Johnson & Johnson announced new Phase 1b data showing encouraging antileukemic activity and a promising safety profile for bleximenib (JNJ-75276617) in combination with venetoclax and azacitidine (VEN + AZA) for the treatment of acute myeloid leukemia (AML) harboring KMT2A gene rearrangements (KMT2Ar) or NPM1 gene mutations (NPM1m). The study evaluated patients with newly diagnosed, intensive chemo-ineligible AML and relapsed or refractory AML.1 The results were featured in an oral presentation at the 2025 European Hematology Association (EHA) Congress (S137). Even though AML is the most common type of acute leukemia in adults, it has the lowest survival rate and is associated with poor patient outcomes, despite treatment advances to date - especially for patients with KMT2Ar and NPM1m.
The Phase 1b dose-finding study (NCT05453903) evaluated 125 patients with relapsed or refractoryAML and newly diagnosed, intensive chemo -ineligible AML who harbored KMT2Ar (n=52) or NPM1m (n=73). Bleximenib in combination with VEN + AZA was evaluated across multiple dose levels without step-up dosing. Of the 85 relapsed or refractory patients, 36% received one, 42% received two and 12% received three lines of prior treatment; 47% had previously been treated with venetoclax.
The bleximenib data at 100 mg twice a day in combination with VEN + ArizonaA showed higher efficacy and a similar safety profile in comparison to other dose levels. Janssen Research & Development, LLC, Janssen Biotech Inc., and Janssen Global Services, LLC are Johnson & Johnson companies.
