Amtagvi (lifileucel) / Iovance Biotherap - LARVOL DELTA

Novel tumor-infiltrating lymphocytes therapy in solid tumors: latest updates from 2025 ASCO annual meeting. (PubMed, Exp Hematol Oncol) - "Notably, innovative TIL-based monotherapies and combination regimens have provided durable clinical responses and survival benefits for patients with various solid tumors. This article summarizes recent advances in TIL therapy for solid tumors presented at the 2025 ASCO Annual Meeting, highlighting monotherapies such as Lifileucel, LM103, OBX-115, GT101, GT300, GT201, and HS-IT101, as well as combination strategies with the oncolytic adenovirus TILT-123 or pembrolizumab."

Journal • Tumor-infiltrating lymphocyte • Melanoma • Oncology • Solid Tumor

SUPRAME: A phase III trial evaluating IMA203 T-cell receptor (TCR) T-cell therapy vs investigator's choice in previously treated advanced cutaneous melanoma (ESMO 2025) - P1/2, P3 | "Pts in the control arm will receive nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (US), or chemotherapy. Secondary endpoints include OS, ORR, safety and PROs (EORTC QLQ-C30, EQ-5D-5L). The trial plans to enroll patients in the US and Europe."

IO biomarker • Metastases • P3 data • Cutaneous Melanoma • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • BRAF • HLA-A • PRAME

Evaluating curative potential of lifileucel in previously treated advanced melanoma: Analyses from C-144-01 trial (ESMO 2025) - P2 | "Conclusions Survival plateaus and hazard trends in C-144-01 trial can be adequately captured by MCMs. Estimated fractions of LTS in the trial highlight lifileucel's potential in fulfilling the unmet need in previously treated unresectable or metastatic melanoma."

Metastases • Melanoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor

Non-relapse mortality and immune-related adverse events with lifileucel: a post-marketing surveillance analysis (SITC 2025) - "Any additional data that will be available on a poster that is beyond what was submitted in the abstract is embargoed until Nov. 7, 2025 at 9 a.m. ET."

Adverse events • P4 data • Oncology

Cutaneous eruptions associated with lifileucel, a first-in-class tumor-infiltrating lymphocyte therapy, and interleukin-2 in individuals with metastatic melanoma: a retrospective prognostic analysis (SITC 2025) - "Any additional data that will be available on a poster that is beyond what was submitted in the abstract is embargoed until Nov. 7, 2025 at 9 a.m. ET."

Metastases • Retrospective data • Tumor-infiltrating lymphocyte • Melanoma • Oncology • Solid Tumor • IL2

Bridging the Gap: Incorporating Lifileucel Into Management of Advanced PD-1 Blockade Resistant Melanomas. (PubMed, J Clin Oncol) - No abstract available

Journal • Melanoma • Oncology • Solid Tumor

Iovance Biotherapeutics B.V. withdrew its application for a marketing authorisation of Amtagvi for the treatment of melanoma (a skin cancer) in adults (European Medicines Agency) - "The company withdrew the application on 22 July 2025."

European regulatory • Melanoma

Current perspectives on Lifileucel tumor-infiltrating lymphocyte therapy: A paradigm shift in immunotherapy. (PubMed, Curr Probl Cancer) - "The Lifileucel concept has initiated a new epoch in personalized cancer therapy. This review offers a forward-looking perspective on the potential advancements and opportunities for establishing Lifileucel and TIL-based therapies as a cornerstone in cancer therapy."

Journal • Review • Tumor-infiltrating lymphocyte • Oncology • Solid Tumor

A Study of LN-144 in People With Metastatic Melanoma to the Brain (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2025 ➔ Nov 2026 | Trial primary completion date: Nov 2025 ➔ Nov 2026

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

Launch Expansion into New Markets (GlobeNewswire) - "Health Canada is expected to approve Amtagvi monotherapy in the coming weeks as the first T cell therapy for a solid tumor cancer and first treatment option in Canada for previously treated advanced melanoma. Iovance is preparing for a commercial launch in Canada over the next few months."

Canada approval • Launch Canada • Melanoma

Immune correlates and mechanisms of TIL therapy efficacy: current insights and knowledge gaps. (PubMed, Trends Cancer) - "Tumor-infiltrating lymphocyte (TIL) therapy has emerged as a transformative approach in cancer immunotherapy, particularly following the recent US Food and Drug Administration (FDA) approval of lifileucel for advanced melanoma...Recent advances in single-cell profiling and biomarker discovery have enabled more precise patient selection and therapy optimization, while novel expansion protocols and engineered TILs are addressing resistance and broadening applicability to non-melanoma tumors. Collectively, these developments underscore the promise of next-generation TIL therapies to revolutionize treatment paradigms across a wider spectrum of solid cancers."

IO biomarker • Journal • Review • Non-melanoma Skin Cancer • Solid Tumor

Feasibility of Manufacturing and Antitumor Activity of TIL for Advanced Endometrial Cancers. (PubMed, Int J Mol Sci) - P2 | "These findings demonstrate the feasibility of ex vivo TIL expansion from EC tumors. This study provides a rationale for the initiation of the phase II clinical trial IOV-END-201 (NCT06481592) to evaluate lifileucel in patients with advanced EC."

Journal • Endometrial Cancer • Melanoma • Oncology • Solid Tumor • Uterine Cancer • CD4 • CD8 • IFNG • TNFA

Launch Expansion into New Markets (GlobeNewswire) - "Australia’s Therapeutic Goods Administration granted Priority Review with a decision anticipated in early 2026; Swiss Medic recommended Priority Review ahead of the Swiss regulatory submission planned in the fourth quarter of 2025."

