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- This is Laura Dedo with the
Becker's Healthcare Podcast.

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I'm thrilled today to be joined by Dr.

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Guru Sode, who's the
medical director of Janitor

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Oncology in the Phase one
Cancer Research Unit at Advent

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Health Cancer Institute.

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Dr. Sode, it's a pleasure to
have you on the podcast today.

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- Thank you for having me on.

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- Now, I'm looking
forward to our discussion.

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I know we're gonna dive
deep into some of the

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clinical research that you're doing

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and really exciting work around, uh,

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a new bladder cancer therapy

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and vaccine that is really, you know,

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representing the forefront
of, uh, precision oncology.

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But before we dive into that discussion,

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can you tell us a little
bit more about, uh,

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yourself and your background?

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- Yeah, thank you for the opportunity.

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So my background is I'm
a medical oncologist

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and focused on clinical trials.

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I have been focused on, um,
continuing to urinary cancers,

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which includes, uh, bladder,
prostate, and kidney cancer,

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and other, some other
urologic system cancers.

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I have primarily been
focused on bladder cancer,

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but at Advent Health,

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I'm also leading the phase
one clinical trial program,

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which, uh, essentially
investigate new drugs coming from

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the lab into the clinic
to, um, look at the safety

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and the feasibility of,
uh, taking the, some

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of these drugs further to treat patients

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with advanced cancers.

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- Well, it's fascinating to hear,

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and you know, really such a important,

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in rewarding place to be.

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Now, I know you recently had
a trial that you were part

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of get FDA approval.

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Can you tell us about
that trial and treatment?

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- Yes. I was fortunate to
be, uh, one of the co-leaders

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of a phase three trial called
the Checkmate 9 0 1 trial.

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This is a phase three trial in
which had several components.

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The component that, uh, was,
uh, recently in the news

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and led to the approval of a new drug, um,

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is a component that compared,
uh, first line chemotherapy

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with cisplatin and gemcitabine in advanced

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urothelial carcinoma, and
that's mostly bladder cancer.

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Um, although there are patients also

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with upper urinary tract carcinoma, uh,

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which had metastasized.

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So in these patients, um,

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who are cisplatin eligible fit enough

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to receive the cisplatin
based chemotherapy,

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the trial compared cisplatin
plus gemcitabine, which is the

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standard, which was a standard back then.

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And this was compared with
cisplatin gemcitabine plus

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nivolumab a PD one inhibitor.

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So essentially, uh, this
combination with nivolumab,

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the PD one inhibitor, immunotherapy drug,

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which essentially turns
out on the, to fight them

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and, uh, attack these
cancer cells, did lead

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to an improvement in survival.

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And this led to us FDA
approval for patients, um,

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who were receiving cisplatin

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and gemcitabine chemotherapy
as first line therapy

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for advanced urothelial carcinoma.

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The key highlight of this trial was

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that there was a 22%
complete remission rate, uh,

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which is the total resolution of all

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of the visible disease on the scans.

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And the patients who had a
complete remission had a very

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long duration of response
within median duration

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of a little over three years.

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And so this is, um, um, a
promising, uh, finding in, uh,

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this group of patients.

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Uh, and this, uh, this data really led

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to the US FDA approving
this combination cisplatin

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gemcitabine plus nivolumab
in patients who were, uh,

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eligible for cisplatin

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and had advanced urothelial carcinoma.

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- Well, that's fascinating to hear

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and really interesting to,
um, know that, you know,

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this type of work is out there
and can be so successful.

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Now, there's also a new phase
two trial at Advent Health

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Cancer Institute located
in central Florida

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that just opened in April
for bladder cancer patients.

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What makes this trial unique

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and what does this mean for
the customized medicine?

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- Right. We are especially
excited about this, uh,

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new randomized phase two
trials that just opened, uh,

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actually globally and
oversight in, uh, Florida.

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The Advent Health Cancer program
is actually the only site,

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uh, open in Florida and, uh, one

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of the first sites globally,

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and the first site in
the US to open, actually.

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So this is the phase two trial,

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which looks at a different
stage of the disease.

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This is patients who have
urothelial carcinoma, um,

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in the urinary tract that's
been removed surgically,

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but they still have a
high risk of recurrence.

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Uh, so there might be
basically microscopic

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disease somewhere that's not
visible yet that might grow

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with time and, um, then become
known as metastatic disease.

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So in these patients, um, what
we know is, um, postoperative

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or adjuvant nivolumab, uh,

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PD one inhibitor immunotherapy
drug is approved.

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But what is also known is

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that very recently the randomized
phase three trial called

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the ambassador trial, uh, showed

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that there was an improvement also

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with adjuvant pembrolizumab.

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Uh, and so pembrolizumab is,
um, awaiting us FDA reviews.

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But what this study is doing here,

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this is called the inter path 0 0 5 trial.

