C-144-01

C-144-01, trial NCT02360579 sponsored by Iovance and reported in 2021, is the single-arm study that got the first cell therapy for a solid tumour approved: one in three patients with advanced melanoma that had progressed after anti-PD-1 therapy, and BRAF and MEK inhibitors where applicable, responded to a single infusion of lifileucel tumour-infiltrating lymphocytes. In 153 patients the objective response rate in the pivotal cohort was 31.4 percent, and the five-year analysis showed a median duration of response of about three years with roughly a third of responders still responding, leading to accelerated FDA approval in February 2024. OnCo links it to melanoma, TIL therapy, lifileucel, Iovance and Amod A. Sarnaik, and the result is consistent with decades of NCI Surgery Branch TIL series. Randomised confirmation rests on TILVANCE-301 in the first line with pembrolizumab.