Adding cabozantinib (Cabometyx) to nivolumab (Opdivo) and ipilimumab (Yervoy) improved progression-free survival (PFS) in patients with previously untreated advanced intermediate- or poor-risk renal cell carcinoma (RCC), according to the primary analysis of the ongoing phase COSMIC-313 trial.1
The findings, which were announced by cabozantinib developer Exelixis in a news release, showed that compared with nivolumab/ipilimumab alone, the triplet of cabozantinib plus the immune checkpoint inhibitors led to a 27% reduction in the risk of disease progression or death (hazard ratio, 0.73; 95% CI, 0.57-0.94; P = .01).
Exelixis also reported that the results of a prespecified interim analysis did not show a significant overall survival (OS) benefit for the triplet versus the doublet, and thus the trial is continuing to next OS analysis.
The company plans to present additional data from the trial at an upcoming medical conference and discuss the top level results with the FDA regarding a potential application submission for the triplet in this setting.
"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," 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, stated in the news release. "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."
Overall, the multicenter, double-blinded, phase 3 COSMIC-313 trial included 855 patients at 177 international locations. Patientswere randomized in a 1:1 ratio to nivolumab and ipilimumab plus either cabozantinib or placebo
According to Exelixis there were no new safety signals compared with previous trials of the drugs both as monotherapies and in the combinations used in the trial.
"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," Vicki L. Goodman, MD, executive vice president, Product Development & Medical Affairs, and chief medical officer, Exelixis, stated in the news release. "With these findings in hand, we look forward discussing the results with the FDA and presenting the data at a future medical meeting."
1. Exelixis Announces Cabozantinib in Combination with Nivolumab and Ipilimumab Significantly Improved Progression-Free Survival in Phase 3 COSMIC-313 Pivotal Trial in Patients with Previously Untreated Advanced Kidney Cancer. Published online July 11, 2022. Accessed July 11, 2022. https://yhoo.it/3ypCimU