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Other Disclosures4506Sumitomo Pharma Co.,Ltd.Pharmaceuticals

Notice of Clinical Data Presentations on the Investigational Anticancer Drugs enzomenib and nuvisertib at ASH 2026

Plans were announced to present clinical trial data on 2 investigational anticancer drugs at ASH 2026. The presentations will cover trial results for acute leukemia with enzomenib and myelofibrosis with nuvisertib.

Worth reading
66In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
57
% (ORR in the enzomenib 300mg BID group)
Wording
Conditional
How definitive the wording is.

Announced details

enzomenib(DSP-5336)nuvisertib(TP-3654)
Applicable field (uses covered by this announcement)
Relapsed or refractory acute leukemia with a KMT2A gene rearrangementRelapsed or refractory acute leukemia with an NPM1 gene mutationMyelofibrosis in patients previously treated with a JAK inhibitorMyelofibrosis with anemia
Launch date12 December 2026 to 15 December 2026 (scheduled meeting dates)
What the company reported numerically
Quantitative Effects

enzomenib ORR: 54% in the 200mg BID group and 57% in the 300mg BID group. CR+CRh rate: 35% in the 200mg BID group and 43% in the 300mg BID group.

Relationship between the counterparty and the company
Sumitomo Pharma Co.,Ltd.4506
Relationship with the Company

Sumitomo Pharma America, Inc., Sumitomo Pharma's US subsidiary, will present clinical data at the meeting.

CounterpartyAmerican Society of Hematology (ASH)

A professional society in the field of hematology. Its 2026 Annual Meeting is scheduled to be held in New Orleans, US, from 12 December 2026 to 15 December 2026.

Award/certification name

FDA Breakthrough Therapy designation, FDA Fast Track designation, FDA Orphan Drug designation, Ministry of Health, Labour and Welfare orphan drug designation, EMA Orphan designation

Awarding / certifying body

U.S. Food and Drug Administration (FDA)

Ministry of Health, Labour and Welfare

European Medicines Agency (EMA)

Location (as indicated in this announcement)

New Orleans Ernest N. Morial Convention Center (New Orleans, US)

Impact on Business Performance

No information was provided on the impact on business performance.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Data to be presented at the 2026 ASH Annual Meeting

Announced details
ItemDetails
Names of Products / Services Coveredenzomenib(DSP-5336), nuvisertib(TP-3654)
CounterpartyAmerican Society of Hematology (ASH)
Counterparty overviewA professional society in the field of hematology. Its 2026 Annual Meeting is scheduled to be held in New Orleans, US, from 12 December 2026 to 15 December 2026.
Relationship with the CompanySumitomo Pharma America, Inc., Sumitomo Pharma's US subsidiary, will present clinical data at the meeting.
Launch date12 December 2026 to 15 December 2026 (scheduled meeting dates)
Applicable areaRelapsed or refractory acute leukemia with a KMT2A gene rearrangement, Relapsed or refractory acute leukemia with an NPM1 gene mutation, Myelofibrosis in patients previously treated with a JAK inhibitor, Myelofibrosis with anemia
Award/certification nameFDA Breakthrough Therapy designation, FDA Fast Track designation, FDA Orphan Drug designation, Ministry of Health, Labour and Welfare orphan drug designation, EMA Orphan designation
Awarding / certifying bodyU.S. Food and Drug Administration (FDA), Ministry of Health, Labour and Welfare, European Medicines Agency (EMA)
LocationNew Orleans Ernest N. Morial Convention Center (New Orleans, US)
Quantitative Effectsenzomenib ORR: 54% in the 200mg BID group and 57% in the 300mg BID group. CR+CRh rate: 35% in the 200mg BID group and 43% in the 300mg BID group.
Impact on Business PerformanceNo information was provided on the impact on business performance.
SourceData to be presented at the 2026 ASH Annual Meeting
Items this document does not state (6)
Contract ValueOffering priceContract DateRegistration number and expiry dateLocation scaleUsage history

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

To help improve treatment outcomes for patients with acute leukemia or myelofibrosis, for whom treatment options are limited.

How to read this page

This is not the documentKomori reads the disclosure the company filed and writes this summary. Figures are as stated by the company and are not audited.
Weight is not a verdictIt measures how much this changes what the company had already told the market. It is not a view on the shares.
Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.
Notice of Clinical Data Presentations on the Investigational Anticancer Drugs enzomenib and nuvisertib at ASH 2026 | Sumitomo Pharma Co.,Ltd. (4506) timely disclosure | Komori