Lifileucel is under clinical development by Iovance Biotherapeutics and currently in Phase I for Rhabdomyosarcoma. According to GlobalData, Phase I drugs for Rhabdomyosarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase I. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Lifileucel LoA Report. 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.
Lifileucel overview
Lifileucel (Amtagvi) is a tumor-derived autologous T cell immunotherapy agent. It is formulated as suspension for intravenous infusion. Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Lifileucel (LN-144) is under development for the treatment of endometrial cancer, relapsed/refractory metastatic melanoma, recurrent head and neck cancer squamous cell carcinoma, non-small cell lung cancer, primary central nervous system carcinoma, rhabdomyosarcoma and Ewing sarcoma. It is administered through intravenous route. The therapeutic candidate comprises of autologous tumor infiltrating lymphocytes (TILs) isolated from the patient’s tumor further expanded and then infused back to the patient enabling the patient robust immune response.
Iovance Biotherapeutics overview
Iovance Biotherapeutics (Iovance) is a biopharmaceutical company. It focuses on the development and commercialization of novel immunotherapy products for treating various cancers. It develops products based on its tumor-infiltrating lymphocyte (TIL) technology. The company’s lead product candidates include Amtagvi (lifileucel), an autologous, ready-to-infuse cell therapy indicated for the treatment of melanoma and metastatic cervical cancer and Proleukin (aldesleukin), an interleukin-2 (IL-2) product used in the Amtagvi treatment regimen. The company also investigates TIL therapy for treating various types of cancers. It operates a manufacturing facility in Philadelphia and a research facility in Tampa, Florida. Iovance is headquartered in San Carlos, California, the US.
For a complete picture of Lifileucel’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.
