The Food and Drug Administration has granted approvals to checkpoint inhibitors nivolumab and ipilimumab in combination for the treatment of intermediate- or poor-risk, previously untreated advanced renal cell carcinoma.
The approvals were based on statistically significant improvements in overall survival (OS) and objective response rate (ORR) for patients receiving the combination of nivolumab and ipilimumab (n = 425), compared with those receiving sunitinib (n = 422) in CheckMate 214, the FDA said in a press statement.
In the randomized, open-label trial, patients with previously untreated advanced renal cell carcinoma received nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for four 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.
Median OS was not yet reached in the combination arm at follow-up of 32 months, compared with 25.9 months in the sunitinib arm (hazard ratio, 0.63; 95% confidence interval, 0.44-0.89; P less than .0001). The ORR was 41.6% (95% CI, 36.9-46.5) for the combination versus 26.5% (95% CI, 22.4-31) in the sunitinib arm (P less than .0001).
Efficacy of the combination was not established for patients with favorable-risk disease.
The most common adverse reactions were fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite.