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All lines of therapy

Pembrolizumab monotherapy

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Study Evidence
Marabelle et al. 2019 (KEYNOTE-158) Phase 2 (RT)

Note: we are not aware of a publication describing the retrospective analysis of KEYNOTE-158 described in the FDA package insert; the reference is to the MSI-H publication.

Biomarker eligibility criteria

  • Tumor mutation burden: at least 10 mutations/megabase (mut/Mb)
  • Alteration: expression
  • Acceptable methods of measurement: FoundationOneCDx


21-day cycle for up to 35 cycles (2 years)


  1. KEYNOTE-158: Marabelle A, Le DT, Ascierto PA, Di Giacomo AM, De Jesus-Acosta A, Delord JP, Geva R, Gottfried M, Penel N, Hansen AR, Piha-Paul SA, Doi T, Gao B, Chung HC, Lopez-Martin J, Bang YJ, Frommer RS, Shah M, Ghori R, Joe AK, Pruitt SK, Diaz LA Jr. Efficacy of Pembrolizumab in Patients With Noncolorectal High Microsatellite Instability/Mismatch Repair-Deficient Cancer: Results From the Phase II KEYNOTE-158 Study. J Clin Oncol. 2020 Jan 1;38(1):1-10. Epub 2019 Nov 4. link to original article PubMed NCT02628067