Monotherapy update from Phase 1 portion in Phase1/2 trial of the menin-MLL inhibitor enzomenib (DSP-5336) in patients with relapsed or refractory acute leukemia
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Key Points
To evaluate the safety and efficacy of enzomenib in patients with relapsed or refractory acute leukemia.
Phase 1/2 dose-escalation trial of enzomenib monotherapy in patients with acute leukemia
Eligibility included ECOG PS ≤ 2 and no active CNS leukemia
Safety assessed via treatment-related adverse events
116 patients enrolled with a median age of 54.5 years
Enzomenib reached a recommended phase 2 dose of 300 mg BID with a 45.5% complete response rate
Median overall survival for patients with KMT2Ar was 11.4 months
Discussion
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Implication
Phase 1 trial shows enzomenib achieves 45.5% complete response in patients with KMT2A leukemia, indicating potential therapeutic benefits.