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Clinical Trial
. 2025 Oct;36(10):1154-1165.
doi: 10.1016/j.annonc.2025.06.005. Epub 2025 Jun 18.

Health-related quality of life of patients with metastatic melanoma treated with tumor-infiltrating lymphocytes compared with ipilimumab in a randomized phase III trial

R M T Ten Ham  1 , M W Rohaan  2 , M Egeler  3 , R Menezes  3 , T Holz Borch  4 , R Kessels  5 , I Jedema  6 , B Nuijen  7 , C M Nijenhuis  7 , L V van de Poll-Franse  3 , M H Geukes Foppen  2 , M Lindenberg  3 , I Mansfield Noringriis  4 , T J Monberg  4 , M Donia  4 , W van Harten  3 , I M Svane  4 , J B A G Haanen  8 , V P Retèl  9
Affiliations
Free article
Clinical Trial

Health-related quality of life of patients with metastatic melanoma treated with tumor-infiltrating lymphocytes compared with ipilimumab in a randomized phase III trial

R M T Ten Ham et al. Ann Oncol. 2025 Oct.
Free article

Abstract

Background: This study aimed to assess health-related quality of life (HRQoL) in patients with metastatic melanoma treated with a tumor-infiltrating lymphocyte investigational medicinal product (TIL-IMP) or ipilimumab (IPI) after failure of first- or second-line treatment.

Patients and methods: In a multicenter, randomized, phase III trial, patients with metastatic melanoma (unresectable stage IIIC-IV) were randomized to TIL-IMP or IPI treatment (NCT02278887). HRQoL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL), EuroQol 5D-3L (EQ-5D), and the Impact of Event Scale (IES). HRQoL outcomes were evaluated using a generalized estimating equations model. Sensitivity analyses were carried out to assess dropout assumptions. Results were interpreted for statistically and clinically significant differences.

Results: Of 168 patients randomized 1 : 1, n = 143 baseline HRQoL scores (85%) were calculated. Of these, 75 (89%) were in the TIL-IMP group and 73 (87%) in the IPI group. TIL-IMP-treated patients reported higher global health status scores at week 24 compared with IPI-treated patients (78.2 versus 73.9; P < 0.05) and higher emotional functioning (85.9 versus 77.9; P < 0.05) scores. Patients treated with TIL-IMP had significantly lower fatigue (25.0 versus 32.4; P < 0.05) and pain (13.7 versus 17.6; P < 0.05) scores at week 24, but marginally higher nausea and vomiting (7.5 versus 5.2; P < 0.05) symptom scores. EQ-5D scores were also higher in the TIL-IMP group (0.89 versus 0.83; P < 0.05). These statistically significant differences were not considered clinically meaningful. The hypothesized higher impact of the more intensive TIL-IMP treatment compared with IPI was not observed, according to IES scores (11.8 versus 17.4; P < 0.05 at 24 weeks). Sensitivity analyses showed similar results.

Conclusions: Patients with metastatic melanoma treated with TIL-IMP experienced similar HRQoL compared with IPI monotherapy, with indications of better HRQoL outcomes over time. Ongoing follow-up is essential to assess longer-term HRQoL and its generalizability to a larger patient population to help guide personalized treatment decisions.

Keywords: cell therapy; immunotherapy; melanoma; population based; quality of life.

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Conflict of interest statement

Disclosure THB: Bristol-Myers Squibb (speaker engagement). MD: Achiles Therapeutics (consulting), AstraZeneca (teaching), Bristol-Myers Squibb (consulting and teaching), F. Hoffman-La Roche (speaker engagement), Genentech (consulting), Merck (speaker engagement), Novartis (speaker engagement). JBAGH: Achilles Therapeutics (Scientific Advisory Board), Amgen (funding), Asher Bio (funding), Bayer (consulting), BioNtech US (Scientific Advisory Board, funding), Bristol-Myers Squibb (consulting, funding, teaching), Eisai (consulting), ESMO IOTECH (Editor-in-chief), Gadeta (Scientific Advisory Board), Immunocore (Scientific Advisory Board), Instil Bio (consulting, teaching), Iovance Biotherapeutics (consulting, teaching), Ipsen Bioscience Inc (consulting), Merck Serono (consulting, teaching), Merck Sharp & Dohme Corporation (funding, consulting, teaching), Molecular Partners (consulting), Neogene Therapeutics (Scientific Advisory Board, shareholder), Novartis (funding, consulting, teaching), Pfizer (consulting, teaching), PokeAcel (Scientific Advisory Board), Roche/Genentech (consulting, teaching), Sanofi (consulting, teaching), Scenic (Scientific Advisory Board), Seattle Genetics (consulting), T-Knife (Scientific Advisory Board), Vaximm (Scientific Advisory Board). IMS: Adaptimmune (funding), Bristol-Myers Squibb (speaking engagement), Enara Bio (funding), Evaxion (funding), IO Biotech (funding, stock, consulting), Lytix Biopharma (funding), Merck (speaking engagement and funding), Novartis (consulting), Pierre Fabre Pharmaceuticals, Inc. (speaking engagement and consulting), Sanofi Pasteur Inc. (speaking engagement), TILT Biotherapeutics (funding). All other authors have declared no conflicts of interest.

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