Taiho Oncology Announces Decitabine and Cedazuridine to be Included in NIH Precision Medicine Trials

• Drug combination part of next-generation trials targeting specific genetic mutations in patients with myelodysplastic syndromes and acute myeloid leukemia

PRINCETON, N.J., Jan. 14, 2025 /PRNewswire/ -- Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, announced today that oral decitabine and cedazuridine will be included in next-generation clinical trials for precision medicine treatments initiated by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). 

Announced by the NIH on Oct. 23, 2024, the Myeloid Malignancies Molecular Analysis for Therapy Choice, or myeloMATCH, trials will be sponsored by NCI and conducted by the NCI-funded National Clinical Trials Network. 

The myeloMATCH program is comprised of trials evaluating new treatment combinations that target cancer-driving genetic mutations in myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). Across the myeloMATCH program, patients will undergo rapid genetic testing of their tumors and then be matched to trials involving oral decitabine and cedazuridine, other studies within myeloMATCH or, if there are no other myeloMATCH targeted combination options for their cancer types, standard treatment.

"The myeloMATCH program is designed to ensure patients with aggressive malignancies of the blood and bone marrow receive therapy directed at specific, identified abnormalities in a timely manner," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We are excited to have oral decitabine and cedazuridine included in this innovative clinical trial program. The inclusion of all oral regimens in the setting of myeloid malignancies has the potential to produce practice-changing data and reduce the treatment burden that patients and their loved ones face."

Oral decitabine and cedazuridine will be included in two trials within the myeloMATCH program:

• A Phase 2 trial (ClinicalTrials.gov, NCT06577441) will compare oral decitabine and cedazuridine to the combination treatment of oral decitabine and cedazuridine and enasidenib in treating patients with higher-risk, IDH2-mutated MDS. The trial will compare the complete remission (CR) rate between the two study groups and assess other endpoints, including safety.
• A Phase 2 trial (ClinicalTrials.gov, NCT06672146) will compare oral decitabine and cedazuridine and venetoclax plus enasidenib compared to oral decitabine and cedazuridine and venetoclax alone for the treatment of older patients with newly diagnosed AML or younger patients who are unable to receive standard treatment, and who have a mutation in the IDH2 gene. The trial will evaluate safety and compare the rate of measurable residual disease (MRD) negative complete remission (CR), as well as other secondary endpoints.

For more information about myeloMATCH and the sub-studies that are currently open, click here.

About Taiho Oncology, Inc. 
The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small molecule clinical candidates targeting solid tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada. 

For more information, visit https://www.taihooncology.com/, and follow us on LinkedIn and X. 

Taiho Oncology Contact:
Leigh Labrie
(609) 664-9878
[email protected] 

SOURCE Taiho Oncology