FDA approves adjuvant pembrolizumab for stage III melanoma

  • U.S. Food and Drug Administration

  • curated by Brian Richardson, PhD
  • Univadis Clinical Summaries
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Takeaway

  • The FDA has approved pembrolizumab for adjuvant treatment of melanoma with lymph node involvement after complete resection.

Why this matters

  • Pembrolizumab was previously indicated for the treatment of unresectable or metastatic melanoma.

Key results

  • Median recurrence-free survival (RFS) was not reached in patients who received pembrolizumab and was 20.4 months in patients who received placebo.
  • Pembrolizumab was associated with fewer recurrences/deaths compared with placebo (26% vs 43%; HR, 0.57; P<.001 style="list-style-type:circle;">
  • This RFS benefit was observed regardless of tumor PD-L1 expression status.
  • 76% of patients received pembrolizumab for ≥6 months.
  • 14% of patients discontinued pembrolizumab because of adverse reactions.
  • The most common adverse events (≥10% of pembrolizumab recipients) were diarrhea, pruritus, nausea, arthralgia, hypothyroidism, cough, rash, asthenia, influenza-like illness, weight loss, and hyperthyroidism.
  • Study design

    • Approval was based on results from the KEYNOTE-054 study, a randomized, double-blind, placebo-controlled trial that included 1019 patients with completely resected, stage IIIA (>1 mm lymph node metastasis), IIIB, or IIIC melanoma.
    • 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.

    Prescribing information, click here.

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