Pembrolizumab gains FDA approval for MCC

  • FDA

  • de Brian Richardson, PhD
  • Résumé d’articles
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Takeaway

  • The FDA has granted accelerated approval to pembrolizumab, a programmed cell death-ligand 1 (PD-L1) inhibitor, for treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Why this matters

  • MCC is a rare cancer type that is often fatal.

Key results

  • Pembrolizumab 2 mg/kg every 3 weeks was associated with an overall response rate of 56% and a complete response rate of 24%.
    • The median response duration was not reached.
  • Among responders, 96% had response durations of >6 months and 54% had response durations of >12 months.
  • The most common adverse reactions (reported in ≥20% of patients who received pembrolizumab as a single agent) were fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.

Study design

  • Approval was based on the KEYNOTE-017, a multicenter, nonrandomized, open-label trial that enrolled 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy.
  • Funding: Pembrolizumab is manufactured by Merck & Co., Inc., Kenilworth, NJ, USA.