Phase 3 bleximenib (JNJ-75276617) menin–KMT2A interaction inhibitor added to intensive AML chemo

This randomized, double-blind, placebo-controlled Phase 3 trial tests whether adding bleximenib (JNJ-75276617)—an oral small-molecule inhibitor of the menin–KMT2A protein interaction—improves outcomes when layered onto intensive “7+3”-style induction and consolidation chemotherapy (cytarabine, a DNA synthesis inhibitor, plus idarubicin, an anthracycline DNA-damaging agent) in newly diagnosed AML. Patients must be adults eligible for intensive chemotherapy whose leukemia harbors either KMT2A rearrangements or NPM1 mutations; NPM1 mutations are common in AML (25–35% overall), while KMT2A rearrangements are less frequent (5–10%) but high-risk. Participants are assigned to: bleximenib throughout + bleximenib maintenance, bleximenib during induction/consolidation + placebo maintenance, or full placebo control alongside the same chemotherapy backbone. The drug developer is Johnson & Johnson (Janssen); the sponsor listed is the Dutch adult hematology-oncology cooperative group (HOVON), reflecting a large international academic-network execution of a registrational-style question. Today’s care for fit newly diagnosed AML remains intensive induction chemotherapy followed by consolidation and risk-adapted allogeneic stem cell transplant for many patients; this trial asks whether targeted menin inhibition can deepen remissions and reduce relapse in these genetically defined subtypes.