PRAME-directed TCR-T (anzu-cel/IMA203CD8) hits 50% cORR with 12.7-mo DoR in R/R synovial sarcoma

Anzutresgene autoleucel (anzu-cel, IMA203) is an autologous PRAME-directed TCR T-cell therapy (HLA-A02:01–restricted), while IMA203CD8 adds an engineered CD8 co-receptor to broaden tumor-cell recognition by both CD4+ and CD8+ T cells; both were tested in the Phase 1 IMA203-101 trial (NCT03686124) in HLA-A02:01+ PRAME+ relapsed/refractory synovial sarcoma with no remaining SOC options. As of Oct 27, 2025, 21 patients were treated (anzu-cel n=9; IMA203CD8 n=12); among 20 efficacy-evaluable patients (median 2.5 prior lines), confirmed ORR was 50% (10/20) with 1 confirmed CR (8%, on IMA203CD8), median tumor reduction in responders was −63.4%, median DoR was 12.7 months (mFU 23 months), and median OS was 18 months—numerically above typical later-line chemo/targeted therapy response rates in synovial sarcoma (often ~10–20% ORR with trabectedin-like regimens) and with more durability than many cytotoxic options, but still in a small, selected HLA-A*02:01/PRAME+ subset. Safety was cell-therapy-typical: lymphodepletion-related cytopenias in 100%, CRS in 86% (G3 10%), and ICANS in 5% (G1); no higher-grade neurotoxicity signal was described.