Melanoma: 5-year pembrolizumab data from KEYNOTE-001

  • Hamid O & al.
  • Ann Oncol
  • 31 Jan 2019

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

  • 5-year analysis of the phase 1b KEYNOTE-001 study reveals 34% OS and 21% PFS in patients with advanced melanoma treated with pembrolizumab.

Why this matters

  • This analysis represents the longest available follow-up data for pembrolizumab.

Key results

  • Estimated 5-year OS was 34% in all patients and 41% in treatment-naive patients.
  • Estimated 5-year PFS was 21% in all patients and 29% in treatment-naive patients.
  • Median time to response was 2.8 months; median response duration was not reached.
  • 16% of patients achieved complete response, 25% achieved partial response, and 24% achieved stable disease (disease control rate, 65%).
  • 86% of patients experienced treatment-related adverse events (TRAEs).
    • 17% of patient experienced grade 3/4 TRAEs.
    • 10% of patients discontinued because of TRAEs.
    • No patients experienced treatment-related death.

Study design

  • 655 patients with advanced/metastatic melanoma (151 treatment-naive) who received pembrolizumab 2 mg/kg every 3 weeks, 10 mg/kg every 3 weeks, or 10 mg/kg every 2 weeks were included.
  • Funding: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Limitations

  • No control group.

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