
35:00
session
35:00
actually
35:01
phase one
35:01
trials,
35:01
the
35:02
that's
35:02
sometimes
35:03
an
35:03
opportunity
35:03
for
35:04
patients
35:04
with
35:04
uveal
35:04
melanoma
35:05
to
35:05
get enrolled
35:06
because
35:06
they're
35:07
still
35:07
looking
35:07
at all
35:08
solid
35:08
tumors.
35:09
Oftentimes
35:09
it's as
35:10
we move
35:10
through
35:10
the process
35:11
and as it
35:12
gets
35:12
closer to
35:13
FDA
35:13
filing,
35:14
they want,
35:15
you know,
35:15
as Justin
35:15
said,
35:15
kind
35:16
of the
35:16
the same
35:18
patient
35:18
population.
35:19
And so
35:20
that's
35:20
where
35:20
we try
35:20
to push
35:21
and say,
35:21
well,
35:22
look,
35:22
it's
35:22
been safe
35:23
for,
35:24
you know,
35:24
these
35:24
patients.
35:25
Can we
35:25
continue
35:25
to
35:25
include them?
35:26
But
35:26
I don't know
35:26
if
35:26
the phase
35:27
one trial
35:27
is to
35:28
be have
35:28
other
35:28
thoughts,
35:30
after
35:31
that,
35:31
that the
35:32
trial
35:33
protocol
35:33
process
35:34
is very
35:34
archaic.
35:37
It's it's
35:38
the same
35:39
stuff
35:39
we've
35:39
been
35:39
doing 20,
35:40
30
35:40
years ago
35:42
that
35:42
we're
35:42
trying
35:43
to
35:43
replicate
35:44
with the
35:44
newer
35:44
drugs.
35:46
I'm not
35:46
going to
35:46
be able
35:47
to change
35:47
that.
35:49
And
35:49
I think
35:49
all of
35:50
my
35:50
generation
35:51
of
35:51
physicians,
35:52
as hard
35:53
as they
35:53
try,
35:54
cannot
35:54
change
35:54
that.
35:57
But
35:58
in my opinion
35:59
there are
35:59
two
35:59
components
36:00
to
36:00
the trial.
36:01
One is
36:01
the
36:01
scientific
36:02
research
36:02
part
36:03
and other
36:03
the
36:03
patient
36:04
treatment
36:04
part.
36:05
Sometimes
36:06
they
36:06
don't
36:08
kind of
36:09
go
36:09
together
36:10
for the
36:11
scientific
36:11
research
36:12
part,
36:12
you want
36:13
as
36:13
pure of
36:14
a
36:14
population
36:15
that you
36:16
can have
36:17
to get
36:17
the signal
36:18
to move
36:18
forward.
36:19
Yeah.
36:20
From a
36:20
treatment
36:21
perspective
36:21
for
36:22
a patient.
36:23
Yeah
36:23
I want
36:24
that
36:24
tool.
36:24
Yeah.
36:25
Right.
36:26
And
36:26
sometimes
36:27
that
36:27
patient
36:28
may
36:28
not fit
36:28
that
36:29
population
36:29
that
36:30
we want.
36:31
And
36:31
that's
36:31
where
36:32
the dis
36:32
cohesion
36:33
comes.
36:33
And
36:34
that's
36:34
where we,
36:35
you know,
36:36
get
36:36
frustrated
36:37
that
36:37
I want
36:37
this
36:37
patient.
36:38
And
36:38
there's
36:38
no sort
36:39
of pat,
36:41
there's
36:41
no
36:43
practical
36:43
parallel
36:44
process
36:44
to get
36:45
that drug
36:46
to that
36:46
patient.
36:46
I know
36:47
there's
36:47
compassionate
36:48
use
36:48
stuff.
36:49
There is
36:49
right
36:49
to try.
36:52
It's not
36:52
very
36:53
practical.
36:54
Yeah.
36:54
I don't know
36:55
if you can
36:55
hear my
36:56
frustration.
36:56
No, no,
36:57
I, I,
36:57
I hear
36:58
you
36:59
and I
36:59
think
36:59
with
37:00
that too,
37:00
you know,
37:00
I think
37:01
I think
37:02
the companies
37:02
are
37:02
on our side.
37:03
I think
37:03
they want
37:04
to be
37:04
as
37:04
inclusive
37:05
as
37:05
possible.
37:06
But,
37:07
you know,
37:07
you're
37:08
right.
37:09
Like it's
37:09
we're
37:10
following
37:10
these
37:10
approval
37:11
processes
37:12
that
37:12
have been
37:12
very
37:12
similar
37:13
for many
37:13
years.
