Brexucabtagene autoleucel is under clinical development by Gilead Sciences and currently in Phase II for Chronic Lymphocytic Leukemia (CLL). According to GlobalData, Phase II drugs for Chronic Lymphocytic Leukemia (CLL) have a 32% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Brexucabtagene autoleucel’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.

Brexucabtagene autoleucel overview

Brexucabtagene Autoleucel (Tecartus) is a CD19-directed genetically modified autologous T cell immunotherapy comprised of patient’s own T cells which are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single-chain variable fragment (scFv) linked to CD28 and CD3-zeta co-stimulatory domains. It is formulated as suspension for intravenous route of administration. Tecartus is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). Tecartus is indicated for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Brexucabtagene autoleucel (KTEX-19) is under development for the treatment of solid tumor, relapsed or refractory B-cell acute lymphoblastic leukemia, relapsed or refractory acute lymphocytic leukemia, mantle cell lymphoma, recurrent chronic lymphocytic leukemia, acute lymphocytic leukemia, refractory acute myeloid leukemia, diffuse large b-cell lymphoma, follicular lymphoma and primary mediastinal large B-cell lymphoma (PMBCL). The therapeutic candidate is an autologous T-cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor. It is administered through intravenous route.

It was under development for waldenstrom macroglobulinemia (lymphoplasmacytic lymphoma), hairy cell leukemia, refractory chronic lymphocytic leukemia, relapsed chronic lymphocytic leukemia, and burkitt lymphoma

Gilead Sciences overview

Gilead Sciences (Gilead) is a research-based biopharmaceutical company. It carries out the discovery, development and commercialization of medicines for the treatment of cardiovascular, hematological and respiratory diseases, inflammation, liver diseases such as hepatitis B virus (HBV) and hepatitis C virus (HCV) infections, cancer, and human immunodeficiency virus (HIV) infection. It markets its products through commercial teams, third-party distributors and corporate partners. Gilead’s commercial teams promote its products through direct field contact with physicians, hospitals, clinics and other healthcare providers. The company sells its products through subsidiaries and distributors in Europe, the Americas, Asia-Pacific, the Middle East, and Africa. Gilead is headquartered in Foster City, California, the US.

For a complete picture of Brexucabtagene autoleucel’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.