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

BACKGROUND: Tumor-infiltrating lymphocyte (TIL) therapy entails isolating, activating, expanding, and reinfusing isolated lymphocytes from tumors, presumably representing a collection of high-affinity T cells that can recognize the melanoma tumor-specific peptides expressed on endogenous human leukocyte antigens. The US Food and Drug Administration (FDA) recently approved commercial TIL (lifileucel [Amtagvi]) for treatment of BRAF wild-type/resistant, checkpoint inhibitor failure, unresectable or metastatic melanoma based on a registrational trial showing an overall response rate of 31.5% in treated patients. Following FDA approval, patient outcomes beyond the originally selected clinical trial populations remain unknown. OBJECTIVE: We report initial real-world, single-institutional observations and outcomes for patients with melanoma referred for TIL therapy. METHODS: A retrospective analysis of the cell therapy database of outcomes in 45 patients with unresectable or metastatic melanoma referred for TIL therapy considerations is reported. RESULTS: The median age of the patients was 68 years (range, 27-83); 37 (82.2%) had stage IV and 38 (84.4%) had BRAF wild-type disease, and 15 (33.3%) had central nervous system disease. Twenty-three patients were male (51.1%); 28 (62.2%) patients completed surgical tumor harvest, 23 (51.1%) patients completed TIL infusion, and 1 patient was just starting lymphodepleting (LD) chemotherapy at the time of data analysis. Three patients died from disease progression, and 1 went on comfort care prior to starting LD chemotherapy. Eight (28.5%) TIL products were out of specification. Seventeen referred patients did not proceed to tumor resection: 8 (47.1%) were deemed ineligible owing to small tumor size (