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Altai Protocol Library

New Reference: Pembrolizumab in Microsatellite-Instability–High Advanced Colorectal Cancer

New Reference: Pembrolizumab in Microsatellite-Instability–High Advanced Colorectal Cancer
Study:
  • Open-label phase 3 trial
  • Previously untreated metastatic MSI-H-dMMR colorectal cancer
  • Pembrolizumab 200 mg q21 (n=153) vs. investigator’s choice of chemo (n=154)
  • Chemo: mFOLFOX6 or FOLFIRI alone or with bevacizumab or with cetuximab
Efficacy:
  • Overall response: 43.8% [35.8% – 52.0%] vs. 33.1% [25.8% – 41.1%]
  • Progressive disease: 29.4% vs. 12.3% (higher in pemrolizumab arm)
  • Median PFS: 16.5 mos [5.4 – 32.4 mos] vs. 8.2 mos [6.1 – 10.2 mos], HR = 0.60 [0.45 – 0.80]
  • Subset analysis showed numerically worse PFS in pembrolizumab arm among k-ras or n-ras mutated patients
  • 9.7 vs. 5.6 mos in CPS >= 10 (HR:0.65 [0.49-0.86])
Safety:
  • Grade 3-5 AEs (overall): 56% vs. 78%
  • Immune-mediated AEs and infusion reactions: 31% vs. 15%

N Engl J Med 2020;383:2207-18.

Andre T, et al. Pembrolizumab in Microsatellite-Instability–High Advanced

Colorectal Cancer.

https://doi.org/10.1056/NEJMoa2017699

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