Dr. Weber on FDA Approval of Pembrolizumab for Stage III Melanoma

Jeffrey S. Weber, MD, PhD, deputy director and co-director of the Melanoma Program, NYU Langone’s Perlmutter Cancer Center, 2016 Giant of Cancer Care in Melanoma, discusses the FDA approval of pembrolizumab for stage III melanoma.

The FDA approved the PD-1 inhibitor pembrolizumab for the adjuvant treatment of patients with high-risk stage III melanoma with lymph node involvement following complete resection in February 2019, making it the first anti—PD-1 therapy evaluated in the adjuvant setting across patients with stage IIIA, stage IIIB, and stage IIIC melanoma.

The decision is based on data from the pivotal phase III EORTC 1325/KEYNOTE-054 trial, in which adjuvant pembrolizumab led to a 43% reduction in the risk of disease recurrence or death compared with placebo in this patient population (HR, 0.57; 95% CI, 0.46-0.70; P <.001).