37:13
And
37:14
obviously
37:14
the drugs
37:15
and how
37:15
we work
37:16
and how
37:16
we can
37:16
monitor
37:17
responses
37:17
have
37:18
really changed.
37:19
And I
37:19
think
37:19
we're
37:19
starting
37:20
to see
37:20
some of
37:21
that
37:21
change.
37:22
You know,
37:22
there was
37:22
a big
37:22
group
37:23
of
37:23
melanoma,
37:23
a medical
37:23
oncologist
37:25
led by
37:25
Jason
37:25
Luke,
37:26
who just
37:26
sent a
37:26
letter to
37:27
the FDA
37:27
saying,
37:27
hey,
37:28
we think
37:28
you guys
37:29
got to
37:29
update
37:29
some things
37:30
and they
37:30
responded
37:31
favorably
37:32
in a
37:32
response
37:32
letter.
37:33
So
37:33
I think
37:33
we're
37:33
starting
37:34
to do
37:34
that.
37:34
So
37:35
hopefully
37:35
in
37:35
the future
37:35
we'll see
37:36
it.
37:36
But it
37:37
it is
37:37
a lot
37:38
of change
37:38
that
37:38
needs to
37:39
happen
37:39
to get
37:39
that
37:40
flexibility.
37:40
And it's
37:41
probably
37:41
going to
37:41
be years
37:42
unfortunately.
37:42
But it is
37:43
starting.
37:43
And
37:44
I mean
37:44
this
37:44
is
37:44
what we
37:45
talked
37:45
about.
37:45
If
37:45
any of you guys
37:46
who
37:46
listen
37:46
to the
37:47
FDA
37:47
session,
37:47
I know
37:47
I wasn't
37:48
over there,
37:48
but
37:49
this is
37:49
why we
37:50
talked
37:50
about
37:50
that,
37:50
right?
37:51
That
37:51
there's
37:51
such a
37:52
long
37:52
process
37:53
talking
37:53
to
37:53
the FDA
37:54
to get
37:54
anything
37:54
changed
37:55
takes
37:55
time.
37:56
Getting
37:56
a drug
37:56
to the
37:56
FDA to
37:57
get
37:57
approved
37:57
takes
37:58
time.
37:59
Taking
37:59
the drug
37:59
to market
38:00
takes
38:00
time.
38:01
And
38:02
that is
38:02
not a fun
38:03
thing
38:03
to hear,
38:03
especially
38:04
if you're
38:04
a
38:04
metastatic
38:05
patient.
38:06
But
38:06
the beauty
38:06
of
38:06
clinical
38:07
trials,
38:07
I think
38:07
that
38:07
we can
38:07
kind of
38:08
round
38:09
this out
38:09
with
38:09
is the
38:10
clinical
38:10
trials
38:10
and the
38:11
people
38:11
who
38:11
participate
38:12
in
38:12
clinical
38:12
trials
38:13
make it
38:13
possible
38:14
for
38:14
that time
38:15
to pass
38:15
in.
38:17
I'm
38:17
trying to
38:17
think of
38:18
the
38:18
phrase
38:18
I like
38:18
to use
38:19
it well,
38:19
like that
38:20
we're
38:20
actually
38:20
using the
38:21
time
38:21
well,
38:21
and we're
38:22
getting
38:22
the
38:22
research.
38:23
We're
38:23
getting
38:23
the data
38:24
to then
38:24
move
38:24
a drug
38:25
toward
38:25
approval.
38:26
That's
38:26
how
38:26
we get
38:26
to
38:26
tebentafusp,
38:27
that's
38:27
how we
38:28
got to
38:28
hepzato
38:28
kit like
38:29
these
38:30
processes
38:30
do take
38:31
time, but
38:32
the results
38:32
of all
38:33
of the
38:33
people
38:33
who did
38:34
those
38:34
trials
38:34
are why
38:35
we have them
38:35
today.
38:38
Anybody
38:38
else have
38:39
questions
38:39
from the
38:39
audience?
38:45
Doctor
38:46
Hadfield,
38:46
let's get
38:47
over
38:47
to you.
38:48
You
38:48
get to
38:49
speak,
38:49
you
38:49
get the
38:50
mic.
38:50
Because,
38:50
you know,
38:52
I could
38:52
I could have done it
38:53
without
38:53
the mic.
38:54
One
38:54
question
38:54
that
38:54
I have
38:55
about,
38:55
this,
38:56
you know,
38:56
this is
38:56
like,
38:56
such
38:57
an exciting
38:57
time
38:57
to work
38:58
in this
38:58
space.
