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, discusses the superior clinical efficacy and improved quality of life for newly diagnosed patients with metastatic renal cell carcinoma in the CheckMate-9ER trial.

 

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 a promising new first-line treatment for patients with advanced kidney cancer, featured at the 2021 Genitourinary Cancer Symposium.

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, there was a lot of buzz at the symposium over the CheckMate 9ER trial, which showed significantly improved patient-reported quality of life outcomes with first-line nivolumab plus cabozantinib versus sunitinib for patients with advanced kidney cancer. Do you think this study will confirm that the superior clinical efficacy of the first-line doublet versus sunitinib is matched with superior quality of life?

Dr. Neeraj Agarwal: So Geraldine, this is a really interesting question in light of the January 22 U.S. Food and Drug Administration approval of the doublet cabozantinib with nivolumab as first-line treatment for patients with metastatic renal cell carcinoma. Before I delve into your question, let me refresh our listeners' memories on the CheckMate 9ER trial (NCT03141177). This was a phase III trial presented last year that randomly assigned patients with metastatic renal cell carcinoma, glial cell type to either cabozantinib plus nivolumab, the experimental arm, or sunitinib, the control arm. The experimental arm in this study met both primary progression-free survival and secondary endpoint of overall survival, objective responses, and safety with significant improvements in outcomes.

So the patient-reported outcomes, results, presented by Dr. David Cella on the CheckMate 9ER trial, were an exploratory endpoint and made use of the Functional Assessment of Cancer Therapy Kidney Symptom INDEX 19--short form would be FKSI-19--and European quality five-dimensional three-level questionnaires. Quality of life questionnaires were completed at baseline, on treatment visits, and during common follow-up appointments, and changes from the baseline were assessed using mixed-model repeated measures after adjusting for baseline scores and stratification factors.

So to summarize, patients received very extensive questionnaires at different time points during the study to assess how they experienced their own quality of life, as reported by patients themselves, without interference by doctors, by nurses, or by any medical provider in the team. So let's look at the results. Patients on the experimental arm experienced lower treatment burden and decreased risk of confirmed deterioration across most measurements. Hazard ratios for time to confirmed deterioration for all measurements also favor the combination of cabozantinib plus nivolumab.

Therefore, Geraldine, to answer your question, I believe these results indicate that superior clinical efficacy of the combination cabozantinib plus nivolumab over sunitinib is also associated with a significantly improved quality of life for these patients. I think these data will definitely position the combination of cabozantinib plus nivolumab as one of the top choices for our patients with newly diagnosed metastatic renal cell carcinoma, which is a great news for our patients.

ASCO Daily News: Yes, that's a great development for this patient population. Thanks again, Dr. Agarwal, for taking the time to tell us about it today.

Dr. Neeraj Agarwal: Thank you for inviting me, Geraldine. It's always a pleasure.

ASCO Daily News: And thank you to our listeners for joining us today. If you're enjoying the content on the podcast, 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.

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.