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Immune cells harvested from a patient's tumour, expanded in the lab and reinfused shrank melanoma in 36% of patients whose disease had progressed on PD-1 blockade, with responses that mostly lasted.
Cohort 2 of the C-144-01 phase 2 trial treated 66 patients with advanced melanoma that had progressed after anti-PD-1 therapy (and BRAF/MEK inhibitors where indicated; median 3.3 prior lines) with a single infusion of lifileucel, autologous tumour-infiltrating lymphocytes expanded centrally over about 22 days, after non-myeloablative lymphodepletion and followed by up to six doses of high-dose interleukin-2. The objective response rate was 36% (2 complete, 22 partial) with disease control in 80%; median duration of response was not reached at 18.7 months of follow-up. Adverse events were largely attributable to lymphodepletion and IL-2 and resolved within two weeks, with two treatment-related deaths. Pooled analysis of 153 patients from cohorts 2 and 4 showed a 31% response rate and supported FDA accelerated approval in February 2024, the first TIL therapy and first cell therapy for a solid tumour.
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.
Patients with advanced synovial sarcoma, a rare cancer of young adults with few effective drugs, now have an approved cell therapy that produces responses lasting about a year in a substantial minority, if their tissue type and tumour antigen match. It proves that engineered T cells can work against a solid tumour when a good target is present, which had been elusive. It is not a cure for most, requires specialised centres, and only a minority of patients are eligible.
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.
Shares Iovance Biotherapeutics, Lifileucel, Tumour-infiltrating lymphocytes (TILs), TIL therapy.
Shares Iovance Biotherapeutics, Lifileucel, TIL therapy, Advanced melanoma (unresectable stage III and stage IV).
Shares Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma, Lifileucel, TIL therapy, Advanced melanoma (unresectable stage III and stage IV).
Shares Iovance Biotherapeutics, Lifileucel, TIL therapy, Manufacturing cost and time for living and radioactive medicines.
Shares Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma, Lifileucel, TIL therapy, Melanoma.
Shares Iovance Biotherapeutics, Lifileucel, TIL therapy.
Shares Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma, Lifileucel, TIL therapy, Melanoma.
Shares Iovance Biotherapeutics, Advanced melanoma (unresectable stage III and stage IV), Melanoma.