Ciltacabtagene autoleucel is under clinical development by Legend Biotech and currently in Phase III for Multiple Myeloma (Kahler Disease). According to GlobalData, Phase III drugs for Multiple Myeloma (Kahler Disease) have a 64% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Ciltacabtagene 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.

Ciltacabtagene autoleucel overview

Ciltacabtagene autoleucel (Carvykti) is a BCMA-directed genetically modified autologous T cell immunotherapy. It is formulated as suspension for intravenous route of administration. Carvykti is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Ciltacabtagene autoleucel (JNJ-4528) is under development for the treatment of newly diagnosed multiple myeloma, refractory multiple myeloma and relapsed multiple myeloma. It is administered through intravenous route. The drug candidate comprises of T-cells modified to express B-cell maturation antigen (BCMA) chimeric antigen receptor(CAR) and single domain antibody. The drug candidate is a autologous T-cells genetically engineered via lentiviral vector technology to express a synthetic receptor directed against B-cell maturation antigen (BCMA) protein target. It is a new molecular entity.

Legend Biotech overview

Legend Biotech, a subsidiary of Genscript Biotech Corp, is a commercial-stage biotechnology company. It primarily focuses on the development, manufacturing, and commercialization of novel cell therapies. The company’s main focus is on diseases considered intractable and incurable, such as hematological malignancies and solid tumors. Its products candidate includes GPC3 for the treatment of non-small cell lung cancer (NSCLC), tumors and others. Legend Biotech‘s therapies are designed for patients worldwide suffering from chronic and life-threatening diseases. The company operates in the Americas and Europe. Legend Biotech is headquartered in Somerset, New Jersey, the US.

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

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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.