Malignant solid neoplasm, TMB-H
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| Last updated on 2024-07-23: 1 regimens on this page
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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
- KEYNOTE-158TMB-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