Lisocabtagene maraleucel is under clinical development by Bristol-Myers Squibb and currently in Phase II for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia). According to GlobalData, Phase II drugs for Acute Lymphocytic Leukemia (ALL, Acute Lymphoblastic Leukemia) have a 36% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Lisocabtagene maraleucel’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.

Lisocabtagene maraleucel overview

Lisocabtagene maraleucel (Breyanzi) is a CD19-directed genetically modified autologous T cell immunotherapy administered as a defined composition of chimeric antigen receptor (CAR) -positive viable T cells. It is formulated as suspension for intravenous route of administration. Breyanzi is indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Breyanzi is indicated for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy. 

Lisocabtagene maraleucel (JCAR-017) is under development for the treatment of as a second and third line therapy for B-cell non-Hodgkin lymphoma includes transformed follicular lymphoma (TFL), double/triple-hit lymphoma [DHL/THL], follicular lymphoma grade 3b [FL3B], 1L high grade B-cell lymphoma, splenic marginal zone B-cell lymphoma, nodal marginal zone B-cell lymphoma, extranodal marginal zone B-cell lymphoma, primary central nervous system lymphoma [PCNSL] and Richter's transformation, acute lymphoblastic leukemia (ALL) and relapsed or refractory indolent lymphoma, follicular lymphoma and mantle cell lymphoma. It is administered intravenously. The therapeutic candidate comprises of isolated T cells transduced with a lentivirus expressing CAR (chimeric antigen receptor) containing an anti-CD19 single chain variable fragment (scFv) fused to the signaling domain of 4-1BB (CD137), the zeta chain of the TCR/CD3 complex (CD3-zeta), and a truncated form of the human epidermal growth factor receptor (EGFRt).

Bristol-Myers Squibb overview

Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, immunology, cardiovascular, and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, medical professionals, hospitals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in Princeton, New Jersey, the US.

For a complete picture of Lisocabtagene maraleucel’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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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.