Positive topline results from pivotal phase III CheckMate -9ER trial of Cabometyx v. sunitinib for advanced renal cell carcinoma.-BMS + Exelixis

Bristol Myers Squibb and Exelixis, Inc. announced that CheckMate -9ER, a pivotal Phase III trial evaluating Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), met its primary endpoint of progression-free survival (PFS) at final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR). The safety profiles of Opdivo and Cabometyx observed in the trial reflect the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in first-line RCC.

“The results from the pivotal CheckMate -9ER trial clearly demonstrate the combination of cabozantinib plus nivolumab provides a clinically meaningful benefit in the key efficacy measures of progression-free survival and overall survival for previously untreated kidney cancer patients,” said Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School. “Preliminary assessment of the data shows the combination of a 40mg dose of cabozantinib plus nivolumab demonstrated a favorable safety profile. If approved, this combination may become an important new first-line option for patients with metastatic renal cell carcinoma. We look forward to presenting detailed results at an upcoming congress.”

About CheckMate -9ER : CheckMate -9ER is an open-label, randomized, multi-national Phase III trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma. Patients are randomized 1:1 to Opdivo and Cabometyx or sunitinib. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS) and objective response rate (ORR). The primary efficacy analysis is comparing the doublet combination versus sunitinib in all randomized patients. The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.

The companies plan to submit detailed results of CheckMate -9ER for presentation at an upcoming medical conference.

Comment:The Opdivo-Cabometyx combination reduced the risk patient tumors would return or grow by 49% when compared to Sutent. An interim analysis of patients also showed the combination reduced the risk of death by 40% versus Sutent.