ENHANCE-3: This phase III study is trying to understand the effectiveness of immunotherapy (magrolimab) versus placebo, in combination with targeted therapy and chemotherapy (venetoclax and azacitidine) in people with newly diagnosed, previously untreated acute myeloid leukaemiaA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Placebo Comparator Arm. In the Experimental Arm, participants will receive magrolimab + venetoclax + azacitidine. Magrolimab will be administered intravenously at a dose of 1mg/kg priming dose on Days 1 and 4; 15mg/kg on Day 8; and 30mg/kg on Days 11, 15 and then every week for 5 doses and every 2 weeks after that. Venetoclax will be administered orally at a dose of 100mg on Cycle 1 Day 1, 200mg on Cycle 1 Day 2, 400mg on Cycle 1 Day 3 and daily after that. Azacitidine will be administered either subcutaneously or intravenously, at a dose of 75mg/m^2 on Days 1-7 or Days 1-5 and 8-9 of each cycle. Each cycle is 28 days. In the Placebo Comparator Arm, participants will receive a magrolimab placebo + venetoclax + azacitidine. Magrolimab placebo will be given intravenously on Days 1, 4, 8, 11 and 15, then every week for 5 doses and every 2 weeks after that. Venetoclax and Azacitidine will be administered the same as in the Experimental Arm.