Adaptimmune Therapeutics plc announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its Biologics License Application (BLA) for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma. The application has a Prescription Drug User Fee Act (PDUFA) target action date of August, 4, 2024. This acceptance is supported by positive data from Cohort 1 of the pivotal trial SPEARHEAD-1, which met its primary endpoint for efficacy.

Data from the trial were presented at the Connective Tissue Oncology Society (CTOS) 2023 Annual Meeting. Afami-cel is an engineered T-cell receptor (TCR) T-cell therapy, targeted to the MAGE A4 cancer target, and designed as a single-dose treatment for advanced synovial sar Coma. The last FDA approved therapy for treatment in this setting was for Votrient in 2012.

The BLA submission for afami-cel was supported by clinical data from the SPEARHEAD-1 pivotal trial, which has met its primary endpoint for efficacy; 39% of patients who received afami-cel had clinical responses with a median duration of response of ~12 months (CTOS 2022). Median overall survival (mOS) was ~17 months in SPEARHEAD-1 compared to historical mOS of <12 months for people with synovial sarcoma who received afami-cel who received afami-cel has demonstrated an impressive response rate of ~39% among heavily pre-treated patients with advanced synovial sarcomA and about a 17-month median survival. This acceptance is support by positive data from Cohort1 of the pivotal trial SPEARhead-1, which met itsprimary endpoint for efficacy.

Data from The trial were presented at the ConnectIVE Tissue Oncology Society ("CTOS") 2023 Annual Meeting.Afami-cel is an engineeredT-cell receptor (TCR") T-cell therapy, targeted To the MAGE A4 cancer targets, and designed as a single -dose treatment for advanced synoval sarcoma. The last FDA approved treatment in this setting was forVotrient in 2012. TheBLA submission for afami-cell was supported by clinical data from The SPEARHEAD-1 pivotal trials, which has met its primary end endpoint for efficacy.

39% of patients who received Afami-cel had clinical responses With a median duration of response of approximately 12 months (CTOS 2022). median overall survival (mOS) were ~17 months in SPEARhead-1 compared to historical m OS of <12 months for people With synovial sarcoma where received two or more prior lines of therapy.