THURSDAY, May 11, 2023 (HealthDay News) — Cabozantinib plus nivolumab and ipilimumab yields significantly longer progression-free survival than treatment with cabozantinib plus nivolumab alone among patients with previously untreated, advanced renal-cell carcinoma with intermediate or poor prognostic risk, according to a study published in the May 11 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 double-blind trial involving patients with advanced clear-cell renal-cell carcinoma who had not previously received treatment and who had intermediate or poor prognostic risk. Participants were randomly assigned to cabozantinib daily in addition to nivolumab and ipilimumab (experimental group) or matched placebo in addition to nivolumab and ipilimumab (control group; 428 and 427 patients, respectively). The primary end point was progression-free survival, which was assessed in the first 550 patients to undergo randomization (276 and 274 in the experimental and control groups, respectively).
The researchers found that the probability of progression-free survival at 12 months was 0.57 and 0.49 in the experimental and control groups, respectively (hazard ratio for disease progression or death, 0.73); 43 and 36 percent of patients in the experimental and control groups, respectively, had a response. Grade 3 or 4 adverse events occurred in 79 and 56 percent of patients in the experimental and control groups, respectively.
“Limitations of this trial include the relatively short duration of follow-up in the intention-to-treat population and the fact that the data for overall survival (which is an important end point for clinical implementation of the regimen) are not mature,” the authors write.
The study was funded by Exelixis, the manufacturer of cabozantinib; Bristol-Myers Squibb provided nivolumab and ipilimumab.
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