Elias Jabbour, MD, MD Anderson Cancer Center, University of Texas, discusses results of a clinical trial evaluating bleximenib for patients with acute leukemia.
Acute myeloid leukemias are a group of neoplasms arising from precursor cells committed to the myeloid cell-line differentiation. All of them are characterized by clonal expansion of myeloid blasts. They manifest by fever, pallor, anemia, hemorrhages and recurrent infections.
A phase 1 clinical trial evaluated bleximenib dose optimization and safety and tolerability determination of RP2D in patients with relapsed/refractory acute leukemia patients with KMT2A and NPM1 alterations. Bleximenib is a potent, selective inhibitor of menin-KMT2A interaction
In the study, 121 patients in dose-escalation received oral bleximenib on a 28-day cycle with step-up dosing. Data was evaluated with three treatment dose subgroups including 45 mg twice daily, 90/100 mg BID, and 150 mg BID.
Treatment-related adverse events were present in 70 patients with the most common being differentiation syndrome, neutropenia, thrombocytopenia, and nausea. Overall response rate was 50% with the 90/100 mg BID group and 150 mg BID group and 39% in the 45 mg BID group. Composite complete response rates were 40% in both 90/100 mg and 150 mg groups while the 45 mg group was 23%. Overall response rates and composite complete response rates were similar between KMT2A and NPM1 patients.
For the 90/100 mg BID group, median time to first response was 30 days and median duration of response was 6.4 months. Additionally, this group resulted in reduced hematologic toxicity, optimized PD effect with MEIS1 reduction, and maximal efficacy.
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To learn more about acute leukemias and other rare blood cancers, visit https://checkrare.com/diseases/cancers/