38:58
You know,
38:59
there's
38:59
obviously
38:59
all these
39:00
new
39:00
therapeutic
39:00
options
39:00
that
39:01
didn't
39:01
exist
39:01
five,
39:01
ten, 15
39:02
years
39:02
ago, but
39:03
the more
39:03
and more
39:04
I see
39:04
the data
39:04
and
39:04
the more
39:05
and more
39:05
I'm
39:05
involved
39:05
in,
39:06
the more
39:06
and more
39:06
I see
39:06
what's
39:06
happening
39:07
at
39:07
my institution.
39:08
Do
39:08
you think
39:08
that
39:08
we're
39:08
going to
39:09
have an
39:10
issue
39:10
in the
39:11
near
39:11
future,
39:11
where
39:11
these
39:12
therapies
39:12
are going
39:12
to get
39:12
more
39:13
and more
39:13
and more
39:13
siloed
39:14
into
39:14
larger
39:14
academic
39:15
centers,
39:15
just
39:15
given how
39:16
complex
39:17
they are
39:17
to give,
39:17
like til
39:18
therapy
39:18
by
39:19
specifics
39:19
that
39:19
require .
39:20
monitoring.
39:21
You know,
39:22
other,
39:22
other
39:23
therapies
39:24
that just
39:24
will only
39:25
be able
39:25
to be
39:25
given
39:26
a large
39:26
academic
39:27
centers.
39:27
Do
39:27
you think
39:27
that's
39:27
going
39:27
to be
39:28
a problem
39:29
in like
39:29
the
39:29
next
39:30
10 or
39:30
15 years?
39:32
What
39:32
can you.
39:34
Sure.
39:34
Yeah.
39:35
I was
39:35
yeah.
39:35
You just
39:36
like,
39:36
toss it
39:36
right
39:36
to me
39:37
because,
39:37
Sara,
39:38
because
39:39
Sara
39:39
Cannon
39:39
Research
39:40
Institute,
39:40
our whole goal
39:41
is trying
39:42
to get
39:42
research
39:42
out into
39:43
the community.
39:44
And
39:44
I think
39:44
we can
39:44
all say
39:45
the
39:45
center's
39:46
where
39:46
we're at.
39:46
So
39:46
I actually
39:47
think
39:47
we're
39:47
making
39:48
a lot
39:48
of
39:48
progress
39:48
here.
39:49
And
39:49
I think
39:49
some of
39:49
this is
39:50
because
39:50
some of
39:50
the drugs
39:51
that
39:51
have been
39:51
approved
39:51
before,
39:52
right now
39:53
that TILs
39:54
approved
39:54
for
39:54
cutaneous
39:55
melanoma,
39:56
I think
39:56
all
39:56
the centers
39:57
are now
39:57
trying to
39:57
figure
39:57
out how
39:59
to
39:59
operationalize
40:00
that.
40:00
Who's
40:00
the team
40:01
at these
40:01
locations?
40:02
I think
40:03
with
40:03
Delcath
40:03
approved,
40:04
you're
40:05
going to
40:05
see more
40:05
and more,
40:06
institutions
40:07
getting
40:07
training
40:08
and
40:08
comfort
40:09
to offer.
40:09
Delcath
40:10
so
40:10
my hope
40:11
is that,
40:11
I mean,
40:11
I think
40:12
uveal is
40:12
still,
40:13
you know,
40:14
this is
40:14
a unique
40:14
patient
40:15
population.
40:16
I think
40:16
there
40:16
still
40:17
will be,
40:18
a need
40:18
for
40:19
kind of
40:19
a
40:20
specialized,
40:21
personalized
40:21
plan for
40:22
each patient.
40:23
But
40:23
I actually
40:23
think
40:23
we're
40:23
making
40:24
a lot
40:24
of
40:24
progress
40:25
and
40:25
trying
40:25
to get
40:25
some of
40:26
these
40:26
treatments
40:26
closer
40:27
to home
40:28
for
40:28
patients,
40:29
because
40:29
that's
40:30
that's
40:30
how we're
40:30
going
40:30
to make
40:31
the most
40:31
progress.
40:32
Right?
40:32
If
40:33
we have
40:33
the best
40:33
drug
40:34
available,
40:34
but
40:34
only 5%
40:35
of
40:35
the patients
40:36
can get
40:36
it,
40:36
we're not
40:37
really
40:37
doing
40:38
a service.
40:38
So
40:38
I think
40:38
it's a
40:39
great
40:39
question.