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Um, this is a randomized
phase two trial, which tries

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to improve upon the
efficacy of pembrolizumab.

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Uh, so basically patients

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with high risk urothelial
carcinoma who under,

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who have undergone surgery, are
randomized to pembrolizumab,

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combined with, uh, placebo
versus pembrolizumab, combined

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with the V nine 40, uh, which
is the experimental new agent.

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And I will explain that in a second,

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but basically what I want to
explain is in this trial, uh,

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nobody is getting only placebo, so all

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of the patients get pembrolizumab,

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and one half of the patients, uh,

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is also receiving the V nine 40,

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which is given intramuscularly every three

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weeks for nine cycles.

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So the V nine 40 is an extremely exciting

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immunotherapy agent.

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Um, what it is, is it codes for the,

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um, neoantigens found
specifically in the cancer cell.

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So neoantigen are new proteins

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found only in the cancer cells

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because of the mutations found
only in the cancer cells.

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So essentially, when you have, um,

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a molecule like the V nine 40, which codes

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for these new proteins

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or new antigen using the
RNA, the corresponding RNA

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for the these proteins,
remember the DNA codes

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for R-N-A-R-N-A codes for protein.

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So what, um, um, uh, the
sponsoring company has done here,

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uh, this is Merck in
collaboration with Moderna,

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is made this mRNA immunotherapeutic,
which codes for this,

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uh, up to 34 neoantigens
found only in the cancer cell.

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And this product is, uh,

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injected into the patient's
intramuscularly every three

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weeks, uh, uh, up to nine times.

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So this is an extremely specific
highly, uh, precise, uh,

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precision immunotherapy,
um, in my judgment, uh,

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which has been looking very promising

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so far in a smaller phase two trial, uh,

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in melanoma a different cancer,

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there was a significant
improvement in the outcomes.

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And this has led to a phase
three trial in melanoma.

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And really, so this
kind of an approach, uh,

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precision immunotherapy
approach based on proteins, uh,

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called neoantigen found
specifically in the cancer cell.

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Um, we think it's a very, uh, good promise

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and also appear very, um, tolerable.

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It was not very toxic at all
in the earlier, uh, trials done

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so far in melanoma.

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- Well, it's fascinating to hear

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and really encouraging to know

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that those early results
are coming through.

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Um, and, and really something

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to be interested and excited about.

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Now, I'm wondering, you know,

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what are you most excited
about in your field?

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Obviously, some

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of the things you just explained
in the phase two trial, um,

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really hold a lot of promise,

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but what else on the macro level are you

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just really looking forward to?

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- Thank you for that opportunity.

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So in this context, I wanna
say that one other, uh,

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really exciting finding that's
emerging is the value of, uh,

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uh, circulating tumor DNA

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or CT DNA to select
the right patients for,

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um, uh, therapy.

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So for example, in the adjuvant
therapy I just mentioned,

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we are actually, um, uh,
looking at the CT DNA,

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which basically the
blood test look to look

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for cancer DNA in the blood.

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Uh, and so this could really help us, uh,

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determine if only patients with
the cancer DNA in the blood,

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uh, in the postoperative
setting have the benefit.

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Um, so this is, uh, going
to be looked at, um,

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once this study is complete.

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In this context, I wanna mention

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that there is a second
adjuvant trial we will

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be participating in.

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This is called the modern trial.

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Uh, the modern trial
is a phase three trial,

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so it's a much larger trial done

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by the US intergroup system.

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And basically in this study, patients

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who undergone radical cystectomy
that removal of the bladder

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for high risk muscle invasive
bladder cancer, they are, um,

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randomized based on whether
they have the circulating tumor

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DNA or not postoperatively.

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So basically, if you have
postoperative ctdna, uh,

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present in the blood, you
randomized to nivolumab,

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which is the standard versus,
um, uh, nivolumab plus, uh,

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a different immunotherapy
drug called related map.

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This is a lag three
inhibiting immunotherapy drug.

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So basically we are escalating therapy

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to a combination immunotherapy
if your CTDNA is positive,

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and on the other hand, if
your CTDNA is negative, um,

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maybe these patients
have a much lower risk

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of the cancer returning.

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So these patients are being randomized

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to nivolumab versus surveillance.

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And in the surveillance
group, when they become CTD NA

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or when, or if they become
CTDNA positive, then they can,

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uh, receive nivo nivolumab.

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So really that's, um, a process
of deescalating therapy.

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So basically CTDNA negative we trying

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to watch without giving therapy so

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that we avoid unnecessary
toxicities in somebody who's not

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destining to recur.

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So this is another interesting
adjuvant trial where the ctd,

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NA, um, is being used to select patients

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for either escalation
by combination therapy

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or deescalating, um,

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with surveillance if the CTDNA negative,

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- That's amazing to hear,

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and you know, really exciting,
um, to have the, those kinds

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of results indefinitely ability to

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navigate those clinical trials.

