First Patient Dosed in 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
“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 diagnosed patients and represents a pivotal opportunity to make a difference right at the start of treatment, where outcomes can have the greatest impact,” said Dirk Huebner, MD, Chief Medical Officer at Aptevo.
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