Cabozantinib plus nivolumab/ipilimumab meets PFS endpoint in RCC trial

The phase 3 COSMIC-313 trial evaluating the combination of cabozantinib, nivolumab, and ipilimumab versus the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk renal cell carcinoma (RCC) met its primary endpoint of progression-free survival (PFS), according to a press release.

“As the treatment landscape continues to evolve, resulting in more options for advanced kidney cancer, there is still a need for additional effective first-line treatment options for patients with intermediate- or poor-risk disease,” said Toni Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School. “These initial findings from COSMIC-313 suggest that the triplet combination of cabozantinib, nivolumab and ipilimumab may have potential to serve as an additional option for this patient population.”

“COSMIC-313 is the first trial to show that a tyrosine kinase inhibitor added to dual checkpoint inhibition can improve progression-free survival in patients with advanced kidney cancer,” said Vicki L. Goodman, MD, Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “With these findings in hand, we look forward discussing the results with the FDA and presenting the data at a future medical meeting.”

At a prespecified interim analysis for the secondary endpoint of overall survival (OS), the triple combination treatment did not demonstrate a significant benefit versus the combination of nivolumab and ipilimumab. The trial will continue to the next analysis of OS.