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Sumitomo Pharma's Groundbreaking Data on Enzomenib and Nuvisertib

In a pivotal presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition held on December 8, 2025, Sumitomo Pharma America, Inc. showcased compelling new data from its ongoing research into two investigational drugs: enzomenib (DSP-5336) and nuvisertib (TP-3654). These findings highlight the promising potential of these therapies in addressing significant unmet needs in the treatment landscapes for acute myeloid leukemia (AML) and myelofibrosis (MF).

Investigational Study of Enzomenib in Acute Myeloid Leukemia

Sumitomo Pharma's study of enzomenib, an oral selective menin inhibitor, focused on patients with relapsed or refractory AML. The Phase 1/2 trial enrolled 116 patients, revealing noteworthy clinical activity, particularly among those with specific genomic abnormalities.

According to data collected as of October 2025, enzomenib demonstrated a remarkable objective response rate of 73.3% in patients harboring KMT2A rearrangements who had not previously received treatment with a menin inhibitor. The combination therapy of enzomenib with venetoclax and azacitidine further illustrated this drug's effectiveness; early results indicated an overall response rate (ORR) of 85% among patients without prior exposure to venetoclax or menin inhibitors, signifying a substantial step forward in the management of this challenging condition.

Efficacy and Safety Profile

The safety profile of enzomenib remained encouraging, with no treatment-related deaths reported and manageable adverse events including nausea and vomiting, which were experienced by 16.4% and 11.2% of patients, respectively. Furthermore, the study ensured that there were no significant drug interactions affecting the treatment's efficacy.

Advancements in Myelofibrosis Treatment: Nuvisertib

Alongside enzomenib, Sumitomo Pharma presented promising preliminary results from the Phase 1/2 study evaluating nuvisertib, a PIM1 kinase inhibitor, in combination with momelotinib for patients suffering from relapsed or refractory myelofibrosis. This study included 18 patients, all of whom had previously undergone JAK inhibitor treatment, the standard care for MF.

The results showed a favorable tolerance to the combination treatment, with 58% of patients achieving a reduction in their total symptom score and half of the patients experiencing a significant reduction in spleen volume. Notably, these outcomes indicate a positive response to nuvisertib's potential in providing relief from the debilitating symptoms associated with myelofibrosis.

Future Directions

Both enzomenib and nuvisertib represent critical advancements in the fight against aggressive blood cancers. As Sumitomo Pharma continues to refine and develop these innovative therapies, the commitment to enhancing patient outcomes remains paramount. The data presented at the ASH Annual Meeting not only supports further research but also represents a beacon of hope for those battling AML and MF.

In summary, the results outlined by Sumitomo Pharma America mark significant progress in the oncology field, showcasing how investigational drugs can potentially transform treatment protocols and improve quality of life for patients facing these formidable diseases.