The Efficacy of Nivolumab in Advanced Melanoma

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.

Clinical Pearls

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.

• In patients with previously treated melanoma, overall survival was 16.8 months with nivolumab
• Treatment with nivolumab resulted in a 31% objective response rate with a median duration of response of approximately 2 years
• Grade 3/4 AEs occurred in 14% of patients with 5% experiencing select immune-related AEs and 6% discontinuing treatment
• Pneumonitis was effectively managed and did not cause additional mortality
• Additional activity was observed in several patients outside of those classified by RECIST criteria