TIL therapy
Immune cells that have already found their way into the tumour are harvested, grown to billions, and returned.
Lifileucel (Amtagvi, Iovance) was approved in 2024 for anti-PD-1-refractory melanoma: ORR 31%, five-year data show durable responses in about a third of responders. Trials in NSCLC (TILVANCE-301), cervical, and head and neck cancer. Next-generation TILs are gene-edited (PD-1 knockout, IL-15 membrane-bound, OBX-115) to reduce IL-2 dependence.
How it works
Surgical harvest → ex vivo expansion of polyclonal tumour-reactive T cells with IL-2 → lymphodepletion → infusion with IL-2 support.
- Naturally polyclonal against the patient's own neoantigens
- Works in solid tumours
- Requires resectable tumour and 3-4 week manufacturing
- IL-2 toxicity
- Single-centre logistics
High-dose interleukin-2 was the first immunotherapy to cure a small fraction of patients with metastatic melanoma and kidney cancer, at the cost of ICU-level toxicity; today it mainly supports TIL therapy.
Lifileucel was the first approved TIL therapy: the patient's own tumour-fighting immune cells are expanded to billions and given back.
This trial supplied the randomised proof that was missing for TIL therapy and showed academic centres can run cell-therapy phase 3 trials without industry. It supports TIL as a standard option after checkpoint inhibitor failure in melanoma and underpinned reimbursement in the Netherlands. The comparator, ipilimumab, is itself only modestly effective in this setting, and overall survival did not differ significantly.
Lifileucel proved that Steven Rosenberg's decades-old TIL concept could be industrialised into a licensed product and gave patients with checkpoint-refractory melanoma, who otherwise have few options, a chance of durable remission. It is the first cell therapy approved for any solid tumour. The treatment requires surgery to harvest tumour, hospitalisation for lymphodepletion and IL-2, and specialised centres, so its reach is limited.
Latest papers
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