Adjuvant Pembrolizumab Reduces Risk of Recurrence in Stage III Melanoma
Improvement in RFS was seen regardless of PD-L1 status.
|The following article features coverage from the American Association for Cancer Research (AACR) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
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.”
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- 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.