Lisocabtagene maraleucel is under clinical development by Bristol-Myers Squibb and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Lisocabtagene maraleucel’s likelihood of approval (LoA) and phase transition for Refractory Chronic Lymphocytic Leukemia (CLL) took place on 26 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 26 Dec 2022 increased Lisocabtagene maraleucel’s LoA and PTSR for Relapsed Chronic Lymphocytic Leukemia (CLL).

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Lisocabtagene maraleucel Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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 diffuse large b-cell lymphoma (DLBCL) nos [de novo or transformed follicular lymphoma (TFL)], double/triple-hit lymphoma [DHL/THL], follicular lymphoma grade 3b [FL3B], 1L high grade B-cell lymphoma, primary central nervous system lymphoma [PCNSL] and Richter's transformation, acute lymphoblastic leukemia (ALL) and relapsed or refractory indolent lymphoma, primary mediastinal B-cell lymphoma, relapsed and refractory chronic lymphocytic leukemia, 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, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals 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 New York City, New York, the US.

Quick View Lisocabtagene maraleucel LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Lisocabtagene maraleucel
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.