Comparing the Efficacy and Safety of Tumor-Infiltrating Lymphocyte Therapy and Pembrolizumab in Advanced Melanoma: A Randomized Controlled Trial

Thaer A.  Hussein; Mohammed H.  Flaih

doi:10.18502/acta.v63i6.20681

Thaer A. Hussein Department of Medical Laboratory Techniques, Nasiriyah Technical Institute, Southern Technical University, Basra, Iraq
Mohammed H. Flaih Department of Medical Laboratory Techniques, Nasiriyah Technical Institute, Southern Technical University, Basra, Iraq

DOI: https://doi.org/10.18502/acta.v63i6.20681

Keywords: Melanoma; Tumor-infiltrating lymphocyte; Pembrolizumab; Progression-free survival; Quality of life; Adverse events

Abstract

TIL and pembrolizumab treatments compared for advanced melanoma patient outcomes. The idea was to determine which one was better, the safety of each, and the quality of life of the patients under the treatments. While understanding the safety profile of both drugs, the assumption was that TIL therapy would be a better alternative to pembrolizumab in survival outcomes and quality of life improvements. 120 patients were randomly allocated (TIL n=60; pembrolizumab n=60). Progression-free survival (PFS) and overall survival (OS) were taken as primary endpoints. Secondary endpoints were objective response rate (ORR), quality of life (EORTC QLQ-C15-PAL), and safety (CTCAE v5.0). Median PFS was 8 vs 6 months (HR=0.85, 95% CI: 0.65-1.12; P=0.15). Median OS was 18 vs 17 months (HR=0.92, 95% CI: 0.70-1.21; P=0.21). ORR was similar (36% vs 34%). TIL improved physical functioning, and both arms provided emotional benefit. TIL was associated with higher rates of grade 3-4 toxicities, including neutropenia and cytokine release syndrome. TIL therapy resulted in survival outcomes similar to those with pembrolizumab, with improved quality of life but higher toxicity.