40:40
And I
40:41
actually
40:41
think
40:41
we're
40:41
making
40:41
a lot
40:42
of
40:42
progress.
40:42
I'll,
40:43
you know,
40:43
I think,
40:43
like with
40:44
kimmtrac,
40:44
the
40:45
Kimmtrac
40:45
connect.
40:46
Right.
40:46
They will
40:47
help
40:47
patients.
40:48
Now
40:48
that it's
40:48
FDA
40:48
approved.
40:49
Hey,
40:49
you can
40:50
get your
40:50
first
40:50
three
40:50
doses
40:51
at kind
40:52
of high
40:52
volume
40:52
centers.
40:53
They'll
40:53
help
40:53
with,
40:54
with
40:54
transportation,
40:55
get those
40:56
kind of,
40:56
highest
40:57
risk
40:57
doses
40:58
at these
40:58
high
40:58
volume
40:59
centers.
40:59
And then,
41:00
hey,
41:00
let's
41:00
go out
41:01
and train
41:01
your
41:02
local
41:02
oncologist
41:03
so
41:03
that team
41:04
feels
41:04
comfortable
41:04
doing
41:05
those
41:05
further
41:05
weekly
41:06
treatment.
41:06
So I do
41:07
applaud
41:08
some
41:08
of the
41:08
pharma
41:08
partners
41:09
that have
41:09
really
41:10
been
41:10
helping
41:11
with this
41:12
problem.
41:13
To, to
41:14
really
41:14
find a
41:14
patient
41:15
centered
41:15
solution,
41:17
I think
41:17
I'm going
41:18
to use
41:18
the
41:18
example
41:19
of,
41:19
opdivo
41:19
and
41:20
yervoy
41:20
when it was
41:21
approved
41:21
because
41:22
it
41:22
toxicity
41:22
concerned
41:24
a lot of
41:24
the
41:24
community
41:25
and
41:25
colleges
41:25
weren't
41:26
favoring.
41:26
They were
41:27
still
41:27
using
41:28
either
41:28
Keytruda
41:29
or opdivo
41:30
alone
41:30
to treat
41:31
their,
41:31
you know,
41:31
patients
41:31
with
41:32
metastatic
41:32
melanoma,
41:33
from skin
41:34
melanoma
41:34
at least.
41:35
And as
41:37
the word
41:37
got out,
41:38
as you
41:38
know,
41:40
expert
41:40
medical
41:41
oncologist
41:41
in
41:41
melanoma
41:42
world
41:42
went and
41:43
talked
41:43
to these
41:44
folks in
41:44
the community
41:45
the confidence
41:46
to treat
41:47
with
41:48
opdivo
41:49
yervoy
41:49
now
41:51
I see
41:51
patients
41:52
that are
41:53
refractory
41:54
to up
41:54
to even
41:54
I mean,
41:54
those are
41:55
difficult
41:55
patients
41:55
to treat.
41:56
But
41:56
I'm glad
41:57
that
41:57
these
41:57
patients
41:58
didn't
41:58
have to
41:58
travel,
41:59
you know,
42:00
from,
42:01
Pasadena
42:02
to Santa
42:02
Monica,
42:03
a three
42:03
hour
42:04
drive
42:04
just
42:04
to get
42:05
their
42:05
one dose
42:05
every
42:06
three
42:06
weeks,
42:06
you know?
42:06
Yeah,
42:07
it's a
42:07
30
42:08
mile drive,
42:08
but
42:09
it takes
42:09
three
42:09
hours,
42:10
right?
42:10
Let alone
42:11
going
42:11
from
42:12
one part
42:12
of
42:12
Arizona
42:13
to
42:13
Scottsdale
42:13
and
42:13
whatnot.
42:14
So
42:15
I think
42:15
with time
42:16
that that
42:17
will
42:18
come.
42:18
Right
42:19
now,
42:19
I agree.
42:19
Like
42:20
I see
42:20
a lot of
42:20
the
42:21
patients,
42:21
the first
42:21
line
42:22
patients
42:22
for
42:22
metastatic
42:23
uveal
42:23
melanoma
42:24
is
42:24
because
42:24
they're
42:25
hla you
42:26
know,
42:26
positive
42:26
and
42:27
they need
42:27
Kimmtrac,
42:27
but
42:28
the local
42:28
oncologist
42:28
isn't
42:29
comfortable
42:29
or
42:30
they don't
42:30
have the
42:31
the
42:31
logistics
42:32
to set
42:33
up,
42:33
you know,
42:33
in a
42:34
small
42:34
hospital
42:34
to
42:35
monitor
42:35
these
42:35
patients
42:35
for
42:36
you know,
42:37
they have
42:38
three
42:38
bed ICU
42:39
in
42:39
middle of
42:40
central
42:40
California.
