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

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.