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    DRUG:

    Amtagvi (lifileucel)

    i
    Other names: LN 144, autologous T cell therapy with tumor infiltrating lymphocytes, TIL-ACT, LN-144, LN144
    Company:
    Iovance Biotherap
    Drug class:
    Immunostimulant, T lymphocyte replacement
    Related drugs:
    5d
    TIL cell therapy in HIV positive patient with metastatic melanoma: case report. (PubMed, Front Oncol)
    After multidisciplinary review, he underwent TIL harvest followed by lymphodepleting chemotherapy, lifileucel infusion, and high-dose interleukin-2 (IL-2)...This case demonstrates that TIL therapy can be feasibly administered to a patient with well-controlled HIV, with manageable toxicity and early radiographic response. These findings underscore the need for prospective inclusion of people living with HIV in cellular therapy trials to better characterize safety, immune dynamics, and predictors of durable benefit.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
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    BRAF V600E • BRAF V600
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    Amtagvi (lifileucel)
    13d
    A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma (clinicaltrials.gov)
    P1, N=30, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: May 2026 --> May 2027 | Trial primary completion date: May 2026 --> May 2027
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Amtagvi (lifileucel) • LN-145
    26d
    IOV-COM-202: Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (clinicaltrials.gov)
    P2, N=225, Terminated, Iovance Biotherapeutics, Inc. | Trial completion date: Aug 2029 --> Feb 2026 | Recruiting --> Terminated | Trial primary completion date: Aug 2029 --> Feb 2026; After reviewing the available safety and efficacy data to date, Iovance concluded that the study reached the required number of events for evaluation of study endpoints.
    Trial completion date • Trial termination • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Keytruda (pembrolizumab) • cisplatin • Yervoy (ipilimumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • Opdualag (nivolumab/relatlimab-rmbw) • Amtagvi (lifileucel) • relatlimab (BMS-986016) • LN-145 • LN-145-S1
    1m
    Advances in cell therapy for solid tumours: European perspective and future directions. (PubMed, Lancet Reg Health Eur)
    The recent US FDA approvals of lifileucel (a TIL therapy for advanced melanoma) and afamitresgene autoleucel (a TCR therapy targeting MAGE-A4 in synovial sarcoma) mark the first regulatory recognition of cell therapies for solid tumours and signal a new era for oncology...Emphasis is placed on emerging innovations like gene-edited and allogeneic therapies, as well as future directions for integrating cell therapies into mainstream oncology. We conclude with recommendations for overcoming barriers related to cost, toxicity management, and equitable access across Europe.
    Review • Journal
    |
    MAGEA4 (Melanoma antigen family A, 4)
    |
    Tecelra (afamitresgene autoleucel) • Amtagvi (lifileucel)
    1m
    Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P2, N=11, Completed, University of Kansas Medical Center | Trial completion date: Nov 2025 --> Jul 2025 | Trial primary completion date: Nov 2025 --> Jul 2025 | Recruiting --> Completed
    Trial completion • Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
    |
    BRAF mutation • BRAF V600
    |
    cyclophosphamide • fludarabine IV • Amtagvi (lifileucel) • Imunace (teceleukin)
    1m
    TILVANCE-301: Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. (clinicaltrials.gov)
    P3, N=670, Recruiting, Iovance Biotherapeutics, Inc. | N=290 --> 670
    Enrollment change
    |
    Keytruda (pembrolizumab) • Amtagvi (lifileucel)
    1m
    SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (clinicaltrials.gov)
    P3, N=360, Recruiting, Immatics US, Inc. | N=108 --> 360
    Enrollment change
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • carboplatin • temozolomide • albumin-bound paclitaxel • cyclophosphamide • dacarbazine • Amtagvi (lifileucel) • relatlimab (BMS-986016) • anzutresgene autoleucel (IMA203)
    1m
    SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (clinicaltrials.gov)
    P3, N=108, Recruiting, Immatics US, Inc.
    New P3 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • carboplatin • temozolomide • albumin-bound paclitaxel • cyclophosphamide • dacarbazine • Amtagvi (lifileucel) • relatlimab (BMS-986016) • anzutresgene autoleucel (IMA203)
    1m
    Real World Clinical Outcomes in Melanoma Patients Treated at a Single-Center Tumor Infiltrating Lymphocyte (TIL) Therapy Program using commercial Lifileucel. (PubMed, Transplant Cell Ther)
    Our institutional real-world data show that only about half of TIL therapy referrals will proceed with the actual TIL infusions. While TIL therapy seeks to achieve the approximately 32% response rate observed in the registrational trial, real-world outcomes in an intent-to-treat population are anticipated to be inferior. Advanced melanoma affords a narrow time window from referral to completion of TIL manufacturing and infusion, necessitating efficient workflows to enable early treatment and optimize patient outcomes.
    Clinical data • Journal • Real-world evidence • Tumor-infiltrating lymphocyte
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Amtagvi (lifileucel)
    2ms
    SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (clinicaltrials.gov)
    P3, N=360, Recruiting, Immatics US, Inc. | N=96 --> 360
    Enrollment change
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • carboplatin • temozolomide • albumin-bound paclitaxel • cyclophosphamide • dacarbazine • Amtagvi (lifileucel) • relatlimab (BMS-986016) • anzutresgene autoleucel (IMA203)
    2ms
    IOV-MEL-202: A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma (clinicaltrials.gov)
    P2, N=100, Active, not recruiting, Iovance Biotherapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Trial initiation date
    |
    BRAF mutation • BRAF V600
    |
    Amtagvi (lifileucel)
    2ms
    SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (clinicaltrials.gov)
    P3, N=96, Recruiting, Immatics US, Inc.
    New P3 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    Keytruda (pembrolizumab) • Yervoy (ipilimumab) • carboplatin • temozolomide • albumin-bound paclitaxel • cyclophosphamide • dacarbazine • Amtagvi (lifileucel) • relatlimab (BMS-986016) • anzutresgene autoleucel (IMA203)