Filing • Priority review • Melanoma

Iovance’s Amtagvi (lifileucel) Receives Health Canada Approval for Advanced Melanoma (GlobeNewswire) - "Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy...and who have no satisfactory alternative treatment options....Market authorization in Canada under the NOC/c guidance was granted based on safety and efficacy results from the...C-144-01 trial."

Canada approval • Melanoma

Adoptive T-Cell Therapy in Sarcomas. (PubMed, Curr Oncol Rep) - "The FDA approval of afamitresgene autoleucel for advanced synovial sarcoma and the breakthrough designation of letetresgene autoleucel for myxoid/round cell liposarcoma signify a major turning point...Tumour infiltrating lymphocyte therapy, including lifileucel, is under investigation with checkpoint inhibitors or oncolytic agents to enhance efficacy and manage toxicity...Challenges include HLA restriction, tumour heterogeneity, and manufacturing complexity. Future strategies involving novel antigens, multi-targeting, and combinatorial regimens could broaden patient eligibility and improve therapeutic outcomes."

Journal • Review • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • CD276 • CTAG1B • FGFR4 • HER-2 • MAGEA4

Lifileucel: “The CHMP was updated on discussions at the CAT. The committee was reminded of the status of this application and its remaining outstanding issues”; Metastatic melanoma (European Medicines Agency) - CHMP Final Minutes of the meeting on 19 - 22 May 2025: “The committee endorsed a list of outstanding issues with a specific timetable, as adopted by CAT”

CHMP • Melanoma • Oncology

Launch Expansion into New Markets (GlobeNewswire) - "Review in the United Kingdom is on track for potential approval and launch in the first half of 2026."

Launch non-US • MHRA approval • Melanoma

Efficacy and safety of one-time autologous tumor-infiltrating lymphocyte cell therapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. (PubMed, J Immunother Cancer) - P2 | "This study demonstrated the feasibility of consistently generating sufficient TIL from HNSCC tumors. Results from this study suggest TIL cell therapy may serve as a potential treatment option for patients with HNSCC and support further development, including TIL cell therapy combined with immune checkpoint inhibitors or other agents or with other TIL products."

Journal • Tumor-infiltrating lymphocyte • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • IL2 • PD-L1

Lifileucel: “The CHMP was updated on discussions at the CAT. The committee discussed the issues identified in this application”; Melanoma (European Medicines Agency) - CHMP Final Minutes of the meeting on 9- 12 Dec 2024: “The committee endorsed the recommendation and scientific discussion together with the list of questions, as adopted by CAT”

CHMP • Melanoma • Oncology

Iovance Biotherapeutics Reports Financial Results and Corporate Updates for First Quarter 2025 (GlobeNewswire) - "2025 Regulatory Approvals for Amtagvi Expected in the UK, EU, and Canada....Named patient programs are planned outside the U.S. to provide early access to treatment prior to national reimbursement and are also expected to provide initial revenue from these markets. Additional regulatory submissions remain on track for Australia in the first half of 2025 and Switzerland in the second half of 2025."

Canada approval • EMA approval • Filing • MHRA approval • Melanoma

Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Fourth Quarter and Full Year 2024 (GlobeNewswire) - "A marketing authorization application (MAA) was submitted to the Medicines and Healthcare products Regulatory Agency in the United Kingdom for potential approval in the first half of 2025. A new drug submission (NDS) to Health Canada was accepted for a prioritized 200-day review process through the Notice of Compliance with Conditions (NOC/c) policy for potential approval in mid-2025. An MAA for all EU member states was accepted for review by the European Medicines Agency for potential approval in the second half of 2025. Named patient programs are planned in the UK, France, Germany, Canada, Switzerland, and Australia in 2025 to provide reimbursed access to treatment prior to approval or final pricing and are also expected to provide initial revenue from these markets. Additional regulatory submissions remain on track in 2025 and 2026, including Australia in the first half of 2025 and Switzerland in the second half of 2025."

Approval • Filing • Patent • Melanoma

Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Second Quarter and First Half 2024 (GlobeNewswire) - "Regulatory dossiers remain on track for submission in the following markets with significant populations of previously treated advanced melanoma patients: UK and Canada in the second half of 2024; Australia in the first half of 2025; Additional countries, including Switzerland, in the second half of 2025 and early 2026."

Canada filing • EMA filing • Filing • MHRA filing • Melanoma • Solid Tumor

Iovance Biotherapeutics Reports First Quarter 2024 Financial Results and Corporate Updates (GlobeNewswire) - "Lifileucel Launch Expansion into New Markets and Indications; Geographic expansion can more than double the total addressable patient population for Amtagvi in advanced melanoma. Regulatory dossiers remain on track for submission in the following markets with significant populations of advanced melanoma patients: EU in the second quarter of 2024; UK and Canada in the second half of 2024; Australia and additional countries in 2025..."

Canadian regulatory • European regulatory

Iovance Biotherapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates (GlobeNewswire) - "Anticipated regulatory submissions include the following: A marketing authorization application (MAA) in the European Union (EU) in the first half of 2024; An MAA in the U.K. and a new drug submission (NDS) in Canada in the second half of 2024; Regulatory submissions in Australia and additional countries with significant populations of advanced melanoma patients in 2025."

Canadian regulatory • European regulatory • Non-US regulatory • Melanoma • Oncology • Solid Tumor

Iovance’s AMTAGVI (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma (GlobeNewswire) - "Iovance Biotherapeutics...today announced that the U.S. Food and Drug Administration (FDA) has approved AMTAGVI (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumor-derived autologous T cell immunotherapy 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. This indication is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase 3 trial to confirm clinical benefit...The FDA approval is based on safety and efficacy results from the C-144-01 clinical trial. C-144-01 is a global, multicenter trial investigating AMTAGVI in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, where applicable."

BLA • Melanoma