Mario Sznol, MD, from the Yale Cancer Center, discusses the long-term follow-up results from a phase I trial investigating the anti-PD-1 monoclonal antibody nivolumab.
Mario Sznol, MD, a professor of medical oncology at the Yale Cancer Center in New Haven, Connecticut, discusses the long-term follow-up results from a phase I trial investigating the anti-PD-1 monoclonal antibody nivolumab.
In patients with previously treated melanoma, overall survival was 16.8 months, which compares well to other agents, Sznol suggests. Objective response rates were 31% with a median duration of response around 2 years, which are very high numbers, Sznol notes.
Nivolumab is a very well tolerated drug, Sznol says. The rates of grade 3/4 adverse events (AEs) were 14% with 5% experiencing select immune-related AEs. Only 6% of patients discontinued treatment due to toxicity. Pneumonitis caused concerns in earlier trials; however, proper side effect management prevented it from occurring.
Additional activity was observed in several patients outside of those classified by RECIST criteria. A prolongation in stable disease was observed in 11% of patients with 4 patients experiencing unconventional responses, characterized by tumor growth followed by shrinkage. These data will ultimately be reflected in the survival curve in the future phase III trial.