42:41
Is it
42:41
that's
42:41
not
42:41
viable.
42:42
So
42:42
they'll
42:42
come to us
42:43
and
42:43
we'll do
42:43
the first
42:43
three
42:44
doses.
42:44
It's
42:44
still painful.
42:45
I mean,
42:46
these
42:46
patients
42:46
are driving.
42:47
They have to
42:47
stay in
42:48
expensive
42:48
hotels
42:49
in LA.
42:50
And but
42:50
I think
42:51
as the
42:51
time
42:52
goes,
42:53
just like up
42:55
things
42:55
will get
42:55
better.
42:56
And
42:56
I
42:57
hope it's
42:57
not
42:57
centralized.
42:59
You know,
42:59
I
43:00
really
43:00
hope it's
43:00
nice
43:00
because
43:01
then
43:01
you're
43:01
excluding
43:02
a number
43:02
of
43:02
patients,
43:03
from
43:03
these
43:03
therapies.
43:06
Kevin
43:06
O'Neill,
43:06
I'm in
43:06
Philadelphia.
43:07
I'm
43:07
a five
43:08
year
43:08
survivor
43:08
and still
43:09
moving
43:10
on.
43:10
So,
43:10
I just
43:11
wanted
43:11
to take
43:11
your point
43:12
and
43:12
take it
43:12
one extra
43:13
step
43:13
there.
43:13
Probably
43:14
a dozen
43:14
centers
43:15
of
43:15
excellence
43:15
for,
43:16
medical
43:16
oncology
43:17
in uveal
43:18
melanoma,
43:19
including
43:19
your centers
43:20
that
43:20
you're.
43:20
You're
43:21
from here
43:21
in
43:22
Arizona,
43:22
in Los
43:22
Angeles,
43:23
in
43:23
Nashville,
43:24
on
43:24
the East Coast.
43:25
But
43:26
that's
43:26
just a
43:26
dozen
43:26
centers.
43:27
And
43:27
that means
43:27
if
43:27
someone
43:28
wants
43:28
access
43:28
to these
43:29
clinical
43:29
trials,
43:30
they're
43:30
likely
43:30
going
43:30
to have
43:31
to
43:31
travel.
43:32
Meredith
43:32
McKane,
43:33
you're
43:33
in.
43:34
Sarah
43:34
Cannon
43:35
and
43:35
Nashville,
43:36
and
43:36
you're
43:36
also
43:36
affiliated
43:37
with
43:37
centers
43:38
in
43:38
Florida.
43:39
And so,
43:40
probably
43:40
two years
43:41
ago,
43:41
I had asked
43:41
you for
43:42
a contact
43:42
at Sara
43:43
Cannon
43:43
for colon
43:44
cancer
43:44
for a
43:45
friend
43:45
living
43:46
in Florida,
43:46
and
43:47
found out
43:47
that that
43:47
trial
43:48
that
43:48
you had,
43:49
Sara
43:49
Cannon
43:50
was
43:50
in one
43:50
of your,
43:52
your
43:52
colleagues
43:52
centers,
43:53
also
43:53
in Florida.
43:54
Can you
43:54
talk
43:54
about
43:55
kind
43:55
of this
43:55
regionalization
43:56
of
43:56
medical
43:57
practice,
43:57
where
43:58
maybe
43:59
in the
43:59
rare
43:59
cancer
44:00
setting,
44:00
some of these
44:00
trials
44:01
can also
44:01
skip
44:02
across
44:02
state
44:02
borders,
44:03
so to
44:03
speak.
44:04
Thank you.
44:06
Yeah.
44:06
And
44:06
I think
44:07
that
44:07
goes back
44:07
to a
44:08
lot of
44:08
the
44:08
conversations
44:09
with,
44:09
pharma
44:10
partners.
44:10
Right.
44:11
And so
44:12
the a lot
44:13
of the
44:13
trials
44:13
like the
44:14
ideaya
44:14
trial.
44:14
No,
44:14
that's
44:15
phase
44:15
three.
44:16
I think
44:16
that
44:17
they've
44:17
done a
44:17
really
44:18
good job
44:18
of trying
44:18
to get
44:19
that out
44:19
into a
44:20
number
44:21
of
44:21
clinics.
44:22
You know,
44:22
across
44:22
the
44:23
nation.
44:24
Now, to
44:24
try
44:24
to make
44:25
it as
44:25
accessible
44:26
as
44:26
possible
44:27
for
44:27
patients.
