NEWS
Phase 1b/2 "RAINIER" Frontline Acute Myeloid Leukemia (AML) Trial Initiated
Aptevo Therapeutics (NASDAQ:APVO) has initiated the Phase 1b/2 'RAINIER' trial for its lead candidate mipletamig (formerly APVO436) in combination with venetoclax and azacitidine for frontline acute myeloid leukemia (AML) patients. The study aims to identify the recommended Phase 2 dose and evaluate safety, tolerability, and efficacy. Previous trials showed promising results, including a 75% complete response rateamong frontline patients and efficacy outcomes more than double the benchmarks. The multi-center, open-label dose-finding study will enroll up to 39 patients across five dose levels. Primary endpoints include safety assessment, determining the maximum tolerated dose, and evaluating cytokine release syndrome incidence.
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