Sumitomo Pharma America Achieves Key Patient Enrollment Milestone for Pivotal Phase 2 Study of Enzomenib in the Treatment of Relapsed/Refractory Acute Leukemia

Sumitomo Pharma America Achieves Key Patient Enrollment Milestone for Pivotal Phase 2 Study of Enzomenib in the Treatment of Relapsed/Refractory Acute Leukemia

Sumitomo Pharma America, Inc. (SMPA) today announced that it has enrolled the required number of participants in its pivotal Phase 2 monotherapy trial for enzomenib, an investigational, oral selective menin inhibitor for the treatment of relapsed/refractory acute leukemia with KMT2A rearrangement, to allow for interim analysis. Achieving this milestone will enable SMPA to obtain results of the interim analysis by the end of calendar year 2026. These results will be promptly disclosed, with detailed data to be presented at an upcoming medical congress. If the primary endpoint is met, SMPA would then proceed with preparation for regulatory submission with the aim of obtaining approval in the US and Japan during FY2027.

“Acute leukemias, especially at the relapsed/refractory stage, are profoundly difficult to treat, and are associated with very poor outcomes,” said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. “Achieving this enrollment milestone is an important step in our efforts to bring a new, differentiated therapeutic option to acute leukemia patients and their families. My sincere thanks to the patients who are taking part in this study to further our scientific understanding of leukemia treatment.”