Amtagvi (lifileucel) / Iovance Biotherap - LARVOL DELTA

Enrichment of putative tumor-reactive clones in NSCLC patients responding to Lifileucel: Temporal single cell analysis from a clinical trial (ESMO 2026) - No abstract available

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Lifileucel versus Nivolumab plus Relatlimab (NIVO+RELA) in anti–PD-(L)1-resistant advanced melanoma: A match-adjusted indirect comparison (MAIC) of efficacy outcomes (ESMO 2026) - No abstract available

Clinical • Metastases • Melanoma • Oncology • Solid Tumor • RELA

Indirect Comparison of Overall Survival (OS) between Lifileucel versus Standard-of-Care (SoC) in US Real-World (RW) Settings in anti-PD-1 resistant advanced melanoma (ESMO 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Melanoma • Oncology • Solid Tumor

Lifileucel in Patients with Undifferentiated Pleomorphic Sarcoma (UPS) or Dedifferentiated Liposarcoma (DDLS) (ESMO 2026) - No abstract available

Clinical • Liposarcoma • Oncology • Sarcoma • Solid Tumor • Undifferentiated Pleomorphic Sarcoma

Efficacy and Safety of Lifileucel and Pembrolizumab in Patients with Immune Check Point Inhibitor-Naïve Advanced Melanoma - Final Results from IOV-COM-202 Study (ESMO 2026) - No abstract available

Clinical • Metastases • Melanoma • Oncology • Solid Tumor

Recent Advances in Tumor-Infiltrating Lymphocyte Therapy for Melanoma. (PubMed, Curr Treat Options Oncol) - "We then review current clinical evidence for conventional TIL products, including lifileucel, TM001, LM103, HS-IT101, and GC101, highlighting their efficacy and safety profiles...In addition, advances in genetically engineered TILs, such as OBX-115, KSQ-001EX, and IOV-4001, are reviewed...Challenges and future directions of TIL therapy in melanoma are also discussed. Overall, TIL therapy constitutes a rapidly evolving and clinically potent treatment modality for melanoma."

Biomarker • IO biomarker • Journal • Review • Tumor-infiltrating lymphocyte • Genetic Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor • IL2

Lifileucel, an Autologous Tumor-infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors. (PubMed, Cancer Discov) - "In this phase 2 multicenter study, we evaluated the efficacy and safety of lifileucel (LN-145), an autologous tumor-infiltrating lymphocyte cell therapy, in patients with metastatic non-small cell lung cancer (mNSCLC) who had received prior immunotherapy and progressed on their most recent therapy. Two patients died of treatment-emergent adverse events: cardiac failure and multiple organ failure. Lifileucel is a potential treatment option for patients with mNSCLC refractory to prior therapy."

Checkpoint inhibition • Clinical • IO biomarker • Journal • Metastases • Monotherapy • Tumor mutational burden • Tumor-infiltrating lymphocyte • Cardiovascular • Congestive Heart Failure • Heart Failure • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • STK11 • TMB

T-cell redirecting therapies in lung cancer - a comprehensive analysis of clinical trials. (PubMed, Front Immunol) - "Among these, tarlatamab, a DLL3×CD3 BiTE, has achieved the most advanced clinical validation, receiving traditional FDA approval in November 2025 for second-line ES-SCLC following Phase 3 DeLLphi-304 data demonstrating superior overall survival versus chemotherapy (median 13.6 vs. 8.3 months; HR 0.60). TIL therapy is the leading adoptive cell approach in non-small cell lung cancer (NSCLC), with lifileucel demonstrating a 25.6% ORR in anti-PD-1-resistant disease and a 64.3% ORR when combined with pembrolizumab in ICI-naïve patients, though manufacturing complexity and cost constrain broad access...Combination strategies pairing T cell-redirected therapies with ICIs, antibody-drug conjugates, and allogeneic or innate immune effectors represent the most promising path toward durable benefit."

IO biomarker • Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Top advances of the year in autologous cellular therapy in melanoma and solid tumors. (PubMed, Cancer) - "Lifileucel, the first Food and Drug Administration-approved tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma, demonstrated durable efficacy in the 5-year analysis of the C-144-01 trial, with an objective response rate (ORR) of 31.4% and prolonged responses in a heavily pretreated population...Preferentially expressed antigen in melanoma (PRAME)-targeted T-cell receptor (TCR) T-cell therapy (anzu-cel, IMA203) showed promising activity in a phase 1 study, with ORR of approximately 50% in checkpoint inhibitor refractory melanoma, durable responses, and manageable toxicity, validating PRAME as a high value target across multiple tumor types...OBX-115, an IL-2 independent TIL platform expressing membrane-bound IL-15 regulated by acetazolamide, demonstrated early clinical activity with ORR of 67% in initial phase 1 data...Finally, afamitresgene autoleucel (afami-cel), a MAGE-A4 directed TCR-T therapy, showed durable efficacy in synovial sarcoma and expanding..."

