Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial
Afamitresgene autoleucel (afami-cel) is an immunotherapy in which a specific kind of white blood cell called a T-cell is removed from the patient’s body and is modified to target a specific protein that is expressed on the tumor. This kind of therapy is called engineered T-cell receptor (TCR) T-cell therapy. A previous study demonstrated acceptable safety and promising efficacy in a phase 1 trial (NCT03132922).
The aim of this study, “Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial,” was to further evaluate the efficacy of afami-cel for the treatment of patients expressing the specific proteins (HLA-A*02 and MAGE-A4) in advanced synovial sarcoma or myxoid round cell liposarcoma. Patients received a single intravenous dose of afami-cel after being treated to deplete their white blood cells called lyphocytes. 52 patients with confirmed synovial sarcoma (n=44) and myxoid round cell liposarcoma (n=8) were enrolled and received afami-cel. Overall response rate was 37% overall, 39% for patients with synovial sarcoma, and 25% for patients with myxoid round cell liposarcoma. Cytokine release syndrome occurred in 71% of patients. A lower than normal level of blood cells called cytopenias were the most common grade 3 or worse adverse events (lymphopenia in 96%, neutropenia 85%, leukopenia 81% of patients). These results indicate that Afami-cel treatment resulted in durable responses in patients with HLA-A*02 and MAGE-A4-expressing synovial sarcoma.