Tazemetostat hydrobromide is under clinical development by Epizyme and currently in Phase II for Mantle Cell Lymphoma. According to GlobalData, Phase II drugs for Mantle Cell Lymphoma have a 34% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Tazemetostat hydrobromide’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Tazemetostat hydrobromide overview
Tazemetostat hydrobromide (Tazverik) is an anti-neoplastic agent. It is formulated as film coated tablets for oral route of administration. Tazverik is indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options. Tazemetostat hydrobromide is under development for the treatment of pancreatic cancer, colorectal cancer, recurrent or metastatic head and neck squamous-cell carcinoma, marginal zone lymphoma, non-Hodgkin lymphoma, mantle cell lymphoma, metastatic castration-resistant prostate cancer, b-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, chordoma, primary mediastinal B-cell lymphoma (EZH2), peripheral T-cell lymphomas (PTCL), other relapsed or refractory solid tumors such as INI1-negative tumors including malignant rhabdoid tumor (MRT), rhabdoid tumor of the kidney (RTK), atypical teratoid / rhabdoid tumor (ATRT), epithelioid malignant peripheral nerve sheath tumor, neuroblastoma, extraskeletal myxoid chondrosarcoma, myoepithelial carcinoma, hepatocellular carcinoma, squamous non-small cell lung cancer, relapsed or refractory mesothelioma (pleural, peritoneal, pericardial, tunica vaginalis), renal medullary carcinoma, urothelial carcinoma, small-cell lung cancer and 3 unspecified indications. The drug candidate is administered orally. It is a selective small molecule inhibitor of protein methyltransferase EZH2. It was also under development for chronic myeloid leukaemia, endometrial cancer, ovarian cancer, peritoneal cancer and uterine cancer. It was also under development for the treatment of synovial sarcoma, rhabdomyosarcoma, hematological tumor, Non-Hodgkin lymphoma, solid tumor and lymphoma.
Epizyme is a biopharmaceutical company that discovers, develops, and markets novel epigenetic therapies for the treatment of cancer and other diseases. The company’s marketed products include Tazverik (tazemetostat), an oral, first-in-class, small-molecule inhibitor of EZH2 for the treatment of patients with metastatic or locally advanced epithelioid sarcoma and relapsed/refractory follicular lymphoma. Its pipeline products include tazemetostat for follicular lymphoma, DLBCL, epithelioid sarcoma and prostate cancer; PRMT 1 Inhibitor (GSK3368715) for solid tumors and DLBCL; and PRMT5 (GSK3368715) for solid tumors and blood cancer. The company develops products through a proprietary drug discovery platform and collaboration with other companies. Epizyme is headquartered in Cambridge, Massachusetts, the US.
For a complete picture of Tazemetostat hydrobromide’s drug-specific PTSR and LoA scores, buy the report here.