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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.



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

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.