Dr. Choueiri on the FDA Approval of Nivolumab/Cabozantinib in mRCC

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, discusses the FDA approval of nivolumab (Opdivo) and cabozantinib (Cabometyx) in metastatic renal cell carcinoma (mRCC).

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, which showed that the combination improved overall survival, progression-free survival, and overall response rate compared with sunitinib (Sutent) as frontline treatment for this patient population. Ultimately, the combination induced a 49% reduction in the risk of disease progression or death compared with sunitinib.

Moreover, during the 2020 ESMO Virtual Congress, health-related quality-of-life (QOL) data showed that patients who received cabozantinib plus nivolumab had significantly better QOL versus sunitinib.

Although other combinations of immunotherapy and VEGF inhibitors, including nivolumab plus ipilimumab (Yervoy), are approved in this space, the combination of cabozantinib/nivolumab is unique in that it demonstrated benefit across all patient subgroups, irrespective of International Metastatic RCC Database Consortium risk score, concludes Choueiri.