“KEYNOTE-158 has confirmed clinical activity of pembrolizumab in tumors harboring a TMB ≥10 (TMB-High) across a variety of previously treated solid tumors including anal, biliary, cervical, endometrial, mesothelioma, neuroendocrine, salivary, small cell lung, thyroid, and vulvar cancers. This marks the second tumor-agnostic approval for pembrolizumab, which is also approved for the treatment of patients with microsatellite instability–high (MSI-H) or mismatch repair deficient solid tumors. The FDA has approved pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden–high (TMB-H ≥10 mutations/megabase), as determined by an FDA-approved test, who have progressed following prior treatment and have no satisfactory alternative treatment options.
