Real-World Clinical Outcomes in Melanoma Patients Treated at a Single-Center Tumor Infiltrating Lymphocyte (TIL) Therapy Program Using Commercial Lifileucel

Researchers from the Knight Cancer Institute in Oregan have reported real-world delivery of commercial tumor-infiltrating lymphocyte (TIL) therapy with lifileucel (Amtagvi) as a feasible treatment for advanced melanoma. Unfortunately, approximately half of patients referred for TIL therapy ultimately received treatment, primarily due to disease progression, surgical ineligibility, comorbidities, autoimmune toxicity, or logistical barriers. Published in Transplantation and Cellular Therapy, this study shows that, while infused patients had strong outcomes, real-world effectiveness depends heavily on early referral, rapid evaluation, successful tumor harvest, manufacturing turnaround, and coordinated cellular therapy workflows.

As clinical trials showed an overall response rate of approximately 31% for BRAF wild-type/resistant, checkpoint inhibitor failure, unresectable or metastatic melanoma, lifileucel has been approved by the FDA, but post-approval outcomes in broader, less selected real-world populations remain uncertain. Therefore, the authors performed a retrospective, single-institution analysis at Oregon Health & Science University of patients referred for TIL therapy between February 2024 and September 2025. Of 50 referrals, 45 patients with unresectable or metastatic melanoma and prior PD-1 inhibitor and/or BRAF inhibitor exposure had at least one outpatient evaluation and were included. Patients eligible for treatment underwent tumor procurement, ex vivo TIL manufacturing, lymphodepleting chemotherapy with cyclophosphamide and fludarabine, lifileucel infusion, and high-dose IL-2 support.

The cohort had a median age of 68 years and included patients with stage IV disease (82.2%; n = 37), BRAF wild-type melanoma (84.4%; n = 38), brain metastases (33.3%; n = 15), and lung metastases (51.1%; n = 23). Twenty-eight patients (62.2%) underwent tumor harvest, and 23 (51.1%) ultimately received TIL infusion; 8/28 products (28.5%) were out of specification, and four patients progressed before infusion. Among infused patients, the objective response rate was 82.6%, including 15 partial responses and four complete responses, with median progression-free survival of 4.59 months and median overall survival not reached. One-year overall survival was 79.2% with TIL versus 42.0% without TIL (P=.007). This study highlights that patient attrition before TIL infusion remains a major real-world barrier, emphasizing the need for faster referral, manufacturing, and treatment pathways in advanced melanoma.

Reference:

Desai A, Valenzuela CD, Christmas K, et al. Real-World Clinical Outcomes in Melanoma Patients Treated at a Single-Center Tumor Infiltrating Lymphocyte (TIL) Therapy Program Using Commercial Lifileucel. Transplant Cell Ther. Published online April 25, 2026. http:doi.org/10.1016/j.jtct.2026.04.032