Jeffrey S. Weber, MD, PhD, discusses the phase III EORTC1325/KEYNOTE-054 trial, which looked at adjuvant pembrolizumab in patients with 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 phase III EORTC1325/KEYNOTE-054 trial, which looked at adjuvant pembrolizumab (Keytruda) in patients with stage III melanoma.
In the trial, investigators evaluated pembrolizumab versus placebo as adjuvant therapy in patients with stage III resected high-risk melanoma, as determined by the American Joint Committee on Cancer seventh edition staging criteria, explains Weber. The primary endpoint was recurrence-free survival (RFS). Data from the trial, which were published in The New England Journal of Medicine, served as the basis for the FDA approval of pembrolizumab as adjuvant therapy in this indication in February 2019, says Weber.
At a median follow-up of 15 months, pembrolizumab showed a 43% reduction in the risk of disease recurrence or death compared with placebo in patients with resected, high-risk stage III melanoma. Notably, the 18-month RFS rate was 71.4% with pembrolizumab versus 53.2% with placebo. These data demonstrate that pembrolizumab is an effective adjuvant therapy for patients with stage III melanoma, concludes Weber.