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Now, before we wrap up here, I'm wondering

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what will the most effective
healthcare leaders need in

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to be successful in the
next two to three years?

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Especially looking at your
field, um, oncology in research

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and innovation, uh,

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I can imagine things are
changing very quickly.

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So what do leaders need to
know in order to keep up?

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- I think that I will
talk in terms of, uh,

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the clinical trial landscape,
um, uh, in this context.

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So basically I think that
the clinical trials, um,

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have been challenging in the sense

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that we have still not maximized, um,

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the reach of these trials.

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So we know that out in the
community there, uh, lots

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of patients are not getting access to, uh,

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these promising new
drugs on clinical trials.

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Uh, so the really, the model that needs

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to be further developed is to
decentralize clinical trials,

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make these trials available
to anybody in the community.

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Uh, that's actually, uh,
easier said than done

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because in addition to
getting these, uh, trials out

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to the community, we also
need to train our, uh,

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clinician medical oncologists
out there in the community.

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Um, there's a lot of education to be done.

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Um, there are a lot of
misperceptions out there, uh,

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not only among patient, uh, you know, uh,

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potential patients, but
also among clinicians.

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So there's a lot of
education to go around, um,

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and on on both sides of that.

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Uh, in order to improve trial
accrual, this is what leads

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to further advances with
new, uh, new drugs emerging

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for patients out there.

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So I really hope that this
decentralizing model will, uh,

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help bring access to the drugs, um,

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and will improve all of the,

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or reduce all of the disparities
we see right now, uh,

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with regard to trial access

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and access to new promising
treatments for advanced, uh,

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mostly incurable cancers.

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- That's fascinating to hear, you know,

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and really great to understand.

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Um, when you talk about some
of these misconceptions,

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is there one that comes
up over and over again

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or just a, a variety of,
um, uh, misconceptions that,

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you know, people tend to, um, latch onto?

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- Yeah, you know, clinical trials, uh,

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are not well understood
by, uh, many patients.

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And I will also say actually, um, uh,

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many clinicians in fact, uh,
I think that one of the things

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to remember is that clinical
trials have the goal of, uh,

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evaluating a new, uh, drug.

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So there are different
phases of, uh, these trials,

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phase one, phase two, phase
three, and then phase four.

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So essentially, uh, one of the
misconceptions is that, uh,

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the patients worry that they
will get, uh, only placebo, uh,

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if they get on any trial, uh,

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or that they're like a lab
rat or something like that.

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Now, one of the things I did
wanna maybe I could mention

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given, since you've given me
the opportunity in phase one

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trials, um, these are new
drugs coming off from the lab.

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Everyone gets, uh, the new drug, uh,

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and, uh, they're being
tested at different doses

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to select the right dose
for further development.

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So there is no placebo
involved in a phase one trial.

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And, and actually most phase two trials,

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which are phase two trials,
are when the drug is found,

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found to be safe, and we have
the right dose from the phase

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one trial, they move on to
phase two trials to test, uh,

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a drug in a specific population
of cancer patients, uh,

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for example, lung cancer, or
you might pick bladder cancer

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where there was some activity seen in the,

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uh, previous phase one trial.

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So in the phase two trial, again,

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usually these trials are
also, uh, not randomized, uh,

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to placebo versus the drug.

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Occasionally they might be, um,

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however, uh, usually there
are, uh, a group of patients

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where everyone gets the
drug, then we move on

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to a phase three trial.

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And this is a trial that is, um, designed

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to lead towards potential
use FDA approval.

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So there is a standard treatment versus

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experimental treatment.

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Now, the standard treatment, um,

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sometimes it's placebo when
there is no good standard

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treatment for these patients, but, uh,

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and many of these trials
are standard treatment plus

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placebo, so they're not just, uh, placebo.

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So this is something that
the patients need to discuss

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with the, uh, investigator
to see what the design is.

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So, uh, so that's, uh, the difference.

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The phase four trials are
later stage trials to further,

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further assess the efficacy of a, uh,

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new drug that's been approved.

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And this is, uh, usually
also not randomized.

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This is a big group of
patients who get the drug

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to further assess the safety,
uh, of the drug in a, uh,

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in, out in the community.

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So really the, I think that,
um, there needs to be a good,

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the long discussion between the patient

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and the investigator
to further clearly, uh,

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understand these trials and
clear out any misperceptions.

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- Amazing. Well, Dr.

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00:16:10,105 --> 00:16:12,635
Avta, thank you so much for
joining us on the podcast today.

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00:16:12,635 --> 00:16:14,515
This has been, you know, a really fun

335
00:16:14,515 --> 00:16:16,435
and fascinating conversation
to hear from you,

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00:16:16,455 --> 00:16:18,315
and I look forward to
connecting with you again soon

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and seeing how the results
continue to play out.

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- Thanks a lot for the opportunity.