Lifileucel is under clinical development by Iovance Biotherapeutics and currently in Phase II for Recurrent Head And Neck Squamous Cell Carcinoma. According to GlobalData, Phase II drugs for Recurrent Head And Neck Squamous Cell Carcinoma have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Lifileucel’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.

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 and non-small cell lung cancer. 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 biotechnology company that 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 lifileucel is an autologous, ready-to-infuse cell therapy indicated for the treatment of melanoma and metastatic cervical cancer; and LN-145 for the treatment of head and neck cancer. The company also focuses on investigating TIL therapy for treatment of a various types of cancer. It has Iovance Cell Therapy Center (iCTC) in Philadelphia for the manufacture of the tumor infiltrating lymphocytes (TIL). The company operates 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.

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.