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Pembrolizumab
Source: Agnostic Cancer Therapies (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: February 12, 2025 · Captured 2026-09-09.
Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary. Independent clinical review is pending.
Context: Tumor Mutational Burden–High (≥10 Mutations/Megabase) Solid Tumors
Indication. Pembrolizumab is indicated for adult and pediatric patients with unresectable or metastatic tumor mutational burden–high (TMB-H) solid tumors, whose disease progressed after prior treatment and who have no satisfactory alternative treatment options. TMB-H is defined as ≥10 mutations/megabase (mut/Mb), as determined by a U.S. Food and Drug Administration (FDA)-approved test.
Evidence. FDA approval was based on a retrospective analysis of 10 cohorts of patients with various previously treated unresectable or metastatic TMB-H solid tumors enrolled in KEYNOTE-158 (NCT02628067), a multicenter, nonrandomized, open-label trial. Patients received 200 mg of pembrolizumab intravenously every 3 weeks until unacceptable toxicity or documented disease progression.[1,2][Level of evidence C3]
Source links and citations
Efficacy. A total of 102 patients (13%) had TMB-H tumors (defined as TMB ≥10 mut/Mb). The objective response rate for these patients was 29% (95% confidence interval, 21%–39%), with a 4% complete response rate and 25% partial response rate.[1] The median follow-up was 13.4 months.[2]
Identification of biomarker. The FoundationOne CDx assay is a companion diagnostic test for pembrolizumab.
Studies cited in this source section
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Publication references
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Preserved source evidence · Independent clinical review pending · Not medical advice