TMB-H

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Advanced or metastatic disease, subsequent lines of therapy

Pembrolizumab monotherapy

Regimen

Study Years of enrollment Evidence
Marabelle et al. 2020 (KEYNOTE-158) 2016-2019 Phase 2 (RT)

Prior treatment criteria

  • One or more lines of standard therapy

Biomarker eligibility criteria

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

Immunotherapy

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

References

  1. KEYNOTE-158: Marabelle A, Fakih M, Lopez J, Shah M, Shapira-Frommer R, Nakagawa K, Chung HC, Kindler HL, Lopez-Martin JA, Miller WH Jr, Italiano A, Kao S, Piha-Paul SA, Delord JP, McWilliams RR, Fabrizio DA, Aurora-Garg D, Xu L, Jin F, Norwood K, Bang YJ. Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. Lancet Oncol. 2020 Oct;21(10):1353-1365. Epub 2020 Sep 10. link to original article PubMed NCT02628067