Aptevo Therapeutics announced a 100% remission rate in Cohort 3 of its Phase 1b/2 RAINIER trial evaluating mipletamig for newly diagnosed Acute Myeloid Leukemia (AML) patients unfit for intensive chemotherapy. Mipletamig is the company's first-in-class CD123 x CD3 bispecific antibody, administered in combination with venetoclax and azacitidine.
In addition to the complete remission rate, 40% of patients in Cohort 3 achieved minimal residual disease (MRD)-negative status, a key indicator linked to improved long-term outcomes in AML. This further reinforces the depth of response achieved with mipletamig therapy.
The trial continues to demonstrate a consistently favorable safety and tolerability profile, with no dose-limiting toxicities or cytokine release syndrome observed in the RAINIER trial to date, or among any frontline patients treated with mipletamig. The trial is progressing efficiently, and Cohort 4 is now open for enrollment, indicating continued momentum in the clinical program.
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