Nivolumab and Ipilimumab Immunotherapy Combination Receives FDA Approval for Kidney Cancer

On 16 April 2018, the United States Food and Drug Administration, FDA, approved combined nivolumab and ipilimumab immunotherapy (Opdivo and Yervoy) for previously untreated, intermediate- or poor-risk advanced (stage 4) renal cell carcinoma.

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Approval was based on CheckMate 214, a randomized, open-label clinical trial. Previously untreated patients with advanced (stage 4) kidney cancer were assigned to two arms. The combination arm received 4 cycles, every 3 weeks, of nivolumab 3 mg/kg plus ipilimumab 1 mg/kg, followed every 2 weeks by nivolumab 3 mg/kg alone. The other arm received each cycle for 4 weeks, daily sunitinib 50 mg (Sutent), followed by a 2-week break.

Efficacy was evaluated in intermediate- or poor-risk patients (n=847). Comparing sunitinib recipients (n=422) with combined nivolumab+ipilimumab, the combination group (n=425) showed statistically significant improvements in overall survival and objective response rate.

Median estimated overall survival was not reached in the combination arm because patients continued responding, versus 25.9 months with sunitinib. Objective response rates were %41.6 with combination therapy and %26.5 with sunitinib.

The most common effects with nivolumab and ipilimumab, occurring in at least %20 of patients, were side effects fatigue, rash, diarrhea, musculoskeletal pain, itching, nausea, cough, fever, joint pain and decreased appetite.

For this combination, the recommended treatment dose is 4 cycles every 3 weeks of nivolumab 3 mg/kg and ipilimumab 1 mg/kg on the same day, followed after these 4 cycles by nivolumab every 2 weeks at 240 mg or every 4 weeks at 480 mg.

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