Long-Term Efficacy and Safety of Lifileucel Tumor-Infiltrating Lymphocyte Cell Therapy in Patients With Advanced Melanoma: A 5-Year Analysis of the C-144-01 Study
Research output: Contribution to journal › Research article › Contributed › peer-review
Contributors
- National Center for Tumor Diseases Dresden
- University of Colorado Anschutz Medical Campus
- University of Louisville Health
- Yale University
- The Angeles Clinic and Research Institute
- Morristown Medical Center (MMC)
- Mount Sinai Medical Center Miami Beach
- AdventHealth Orlando
- University of Connecticut Health
- UPMC Hillman Cancer Center
- Royal Marsden NHS Foundation Trust
- New York University Langone Health
- Iovance Biotherapeutics, Inc.
- H. Lee Moffitt Cancer Center & Research Institute
Abstract
Patients with advanced melanoma resistant to immune checkpoint or BRAF/MEK inhibitors have treatment options with relatively low efficacy. Lifileucel, a one-time autologous tumor-infiltrating lymphocyte cell therapy, was approved in the United States on the basis of the pivotal C-144-01 study. A 5-year follow-up of the C-144-01 trial assessed the long-term efficacy and safety of lifileucel. At the cutoff date (November 20, 2024), the objective response rate was 31.4% (complete response [CR], 5.9%; partial response [PR], 25.5%). Overall, 79.3% of patients had tumor burden reduction; 16 had deepened responses with four converting from PR to CR > 1 year after lifileucel infusion; 31.3% of responders completed the 5-year assessment with ongoing responses. The median duration of response was 36.5 months. Responders (n = 48) had lower tumor burden and fewer liver or brain metastases than the overall population. The median overall survival (OS) was 13.9 months, with a 5-year OS of 19.7%. Adverse events were consistent with nonmyeloablative lymphodepletion and interleukin-2 safety profiles and declined rapidly within 2 weeks after lifileucel infusion. 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.
Details
| Original language | English |
|---|---|
| Pages (from-to) | 3565-3572 |
| Number of pages | 8 |
| Journal | Journal of Clinical Oncology |
| Volume | 43 |
| Issue number | 33 |
| Publication status | Published - 20 Nov 2025 |
| Peer-reviewed | Yes |
External IDs
| PubMedCentral | PMC12622280 |
|---|---|
| Scopus | 105009828256 |
Keywords
Sustainable Development Goals
ASJC Scopus subject areas
Keywords
- autologous transplantation, skin neoplasms, tumor infiltrating lymphocytes