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. 2025 Oct;45(10):1229-1234.
doi: 10.1002/cac2.70050. Epub 2025 Jul 22.

Lifileucel tumor-infiltrating lymphocyte cell therapy in patients with unresectable or metastatic mucosal melanoma after disease progression on immune checkpoint inhibitors

Harriet Kluger  1 , Götz Ulrich Grigoleit  2 , Sajeve Thomas  3 , Evidio Domingo-Musibay  4 , Jason A Chesney  5 , Miguel F Sanmamed  6 , Theresa Medina  7 , Mirjana Ziemer  8 , Eric Whitman  9 , Friedrich Graf Finckenstein  10 , Brian Gastman  10 , Jeffrey Chou  10 , Xiao Wu  10 , Giri Sulur  10 , Rana Fiaz  10 , Rongsu Qi  10 , Amod A Sarnaik  11
Affiliations

Lifileucel tumor-infiltrating lymphocyte cell therapy in patients with unresectable or metastatic mucosal melanoma after disease progression on immune checkpoint inhibitors

Harriet Kluger et al. Cancer Commun (Lond). 2025 Oct.
No abstract available

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Conflict of interest statement

Harriet Kluger: research funding from institution (Apexigen, BMS, and Merck) and consulting/advisory role (BMS, Chemocentryx, Signatero, Merck, Gigagen, GI Reviewers, Pliant Therapeutics, Eisai, Invox, Wherewolf, Teva, and Iovance Biotherapeutics).

Sajeve Thomas: speaker's bureau (BMS, Merck, Pfizer, Ipsen, Amgen, Genentech, and Foundation One), travel, accommodations, and expenses (BMS, Merck, Pfizer, Ipsen, Amgen, Genentech, and Foundation One), consulting/advisory role (BMS, Merck, Pfizer, Ipsen, Amgen, Genentech, and Foundation One) and research funding (BMS, Merck, Pfizer, Ipsen, Amgen, Genentech, and Foundation One).

Evidio Domingo‐Musibay: grants or contracts (Instil Bio).

Miguel F Sanmamed: invited speaker (MSD, BMS, and Roche), advisory board (Numab, BMS, and MSD) and research grant (Roche and BMS).

Theresa Medina: consulting/advisory role (Merck, BMS, Iovance Biotherapeutics, Moderna, Nektar, Regeneron, Exicure, Checkmate, BioAtla, Xencor, Replimune, Day One Pharmaceutical, Pfizer, and Taiga).

Mirjana Ziemer: invited speaker (MSD, BMS, Sanofi, Sunpharma, Pierre Fabre, and Astra Zeneca), advisory board (BMS and Philogen), research grant (Novartis), consulting/advisory role (MSD, BMS, Sanofi, and Sunpharma), and travel, accommodations, and expenses (Pierre Fabre and Sunpharma).

Eric Whitman: consulting/advisory role (Merck) and speaker's bureau (Merck, BMS, Regeneron, and Castle BioSciences).

Friedrich Graf Finckenstein: employment (Iovance Biotherapeutics), stock or stock options (Iovance Biotherapeutics, BMS, and Roche), travel, accommodations, and expenses (Iovance Biotherapeutics), and patents, royalties, and other intellectual properties (Iovance and BMS).

Brian Gastman: employment (Iovance Biotherapeutics), stock or stock options (Iovance Biotherapeutics), and travel, accommodations, and expenses (Iovance Biotherapeutics).

Jeffrey Chou: employment (Iovance Biotherapeutics), stock or stock options (Iovance Biotherapeutics), and travel, accommodations, and expenses (Iovance Biotherapeutics).

Xiao Wu: employment (Iovance Biotherapeutics), stock or stock options (Iovance Biotherapeutics), and travel, accommodations, and expenses (Iovance Biotherapeutics).

Giri Sulur: employment (Iovance Biotherapeutics), stock or stock options (Iovance Biotherapeutics), and travel, accommodations, and expenses (Iovance Biotherapeutics).

Rana Fiaz: employment (Iovance Biotherapeutics), stock or stock options (Iovance Biotherapeutics), and travel, accommodations, and expenses (Iovance Biotherapeutics).

Rongsu Qi: employment (Iovance Biotherapeutics), stock or stock options (Iovance Biotherapeutics), and travel, accommodations, and expenses (Iovance Biotherapeutics).

Amod A Sarnaik: royalties and licenses (Iovance Biotherapeutics), consulting fees (Iovance Biotherapeutics, Guidepoint, Defined Health, Boxer Capital, Huron Consulting Group, KeyQuest Health, Istari, Rising Tide, Second City Science, Market Access, and Gerson‐Lehrman Group), honoraria (Society for Immunotherapy of Cancer, Physician's Education Resource, Medscape, WebMD, and Medstar Health), travel, accommodations, and expenses (Iovance Biotherapeutics, and Provectus Biopharmaceuticals), patents (Moffit Cancer Center and Provectus Biopharmaceuticals), and receipt of equipment, materials, drugs, medical writing, gifts, or other services (BMS and Genentech).

Figures

FIGURE 1
FIGURE 1
Outcomes with lifileucel in patients with MM. (A) Best percentage change from baseline in target lesion sum of diameters. Dotted line at −30% indicates threshold for PR per RECIST v1.1. (B) Time to response and time on study for confirmed responders (PR or better). (C) TMB in patients with mucosal or CM. Comparison of TMB was performed using the two‐sided t test. (D) Mutational signature determined from whole exome sequencing of pretreatment tumor from patients with mucosal or CM. Tumor mutational signature scores were calculated using the MutationalPatterns R package for COSMIC Single Base Substitution Signatures (See Supplementary Materials and Methods). (E) Persistence of TCR clonotypes found in TIL drug product in blood over time in patients with mucosal or CM. a100% change from baseline is presented for CR assessment that includes lymph node lesions. bPatient 11 discontinued the efficacy follow‐up while still in response. cThe horizontal bar represents the standard deviation. dFrom TIL infusion product. COSMIC, Catalogue of Somatic Mutations in Cancer; CR, complete response; D, day; DOR, duration of response; M, month; mut, mutation; NS, not significant; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; TCR, T‐cell receptor; TIL, tumor‐infiltrating lymphocyte; TMB, tumor mutational burden.
See this image and copyright information in PMC

References

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