Amtagvi (lifileucel) / Iovance Biotherap - LARVOL DELTA

Initial results from the IOV-END-201 clinical trial of lifileucel in previously treated advanced endometrial cancer are on track for early 2026. (GlobeNewswire)

P2 data • Endometrial Cancer

Iovance Biotherapeutics Reports Financial Results and Corporate Updates for First Quarter 2025 (GlobeNewswire) - "The IOV-LUN-202 trial is intended to support a potential accelerated approval of lifileucel in post-anti-PD-1 NSCLC in the U.S., with an anticipated regulatory decision in 2027....Iovance is actively enrolling in the IOV-END-201 Phase 2 trial for advanced endometrial cancer, with initial results expected in the second half of 2025."

FDA approval • P2 data • Non Small Cell Lung Cancer

SUPRAME: A Phase 3 trial evaluating IMA203 PRAME-directed TCR T-cell therapy vs investigator's choice in previously treated advanced cutaneous melanoma (SITC 2025) - P1/2, P3 | "Patients in the control arm will receive nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (US), or chemotherapy. The trial is currently enrolling patients in the US and Germany and plans to enroll patients in France, the Netherlands, Canada, and the United Kingdom.Acknowledgements Study funding provided by Immatics US, Inc.Trial Registration NCT06743126Ethics Approval The protocol and all amendments were approved by the appropriate institutional review board or independent ethics committee at each participating study site. The study is being conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines."

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

Non-relapse mortality and immune-related adverse events with lifileucel: a post-marketing surveillance analysis (SITC 2025) - "While ICANS and CRS were less frequently linked to severe outcomes, ongoing monitoring is essential. Real-world evaluation of TIL therapies remains critical to understanding their full safety profile outside clinical trial settings.Abstract 386 Table 1View inline•Open as popupAdverse events"

Adverse events • P4 data • Melanoma • Oncology • Solid Tumor • IL2

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) - "I) Rare eosinophils (circled) (H&E stain, 600x). J) Colloidal iron stain with dermal mucin (400x)"

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

Lymphotoxin-driven cancer cell eradication by tumoricidal CD8+ TIL (SITC 2025) - P2 | "To determine if enrichment of LTB+CD8 + T cells was associated with clinical response to lifileucel, we examined scRNA-seq data from TIL products (n = 34) for patients with advanced melanoma...The study was approved by the Institutional Review Board (IRB) at each site and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines of the International Conference on Harmonization. All patients provided written informed consent."

IO biomarker • Melanoma • Oncology • Solid Tumor • B2M • CD8 • IFNAR2 • IFNGR1 • JAK1 • JAK2

Lymphotoxin-driven cancer cell eradication by tumoricidal CD8+ TIL (SITC 2025) - P2 | "To determine if enrichment of LTB+CD8 + T cells was associated with clinical response to lifileucel, we examined scRNA-seq data from TIL products (n = 34) for patients with advanced melanoma...The study was approved by the Institutional Review Board (IRB) at each site and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines of the International Conference on Harmonization. All patients provided written informed consent."

IO biomarker • Melanoma • Oncology • Solid Tumor • B2M • CD8 • IFNAR2 • IFNGR1 • JAK1 • JAK2

The U.S. Food and Drug Administration (FDA) previously provided positive regulatory feedback on the IOV-LUN-202 trial design and the proposed potency assay matrix to support registration. (The Manila Times) - "The IOV-LUN-202 trial is expected to progress in 2026 towards a supplemental Biologics License Application for lifileucel in nonsquamous NSCLC and a potential launch in the second half of 2027."

