Adjuvant Pembrolizumab Reduces Risk of Recurrence in Stage III Melanoma

Adjuvant pembrolizumab may improve recurrence-free survival (RFS) among patients with high-risk stage III melanoma, according to research presented at the 2018 American Association for Cancer Research Annual Meeting in Chicago, Illinois.¹

Nivolumab, a PD-1 inhibitor, and ipilimumab, a CTLA-4 inhibitor, are approved by the US Food and Drug Administration (FDA) as adjuvant therapies for high-risk stage III melanoma. For the randomized phase 3 EORTC 1325/KEYNOTE-054 study (ClinicalTrials.gov Identifier: NCT02362594), researchers evaluated whether adjuvant pembrolizumab, a PD-1 inhibitor, would improve outcomes in this patient population vs placebo.

Among 1019 enrolled patients, 15%, 46.5%, and 37.5% patients had stage IIIA, IIIB, and IIIC disease, respectively. Patients were randomly assigned to receive pembrolizumab (N = 514) or placebo (N = 505) for 1 year or until disease recurrence. Those without brain metastases who had disease recurrence were eligible for crossover or re-challenge depending on initial assignment.

Median follow-up was 1.25 years. In the pembrolizumab and placebo groups there were 135 and 216 events, respectively, corresponding to a 12-month RFS rate of 75.4% vs 61% (hazard ratio, 0.57; P < .0001). Improvement in RFS was seen regardless of PD-L1 status.

Grade 3 to 5 adverse events were noted in 14.7% of patients treated with pembrolizumab vs 3.4% of patients who received placebo. One patient died of pembrolizumab-related myositis.

The authors concluded that as “adjuvant therapy for resected high-risk stage III melanoma pembrolizumab 200 mg every 3 weeks, for up to 1 year, resulted in significantly prolonged RFS with a favorable benefit-risk profile.”

Read more of Cancer Therapy Advisor‘s coverage of the American Association for Cancer Research (AACR) 2018 meeting by visiting the conference page.

Reference

1. Eggermont AMM, Blank CU, Mandala M, et al. Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: efficacy and safety results from the EORTC 1325-MG/Keynote 054 double-blinded phase III trial. Oral presentation at: 2018 American Association for Cancer Research Annual Meeting; April 14-18, 2018; Chicago, IL.