IASO Bio's CAR-T Therapy FUCASO Shows Efficacy in China Real-World Study

IASO Biotechnology announced that its CAR-T cell therapy, FUCASO (equecabtagene autoleucel), demonstrated significant efficacy in a real-world study conducted in China among heavily pretreated patients with relapsed/refractory plasma cell neoplasms. The findings were presented at the 2026 International Myeloma Society (IMS) Annual Meeting.

The multicenter study involved 281 patients with plasma cell neoplasms who had undergone a median of four prior lines of therapy. A substantial proportion, 84%, had received prior anti-CD38 therapy, and 82.4% presented with high-risk cytogenetic abnormalities.

In the study, FUCASO achieved an objective response rate (ORR) of 95.9%, with a complete response (CR) or stringent complete response (sCR) rate of 77.2%. Furthermore, 94.1% of patients achieved minimal residual disease (MRD) negativity. Median progression-free survival (PFS) and median overall survival (OS) had not yet been reached, with 12-month PFS and OS rates of 71.5% and 87.8%, respectively.

Consistent efficacy was observed across various subgroups, including elderly patients and those previously treated with anti-CD38 therapy. Cytokine release syndrome (CRS) occurred in 88.2% of patients, but severe (grade ≥3) CRS was reported in only 3.8%. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 6.8% of patients.

These real-world data validate the efficacy and safety profile of FUCASO, consistent with findings from its pivotal registration study. IASO Bio continues to focus on developing cell therapies and biologics for hematologic malignancies and autoimmune diseases.