By: IPP Bureau
Last updated : November 06, 2025 12:57 pm
Enzomenib, an oral, small-molecule inhibitor designed to disrupt the menin-MLL protein interaction involved in leukemogenesis
Sumitomo Pharma America announced that new investigational data from its hematology portfolio will be presented during the 67th American Society of Hematology (ASH) Annual Meeting & Exposition, taking place December 6–9, 2025, in Orlando, Florida. The company will deliver three oral presentations and one poster presentation featuring new results from ongoing clinical development programs evaluating the menin inhibitor enzomenib (DSP-5336) and the PIM1 kinase inhibitor nuvisertib (TP-3654).
New findings from the Phase 1/2 study of enzomenib continue to demonstrate promising clinical activity across a wide range of potentially therapeutic doses in patients with relapsed or refractory acute leukemia, including KMT2A-rearranged (KMT2Ar), NPM1-mutated (NPM1m), and other HOXA9/MEIS1-driven subtypes.
Enzomenib, an oral, small-molecule inhibitor designed to disrupt the menin-MLL protein interaction involved in leukemogenesis, was escalated from 40 mg twice daily (BID) to 400 mg BID in the study. No dose-limiting toxicities (DLTs) were observed among 116 patients treated, and sustained complete remissions (CR) and complete remissions with partial hematologic recovery (CRh) were reported at 200 mg, 300 mg, and 400 mg BID. The data support the potential for individualized dosing approaches informed by disease biology.
Preliminary results from an ongoing Phase 1 study evaluating enzomenib in combination with venetoclax and azacitidine in relapsed or refractory AML also show that the regimen was well tolerated at doses up to 300 mg BID, without DLTs or evidence of significant drug-drug interactions. Encouraging early clinical activity was observed, particularly in patients without prior exposure to venetoclax or menin inhibitors.
SMPA will also present new data from a Phase 1/2 trial of nuvisertib in combination with momelotinib in patients with relapsed or refractory myelofibrosis (MF). The combination demonstrated encouraging early clinical activity and was generally well tolerated. Findings from the monotherapy arm of the same study continue to support that nuvisertib is well tolerated with no DLTs and that modulation of inflammatory cytokine profiles correlates closely with clinical response.
“Patients living with relapsed or refractory AML or MF urgently need more effective treatment options, particularly those with high-risk molecular subtypes such as KMT2A-rearranged and NPM1-mutated disease,” said Jatin Shah, M.D., Chief Medical Officer, Oncology, Sumitomo Pharma America. “The clinical data being presented at ASH are highly compelling and provide further support for the continued development of both enzomenib and nuvisertib. We look forward to sharing the full results at the upcoming meeting as we advance these programs with the goal of improving outcomes for patients.”