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FDA Approves Adjuvant Pembrolizumab for Melanoma

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On February 15, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with melanoma with lymph node involvement following complete resection.

Approval was based on the phase III EORTC1325/KEYNOTE-054 trial, a randomized, double-blind, placebo-controlled study in 1,019 patients with completely resected stage IIIA (> 1 mm lymph node metastasis), IIIB, or IIIC melanoma. Patients with mucosal or ocular melanoma were not eligible. Patients were randomly assigned (1:1) to receive pembrolizumab 200 mg every 3 weeks or placebo for up to 1 year until disease recurrence or unacceptable toxicity. Enrollment required complete resection of melanoma with negative margins, lymph node dissection, and completion of radiotherapy (if indicated) within 13 weeks prior to starting treatment.

The primary efficacy outcome measure was recurrence-free survival (RFS), as assessed by investigators per RECIST version 1.1. RFS was defined as the time between the date of randomization and first recurrence (local, regional, or distant metastasis) or death from any cause, whichever occurred first.

Patients receiving pembrolizumab experienced fewer recurrences/deaths, 26% (n = 135), compared with 43% (n = 216) on the placebo arm (hazard ratio = 0.57; 95% confidence interval = 0.46–0.70; P < .001). The RFS benefit for pembrolizumab compared with placebo was observed regardless of tumor programmed cell death ligand 1 expression. Median RFS was 20.4 months in the placebo arm vs not reached for those receiving pembrolizumab.

Seventy-six percent of patients received pembrolizumab for 6 months or longer. Pembrolizumab was discontinued for adverse reactions in 14% of patients. The most common adverse reactions (reported in at least 10% of patients treated with pembrolizumab) were diarrhea, pruritus, nausea, arthralgia, hypothyroidism, cough, rash, asthenia, influenza-like illness, weight loss, and hyperthyroidism.

The recommended pembrolizumab dose and schedule for the adjuvant treatment of melanoma is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease recurrence or unacceptable toxicity for a maximum of 1 year.

The FDA granted this application standard review and Orphan Drug designation. View the full prescribing information for pembrolizumab.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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