44:28
So,
44:28
you know,
44:30
one of
44:30
the
44:30
challenges
44:30
is the
44:31
early
44:31
phase
44:31
one
44:31
studies.
44:32
Those
44:32
still do
44:33
require,
44:34
you know,
44:35
because
44:36
we're
44:36
trying
44:36
to
44:36
understand
44:37
the safety,
44:38
the the
44:39
levels,
44:40
you know,
44:40
those
44:41
will need
44:42
to
44:42
continue
44:43
to be
44:43
done
44:43
at more
44:43
specialized
44:44
centers.
44:45
But like
44:45
one of
44:46
the
44:46
things
44:46
that
44:46
we do
44:46
it, Sarah
44:47
Cannon
44:47
is, okay,
44:48
well,
44:48
once
44:48
we've
44:48
found the dose
44:49
and
44:50
even if
44:50
it's
44:50
phase
44:50
one B
44:51
and we're
44:52
it's
44:52
still
44:53
a phase
44:53
one trial,
44:54
but
44:54
we kind of
44:55
understand
44:55
we have
44:55
a good idea
44:56
of what
44:56
the safety
44:56
is going
44:57
to be.
44:57
We have a
44:57
good idea
44:58
the dose.
44:58
We're
44:58
just
44:59
enrolling
44:59
more
44:59
patients.
45:00
Can
45:00
we push
45:00
that out
45:01
to like
45:01
the next
45:02
level of,
45:03
clinics
45:03
in the
45:04
community,
45:04
that are
45:05
familiar
45:06
with
45:06
these
45:07
types of
45:07
studies
45:08
to try
45:08
to
45:09
offer it
45:09
to more
45:10
patients?
45:10
Maybe
45:11
even,
45:11
you know,
45:11
earlier.
45:12
So
45:12
these patients
45:13
have
45:13
access
45:13
before
45:14
they've
45:14
had
45:14
multiple
45:15
lines of
45:15
therapy
45:16
and are
45:16
having
45:16
a lot
45:16
of
45:16
symptoms
45:17
from their disease.
45:18
And so
45:19
I think
45:19
that's
45:20
really
45:20
where
45:20
we're
45:21
trying to
45:21
go in
45:21
oncology
45:22
is trying
45:22
to
45:23
sort of
45:23
push
45:24
them out
45:24
as close
45:25
as
45:25
possible
45:25
for
45:25
patients.
45:26
I think
45:27
we're all
45:27
part
45:27
of kind
45:28
of,
45:28
networks
45:29
where we do
45:30
try to,
45:31
not only
45:32
communicate
45:32
with
45:32
other,
45:33
specialized
45:34
centers
45:34
of what
45:34
trials
45:35
are
45:35
available,
45:35
but then
45:36
also
45:36
how
45:37
can
45:37
we get
45:37
this
45:37
treatment
45:38
as close
45:38
to home
45:39
for you
45:39
as possible?
45:40
Because
45:40
I think
45:40
everyone
45:40
can
45:41
agree.
45:41
Sleeping
45:41
in
45:41
your own
45:42
bed at
45:42
night
45:42
is
45:43
probably
45:43
the best
45:43
medicine.
45:44
So, you
45:45
know,
45:45
travel,
45:45
having to
45:46
travel,
45:47
you know,
45:47
every week
45:48
for,
45:48
you know,
45:48
three
45:49
hours
45:49
one way
45:49
is is
45:50
challenging.
45:50
And so
45:51
I think,
45:51
like for
45:52
for Sarah
45:53
cannon
45:53
and
45:53
we certainly
45:54
do try
45:54
to
45:54
look at
45:54
the network
45:55
now like
45:56
we have
45:56
trials
45:57
across
45:57
most
45:57
of the U.S.
45:59
now
45:59
to say,
46:00
well,
46:00
can we
46:00
get this
46:01
closer
46:01
for this
46:02
patient
46:02
or
46:03
some of
46:03
the
46:03
models
46:04
are okay,
46:05
well,
46:05
maybe
46:05
it's
46:05
not open
46:06
yet, but
46:07
we actually
46:07
have
46:08
communication
46:08
that if
46:09
we find
46:09
that
46:09
patient
46:10
that we
46:11
can
46:11
open up
46:11
at that
46:12
site
46:12
within
46:12
two weeks.
46:14
And
46:14
I think
46:14
that's
46:14
maybe
46:15
a model
46:16
we'd
46:16
probably
46:16
love
46:17
to do
46:17
for every
46:17
uveal study.
