On November 13, 2025 Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, reported the presentation of new data from 14 studies across company-sponsored and company-funded externally led studies at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held Dec. 6-9, 2025, in Orlando, Florida.

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Taiho Oncology will share findings from clinical trials in two oral presentations and evidence from real-world studies in two online abstracts.

The oral presentations will highlight results from the Phase 2 part of ASTX030-01, a randomized, open-label, crossover trial comparing oral combination of azacitidine and cedazuridine to subcutaneous azacitidine and the Phase 2 portion of the Phase 1/2 trial ASTX727-03 of low-dose versus standard-dose oral decitabine and cedazuridine in patients with lower-risk myelodysplastic syndromes (MDS).
The two online posters will present real-world data on U.S. adults with acute myeloid leukemia (AML), describing treatment patterns and outcomes with hypomethylating agent (HMA) plus venetoclax, and evaluating the time burden of initiating parenteral HMA-based therapy in routine practice.
Additionally, 10 presentations – including four oral presentations – led by independent investigators will feature data from Taiho-funded investigator-initiated or collaborative studies. These presentations will highlight:

Results from a UK multicenter Phase 2 randomized trial comparing ASTX727 with hydroxycarbamide or best supportive care in advanced MDS/ myeloproliferative neoplasm (MPN).
Data from a Phase 2 study evaluating the all-oral combination of ASTX727, venetoclax and revumenib in newly diagnosed AML patients with NPM1m, KMT2Ar or NUP98r AML mutations.
Results of a Phase 1/2 clinical trial of the combination of oral decitabine/cedazuridine with the venetoclax in patients with untreated high-risk MDS and chronic myeloid leukemia (CMML).
Safety and efficacy results from a Phase 1/2 trial evaluating an all-oral combination of ASTX727, venetoclax and gilteritinib in both relapsed refractory and newly diagnosed FLT3-mutated AML, high-risk MDS or MPN.
"As the leader of oral HMA development, we’re excited that these data will be featured in six oral presentations at the ASH (Free ASH Whitepaper) Annual Meeting," said Harold Keer, MD, PhD, Taiho Oncology Chief Medical Officer. "These data highlight our increasing understanding of novel oral regimens in hematology. We are invested in developing treatments that have the potential to improve flexibility and lower the treatment burden for patients, and collaborating with leading institutions, evidenced by our continued support of independent clinical research to advance cancer care. We look forward to participating in the essential scientific exchange that contributes to progress in hematology at the ASH (Free ASH Whitepaper) Annual Meeting."

Data being presented by Taiho Oncology and its partners at the 2025 ASH (Free ASH Whitepaper) Annual Meeting and Exposition include:

Company-Sponsored Studies

Oral Presentations

Title: A phase 2 dose confirmation trial of oral ASTX030, a combination of oral azacitidine with cedazuridine among patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia
Abstract Number: 491
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Moving the Needle Through Novel Approaches in MDS and CMML
Session Date: Dec. 7, 2025
Session Time: 9:30 a.m. to 11a.m.
Presentation Time: 10:15 to 10:30 a.m.
Location: OCCC – Valencia Room W415D
Presenter: Guillermo Garcia-Manero, MD

Title: Low-dose oral decitabine and cedazuridine among patients with low-risk myelodysplastic syndromes
Abstract Number: 790
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Treatment Advances in Lower risk Myelodysplastic Syndromes and Myelodysplastic/Myeloproliferative Neoplasms
Session Date: Dec. 8, 2025
Session Time: 10:30 a.m. to 12 p.m.
Presentation Time: 11:15 to 11:30 a.m.
Location: OCCC – Valencia Room W415A
Presenter: Guillermo Garcia-Manero, MD

Online Abstracts

Title: Time burden of treatment with parenteral HMAs in combination with venetoclax among patients with newly diagnosed AML
Abstract Number: 6990
Lead Author: Amer Zeidan, MD

Title: Real-World Characteristics, Treatment Modifications, and Outcomes for AML Patients Receiving HMAs + Venetoclax (1L)
Abstract Number: 8176
Lead Author: Amer Zeidan, MD

