Adaptimmune Therapeutics announced that the FDA granted accelerated approval for Tecelra (afamitresgene autoleucel), for the treatment of advanced MAGE-A4+synovial sarcoma in adults with certain HLA types who have received prior chemotherapy
This marks the first FDA approval of an engineered cell therapy for solid tumors, targeting advanced MAGE-A4+ synovial sarcoma in adults with specific HLA types who have previously undergone chemotherapy. The drug is also the first new treatment for synovial sarcoma in over a decade.
Tecelra, a genetically modified autologous T-cell immunotherapy, was approved based on the results from the spearhead-1 trial. This trial demonstrated a significant overall response rate (ORR) and duration of response in 44 patients. Tecelra achieved an ORR of 43% and a complete response rate of 4.5%. Notably, 39% of the responsive patients maintained their response for 12 months or longer. The approval is contingent upon further verification and description of clinical benefits in a confirmatory trial.
Tecelra works by modifying a patient’s own T-cells to target and attack cancer cells. The treatment involves extracting T-cells from the patient, genetically engineering them to recognize the MAGE-A4 antigen on the cancer cells, and then reintroducing these modified cells back into the patient's body to fight the tumor.
Adaptimmune is looking to support the implementation of Tecelra through its support program, AdaptimmuneAssist, and plans to establish at least six to ten authorized treatment centers this year, expanding to approximately 30 centers within the next two years.
