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First Patient Dosed in Aptevo's Ongoing RAINIER Trial Achieves 90% Reduction in Leukemic Blasts Within the First 30 Days of Treatment, Continues Overall Efficacy Trend Seen in Prior Mipletamig AML Studies
Potential to redefine frontline AML treatment being evaluated in clinic: Mipletamig, CD3 x CD123 bispecific, in combination with standard of care, offers a
About this update from Aptevo Therapeutics Inc.
[{"type":"text","content":"Potential to redefine frontline AML treatment being evaluated in clinic: Mipletamig, CD3 x CD123 bispecific, in combination with standard of care, offers a multi-mechanism strategy for potential improved patient outcomesFavorable early safety, efficacy, tolerability and durability of remission data informed Aptevo's ongoing RAINIER Phase 1b/2 trialSEATTLE, WA / ACCESSWIRE / November 20, 2024 / Aptevo Therapeutics (\"Aptevo\") (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today expanded on the potential of mipletamig, currently being evaluated as frontline therapy for the treatment of Acute Myeloid Leukemia (AML), in combination with standard of care venetoclax and azacitidine, noting the first patient dosed in the ongoing RAINIER trial achieved a 90% reduction in leukemic blasts within the first 30 days of treatment, continuing the overall efficacy trend seen in prior studies.The Company's move to evaluate mipletamig as frontline combination therapy is informed by favorable data from earlier trials, which demonstrated strong safety, efficacy, and tolerability profiles, alongside evidence of durable remission. These early findings have fueled excitement around RAINIER among the group of investigators at premier cancer treatment institutions who have been working with the drug and members of the biotechnology industry who have been following its progress.RAINIER seeks to further demonstrate the impact of mipletamig's unique, dual targeted mechanism of action by combining it with standard of care therapies venetoclax and azacitidine. The triplet combination targets AML from multiple angles and has the potential to improve patient outcomes, especially among the elderly who have few treatment options available.\"The FDA's decision to allow the RAINIER trial to proceed in a frontline setting allows us to explore mipletamig and the potential synergistic effect with standard of care in a well-defined patient population in need of improved therapy options. Safety data from our prior studies support our approach to conduct a study that is designed for a statistically defined quantitative efficacy analysis. RAINIER represents a clear development path that allows us to evaluate mipletamig in newly diagn...