FDA approves pembrolizumab for MSI-H/dMMR CRC

  • FDA
  • 29 Jun 2020

  • curated by Pavankumar Kamat
  • Univadis Clinical Summaries
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Takeaway

  • The US Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).
  • The recommended dose is 200 mg every 3 weeks or 400 mg every 6 weeks. 

Why this matters

  • Pembrolizumab has demonstrated robust antitumor activity and a favorable safety profile in multiple tumor types.

Key highlights

  • The approval was based on data from the multicenter, randomized KEYNOTE-177 trial
  • 307 patients with previously untreated unresectable or metastatic MSI-H/dMMR CRC were randomly assigned to either pembrolizumab (n=153) or investigator choice of chemotherapy (n=154).
  • Pembrolizumab monotherapy vs chemotherapy group had:
    • Lower risk for disease progression or death (HR, 0.60; 95% CI, 0.45-0.80; P=.0004);
    • Better PFS (16.5 vs 8.2 months);
    • Better overall response rate (44% vs 33%);
    • Better complete response (11% vs 4%);
    • Fewer grade 3 treatment-related adverse events (AEs; 22% vs 66%); and
    • More immune-mediated AEs and infusion reactions (31% vs 13%).

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