Johnson & Johnson announces new Phase 1b data on bleximenib
Johnson & Johnson announced new Phase 1b data showing antileukemic activity and a safety profile for bleximenib in combination with venetoclax and azacitidine for the treatment of acute myeloid leukemia harboring KMT2A gene rearrangements or NPM1 gene mutations. The study evaluated patients with newly diagnosed, intensive chemo-ineligible AML and relapsed or refractory AML. The results were featured in an oral presentation at the 2025 European Hematology Association Congress. 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 evaluated 125 patients with relapsed or refractory AML and newly diagnosed, intensive chemo-ineligible AML who harbored KMT2Ar or NPM1m. Bleximenib in combination with VEN + AZA was evaluated across multiple dose levels without step-up dosing. Of the 85 relapsed or refractory patients, 36 percent received one, 42 percent received two and 12 percent received three lines of prior treatment; 47 percent had previously been treated with venetoclax. The bleximenib data at 100 mg twice a day in combination with VEN + AZA showed higher efficacy and a similar safety profile in comparison to other dose levels. At the recommended Phase 2 dose, patients with relapsed or refractory AML achieved an overall response rate of 82 percent and a composite complete response rate of 59 percent. The newly diagnosed, intensive chemo-ineligible patient population showed an ORR of 90 percent and a cCR rate of 75 percent. Safety analysis of the study population showed a profile comparable among dose groups, genetic subtypes and disease settings. At the RP2D in combination with VEN+AZA, differentiation syndrome events were reported in two of 49 patients. Bleximenib safety data continued to support a lack of QTc prolongation signal, with no events of Grade 3 or higher and only three Grade 1 events at the RP2D. The most common all-grade treatment-emergent adverse events were nausea, thrombocytopenia, neutropenia and anemia. The most common Grade 3 or higher TEAEs were thrombocytopenia, neutropenia, and anemia.
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