Opdivo Plus Cabometyx Demonstrates Significant Improvement in PFS and OS in Phase 3 CheckMate-9ER Trial for First-Line Treatment of Advanced Renal Cell Carcinoma

On April 20, BMS/Exelixis announced positive first-line results from the pivotal Phase III CheckMate -9ER study. The study primarily evaluated the efficacy and safety differences of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) versus sunitinib as first-line treatment for advanced or metastatic renal cell carcinoma (RCC).

The prespecified interim analysis results showed that the CheckMate -9ER study met its primary endpoint of improved progression-free survival (PFS), as well as secondary endpoints of improved overall survival (OS) and objective response rate (ORR). In terms of safety, no adverse events beyond expectations were observed. The two companies plan to present detailed data at an upcoming medical conference.

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, causing more than 140,000 deaths worldwide each year. The incidence of kidney cancer in men is approximately twice that in women, with the highest rates observed in North America and Europe. Globally, the five-year survival rate for patients with metastatic or advanced renal cell carcinoma is 12.1%.

Brian Lamon, Ph.D., Head of Genitourinary Cancer Research at Bristol-Myers Squibb (BMS), stated, “The positive results from the CheckMate -9ER study regarding the combination of Opdivo and Cabometyx further enhance our understanding of Opdivo as a foundational therapy in oncology. We look forward to collaborating with global health authorities to make this new combination regimen available to patients with previously untreated renal cell carcinoma. Although progress has been made in the treatment of renal cell carcinoma in recent years, there remains a need for additional therapies that can extend survival.”

Gisela Schwab, President of Product Development and Medical Affairs and Chief Medical Officer at Exelixis, stated, “An increasing body of data suggests that cabozantinib may create a microenvironment more conducive to the activity of immunotherapeutic agents, thereby potentially enhancing the efficacy of immune checkpoint inhibitors. We have eagerly awaited the results of the study evaluating cabozantinib in combination with Opdivo as first-line treatment for renal cell carcinoma, and we are pleased that the study met its primary endpoint of progression-free survival, as well as the secondary endpoints of overall survival and objective response rate, demonstrating the sustained benefit of this combination in patients with previously untreated renal cell carcinoma. We look forward to continuing our collaboration with BMS to submit marketing applications to regulatory authorities as soon as possible.”