FDA Approval Insights: Nivolumab/Cabozantinib in Advanced RCC

Welcome to OncLive^® On Air! I’m your host today, Jessica Hergert.

OncLive On Air^TM is a podcast from OncLive, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

Today, we had the pleasure of speaking with Toni K. Choueiri, MD, director of the Lank Center for Genitourinary Oncology, director of the Kidney Cancer Center, and senior physician at Dana-Farber Cancer Institute, as well as the Jerome and Nancy Kohlberg chair and professor of medicine at Harvard Medical School, to discuss the FDA approval of nivolumab (Opdivo) and cabozantinib (Cabometyx) in advanced renal cell carcinoma (RCC).

On January 22, 2021, the FDA approved the combination of cabozantinib and nivolumab for the frontline treatment of patients with advanced RCC. The regulatory decision was based on findings from the phase 3 CheckMate-9ER trial in which the combination led to an improvement in overall survival, progression-free survival, and overall response rate versus sunitinib (Sutent).

Additionally, health-related quality-of-life (QOL) data, which were presented during the 2020 ESMO Virtual Congress, showed that patients who received the combination experienced a significant improvement in QOL versus sunitinib.

Although other combinations are approved in the frontline setting, the combination of cabozantinib and nivolumab is unique in that it demonstrated benefit across all patient subgroups, irrespective of International Metastatic RCC Database Consortium risk score, said Choueiri.

In our exclusive interview, Choueiri provided additional perspective on the FDA approval of nivolumab and cabozantinib in advanced RCC.