Malignant solid neoplasm, TMB-H

1 regimens on this page 1 variants on this page

Advanced or metastatic disease, subsequent lines of therapy

Pembrolizumab monotherapy

Regimen

Study	Dates of enrollment	Evidence
Marabelle et al. 2020 (KEYNOTE-158TMB-H)	2016-01-15 to 2019-06-25	Phase 2 (RT)

Note: KEYNOTE-158 was a basket study with multiple arms of different enrollment periods.

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

• Pembrolizumab (Keytruda) 200 mg IV over 30 minutes once on day 1

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

References

1. KEYNOTE-158_TMB-H: 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