Positive results from CheckMate-037, a Phase III, randomized, controlled, open-label study of nivolumab (Opdivo, Bristol-Myers Squibb), versus investigator’s choice chemotherapy (ICC) in patients with advanced melanoma who were previously treated with ipilimumab (Yervoy, Bristol-Myers Squibb) were recently presented at the European Society for Medical Oncology meeting. Nivolumab is an investigational PD-1 immune checkpoint inhibitor.
Based on a planned interim analysis of the co-primary endpoint, the objective response rate (ORR) was 32% (95% confidence interval (CI) = 24, 41) in the nivolumab arm (N=120) and 11% (95% CI = 4, 23) in the ICC reference arm (N=47) in patients with at least 6 months of follow-up. The majority (95%) of responses were ongoing in the nivolumab arm and the median duration of response was not reached. ORR was based on RECIST criteria as evaluated by an independent radiologic review committee.
Overall frequency of adverse events was lower with nivolumab compared to chemotherapy; nivolumab treatment-related adverse events were managed using recommended treatment algorithms.
