Polatuzumab vedotin is under clinical development by Genentech USA and currently in Phase III for Primary Mediastinal B-Cell Lymphoma. According to GlobalData, Phase III drugs for Primary Mediastinal B-Cell Lymphoma have a 75% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Polatuzumab vedotin’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.
Polatuzumab vedotin overview
Polatuzumab vedotin (Polivy / Ropolivy) is a monoclonal antibody, acts as an anti-neoplastic agent. It is produced by mammalian Chinese hamster ovary (CHO) cells. It is formulated as lyophilized powder for solution for intravenous route of administration. It is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies. Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
Polatuzumab vedotin (RG-7596) is under development for the treatment of hematologic malignancies including Burkitt lymphoma, non-Hodgkin's lymphoma, primary mediastinal B-cell lymphoma, primary cutaneous DLBCL, High-grade B-cell lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, Non-Hodgkin lymphoma, Hodgkin lymphoma (B-Cell Hodgkin Lymphoma),thymic carcinoma and T-Cell lymphomas, T-cell/histiocyte-rich large-B-cell lymphoma, epstein-barr virus (EBV) + DLBCL, NOS, ALK+ large B-cell lymphoma, relapsed or refractory follicular lymphoma and previously untreated relapsed or refractory diffuse large B-cell lymphoma. The drug candidate is administered intravenously. It is an anti-CD79b antibody-drug conjugate (ADC) composed of the cytotoxic agent monomethyl auristatin E (MMAE) linked to an anti-CD79b monoclonal antibody targeting MMAE to B-cells through CD79b. It was also under development for mantle cell lymphoma and chronic lymphocytic leukemia.
Genentech USA overview
Genentech USA (Genentech), a subsidiary of F. Hoffmann-La Roche Ltd, is a biotechnology company that discovers, develops, manufactures and commercializes medicines to address serious medical needs. It offers drugs in various therapeutic areas including oncology, immunology, ophthalmology, metabolism, neurology, and infectious disease, among others. The company’s pipeline products include Emicizumab (RG6013, ACE910), a bispecific monoclonal antibody used to replace the function of protein in the blood clotting process; and Entrectinib (RXDX-101, RG6268), a CNS-active tyrosine-kinase inhibitor intended for the treatment of non-small cell lung cancer; among others. The company has partnership with BioLineRx, Charles River Laboratories International, Amunix, among others. Genentech is headquartered in South San Francisco, California, the US.
For a complete picture of Polatuzumab vedotin’s drug-specific PTSR and LoA scores, buy the report here.