FDA Approves Pembrolizumab in Adjuvant Treatment of Melanoma
Posted: Wednesday, February 20, 2019
On February 19, 2019, the U.S. Food and Drug Administration (FDA) approved the anti–PD-1 therapy pembrolizumab (Keytruda) in the adjuvant treatment of patients with melanoma with involvement of lymph node(s) after complete resection.
Approval was based on the results from the EORTC1325/KEYNOTE-054 trial (ClinicalTrials.gov identifier NCT02362594). This phase III trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer, demonstrated that patients with resected, high-risk stage III melanoma who received pembrolizumab experienced fewer recurrences/deaths, 26% (n = 135), than those who received placebo, 43% (n = 216). Pembrolizumab is the first ant–-PD-1 therapy studied in the adjuvant setting across patients with stages IIIA, IIIB, and IIIC melanoma.
A total of 76% of patients received pembrolizumab for 6 months or longer. Pembrolizumab was discontinued for adverse reactions in 14% of patients. The most common adverse reactions were diarrhea, pruritus, nausea, arthralgia, hypothyroidism, cough, rash, asthenia, influenza-like illness, weight loss, and hyperthyroidism.