(HealthDay News) — Adding cabozantinib to first-line treatment with ipilimumab plus nivolumab improved progression-free survival (PFS) in patients with advanced, intermediate- or poor-risk renal cell carcinoma (RCC), according to a study published in The New England Journal of Medicine.
Researchers conducted a phase 3, double-blind trial of patients with advanced clear-cell RCC who had not previously received treatment and who had intermediate or poor prognostic risk.
Patients were randomly assigned to receive cabozantinib (n=428) or placebo (n=427), each in combination with nivolumab and ipilimumab. The median duration of treatment exposure was 10.9 months in the triplet arm and 10.3 months in the doublet arm.
The objective response rate was 50% in the triplet arm and 41% in the doublet arm. The complete response rate was 4% and 5%, respectively. The median duration of response was 18.7 months and not reached, respectively.
The median PFS was not reached in the triplet arm and was 11.3 months in the doublet arm (hazard ratio, 0.73; 95% CI, 0.57-0.94; P =.01). The researchers noted that follow-up for overall survival is ongoing.
Adverse events (AEs) that were considered treatment-related occurred in 99% of patients in the triplet arm and 91% in the doublet arm. Grade 3-4 treatment-related AEs occurred in 73% and 41%, respectively.
The most common grade 3-4 treatment-related AEs were alanine aminotransferase increase (26% in the triplet arm and 6% in the doublet arm) and aspartate aminotransferase increase (20% and 5%, respectively).
This study was funded by Exelixis, the manufacturer of cabozantinib. Bristol-Myers Squibb provided nivolumab and ipilimumab.
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