Feb 15, 2021
In today’s episode, Dr. Neeraj Agarwal, medical oncologist and director of the Genitourinary Oncology Program at the University of Utah’s Huntsman Cancer Institute, highlights the EV-301 study and its promising developments in treatment for patients with metastatic urothelial carcinoma.
Transcript
ASCO Daily News: Welcome to the ASCO Daily News podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. My guest today is Dr. Neeraj Agarwal, who is a medical oncologist and director of the genitourinary oncology program at the University of Utah's Huntsman Cancer Institute.
Dr. Agarwal will discuss the EV-301
trial, featured at the 2021 Genitourinary Cancer Symposium, and
its potential as the preferred treatment for some patients with
metastatic urothelial carcinoma. Dr. Agarwal has served in a
consulting or advisory role for AstraZeneca, Bristol Myers Squibb,
Exelixis, and Merck, among other organizations. His full
disclosures and those relating to all of our episodes are available
on our transcripts at asco.org/podcasts.
Dr. Agarwal, looking at abstract 393 and the primary results of the
EV-301 trial. So this study demonstrated a significant survival
advantage with enfortumab vedotin over standard chemotherapy in
patients previously treated for locally advanced or metastatic
urothelial carcinoma. Will EV be the new standard of care for this
patient population?
Dr. Neeraj Agarwal: Yes. So short answer is yes.
So let me start with the background first.
In December 2019, enfortumab vedotin received accelerated approval
by the U.S. Food and Drug Administration based on the response
waves from the phase II single arm EV-201 trial (NCT03219333).
Moreover, in February 2020, the U.S. Food and Drug Administration
designated this agent as a breakthrough therapy for this patient
population. Therefore, we have been waiting with great anticipation
the primary results of the phase III EV-301 trial, which Dr. Tom
Powles presented at the GU 2021 Symposium.
This trial randomly assigned patients to either enfortumab vedotin,
the experimental arm, or investigator's choice of standard
chemotherapy with the either docetaxel, paclitaxel, or vinflunine,
which comprise control arm. The primary endpoint of this trial is
overall survival with secondary endpoint of progression-free
survival, objective responses, and safety and tolerability.
Eligible patients must have received a platinum-containing
chemotherapy and had progression during or after immune checkpoint
inhibitor therapy.
608 patients enrolled in this trial, with 301 randomized to the
enfortumab vedotin and 307 to the control arm, respectively. The
results from the prespecified interim analysis presented at the
symposium by Dr. Powles further support the findings from the
earlier EV-201 study. With the 11.1 month median follow up, median
overall survival was significantly prolonged in the enfortumab
vedotin arm at 12.9 months versus 9 months in the control arm, with
a p-value equaling 0.001.
Secondary endpoints of progression-free survival, objective
responses, and disease control rates significantly favored
enfortumab vedotin arm, while safety and tolerability were
comparable between both arms. Based on these outstanding primary
results, I believe enfortumab vedotin will likely become the
preferred treatment for patients with metastatic urothelial
carcinoma with prior disease progression on a platinum-based
chemotherapy and an immune checkpoint inhibitor.
ASCO Daily News: Thank you, Dr. Agarwal,
for sharing your insight with us today. I look forward to hearing
more of your highlights from the symposium in our next episode of
the podcast.
Dr. Neeraj Agarwal: Thank you for inviting me,
Geraldine. It's always a pleasure.
ASCO Daily News: And thanks to our
listeners for joining us, as well. Please take a moment to rate,
review, and subscribe wherever you get your podcasts.
Disclosures: Dr. Neeraj Agarwal
Consulting or Advisory Role: Pfizer, Medivation/Astellas, Bristol-Myers Squibb, AstraZeneca, Nektar, Lilly, Bayer, Foundation One Inc, Pharmacyclics, Foundation Medicine, Astellas Pharma, Exelixis, Merck, Novartis, Eisai, Seattle Genetics, EMD Serono, Janssen Oncology, AVEO, Calithera Biosciences, MEI Pharma, Genentech
Research Funding (Institution): Bayer, Bristol-Myers Squibb, GlaxoSmithKline, Takeda, Novartis, Pfizer, BN ImmunoTherapeutics, Exelixis, TRACON Pharma, Rexahn Pharmaceuticals, Amgen, AstraZeneca, Active Biotech, Bavarian Nordic, Calithera Biosciences, Celldex, Eisai, Genentech, Immunomedics, Janssen, Merck, Newlink Genetics, Prometheus, Sanofi
Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.