Tisagenlecleucel is under clinical development by Novartis and currently in Phase II for Primary Mediastinal B-Cell Lymphoma. According to GlobalData, Phase II drugs for Primary Mediastinal B-Cell Lymphoma have an 82% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Tisagenlecleucel’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.

Tisagenlecleucel overview

Tisagenlecleucel (Kymriah) is a CD19-directed genetically modified autologous of T cell immunotherapy comprised of autologous T cells that are genetically modified using a lentiviral vector to encode an anti-CD19 chimeric antigen receptor (CAR), acts as antineoplastic agent. It is formulated as injectable suspension for intravenous route of administration. Kymriah indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. It is also 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),  refractory to treatment or relapse after two prior lines follicular lymphoma, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma and relapsed or refractory ALL. Kymriah is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Tisagenlecleucel (CTL-019, CART-19) is under development for the treatment of primary central nervous system lymphoma, relapsed or refractory B-cell acute lymphoblastic leukemia, hematological malignancies including leukemia and lymphomas such as Burkitt lymphoma, marginal zone lymphoma, non-Hodgkin lymphoma, multiple myeloma, B-cell lymphomas including diffuse large B-cell lymphoma, gray zone lymphoma, small lymphocytic lymphoma, relapsed or refractory diffuse large B-cell lymphoma primary mediastinal B-cell lymphoma and refractory to treatment or relapse after two prior lines follicular lymphoma.

It was under development for treatment of mantle cell lymphoma, relapsed and refractory chronic lymphocytic leukemia and B-cell acute lymphocytic leukemia.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. Novartis conducts research in various disease areas through the BioMedical Research division. The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

For a complete picture of Tisagenlecleucel’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.