On May 22, 2025 Taiho Pharmaceutical Co., Ltd. reported that its U.S. subsidiary, Taiho Oncology, Inc., will present the results of a Phase 1/2 clinical trial of the combination regimen of decitabine and cedazuridine plus venetoclax for acute myeloid leukemia (AML) in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 30 through June 3 in Chicago (Press release, Taiho, MAY 22, 2025, View Source [SID1234653716]).
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This Phase 1/2 trial evaluated the safety and efficacy of an oral administration regimen of decitabine-cedazuridine paired with venetoclax in 101 adult AML patients who were ineligible for first-line induction chemotherapy.
Study results
Complete remission (CR), which was the primary endpoint of the study, was 46.5%, and CR with incomplete hematologic recovery rates was 63.4%. Median time to CR was 2.4 months. Median CR duration was not reached; among patients who achieved it, 80% maintained that status at 6 months and 75.3% at 12 months. Median OS was 15.5 months.
98% of patients reported treatment-emergent adverse events of grade 3 or higher*, most commonly febrile neutropenia (49.5%), anemia (38.6%) and neutropenia (35.6%). The 30- and 60-day mortality rates were 3% and 9%, respectively.
*Revsied on June 4
About acute myeloid leukemia (AML)
AML is a disease in which the proliferation of leukemia cells inhibits the normal production of blood in the bone marrow. It is the most common type of acute leukemia in adults, and its incidence increases with age. There is a need for less toxic treatment methods for elderly patients who have difficulty receiving first-line induction chemotherapy.
About decitabine-cedazuridine
This combination is the world’s first oral DNA methylation inhibitor combined with a novel metabolic inhibitor that inhibits the breakdown of decitabine when administered orally.
It was approved in the U.S. and Canada in 2020 for the indications of myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML), and in Europe in 2023 for the indication of AML.