Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025
FDA Approval Summary: Lifileucel for Unresectable or Metastatic Melanoma Previously Treated with an Anti-PD-1-Based Immunotherapy.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Chimeric Antigen Receptor T-Cell Therapy for the Treatment of Melanoma: A Systematic Review of Phase One Clinical Trials.Technology in cancer research & treatmentPooled it
- IL-21 boosts T cell-therapy efficacy for solid tumors by enhancing mitochondrial Ca2+-mediated motility of effector CD8+ T cells.Cancer immunology research · 2026Article
- Focused Ultrasound is Poised to Take Non-Viral Gene Therapies to the Blood-Brain Barrier - and Beyond.Cell biomaterials · 2026Article
- Recent Advances in Tumor-Infiltrating Lymphocyte Therapy for Melanoma.Current treatment options in oncology · 2026Review
- Cell-based cancer immunotherapy: milestones, mechanistic insights, and emerging therapeutic directions.Acta pharmacologica Sinica · 2026Review
- Listening to Immunotherapy - Ultrasound and Photoacoustic Imaging Strategies to Guide and Enhance Cancer Treatments.Molecular imaging and biology · 2026Review
- Tumor-infiltrating lymphocyte (TIL) therapy: Historical context, clinical applications, and future directions.Cancer · 2026Review
- Cancer Immunotherapy: Therapeutic Limitations and Next-Generation Precision Strategies.Immune network · 2026Review
- Real-World Tumor-Infiltrating Lymphocyte Therapy for Metastatic Melanoma: Treatment Delivery, Immune Reconstitution, and Cardiac Monitoring During High-Dose IL-2.Current oncology (Toronto, Ont.) · 2026Article
- Cellular immunotherapy in melanoma: the next frontier in cancer treatment.Journal of experimental & clinical cancer research : CR · 2026Review
- Combination Immunotherapy as a Promising Strategy to Overcome Immunotherapy Resistance: From Emergence to Next-Generation Approaches.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- Targeting T-Cells for Cancer Treatment: Current Clinical Strategies and Challenges.Biomedicines · 2026Review
- Special Issue "New Molecular Mechanisms and Advanced Therapies for Solid Tumors".International journal of molecular sciences · 2026Article
- From Immunobiology to Clinical Application: Tumor-Infiltrating Lymphocytes in Melanoma.Journal of personalized medicine · 2026Review
- Rewiring tumor cytokine networks to enhance immune checkpoint blockade: mechanisms, engineering, and clinical translation.Journal of experimental & clinical cancer research : CR · 2026Review
- Immunotherapy in Melanoma: A Dynamic Frontier in Cancer Treatment : Author List.Current treatment options in oncology · 2026Review
- Adoptive cell therapies in solid tumors: current clinical landscape, challenges, and future directions.Frontiers in immunology · 2026Review
- T-cell redirecting therapies in lung cancer - a comprehensive analysis of clinical trials.Frontiers in immunology · 2026Review
- Review
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Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
On February 16, 2024, the FDA granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.) 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 an MEK inhibitor. Lifileucel is the first tumor-derived T-cell therapy approved by the FDA. In the phase II single-arm trial, Study C-144-01, that served as the basis for approval, the objective response rate among patients treated with lifileucel within FDA-approved dose range (7.5 × 109 to 72 × 109 viable cells, n = 73) in the primary efficacy cohort was 31.5% (95% confidence interval, 21.1%-43.4%), including three (4.1%) complete responses and 20 (27.4%) partial responses. The median duration of response was not reached (95% confidence interval, 4.1 months-not reached). Among the responders (n = 23), 56.5%, 47.8%, and 43.5% maintained durable responses at 6, 9, and 12 months, respectively. Among all patients who received lifileucel (n = 156) in the primary and supportive cohorts of Study C-144-01, 95.5% of patients experienced at least one Grade 3 treatment-emergent adverse event and 87.8% experienced at least one Grade 4 treatment-emergent adverse event. Lifileucel labeling includes a Boxed Warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary impairment, and renal impairment.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.