- 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.
- 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.
- 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.