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John F. DiPersio presented at the 60th American Society of Hematology Annual Meeting & Exposition, data from a phase I/II study of flotetuzumab, a CD123 x CD3 bispecific dual-affinity re-targeting (DART®) molecule, in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). Flotetuzumab is a humanized DART® molecule that is generated from antibodies to CD3 and CD123. Flotetuzumab acts to redirect T-cells via CD3 to target blast cells expressing CD123. This interaction can mediate, target-effector cell association, T-cell activation, proliferation and receptor diversification.
In this phase I/II study, the safety and preliminary clinical activity of flotetuzumab were assessed in 31 patients (median age = 64.0 years; range, 29.0–82.0) with R/R AML. Of these enrolled patients, 19 (61.3%) had primary refractory disease. Patients received a lead-in dose (30 ng/kg/day for 3 days followed by 100 ng/kg/day for 4 days) during week 1, followed by flotetuzumab at the recommended phase 2 dose, 500 ng/kg/d during week 2–4 of cycle 1. In cycle 2 and beyond, patients received flotetuzumab on a 4-day on/3-day off regimen.
In conclusion, the speaker noted that flotetuzumab demonstrated “antileukemic activity with an acceptable safety profile, in particular, among refractory patients, a difficult-to-treat patient population that represents a significant area of unmet medical need.”
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