FDA Approval Sought for Lifileucel in Advanced Melanoma
Source: Onc Live, August 2022
A rolling biologics license application (BLA) seeking the approval of lifileucel (LN-44) in patients with advanced melanoma who progressed on or after previous anti–PD-1/PD-L1 therapy, and if BRAF mutation positive, also previous BRAF or BRAF/MEK inhibitor therapy, has been submitted to the FDA.
The application is based on findings from the phase 2 C-144-01 trial (NCT02360579).
In cohort 4 (n = 87), the tumor-infiltrating lymphocyte therapy elicited an objective response rate (ORR) of 29% (95% CI, 19.5%-39.4%) per independent review committee (IRC) assessment and by RECIST v1.1 criteria. Among those who responded to treatment, 3 achieved complete responses (CRs) and 22 experienced partial responses (PRs). At a median follow-up of 23.5 months, the median duration of response (DOR) in this cohort was 10.4 months by IRC.