FDA filing • Launch US • Lung Non-Squamous Non-Small Cell Cancer

Iovance Biotherapeutics, Inc…announced interim data from its registrational Phase 2 IOV-LUN-202 trial of lifileucel monotherapy in patients with previously treated advanced nonsquamous NSCLC without actionable genetic mutations. (The Manila Times) - "The objective response rate (ORR) was 25.6% by RECIST v1.1 following one-time treatment with lifileucel monotherapy in patients with advanced nonsquamous NSCLC. An objective response was observed in 10 out of 39 patients, including 2 complete responses, 7 partial responses (PRs), and 1 unconfirmed PR (pending confirmatory assessment), with a disease control rate of 71.8%.1 The median duration of response (mDOR) was not reached after a median follow up of 25.4 months...Iovance will present additional data from the IOV-LUN-202 trial at an upcoming medical meeting in 2026."

P2 data • Lung Non-Squamous Non-Small Cell Cancer

IOV-LUN-202 is a registrational, global phase 2 study investigating lifileucel monotherapy in patients with advanced (metastatic or unresectable) NSCLC without EGFR, ROS1 or ALK actionable genetic mutations and previously treated with an immune checkpoint inhibitor and chemotherapy. (The Manila Times) - "Enrollment is expected to be completed during the second half of 2026."

Enrollment status • Lung Non-Squamous Non-Small Cell Cancer

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. Legal entity responsible for the study Immatics GmbH. Funding Immatics GmbH."

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

Current progress and latest therapeutic options in immuno-oncology (PubMed, Dtsch Med Wochenschr) - "For solid cancers, these comprise the antibody-drug-conjugate Mirvetuximab Soravtansine for platinum-resistant ovarian cancer, the monoclonal antibody Zolbetuximab for Claudin-18.2 positive gastric adenocarcinoma and the checkpoint inhibitor Tislelizumab for esophageal squamous cell carcinoma. For the treatment of relapsed or refractory hematologic B cell malignancies, the use of bispecific T cell engaging antibodies like the BCMA-CD3 targeting Teclistamab and CD20-CD3 targeting Glofitamab were approved by the EMA recently.Combinatorial approaches of conventional chemotherapy and checkpoint inhibitors for the treatment of cholangiocarcinoma, urothelial carcinoma and endometrial carcinoma received recent approval.A CD38 antibody-based bridging therapy for the treatment of newly diagnosed multiple myeloma and the Glofitamab-based approach in combination with Gemcitabine and Oxaliplatin for relapsed DLBCL are the latest additions for hematologic malignancies after promising..."

Journal • Review • Biliary Cancer • Cholangiocarcinoma • Diffuse Large B Cell Lymphoma • Endometrial Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Adenocarcinoma • Gastric Cancer • Hematological Disorders • Hematological Malignancies • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Synovial Sarcoma • Urothelial Cancer • CLDN18

Advanced Practice Provider-Led Outpatient Lymphodepleting Chemotherapy Administration for Patients Receiving Tumor-Infiltrating Lymphocyte Therapy for the Treatment of Advanced Melanoma (JADPRO 2025) - "Introduction / Background In February 2024, lifileucel became the first FDA-approved adoptive cell therapy for the treatment of any solid tumor and was specifically approved to treat advanced melanoma. The package insert specifies a lymphodepleting (LD) chemotherapy regimen of cyclophosphamide 60 mg/kg IV with mesna for 2 days, followed by fludarabine 25 mg/m2 IV for 5 days before cell infusion...Infection prophylaxis: • Acyclovir - Start on Day -7...Olanzapine-Start on Day -8 at bedtime & continue nightly for up to one week...Ondansetron - Day -7 through Day -3 as pre-medication to chemotherapy...Prochlorperazine - Prescription provided for breakthrough nausea...It will be essential to better define the training for APPs in solid tumor cellular therapies. Continued exploration of APP-led outpatient models may reduce hospital stays, improve patient outcomes and satisfaction, and lower healthcare costs-benefiting not only melanoma patients but potentially those with..."

Clinical • Metastases • Tumor-infiltrating lymphocyte • Hematological Disorders • Infectious Disease • Melanoma • Oncology • Solid Tumor

Lifileucel infusions in the real world: a single-institution series (ESMO-IO 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Oncology

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

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