Company-Funded Externally Led Studies

Oral Presentations

Title: Phase II Study of the All-Oral Combination of Revumenib (SNDX-5613) with Decitabine/Cedazuridine (ASTX727) and Venetoclax (SAVE) in Newly Diagnosed AML
Abstract Number: 47
Session Name: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Frontline treatment with intensive or lower-intensity regimens
Session Date: Dec. 6, 2025
Session Time: 9:30 to 11 a.m.
Presentation Time: 10:30 to 10:45 a.m.
Location: OCCC – Valencia Room W415A
Presenter: Wei-Ying Jen, BM BCh, FRCPath

Title: Oral decitabine/cedazuridine in combination with venetoclax in treatment-naïve high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia: Updates of a Phase 1/2 clinical trial
Abstract Number: 237
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Treatment Advances in Higher Risk Myelodysplastic Syndromes
Session Date: Dec. 6, 2025
Session Time: 2 to 3:30 p.m.
Presentation Time: 2:30 to 2:45 p.m.
Location: OCCC – Chapin Theater W415BC
Presenter: Alex Bataller, MD, PhD

Title: ASTX727 delivers superior response rates and associated survival benefit versus hydroxycarbamide/best supportive care in CMML and other MDS/MPN overlap syndromes: First results from the Phase 2 UK multicenter randomized ammo trial
Abstract Number: 488
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Moving the Needle Through Novel Approaches in MDS and CMML
Session Date: Dec. 7, 2025
Session Time: 9:30 to 11 a.m.
Presentation Time: 10:45 to 11 a.m.
Location: OCCC – Valencia Room W415D
Presenter: Daniel H. Wiseman, MB, ChB, PhD

Title: Phase I/II Study of Decitabine/Cedazuridine (ASXT727), Venetoclax, and Gilteritinib for Patients with FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Abstract Number: 997
Session Name: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Frontline treatment with intensive or lower-intensity regimens
Session Date: Dec. 8, 2025
Session Time: 4:30 to 6 p.m.
Presentation Time: 4:30 to 4:45 p.m.
Location: OCCC – Chapin Theater W320
Presenter: Roberta S. Azevedo, MD

Poster Presentations

Title: Translational Investigation of Tolinapant (ASTX660) in Acute Myeloid Leukemia Using Integrated Clinical, Bioinformatic, and Pharmacological Approaches
Abstract Number: 2552
Session Name: 802. Chemical Biology and Experimental Therapeutics: Poster I
Session Date: Dec. 6, 2025
Session Time: 5:30 to 7:30 p.m.
Location: OCCC – West Halls B3-B4

Title: A Randomized Phase II Trial of ASTX727 and Venetoclax With or Without Enasidenib for Newly Diagnosed Older Adults With IDH2 Mutant Acute Myeloid Leukemia: A MyeloMATCH Substudy (MM1OA-S03)
Abstract Number: 3466
Session Name: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Poster II
Session Date: Dec. 7, 2025
Session Time: 6 to 8 p.m.
Location: OCCC – West Halls B3-B4

Title: Trial in progress: A Phase I Study Evaluating the Safety of cirtuvivint (CIRT) as Monotherapy and in Combination with ASTX727 in Patients with MDS and AML
Abstract Number: 3431
Session Name: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II
Session Date: Dec. 7, 2025
Session Time: 6 to 8 p.m.
Location: OCCC – West Halls B3-B4

Title: Trial in Progress – A Randomized Study of ASTX727 With or Without Ladademstat in Accelerated/Blast-Phase Myeloproliferative Neoplasms
Abstract Number: 3827
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Session Date: Dec. 7, 2025
Session Time: 6 to 8 p.m.
Location: OCCC – West Halls B3-B4

Title: A Comparison of Overall Survival and Quality of Life in MDS Patients Treated with Azacitidine vs Decitabine: A Propensity-Matched Registry Study
Abstract Number: 3862
Session Name: 637. Myelodysplastic Syndromes: Clinical and Epidemiological: Poster II
Session Date: Dec. 7, 2025
Session Time: 6 to 8 p.m.
Location: OCCC – West Halls B3-B4

Title: A Multiarm Phase 1b Study of Personalized Oral Maintenance Therapy with Decitabine/Cedazuridine (ASTX727) Plus Physician’s Choice of Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib in Acute Myeloid Leukemia
Abstract Number: 5228
Session Name: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Poster III
Session Date: Dec. 8, 2025
Session Time: 6 to 8 p.m.
Location: OCCC – West Halls B3-B4

(Press release, Taiho, NOV 13, 2025, View Source [SID1234659936])