Journal • Review • Melanoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • IL15 • MAGEA4 • PRAME

SUPRAME: A phase 3 trial comparing IMA203, an engineered T-cell receptor expressing T cell therapy (TCR-T) vs investigator's choice in patients with previously treated advanced cutaneous melanoma. (ASCO 2025) - P3 | "Following lymphodepletion with cyclophosphamide (500 mg/m2 x 4 days) and fludarabine (30 mg/m2 x 4 days), 1-10x109 IMA203 TCR-T cells will be administered, followed by low-dose IL-2 (1mio IU daily x5 days, twice daily x5 days). Patients in the control arm will receive approved investigator's choice of standard treatment (nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (US), chemotherapy)...Secondary endpoints include OS, ORR, safety and patient-reported outcomes (EORTC QLQ-C30, EQ-5D-5L). The trial will enroll patients in the US and Europe."

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

Efficacy and safety of lifileucel, an autologous tumor-infiltrating lymphocyte cell therapy, and pembrolizumab in patients with immune checkpoint inhibitor-naive unresectable or metastatic melanoma: Updated results from IOV-COM-202 cohort 1A. (ASCO 2024) - P2, P3 | "The tx regimen consists of pembro, nonmyeloablative lymphodepletion (cyclophosphamide and fludarabine), a single lifileucel infusion (1 × 10 9 – 150 × 10 9 cells), ≤6 doses of IL-2 (600,000 IU/kg IV), and continued pembro until disease progression, or unacceptable toxicity for ≤24 months. These results demonstrate encouraging efficacy and durability for the combination of lifileucel and pembro and support its further evaluation in pts with untreated advanced melanoma in the phase 3 study TILVANCE-301 (NCT05727904)."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • Tumor-infiltrating lymphocyte • Anemia • Hematological Disorders • Hepatology • Melanoma • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia

Lifileucel TIL cell monotherapy in patients with advanced melanoma after progression on immune checkpoint inhibitors (ICI) and targeted therapy: Pooled analysis of consecutive cohorts (C-144-01 study) (SITC 2022) - P2 | "Conclusions Lifileucel demonstrated clinically meaningful and durable activity (ORR: 31%; mDOR: NR) in heavily pretreated patients with advanced melanoma and high tumor burden after ICI (and targeted therapy, where appropriate). Favorable safety profile and sustained responses support the potential benefit of one-time lifileucel TIL cell therapy as a novel treatment option for patients without approved therapies post-ICI."

Checkpoint inhibition • Monotherapy • Retrospective data • Melanoma • Oncology • Solid Tumor

A pilot trial of autologous tumor infiltrating lymphocytes (lifileucel, LN-144) for patients with asymptomatic melanoma brain metastases. (ASCO 2023) - P1 | "Patients are not eligible if they have symptomatic MBM and/or require corticosteroids of ≥10 mg/day of prednisone or equivalent. Extensive correlative analyses of peripheral blood mononuclear cells, plasma, tumors, and cerebrospinal fluid are planned to better understand MBM growth, treatment resistance, and response of the central nervous system to lifileucel. Clinical trial information: NCT05640193."

Clinical • IO biomarker • Tumor-infiltrating lymphocyte • Eye Cancer • Melanoma • Oncology • Solid Tumor • BRAF

Reduced dose fludarabine/cyclophosphamide lymphodepletion for tumor-infiltrating lymphocytes therapy (LN-144, lifileucel) in metastatic melanoma. (ASCO 2024) - P2 | "If TIL persistence is roughly equivocal between the reduced and high-dose Flu/Cy LD regimens, the design of a larger-scale trial using reduced-dose Flu/Cy LD for TIL therapy may be considered. Study follow-up will continue for one year."

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

Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study. (PubMed, J Immunother Cancer) - "Investigational lifileucel demonstrated clinically meaningful activity in heavily pretreated patients with advanced melanoma and high tumor burden. Durable responses and a favorable safety profile support the potential benefit of one-time lifileucel TIL cell therapy in patients with limited treatment options in ICI-refractory disease."

