Lifileucel
Lifileucel is a tumor-infiltrating lymphocyte (TIL) cell therapy developed by Iovance Biotherapeutics, sold as AMTAGVI. The next event is Phase 2 updated results (IOV-COM-202) for Lifileucel, expected October 2026 (source).
- Also known as
- AMTAGVI
- Company
- Iovance Biotherapeutics (IOVA) · Developer
- How it works
- Tumor infiltrating lymphocyte (TIL) therapy
- Approved
- AMTAGVI: United States, Canada, Australia
Development by disease
| Melanoma | Approved |
| Endometrial cancer | Phase 2 |
| Non-small cell lung cancer | Phase 2 |
| Sarcoma | Phase 2 |
Upcoming events
Estimated timing · a month, quarter, half-year or year-end the company gave
Expected in October 2026
- October 2026Lifileucel · Phase 2 updated results (IOV-COM-202) · Advanced melanoma · frontline
Expected in H2 2026
- H2 2026Amtagvi · UK regulatory decision · Advanced melanoma · anti-PD-1 failed
Expected in H1 2027
- H1 2027Amtagvi · Switzerland regulatory decision · Advanced melanoma · anti-PD-1 failed
- H1 2027Lifileucel · Interim results · Cutaneous squamous cell and Merkel cell carcinoma
Past results and milestones
- Aug 6, 2026FDA granted Fast Track Designation for lifileucel in undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS) based on positive early data showing 50% ORR in the first six evaluable patients. Source
- Jun 3, 2026Australia's TGA granted approval with conditions for Amtagvi (lifileucel) for previously treated advanced melanoma, marking the third marketing authorization for the product and the first T cell therapy for a solid tumor approved in Australia. Source
- May 7, 2026IOV-END-201 initial Phase 2 results delivered positive data: 40% confirmed objective response rate and 100% disease control rate in first five evaluable patients with metastatic serous endometrial cancer who were mismatch repair proficient and had progressed on prior chemotherapy and checkpoint inhibitor. Source
- Feb 24, 2026reportedFDA granted Fast Track Designation for lifileucel in previously treated metastatic non-squamous NSCLC (IOV-LUN-202) based on initial results supporting efficacy in this indication. Source
- Jan 9, 2026reportedIovance submitted the Amtagvi regulatory dossier to SwissMedic in Q4 2025, as confirmed in the January 2026 corporate overview. Source
- Nov 6, 2025reportedPositive interim data delivered: ORR 26% and median duration of response not reached at more than 25 months of follow-up in previously treated advanced nonsquamous NSCLC. FDA previously provided positive feedback on trial design and potency assay matrix. Source
- Aug 18, 2025Health Canada issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi in advanced melanoma on August 18, 2025, making it the first T cell therapy for a solid tumor approved in Canada. The authorization is conditional pending confirmatory trial results. Source
- Aug 7, 2025reportedIovance completed the Australian regulatory submission for Amtagvi in H1 2025; TGA subsequently granted Priority Review and later approved the application. Source
- May 23, 2024In 23 patients, lifileucel plus pembrolizumab produced a 65.2% objective response rate (15/23), including 30.4% complete responses (7/23), at a median follow-up of 21.7 months. These Phase 2 results supported the rationale for TILVANCE-301; they are not Phase 3 results. Registry lists Terminated because Iovance concluded sufficient events had accrued to evaluate the endpoints; this is the earlier supporting study, not the ongoing TILVANCE-301 trial. Source
- Feb 16, 2024Amtagvi (lifileucel) received FDA approval on February 16, 2024 for patients with advanced melanoma after anti-PD-1 and targeted therapy, becoming the first FDA-approved T cell therapy for a solid tumor indication. Source