A Phase 2 Study of the Fully Oral Combination of ASTX727 (Decitabine/Cedazuridine) Plus Venetoclax for Older and/or Unfit Patients with Acute Myeloid Leukemia

Alexandre Bazinet,Guillermo Garcia-Manero, Nicholas J. Short,Yesid Alvarado Valero,Tareq Abuasab, Md Rabiul Islam,Kathryn Montalbano,Ghayas C. Issa,Abhishek Maiti,Musa Yilmaz,Nitin Jain,Lucia Masarova,Steven M. Kornblau,Elias Jabbour,Guillermo Montalban-Bravo,Sherry Pierce,Courtney D. DiNardo,Tapan M. Kadia,Naval Daver,Marina Y. Konopleva

Blood（2023）

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摘要

Background: The combination of a hypomethylating agent (HMA) plus venetoclax is the standard of care for patients (pts) with acute myeloid leukemia (AML) who are older (age ≥ 75 yrs) and/or unfit for intensive chemotherapy. ASTX727 (oral decitabine/cedazuridine) is an oral formulation of decitabine with pharmacokinetic AUC equivalent exposures to IV decitabine. We performed a phase 2 study to evaluate the efficacy and safety of ASTX727 plus venetoclax in the frontline (FL) and relapsed-refractory (R/R) settings.

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