Results from the pivotal phase 3 CheckMate-9ER clinical trial evaluating nivolumab (Opdivo) in combination with cabozantinib (Cabometyx) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC) were released today. These top-line results were positive for the combination treatment, which improved progression-free survival, overall survival and objective response rate compared to sunitinib.
The safety profile of the nivolumab plus cabozantinib combination was similar to that seen in other immunotherapy and tyrosine kinase inhibitor combinations used for the first-line treatment of advanced or metastatic 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, from the Dana-Farber Cancer Institute and Harvard Medical School. “Preliminary assessment of the data shows the combination of a 40mg dose of cabozantinib plus nivolumab demonstrated a favourable 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.”