Amtagvi (lifileucel) / Iovance Biotherap - LARVOL DELTA

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

Evaluating curative potential of lifileucel in previously treated advanced melanoma: Analyses from C-144-01 Trial (ESMO 2025) - No abstract available

Metastases • Melanoma • Oncology • Solid Tumor

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

Lifileucel Franchise in Solid Tumors: Priority Programs (GlobeNewswire) - "Iovance remains on track to share additional data in the second half of 2025 from the IOV-LUN-202 registrational Phase 2 trial to support a potential U.S. accelerated approval of lifileucel monotherapy in post-anti-PD-1 NSCLC in 2027....Iovance is actively enrolling in the IOV-END-201 Phase 2 trial for advanced endometrial cancer, a significant unmet medical need. The trial is investigating lifileucel after platinum-based chemotherapy and anti-PD-1 therapy regardless of mismatch repair (MMR) status, with initial results on track for the second half of 2025."

FDA approval • P2 data • Endometrial Cancer • Non Small Cell Lung Cancer

Lacklustre Amtagvi launch forces Iovance to cut 19% of staff (Firstwordpharma Press Release) - "Suffering from a slower-than-expected launch of its tumour-infiltrating lymphocyte (TIL) therapy Amtagvi (lifileucel), Iovance Biotherapeutics is axing around 19% of its workforce. The cuts will come in the third quarter, with the company hoping to save over $100 million in annual costs, extending its cash runway into the tailend of 2026....generated sales of $54.1 million in the second quarter of 2025, up from $43.6 million in the prior three-month period."

Sales • Melanoma

Tumour-infiltrating lymphocyte therapy landscape: prospects and challenges. (PubMed, BMJ Oncol) - "The recent accelerated approval of lifileucel by the Food and Drug Administration marks a significant milestone in the clinical application of TIL therapy...Emerging strategies, including checkpoint inhibitor combinations, engineered TIL constructs and metabolic reprogramming, aim to improve TIL therapeutic efficacy. This review provides insights into the evolving landscape of TIL therapy and its potential to enhance current cancer immunotherapy."

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

FDA approval summary: Lifileucel for unresectable or metastatic melanoma previously treated with an anti-PD-1 based immunotherapy. (PubMed, Clin Cancer Res) - "Among all patients who received lifileucel (N=156), 95.5% of patients experienced at least one Grade 3 treatment-emergent adverse event (TEAE) and 87.8% experienced at least one Grade 4 TEAE. Lifileucel labeling includes a Boxed Warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary impairment, and renal impairment."

FDA event • IO biomarker • Journal • Hematological Disorders • Infectious Disease • Melanoma • Oncology • Renal Disease • Solid Tumor

Lifileucel tumor-infiltrating lymphocyte cell therapy in patients with unresectable or metastatic mucosal melanoma after disease progression on immune checkpoint inhibitors. (PubMed, Cancer Commun (Lond)) - No abstract available

Checkpoint inhibition • Journal • Tumor-infiltrating lymphocyte • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

Cost-utility of lifileucel in patients with advanced melanoma after progression on immune checkpoint inhibitors And targeted therapies: a middle-income economy setting. (PubMed, Br J Clin Pharmacol) - "The treatment of therapy-resistant advanced melanoma using TILs (lifileucel) is currently not cost-effective in small, middle-income economies and is unlikely to become so in the near future."

Checkpoint inhibition • HEOR • Journal • Melanoma • Oncology • Solid Tumor • BRAF

Amtagiv for Advanced Melanoma Shows Strong Results in Real-World Use (Managed Healthcare Executive) - "A real-world study tracking the use of Amtagvi (lifileucel) in patients with advanced melanoma found nearly half saw their tumors shrink or disappear, matching the therapy’s effects in research settings and supporting its role as a new option after other treatments have failed. Among 41 patients with unresectable or metastatic melanoma, 49% experienced tumor shrinkage after receiving the first FDA-approved T cell therapy for solid tumors. Patients who had received fewer prior treatments responded even better: 61% of those who had tried two or fewer therapies before Amtagvi responded to treatment, compared with 33% among those with more heavily treated disease. The findings come from a retrospective study led by Amtagvi drugmaker Iovance Biotherapeutics and included a diverse group of patients previously treated with immune checkpoint inhibitors and targeted therapies."

Retrospective data • Melanoma

Lifileucel Therapy for Metastatic Melanoma: Advancements in Tumor-infiltrating Lymphocyte-based Immunotherapy. (PubMed, Anticancer Agents Med Chem) - "This breakthrough therapy not only addresses a critical unmet need in melanoma treatment but also represents a paradigm shift toward personalized medicine in oncology. Lifileucel underscores the potential of TILbased approaches to revolutionize cancer care, setting the stage for future advancements in immunotherapy."

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