Taiho Oncology's oral decitabine and cedazuridine will be incorporated into the National Institutes of Health (NIH) precision medicine trials, known as Myeloid Malignancies Molecular Analysis for Therapy Choice (myeloMATCH). This initiative, sponsored by the National Cancer Institute (NCI), aims to match patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) to targeted treatments based on their tumors' genetic profiles.
The myeloMATCH program, announced by the NIH on October 23, 2024, facilitates rapid genetic testing of patient tumors to identify suitable treatment arms. Patients will be assigned to trials involving oral decitabine and cedazuridine, other myeloMATCH studies, or standard treatment if no targeted options are available.
Clinical Trial Details
Oral decitabine and cedazuridine will be investigated in two distinct Phase 2 trials within the myeloMATCH program:
- NCT06577441: This trial will compare oral decitabine and cedazuridine alone versus in combination with enasidenib for patients with higher-risk MDS harboring IDH2 mutations. The primary endpoint is the complete remission (CR) rate, with safety as a key secondary endpoint.
- NCT06672146: This trial will evaluate two arms: oral decitabine and cedazuridine plus venetoclax, with or without enasidenib, in older patients with newly diagnosed AML or younger patients ineligible for standard chemotherapy who also have an IDH2 mutation. The trial will assess safety and compare measurable residual disease (MRD)-negative complete remission (CR) rates, along with other secondary endpoints.
Expert Commentary
"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."
About Decitabine and Cedazuridine
Decitabine is a DNA methyltransferase inhibitor, and cedazuridine is a cytidine deaminase inhibitor. The combination of these drugs allows for oral administration of decitabine, potentially improving patient convenience and reducing the need for intravenous infusions. This oral formulation could offer a significant advantage in managing myeloid malignancies, particularly in elderly or frail patients.
Myeloid Malignancies: A Significant Unmet Need
MDS and AML are aggressive hematologic cancers with significant morbidity and mortality. The development of targeted therapies based on genetic mutations is crucial for improving patient outcomes. The myeloMATCH program represents a significant step forward in precision medicine for these diseases, and the inclusion of oral decitabine and cedazuridine offers a promising treatment option for specific patient populations.
