FDA Approves Opdivo Plus Yervoy Combination for Certain Renal Cell Carcinoma

Regimen showed significant improvement in overall survival in trial versus Sutent

The FDA has granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb) in combination for the treatment of intermediate- or poor-risk, previously untreated advanced renal cell carcinoma (RCC).

The approvals were based on CheckMate 214 (NCT02231749), a randomized open-label trial. Patients with previously untreated advanced RCC received nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every three weeks for four doses followed by nivolumab monotherapy (3 mg/kg) every two weeks, or sunitinib (Sutent, Pfizer) 50 mg daily for four weeks followed by two weeks off every cycle.

Efficacy was evaluated in intermediate- or poor-risk patients (N = 847). The trial demonstrated statistically significant improvements in overall survival (OS) and objective response rate (ORR) for patients receiving the combination (n = 425) compared with those receiving sunitinib (n = 422). Estimated median OS was not estimable in the combination arm compared with 25.9 months in the sunitinib arm (hazard ratio, 0.63; 95% confidence interval [CI], 0.44–0.89; P < 0.0001). 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 < 0.0001). The efficacy of the combination in patients with previously untreated renal cell carcinoma with favorable-risk disease was not established.

The most common adverse reactions (reported in at least 20% of patients treated with the combination) were fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite.

The recommended schedule and dose for this combination is nivolumab, 3 mg/kg, followed by ipilimumab, 1 mg/kg, on the same day every three weeks for four doses, then nivolumab, 240 mg, every two weeks or 480 mg every four weeks.

Source: FDA; April 16, 2018.