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Cusatuzumab, an anti-CD70 antibody, has demonstrated efficacy at doses ≥10 mg/kg in combination with azacitidine in patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy in a phase I/II trial.1 However, there were no dose-limiting toxicities associated with cusatuzumab across the dosing range of 1–20 mg/kg in this trial, raising the need to identify the optimal dose.1
The multicenter, randomized, phase II CULMINATE trial (NCT04023526) assessed the safety and efficacy of two dose levels of cusatuzumab, 10 mg/kg and 20 mg/kg, plus azacitidine in this patient population.1 Here, we summarize results from part 1 of the CULMINATE trial published by Pabst et al.1 in The Lancet Haematology
Figure 1. Response rates by dose level in the CULMINATE trial*
CR, complete remission; CRh, CR with partial hematological recovery; CRi, CR with incomplete hematological recovery; MLFS, morphological leukemia-free state; NE, not evaluable; ORR, overall response rate; PD, progressive disease; PR, partial remission; SD, stable disease.
*Data from Pabst, et al.1
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