Alexander M. M. Eggermont, MD, PhD, discusses the rationale for the phase 3 EORTC 1325/KEYNOTE-054 trial, evaluating adjuvant pembrolizumab versus placebo, in advanced melanoma.
Alexander M. M. Eggermont, MD, PhD, professor of oncology, University of Paris-Sud, professor of oncological surgery, chair, International Research Network on Cancer, Erasmus University of Rotterdam, Joseph Maisin Honorary Chair of Oncological Surgery, Louvain Catholic University, discusses the rationale for the phase 3 EORTC 1325/KEYNOTE-054 trial, evaluating adjuvant pembrolizumab (Keytruda) versus placebo, in advanced melanoma.
Early research showed response rates of about 45% to 50%, as well as 5-year overall survival rates of about 45%, with pembrolizumab (Keytruda) in treatment-naïve patients with advanced melanoma, says Eggermont.
As such, the phase 3 KEYNOTE-054 trial further evaluated pembrolizumab in the adjuvant setting versus placebo in patients with resected, high-risk, stage III melanoma, says Eggermont.
The trial randomized 1019 lymph node–positive patients to pembrolizumab at a flat dose of 200 mg or placebo every 3 weeks for 1 year or until recurrence or unacceptable toxicity.
The primary end point of the study was recurrence-free survival; secondary end points included distant metastasis-free survival and overall survival, concludes Eggermont.