FDA Approves Combo Tx for Intermediate, Poor-Risk Advanced Kidney Cancer

The FDA approval was supported by data from CheckMate 214
The FDA approval was supported by data from CheckMate 214

The Food and Drug Administration (FDA) has approved nivolumab (Opdivo; Bristol-Myers Squibb) and ipilimumab (Yervoy; Bristol-Myers Squibb) as combination therapy for the treatment of intermediate or poor-risk, previously untreated advanced renal cell carcinoma (RCC)

The FDA approval was supported by data from CheckMate 214, a randomized, open-label trial that enrolled patients with previously untreated advanced RCC. Patients received nivolumab 3mg/kg/ + ipilimumab 1mg/kg every 3 weeks for 4 doses followed by nivolumab monotherapy every 2 weeks or sunitinib 50mg daily for 4 weeks, followed by 2 weeks off every cycle. 

Among intermediate or poor-risk patients (N=847) who received the combination therapy, there was a statistically significant improvement in overall survival (OS) and objective response rate (ORR) vs patients who received sunitinib alone. The median OS was not estimable in the combination arm vs 25.9 months in the sunitinib arm (hazard ratio [HR] 0.63, 95% CI: 0.44 0.89; P<0.0001) but the ORR was greater in the combination arm vs sunitinib arm (41.6% vs 26.5%; P<0.0001). 

At the time of analysis, the efficacy of the combination therapy in patients with previously untreated RCC with favorable-risk disease was not established. 

Regarding safety, the most frequent adverse reactions (at least 20%) were fatigue, rash, diarrhea, musculoskeletal pain, pruritus, nausea, cough, pyrexia, arthralgia, and decreased appetite. 

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Opdivo, a human programmed death receptor-1 (PD-1)-blocking antibody, is already approved to treat various renal carcinomas, urothelial carcinomas, colorectal and hematologic cancers, certain melanomas, and metastatic non-small cell lung cancer (NSCLC). Yervoy, a cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody, is indicated to treat certain unresectable or metastatic melanomas as well as certain cutaneous melanomas. 

For more information call (800) 321-1335 or visit FDA.gov.