46:18
But
46:18
something
46:19
that
46:19
we're all
46:19
working
46:19
towards.
46:22
So I love
46:23
that you
46:23
guys are
46:23
talking
46:24
about,
46:24
like,
46:24
clinical
46:24
trials.
46:25
And
46:25
just as
46:25
we're
46:26
finishing
46:26
up,
46:26
before
46:27
we go to
46:27
our
46:27
break,
46:27
I guess
46:28
I'll get
46:28
back
46:28
up here
46:29
where
46:29
you guys
46:29
can see
46:29
me.
46:32
It's kind
46:32
of like
46:33
hearing
46:33
you guys
46:33
talk.
46:34
It
46:34
sounds like
46:34
there's
46:34
this
46:35
this kind
46:35
of
46:35
gradual
46:36
graduation
46:37
from
46:37
level one
46:38
to level
46:38
two.
46:38
And
46:38
obviously
46:39
we have
46:39
the
46:39
phases,
46:40
and
46:40
that's
46:40
how
46:40
it works.
46:41
But
46:41
I just
46:42
I love
46:42
that
46:42
we've
46:42
been able
46:42
to break
46:43
down
46:43
some of the
46:43
aspects.
46:44
Right.
46:44
There's
46:44
the
46:44
travel
46:45
things,
46:45
the things
46:45
that
46:45
you guys
46:46
as
46:46
oncologists
46:47
think
46:47
about
46:47
when
46:48
you're
46:48
sending
46:48
a patient
46:49
to a
46:49
trial.
46:49
So,
46:50
thank
46:50
you guys
46:50
for these
46:51
thoughts
46:51
and for
46:52
everything
46:52
that you
46:52
have
46:53
given
46:53
and that
46:54
you
46:54
continue
46:54
to give
46:54
for
46:54
your patients
46:55
to make
46:55
sure that
46:55
they have
46:56
the best
46:56
care
46:56
possible
46:57
and
46:57
the best
46:57
chance
46:58
at,
46:58
like you
46:58
said,
46:59
like just
46:59
having
46:59
more time
47:00
and
47:00
continuing
47:01
to see
47:01
research
47:01
evolve.
47:02
So let's
47:02
give them
47:02
a round
47:02
of
47:03
applause.
47:06
Thank
47:06
you guys.
47:07
Okay.
47:07
So
47:08
next up
47:10
we're
47:10
going to.
47:14
thank
47:14
immuno
47:15
core.
47:16
So immuno
47:17
core
47:18
is a
47:18
commercial
47:19
stage
47:19
biotech
47:20
company
47:20
that
47:20
discovered,
47:21
developed
47:21
and
47:21
commercialized
47:22
the world's
47:22
first
47:23
approved
47:23
T cell
47:24
receptor
47:24
TCR
47:25
therapy.
47:25
Kimmtrac
47:26
And our
47:27
mission
47:27
or their
47:28
mission
47:28
to is
47:28
to
47:29
radically
47:29
improve
47:29
outcomes
47:30
for
47:30
patients
47:30
with
47:30
cancer,
47:31
infectious
47:31
diseases
47:32
and
47:33
autoimmune
47:33
diseases
47:34
by
47:34
pioneering
47:35
and
47:35
delivering
47:35
transformative
47:36
immuno
47:37
modulating
47:37
medicines.
47:39
So we are
47:40
so excited
47:41
that
47:41
they are
47:41
here.
47:41
And I
47:42
can't
47:42
tell is
47:42
Katie
47:43
Wall,
47:43
are you
47:43
here?
47:44
Katie?
47:44
Katie.
47:45
Hi.
47:45
I talk
47:46
to you
47:46
a lot
47:46
on email
47:47
and
47:47
the phone
47:47
and
47:47
all the things,
47:48
and I
47:48
think
47:48
you also
47:49
have
47:49
Blake
47:49
with you,
47:49
correct?
47:50
Yeah.
47:50
So, Katie
47:51
Blake,
47:51
raise
47:51
your
47:51
hands.
47:52
Patients
47:52
in the room
47:53
there,
47:53
over
47:53
here.
47:54
You guys
47:54
can chat
47:54
with
47:54
them.
47:55
Their
47:55
your
47:56
their go
47:56
to to
47:57
talk
47:57
about
47:57
Kimmtrac
47:58
connect.
47:58
Make sure
47:58
that
47:59
you know
47:59
that
47:59
you have
47:59
the right
48:00
hla
48:00
typing
48:00
testing
48:01
done.
48:01
Probably
48:02
sound
48:02
like
48:02
I don't
48:02
know
48:02
what I'm
48:03
talking
48:03
about.
