Exelixis, Inc. announced final results from the phase 3 CheckMate -9ER pivotal trial evaluating CABOMETYX^® (cabozantinib) in combination with Opdivo^® (nivolumab) versus sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC). After more than five years of follow-up, the findings demonstrated that efficacy benefits with CABOMETYX in combination with Opdivo were sustained long term. These results, including subgroup analyses, will be presented at 8:10 a.m. PT on February 15 during Oral Abstract Session C: Renal Cell Cancer and Testicular Cancer at the American Society of Clinical Oncology 2025 Genitourinary Cancers Symposium (ASCO GU).

“In this evolving treatment landscape for renal cell carcinoma, patients are looking for options that have shown improved survival time in the long-term,” said Robert J. Motzer, M.D., Kidney Cancer Section Head, Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center. “These final five-year results from CheckMate -9ER demonstrated the durable clinical benefits of cabozantinib in combination with nivolumab—including for those with organ metastases or intermediate- or poor-risk disease classifications—and continue to support this combination regimen as a valuable first-line option for this patient population.”

At a median follow-up of 67.6 months, CABOMETYX in combination with Opdivo improved progression-free survival (PFS; hazard ratio [HR]: 0.58; 95% confidence interval [CI]: 0.49-0.70) and overall survival (OS; HR: 0.79; 95% CI: 0.65-0.96) compared with sunitinib in the intent-to-treat population. A subgroup analysis by International Metastatic RCC Database Consortium (IMDC) risk showed PFS and objective response rates (ORR) favored CABOMETYX in combination with Opdivo versus sunitinib regardless of IMDC risk group.