Health-related quality of life following tumor-infiltrating lymphocyte (TIL) therapy with commercial lifileucel in metastatic melanoma: Real-world longitudinal patient-reported outcomes.

Abstract

9547 Background: Although the efficacy of lifileucel has been demonstrated in metastatic melanoma, real-world longitudinal patient-reported outcomes remain limited. We evaluated health-related quality of life (HRQoL) among patients treated with commercial lifileucel at Moffitt Cancer Center using the Functional Assessment of Cancer Therapy–Melanoma (FACT-M) instrument. Methods: FACT-M surveys were administered at Baseline, Day +7, Month +6, and End of Treatment (April–December 2025). Scores were calculated using validated procedures. Clinical benefit was defined as complete response/ no evidence of disease or partial response as the best response per RECIST v1.1. Minimally important differences (MID) were defined as 4–7 points for the FACT-G total score and 4–6 points for the FACT-M combined scores. Comparisons used Wilcoxon rank-sum tests. Results: Thirty-two patients were enrolled, with 97 surveys completed out of 105 requested (92% completion rate). Median age was 66 years (range 29–78); 56% were male (n=18) and 44% female (n=14). ECOG performance status was 0–1 in 93%. Patients received a median of 5 IL-2 doses (range 1–6), and 53% experienced clinical benefit (n=17). Baseline, Day +7, and Month +6 FACT-M subscale and total scores are presented in Table 1. Among all patients, FACT-M and FACT-G scores remained stable from baseline to Day +7 and demonstrated clinically meaningful improvement exceeding the minimally clinically important difference at Month +6. While baseline HRQoL scores did not differ by treatment outcome (median FACT-G, 87 in both groups; median FACT-M, 108 in patients without clinical benefit and 109 in those with benefit), scores were significantly higher across follow-up assessments among patients with clinical benefit compared with those without. Median FACT-G scores were 102 vs. 76 (p=0.012), and median FACT-M scores were 125 vs. 94 (p=0.017), respectively. Conclusions: HRQoL, as measured by FACT-G and FACT-M, was maintained following commercial lifileucel in a real-world metastatic melanoma cohort, supporting the tolerability of TIL therapy. HRQoL outcomes varied according to clinical benefit. Larger studies with extended follow-up are warranted to confirm these findings. Median baseline, day+7, and month +6 FACT-M subscale and total scores. Characteristic BaselineN = 17 1 Day +7N = 11 1 Month +6N = 13 1 Baseline to Month+6 difference Physical well Being (PWB) 25 20 26 +1 Social well Being (SWB) 25.67 25.20 26.00 +0.33 Emotional well Being (EWB) 22.2 22.2 23.3 +1.1 Functional well Being (FWB) 21 20 23 +2 Melanoma (MS) 22.3 20.6 24.5 +2.2 Melanoma Surgery (MSS) 24.5 24.5 27.1 +2.6 FACT-G (sum of PWB, SWB, EWB, + FWB) 90 89 97 +7 FACT-M (sum of FACT-G + MS) 111 111 124 +13 1 Median.