The FDA has approved pembrolizumab (Keytruda) to treat adult and pediatric patients with unresectable or metastatic solid tumors that are tissue tumor mutational burden–high (≥10 mutations/megabase) and have progressed following prior therapy and who have no satisfactory alternative treatment options. ...
Objectives: Recently, TMB ≥10 tumor mutational burden-high (TMB-high)mutations/megabase (mut/Mb) was approved as a companion diagnostic for pembrolizumab in patients with unresectable or metastatic solid tumor based on the KEYNOTE-158 trial. This approval offers patients with gynecologic tumors ...
However, even among advanced NSCLCs with high PD-L1 expression on 50% or more of tumor cells, only a minority of patients will respond to treatment with first-line PD-L1 inhibitors, such as pembrolizumab, atezolizumab, and cemiplimab, highlighting the pressing need to identify more effective ...
Associations of tissue tumor mutational burden and mutational status with clinical outcomes in KEYNOTE-042: Pembrolizumab versus chemotherapy for advanced PD-L1-positive NSCLC. Ann. Oncol. 2023, 34, 377–388. [Google Scholar] [CrossRef] Wu, Y.; Xu, J.; Du, C.; Wu, Y.; Xia, D.; Lv...
In particular, as the current approval for pembrolizumab is based on the presence of either dMMR or MSI2, the concordance of these markers in individual tumours is a crucial area for future research. In the future, large-scale studies reporting the concordance of all three biomarkers in ...
1.https://www./drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-adults-and-children-tmb-h-solid-tumors 2.Nandakumar V, Mills JR. The now and beyond of tumor mutational burden as a predictor of response to immune checkpoint inhibitors. Clin Chem 2019; 65: 357. ...
"KEYNOTE-158 has confirmed clinical activity of pembrolizumab in tumors harboring a TMB ≥10 across a variety of solid tumors including anal, biliary, cervical, endometrial, mesothelioma, neuroendocrine, salivary, small cell lung, thyroid, and vulvar can
Pembrolizumab with external radiation therapy effectively controlled TMB-high unresectable recurrent parathyroid cancer: a case report with review of literaturedoi:10.1507/endocrj.EJ24-0126Hiroshi KatohTomoya MitsumaRiku OkamotoKanako NaitoTakaaki Tokito...
genesgliomaobjective (goal)immunotherapyBACKGROUND. Efforts have been directed toward searching for molecular biomarkers predicting response to immunotherapy in glial tumors. Recently, FDA granted accelerated approval of pembrolizumab for treatment patients with solid tumors with high mutational burden (TMB-H...
Food and Drug Administration recently approved treatment with pembrolizumab, an immune checkpoint inhibitor (ICI) targeting PD1 (anti-PD1), for all advanced solid tumors with high tumor mutational burden (TMB), defined as 鈮 10 mutations/Megabase (mut/Mb). Recent studies have suggested that ...