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Three-year follow up results from the ongoing phase I study (NCT04594642) evaluating surovatamig, a novel CD19×CD3 T-cell engager, in patients with relapsed/refractory (R/R) follicular lymphoma (FL) (N = 61) were presented by Jing-Zhou Hou during the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US. Primary endpoints were safety, tolerability, pharmacokinetics, and the recommended phase II dose (RP2D).
Key data: Eligible patients had received ≥2 prior lines of therapy. The complete response (CR) rates for patients who received 2.4 mg (n = 14), 7.2 mg (n = 22), and 15 mg (n = 15) of surovatamig were 92.9%, 86.4%, and 100%, respectively. Of the 43 patients with CR rates evaluable for measurable residual disease (MRD), 95% had undetectable MRD. The estimated 12-month rates of duration of response (DoR) and progression-free survival (PFS) were 91.4% and 87.9%, respectively. The most common adverse events (AEs) were infections, which occurred in 70% of patients (Grade 3/4, 13%; Grade 5, 3%), and cytokine release syndrome (CRS), which occurred in 57% of patients (all Grades 1 or 2). Based on the results from this trial, 7.2 mg was selected as the RP2D.
Key learning: Results show that surovatamig is well tolerated and achieves high CR rates that are durable in patients with heavily pretreated R/R FL.
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