Evaluation of Health-Related Quality of Life (HRQoL) Among Patients Treated With Lifileucel After Progression on Immune Checkpoint Inhibitors (ICIs) and Targeted Therapies: Analyses From the C-144-01 Trial
Author(s)
Jennifer Hinkel, MSc1, Josh Wang, MBA2, Jennifer Chang, MBA2, Jessie Jiang, MBA2, Murat Kurt, BS, MS, PhD2.
1Sigla Sciences, Incline Village, NV, USA, 2Iovance Biotherapeutics, San Carlos, CA, USA.
1Sigla Sciences, Incline Village, NV, USA, 2Iovance Biotherapeutics, San Carlos, CA, USA.
OBJECTIVES: Lifileucel is a one-time autologous tumor infiltrating lymphocyte therapy associated with durable survival and response benefits in advanced melanoma after progression on ICIs. However, there is a paucity of HRQoL data due to lack of treatment options and clinical studies, particularly among heavily pre-treated patients. We present descriptive analyses of HRQoL data among patients treated with lifileucel in the single arm C-144-01 trial.
METHODS: In the trial, HRQoL was assessed via EORTC QLQ-C30 questionnaires at baseline and scheduled clinic visits. Responses to questionnaires were mapped to EQ-5D-3L utilities using a published algorithm [Kim et al. 2012] which was developed using ordinary least squares and validated on a broad set of cancers. Mapped EQ 5D scores and corresponding 95% CIs were summarized for all treated patients and in subgroups with respect to patients’ response status and prior lines of systemic therapy.
RESULTS: There were 405 evaluable observations from 146 patients with baseline assessment. Median time between successive assessments was 131 days. Across all patients mean and median EQ-5D scores were 0.870 (95% CI: 0.862-0.878) and 0.884, respectively (range 0.468-0.994). Stratified by clinical response, mean EQ-5D utilities were 0.873 (95% CI: 0.858-0.889) and 0.867 (95% CI: 0.851-0.882) for responders and non-responders, respectively. Cumulative prior therapy exposure was associated with slightly lower HRQoL. Mean EQ-5D scores among patients with ≤ (2, 3, 4, 5) prior lines of treatment were 0.902 (95% CI: 0.886-0.919), 0.884 (95% CI: 0.871-0.897), 0.878 (95% CI: 0.866-0.889) and 0.874 (95% CI: 0.862-0.885), respectively.
CONCLUSIONS: Across all treated patients and various subgroups with clinical relevance, mapped EQ-5D scores were higher than the range of published utilities (0.68-0.84) indicating lifileucel’s potential to enhance HRQoL and address the unmet need in previously treated advanced melanoma. Data sparsity and single-arm study may limit generalizability of the findings, emphasizing the value of additional data from confirmatory studies.
METHODS: In the trial, HRQoL was assessed via EORTC QLQ-C30 questionnaires at baseline and scheduled clinic visits. Responses to questionnaires were mapped to EQ-5D-3L utilities using a published algorithm [Kim et al. 2012] which was developed using ordinary least squares and validated on a broad set of cancers. Mapped EQ 5D scores and corresponding 95% CIs were summarized for all treated patients and in subgroups with respect to patients’ response status and prior lines of systemic therapy.
RESULTS: There were 405 evaluable observations from 146 patients with baseline assessment. Median time between successive assessments was 131 days. Across all patients mean and median EQ-5D scores were 0.870 (95% CI: 0.862-0.878) and 0.884, respectively (range 0.468-0.994). Stratified by clinical response, mean EQ-5D utilities were 0.873 (95% CI: 0.858-0.889) and 0.867 (95% CI: 0.851-0.882) for responders and non-responders, respectively. Cumulative prior therapy exposure was associated with slightly lower HRQoL. Mean EQ-5D scores among patients with ≤ (2, 3, 4, 5) prior lines of treatment were 0.902 (95% CI: 0.886-0.919), 0.884 (95% CI: 0.871-0.897), 0.878 (95% CI: 0.866-0.889) and 0.874 (95% CI: 0.862-0.885), respectively.
CONCLUSIONS: Across all treated patients and various subgroups with clinical relevance, mapped EQ-5D scores were higher than the range of published utilities (0.68-0.84) indicating lifileucel’s potential to enhance HRQoL and address the unmet need in previously treated advanced melanoma. Data sparsity and single-arm study may limit generalizability of the findings, emphasizing the value of additional data from confirmatory studies.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO112
Topic
Clinical Outcomes, Patient-Centered Research
Disease
Oncology