Lifileucel is under clinical development by Iovance Biotherapeutics and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Lifileucel’s likelihood of approval (LoA) and phase transition for Non-Small Cell Lung Cancer took place on 12 Apr 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 12 Apr 2022 decreased Lifileucel’s LoA and PTSR for Recurrent Head And Neck Cancer Squamous Cell Carcinoma.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Lifileucel Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Lifileucel overview

Lifileucel (LN-144) is under development for the treatment of relapsed/refractory metastatic melanoma, recurrent head and neck cancer squamous cell carcinoma and non-small cell lung cancer. The therapeutic candidate is administered through intravenous route. It is developed as a ready to infuse autologous cellular immunotherapy product and contains adoptive cellular immunotherapy regimen. The therapeutic candidate consists 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 range of cancer. The company operates a research facility in Tampa, Florida. Iovance is headquartered in San Carlos, California, the US.

Quick View Lifileucel LOA Data

Report Segments
  • Innovator
Drug Name
  • Lifileucel
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.