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Cabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma

In a phase 3 trial of patients with previously untreated, advanced renal-cell carcinoma who had intermediate or poor prognostic risk, cabozantinib plus nivolumab and ipilimumab resulted in significantly longer progression-free survival than treatment with nivolumab and ipilimumab alone, but with more grade 3 or 4 adverse events in the experimental group.

Participants had treatment-naive advanced clear-cell renal-cell carcinoma with intermediate or poor prognostic risk when they were randomized to cabozantinib 40 mg daily in addition to nivolumab and ipilimumab (experimental group) or matched placebo in addition to nivolumab 3 mg/kg and ipilimumab 1 mg/kg (control group) once every 3 weeks for 4 cycles. Patients then received nivolumab maintenance therapy 480 mg once every 4 weeks for up to 2 years.

Based on a primary endpoint of progression-free survival, the investigators found: “Overall, 855 patients underwent randomization: 428 were assigned to the experimental group and 427 to the control group. Among the first 550 patients who had undergone randomization (276 in the experimental group and 274 in the control group), the probability of progression-free survival at 12 months was 0.57 in the experimental group and 0.49 in the control group (hazard ratio for disease progression or death, 0.73; 95% confidence interval, 0.57 to 0.94; P = 0.01); 43% of the patients in the experimental group and 36% in the control group had a response. Grade 3 or 4 adverse events occurred in 79% of the patients in the experimental group and in 56% in the control group. Follow-up for overall survival is ongoing.”

Source: New England Journal of Medicine