What changed
Aptevo reported a substantial reduction in the frequency and severity of infusion-related reactions with mipletamig after successive refinements to its priming-dose regimen in the ongoing RAINIER dose optimization study. Mipletamig is being evaluated with venetoclax and azacitidine in newly diagnosed AML patients unfit for intensive chemotherapy. The company said the improvement supports an optimized dose consistent with FDA discussion objectives as it prepares for Phase 2, and it expects to complete the current study by year-end 2026. Data will be presented at the ASH 68th Annual Meeting, December 12-15, 2026.