Dr. Eggermont on the Rationale for Evaluating Adjuvant Pembrolizumab 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.