48:03
My mouth
48:04
is just a
48:04
little
48:04
tired, so
48:07
you guys
48:07
know what
48:07
I mean.
48:07
The HLA
48:08
type
48:08
test.
48:09
There's
48:09
all kinds
48:10
of little
48:10
nuances
48:11
we've
48:11
had,
48:11
I think a
48:12
couple
48:12
of years
48:12
under
48:13
our belt
48:13
as a
48:13
patient
48:14
population
48:14
of trying
48:15
to
48:15
make sure
48:16
that
48:16
patients
48:17
know what
48:17
they need
48:17
to talk
48:18
to their
48:18
oncologist
48:19
about.
48:19
And
48:19
I think
48:19
that the
48:20
oncologists
48:20
all
48:21
around
48:21
the
48:21
regional centers
48:22
that
48:22
treat
48:22
uveal
48:22
melanoma
48:23
are a
48:23
lot more,
48:24
consistent
48:25
now
48:25
with
48:25
making
48:26
sure
48:26
that HLA
48:26
testing is done.
48:27
But
48:28
if you
48:28
haven't
48:28
had
48:28
your HLA
48:29
typing
48:30
done,
48:31
talk to
48:31
your oncologist.
48:32
It can be
48:33
done.
48:33
It
48:33
doesn't
48:33
have
48:33
to be done
48:34
because
48:34
you're
48:34
metastatic.
48:35
And
48:35
if anything,
48:36
it should be done
48:36
first way
48:37
before
48:37
you ever
48:38
have the
48:38
potential
48:39
or the
48:39
possibility
48:40
of
48:40
metastatic
48:40
disease.
48:42
For
48:42
those
48:42
of you
48:42
guys
48:42
online,
48:44
head to
48:44
your
48:44
websites.
48:45
Those
48:45
of
48:45
you guys
48:45
here in
48:46
person
48:46
don't
48:46
do this
48:47
yet.
48:47
We want you
48:48
to stay
48:49
here.
48:49
But
48:49
you can
48:50
head to
48:50
our registry
48:50
and
48:51
you can
48:51
help
48:51
further
48:51
research.
48:52
And
48:52
you can
48:53
also help
48:53
find
48:54
trials.
48:54
One of
48:55
the cool
48:55
things
48:55
about our
48:56
registry
48:57
is that
48:57
we work
48:57
with
48:57
pharma.
48:58
We work
48:58
with our
48:58
biotech
48:59
companies
48:59
to create
49:00
surveys.
49:01
Sometimes,
49:01
and to
49:01
give them
49:02
an
49:02
opportunity
49:02
to look
49:03
for the
49:03
right
49:04
kinds of
49:05
patients
49:05
to
49:06
participate
49:06
in a trial.
49:07
So
49:07
if you want
49:07
to be on
49:08
those lists
49:08
and
49:08
you want
49:09
to get
49:09
an email
49:09
that
49:09
says,
49:10
you know,
49:10
are you
49:10
interested
49:11
in
49:11
a clinical
49:11
trial,
49:12
then
49:12
you need
49:13
to be
49:13
part of
49:13
the
49:13
registry.
49:14
You need
49:14
to be
49:15
registered,
49:16
you need to
49:16
sign
49:17
your consents,
49:17
and
49:17
you need
49:18
to start
49:18
filling
49:18
out
49:18
the surveys
49:19
that have
49:19
information
49:20
about
49:20
your
49:20
demographics,
49:21
like
49:21
where
49:21
you live,
49:22
how old you are.
49:23
Those are
49:23
important
49:24
kinds
49:24
of things,
49:24
because
49:25
if
49:25
they're
49:25
looking
49:25
for a trial
49:26
and
49:26
they want
49:26
to do
49:27
a trial
49:27
of people
49:27
who are
49:28
over
49:28
the
49:28
ages of
49:28
20 to 50,
49:29
they're
49:30
going
49:30
to
49:30
look in
49:30
the registry
49:31
and
49:31
they're
49:31
going
49:31
to pull
49:32
that data.
49:32
So if
49:33
you are
49:33
not
49:33
answering
49:33
your surveys
49:34
and
49:34
telling us
49:35
who
49:35
you are,
49:35
how
49:36
your medical
49:36
history
49:37
is going,
49:38
we can't give
49:39
you the
49:39
clinical
49:40
trial
49:40
access
49:40
kind of
49:41
as easily
49:42
as we
49:42
could.
49:42
So make
49:43
sure
49:43
to join
49:43
the
49:43
registry