The phase III CheckMate-9ER trial evaluating Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma met its primary endpoint of progression-free survival at final analysis.
CheckMate-9ER has also met secondary endpoints of overall survival at a prespecified interim analysis, and objective response rate.
Opdivo is sponsored by Bristol-Myers Squibb, and Cabometyx is sponsored by Exelixis. The trial is sponsored by BMS and Ono Pharmaceutical Co. and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Ltd.
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. Secondary endpoints include overall survival and objective response rate. The primary efficacy analysis is comparing the doublet combination versus sunitinib in all randomized patients.
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,” 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, said in a statement.
