Addition of Lifileucel to Advanced Melanoma Arsenal Marks Milestone for TIL Therapy in Solid Tumor Management
Source: OncLive, February 2024
As the first cellular and tumor infiltrating lymphocyte (TIL) therapy product to be approved by the FDA for patients with solid tumors, lifileucel (Amtagvi) could usher in a paradigm shift in advanced melanoma management, thereby paving the way for several other TIL products to gain approval, according to Daniel Olson, MD.
On February 16, 2024, the FDA granted accelerated approval to lifileucel for the treatment of adult patients with unresectable or metastatic melanoma whose disease has been previously treated with a PD-1 inhibitor, as well as a BRAF inhibitor with or without a MEK inhibitor for BRAF V600–mutated disease. Data from cohorts 2 and 4 of the phase 2 C-144-01 trial (NCT02360579) supported this regulatory decision and demonstrated that treatment with lifileucel at the recommended dose (n = 73) of 7.5 x 109 to 72 x 109 viable cells produced an overall response rate (ORR) of 31.5% (95% CI, 21.1%-43.4%),1 comprising a complete response rate of 4.1% and a partial response rate of 27.4%.
Moreover, 56.5%, 47.8%, and 43.5% of responders had ongoing responses without tumor progression or death at 6, 9, and 12 months, respectively.2 The median time to best response to the therapy was 1.5 months, and the median duration of response was not yet reached (NR; 95% CI, 4.1 months-NR).