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Safety and efficacy of combined treatment with tumor-infiltrating lymphocytes and oncolytic adenovirus TILT-123 in metastatic melanoma

Tine J. Monberg, Santeri A. Pakola, Benedetta Albieri, Eva Ellebaek, Marco Donia, Rikke L. Eefsen, Troels H. Borch, Tatiana V. Kudling, Torben Lorentzen, Helle W. Hendel, Cecilie Vestergaard, Cathrine Lorentzen, Rikke B. Holmstroem, Victor Arias, Amir Khammari, Claudia Kistler, João M. Santos, James H.A. Clubb, Lyna Haybout, Marie C.W. WestergaardÖzcan Met, Dafne C.A. Quixabeira, Elise Jirovec, Riikka Havunen, Suvi Sorsa, Victor Cervera-Carrascon, Brigitte Dreno, Akseli Hemminki*, Inge Marie Svane*

*Corresponding author for this work
17 Citations (Scopus)

Abstract

Tumor-infiltrating lymphocytes (TILs) are effective in the treatment of metastatic melanoma (MM), but toxicity limits its application. TILT-123 (igrelimogene litadenorepvec) is an oncolytic adenovirus producing interleukin-2 (IL-2) and tumor necrosis factor (TNF) upon replication. In this phase 1 trial, 17 patients with metastatic checkpoint inhibitor-resistant melanoma are treated with TILT-123 and TILs without preconditioning chemotherapy or postconditioning IL-2. The treatment is safe and feasible. According to computed tomography (CT), the objective response rate is 11.7% (2/17) and disease control is observed in 35% (6/17), including a partial response lasting >8 months and a durable complete response in a mucosal melanoma patient. According to positron emission tomography (PET), disease control is observed in 7/15 (47%) with minor or partial responses in 4/15 (27%). In the initial TILT-123 monotherapy phase of the trial, disease control is observed in 6/17 (35%) and 10/16 (63%) in CT and PET, respectively. The study demonstrates good tolerability and preliminary efficacy.

Original languageEnglish
Article number102016
JournalCell Reports Medicine
Volume6
Issue number3
ISSN2666-3791
DOIs
Publication statusPublished - 18 Mar 2025

Keywords

  • cancer immunotherapy
  • combination immunotherapy
  • cutaneous melanoma
  • mucosal melanoma
  • oncolytic virus therapy
  • TIL therapy
  • tumor-infiltrating lymphocytes
  • uveal melanoma

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