Nivolumab, Cabozantinib Demonstrate Positive Results in Treating Renal Cell Carcinoma


The phase 3 trial evaluating nivolumab in combination with cabozantinib demonstrated positive results in the treatment of renal cell carcinoma (RCC).

Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults in the world, accounting for 140,000 deaths annually. Currently, the 5-year survival rate for those diagnosed with metastatic kidney cancer is 12.1%.1

On April 20, the CheckMate -9ER phase 3 trial evaluating nivolumab (Opdivo, Bristol Myers Squibb and Exelixis) in combination with cabozantinib (Cabometyx, Bristol Myers Squibb and Exelixis) demonstrated positive results in the treatment of RCC. When compared with sunitinib in previously untreated advanced or metastatic RCC, the results of the trial met the 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.1

In CheckMate -9ER, researchers evaluated patients with previously untreated metastatic RCC in a randomized 1-to-1 trial with nivolumab and cabozantinib or sunitinib. The researchers analyzed the primary efficacy of the treatments by comparing the doublet combination versus sunitinib in all of the randomized patients.1

The results from the trial demonstrated that combination therapy with cabozantinib and nivolumab offer a clinically meaningful benefit in the key efficacy measures of PFS and OS for patients with kidney cancer who had been previously untreated, explained Toni Choueiri, MD, 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, in a press release.1

The researchers also found that the combination of a 40 mg dose of cabozantinib plus nivolumab demonstrated a favorable safety profile, reflecting the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in first-line RCC.1

“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,” Choueiri said.1


  • Bristol Myers Squibb and Exelixis Announce Positive Topline Results from Pivotal Phase 3 CheckMate -9ER Trial Evaluating Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Previously Untreated Advanced Renal Cell Carcinoma [news release]. Princeton, NJ: Bristol Myers Squibb; April 20, 2020. Accessed April 20, 2020.

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