Lifileucel (AMTAGVI®) for previously treated unresectable or metastatic melanoma
AIHTA Appraisal Board Author Group
Record ID 32018014582
English
Authors' objectives:
Lifileucel (AMTAGVI®) is a treatment for patients with previously treated inoperable or metastatic melanoma. Through autologous tumour-infiltrating lymphocyte therapy, in which T-cells are isolated from patients’ tissue, expanded ex vivo, and reinfused, the goal is to trigger an anti-tumour response. The US Food and Drug Administration (FDA) approved lifileucel in February 2024 for patients with inoperable or metastatic melanoma who had previously received an anti-PD-1 therapy and, in case of BRAF-V600 positivity, BRAF inhibitors (with or without MEK inhibitors).
Authors' results and conclusions:
The efficacy and safety of lifileucel were investigated in a single-arm phase 2 multi-cohort study. The pooled analysis of two cohorts showed a complete response rate of 5%, a partial response rate of 26%, and a stable disease rate of 46%. Additional results include an objective response rate of 31.4%, a median overall survival of 13.9 months, and a progression-free survival of 4.1 months. Regarding safety, all patients experienced at least one treatment-related adverse event, with thrombocytopenia (76.9%), anaemia (50.0%), and febrile neutropenia (41.7%) being the most frequently observed. Six patients died within 30 days after lifileucel infusion.
Lifileucel represents an option for heavily pre-treated patients; however, there are currently no studies that directly compare lifileucel with other therapies. The absence of a specialised melanoma registry also reinforces the existing evidence gap. Additionally, treatment with lifileucel is associated with high costs and structural challenges (production of cell therapy as well as equipment for specialised centres).
Details
Project Status:
Completed
URL for project:
https://aihta.at/page/htas-fuer-bewertungsboard/en
Year Published:
2025
URL for published report:
https://eprints.aihta.at/1570/1/Appraisal_Board_Document_004.pdf
URL for additional information:
https://eprints.aihta.at/1570/
English language abstract:
An English language summary is available
Publication Type:
Full HTA
Country:
Austria
MeSH Terms
- Melanoma
- Lymphocytes, Tumor-Infiltrating
- Cell- and Tissue-Based Therapy
- Neoplasm Metastasis
- Immunotherapy, Adoptive
Keywords
- Lifileucel
- melanoma
- metastatic or unresectable
- tumour-infiltrating lymphocyte therapy
- autologous therapy
Contact
Organisation Name:
Austrian Institute for Health Technology Assessment
Contact Address:
Josefstaedter Strasse 39, A-1080 Vienna, Austria
Contact Name:
office@aihta.at
Contact Email:
office@aihta.at
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.