Adoptive cell therapy using TILs shows clinically meaningful and durable efficacy in advanced mucosal melanoma
Source: Daily Reporter, October 2023
Antitumour responses were consistent with those previously reported for a broader population of patients with advanced melanoma
Results from the phase II C-144-01 study presented at the ESMO Congress 2023 (Madrid, 20–24 October) showed clinically meaningful and durable antitumour activity of lifileucel, an autologous, centrally manufactured tumour-infiltrating lymphocyte agent, in patients with advanced mucosal melanoma who had progressed on or after anti-PD-1/PD-L1 therapy (Abstract 1086MO). After a median follow-up of 35.7 months, the confirmed objective response rate (ORR) was 50.0% (95% confidence interval [CI] 21.1–78.9) in a study subgroup of 12 patients with this difficult-to-treat cancer. Median duration of response (DoR) was not reached, with 4 of 6 responders having durable and ongoing responses at data cutoff.
A median 26.1 × 109 (range 3.3–72) tumour-infiltrating lymphocytes (TILs) were infused, followed by a median of 5.5 (range 3–6) interleukin-2 (IL-2) doses. Safety was consistent with the known safety profiles of non-myeloablative lymphodepletion and IL-2. Febrile neutropenia (58.3%) and hypotension (33.3%) were the most common grade 3–4 non-haematological treatment-emergent adverse events. Grade 3–4 haematological laboratory abnormalities reflected non-myeloablative lymphodepletion, with neutropenia, leukopenia, lymphocytopenia and thrombocytopenia reported for all 12 patients; 66.7% experienced anaemia.