Feb 16, 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, 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.