Mosunetuzumab is under clinical development by Genentech USA and currently in Phase II for Refractory Chronic Lymphocytic Leukemia (CLL). According to GlobalData, Phase II drugs for Refractory Chronic Lymphocytic Leukemia (CLL) have a 27% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Mosunetuzumab’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.

Mosunetuzumab overview

Mosunetuzumab (Lunsumio) is a bi-specific monoclonal antibody works by allowing one arm to target B cell antigen CD20 and the other arm to recruit T cells by binding to CD3 of the T-cell receptor. It is formulated as concentrated solution and solution for intravenous and subcutaneous route of administration. Lunsumio is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Mosunetuzumab is under development for the treatment of diffuse large b-cell lymphoma, follicular lymphoma, vesicular lymphoma, primary mediastinal b-cell lymphoma and high grade b-cell lymphoma (HGBCL), relapsed or refractory b-cell acute lymphoblastic leukemia, relapsed and refractory hematological tumors like high-grade B-cell lymphoma (HGBCL), chronic lymphocytic leukemia, non-Hodgkin lymphomas including follicular lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma. It is administered intravenously and subcutaneously. The drug candidate is a bi-specific antibody targeting CD20 expressing cells by recruiting CD3 T-cells. The drug candidate is developed based on knobs-into-hole technology. It was also under development for marginal zone lymphoma, primary mediastinal B-cell lymphoma and small lymphocytic lymphoma.

It was also under development for the treatment of b-cell acute lymphocytic leukemia (b-cell acute lymphoblastic leukaemia).

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 Mosunetuzumab’s drug-specific PTSR and LoA scores, buy the report here.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.