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Nivolumab Plus Cabozantinib Tops Sunitinib for Renal Cell Carcinoma

WEDNESDAY, March 3, 2021 -- For patients with previously untreated advanced renal cell carcinoma, nivolumab plus cabozantinib has significant benefits over sunitinib with respect to progression-free and overall survival, according to a study published in the March 4 issue of the New England Journal of Medicine.

Toni K. Choueiri, M.D., from the Dana-Farber Cancer Institute in Boston, and colleagues conducted a phase 3, randomized, open-label trial involving adults with previously untreated clear-cell, advanced renal cell carcinoma with clear-cell histologic features. Participants were randomly assigned to receive either nivolumab plus cabozantinib or sunitinib (323 and 328 patients, respectively).

The researchers found that median progression-free survival was 16.6 and 8.3 months for nivolumab plus cabozantinib and sunitinib, respectively, at a median follow-up of 18.1 months (hazard ratio for disease progression or death, 0.51). At 12 months, the probability of overall survival was 85.7 and 75.6 percent for nivolumab plus cabozantinib and sunitinib, respectively (hazard ratio for death, 0.60). An objective response occurred in 55.7 and 27.1 percent of those receiving nivolumab plus cabozantinib and sunitinib, respectively. Adverse events of any cause of grade 3 or higher occurred in 75.3 and 70.6 percent of those receiving nivolumab plus cabozantinib and sunitinib, respectively. Overall, 19.7 and 5.6 percent of patients in the combination group discontinued at least one or both of the drugs, respectively, due to adverse events. Better patient-reported health-related quality of life was seen with nivolumab plus cabozantinib versus sunitinib.

"These results are consistent with previous data suggesting that cabozantinib may enhance immune-checkpoint inhibition," the authors write.

The study was funded by Bristol Myers Squibb in collaboration with Ono Pharmaceutical, Exelixis, Ipsen Pharma, and Takeda Pharmaceutical.

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