Bristol Myers Squibb and Exelixis have announced that a late-stage study testing a combination of Opdivo (nivolumab) and Cabometyx (cabozantinib) has hit its primary target of extending progression-free survival in certain patients with kidney cancer.
The Phase III CheckMate-9ER trial, which is evaluating the combination compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), also achieved secondary targets of of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR).
Also of note, the firms said that 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.
“Given the growing body of data showing that Cabometyx may create a more immune-permissive tumour environment that may enhance response to immune checkpoint inhibitors, we have been eagerly awaiting the results for the combination of cabozantinib and nivolumab in previously untreated renal cell carcinoma,” said Gisela Schwab, president, product development and medical affairs and chief medical officer at Exelixis.
“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,” added 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.
“If approved, this combination may become an important new first-line option for patients with metastatic renal cell carcinoma.”
The companies plan to submit detailed results of CheckMate-9ER for presentation at an upcoming medical conference.