FDA Approves Combination Immunotherapy for Renal Cell Carcinoma

The FDA has approved the combination of nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) to treat intermediate- or poor-risk advanced renal cell carcinoma that was previously untreated.

The approval is based on data from the randomized, open-label CheckMate 214 trial, which included 1082 patients with previously untreated renal cell carcinoma. Efficacy was assessed in 847 intermediate- or poor-risk patients. The trial gave eligible patients nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for 4 doses followed by nivolumab monotherapy (3 mg/kg) every 2 weeks, or sunitinib 50 mg daily for 4 weeks followed by 2 weeks off every cycle.

The 425 patients who received the combination therapy showed statistically significant improvements in overall survival (OS) and in objective response rate (ORR), compared with the 422 patients who received sunitinib.

Estimated median OS was not estimable in the combination arm, though it was 25.9 months in the sunitinib arm (hazard ratio 0.63; P<0.0001). The ORR was 41.6% for patients receiving combination treatment versus 26.5% for those receiving sunitinib arm. The efficacy of the combination in patients with previously untreated renal cell carcinoma with favorable-risk disease was not established, so the combination has not been approved for that group of patients.

At least 20% of patients in the combination arm reported adverse reactions that included fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite.

“Our goal is to provide cancer patients with medicines that have the potential to extend their lives. As the first treatment option to increase overall survival for subgroups of patients with advanced RCC compared to sunitinib, the Opdivo plus low-dose Yervoy combination helps deliver on that promise,” said Johanna Mercier, head, U.S. Commercial, Bristol-Myers Squibb, stated in a press release.


FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma [press release]. U.S. Food and Drug Administration. Silver Springs, MD. April 16, 2018.