Checkpoint inhibition • Journal • Metastases • Retrospective data • Tumor-infiltrating lymphocyte • Febrile Neutropenia • Hematological Disorders • Immune Modulation • Inflammation • Melanoma • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia

Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma. (PubMed, J Clin Oncol) - "Lifileucel demonstrated durable responses and addresses a major unmet need in patients with metastatic melanoma with limited treatment options after approved therapy, including the primary refractory to anti-PD-1 or PD-L1 therapy subset."

Clinical • Journal • Immune Modulation • Inflammation • Melanoma • Oncology • Solid Tumor

Lifileucel in patients with advanced melanoma: 5-year outcomes of the C-144-01 study. (ASCO 2025) - P2 | "Before lifileucel infusion, pts underwent nonmyeloablative lymphodepletion (NMA-LD; cyclophosphamide, 60 mg/kg × 2 d plus fludarabine 25 mg/m2 × 5 d). This 5-year analysis of the C-144-01 trial is the longest follow-up of the largest group of pts with melanoma treated with tumor-infiltrating lymphocytes in a single study. This study illustrates lifileucel's continued durability of response and survival benefit up to 5 years after a single administration without any long-term safety concerns."

Clinical • IO biomarker • Metastases • Melanoma • Oncology • Solid Tumor

Lifileucel Delivers in Practice-Can Attrition be Reduced? (PubMed, Transplant Cell Ther) - No abstract available

Journal

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

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 2026 ➔ Nov 2027 | Trial primary completion date: Nov 2026 ➔ Nov 2027

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

Long-term Efficacy and Safety of Lifileucel Tumor-infiltrating Lymphocyte (TIL) Cell Therapy in Patients with Advanced Melanoma: A 5-year Analysis of the C-144-01 Study. (PubMed, J Clin Oncol) - "Most grade 3/4 cytopenias resolved to grade ≤ 2 by day 30. This 5-year analysis demonstrated long-term benefit and meaningful OS with one-time lifileucel therapy, with no additional long-term safety concerns."

Journal • Tumor-infiltrating lymphocyte • Hematological Disorders • Melanoma • Oncology • Skin Cancer • Solid Tumor • Transplantation • IL2

A multicenter phase 2 trial of lifileucel plus pembrolizumab in patients with checkpoint inhibitor-naive metastatic NSCLC: updated results (SITC 2024) - P2 | "Patients received nonmyeloablative lymphodepletion (cyclophosphamide and fludarabine), followed by a single lifileucel infusion, and ≤6 doses of high-dose interleukin-2 (IL-2). All patients provided written informed consent.Download figure Open in new tab Download powerpoint Abstract 1488 Figure 1 Time on study for responders. BOR, best overall response; CR, complete response; PD-L1, programmed death ligand 1; PR, partial response; TIL, tumor-infiltrating lymphocytes; TKI, tyrosine kinase inhibitor; TPS, tumor proportion score"

Checkpoint inhibition • Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Phase 2, multicenter study of frontline maintenance therapy with lifileucel plus pembrolizumab in advanced non-small cell lung cancer. (ASCO 2025) - P2 | "We added two new cohorts within this basket study, 3D and 3E, which evaluate if adding lifileucel to pembro ± pemetrexed in the maintenance phase of standard-of-care (SOC) therapy (from tumors procured in treatment-naive pts [3D] versus those who had already started receiving SOC chemotherapy [3E]) is feasible and provides added benefit with an acceptable safety profile...After completion of SOC chemotherapy, a dose of pembrolizumab will be given followed by nonmyeloablative lymphodepletion (NMA-LD) (day −5 to day −3: cyclophosphamide 20 mg/kg/day; day −5 to day −2: fludarabine 25 mg/m2/day)...Prior organ allograft or cell transfer therapy, symptomatic brain metastases, current systemic steroid therapy >10 mg/day of prednisone or other steroid equivalent, and active illnesses or autoimmune disorders are not permitted...Selected exploratory endpoints include in vivo T-cell persistence, correlative biomarkers, and circulating tumor DNA. Enrollment of..."

Clinical • IO biomarker • Metastases • P2 data • Immunology • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • IL2

Outpatient Treatment-Related Toxicity After Hospital Discharge Among Patients Receiving Lifileucel for Advanced Melanoma. (PubMed, JCO Oncol Pract) - "Overall, rates of new severe toxicity and treatment-related readmissions were low among patients discharged after lifileucel. These findings support individualized follow-up in this population compared with other cellular therapies and highlight the need for specific postdischarge guidelines for patients receiving TIL therapy."

Journal • Hematological Disorders • Melanoma • Neutropenia • Oncology • Pulmonary Disease • Solid Tumor • IL2

U.S. Amtagvi Revenue Reaches ~$91M and Total Revenue Increased 66% Year-over-Year (GlobeNewswire)

Sales • Melanoma