T-cell Immunotherapy Greenlighted for Synovial Sarcoma

The FDA granted accelerated approval to afamitresgene autoleucel (Tecelra; afami-cel; Adaptimmune), a MAGE-A4–directed genetically modified autologous T-cell immunotherapy. The treatment can now be prescribed to adults with inoperable or metastatic synovial sarcoma who have already received chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumors express the MAGE-A4 antigen. In the SPEARHEAD-1 trial, 44 patients received a single infusion of afami-cel. The overall response rate was 43.2%, and the median duration of response (DOR) was 6 months. Among patients who responded, 45.6% and 39.0% had a DOR of at least 6 months and 12 months, respectively.