ASTX727 Plus Venetoclax Is a Safe Regimen in Older Patients With AML

By Melissa Badamo - Last Updated: May 21, 2024

When combined with venetoclax, oral decitabine and cedazuridine (ASTX727) is safe in older or unfit patients with acute myeloid leukemia (AML), according to a recent study.

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The single center, phase II study was led by Alexandre Bazinet, MD, of the University of Texas MD Anderson Cancer Center, and published in The Lancet Haematology.

The study included two treatment groups: the frontline group (n=49), which included patients with newly diagnosed AML who were ineligible for chemotherapy, and the relapsed or refractory group (n=13), which included patients aged 18 years or older with an Eastern Cooperative Oncology Group (ECOG) performance status of two or less.

All 62 patients received cedazuridine at 100 mg and decitabine at 35 mg orally for five days, and venetoclax at 400 mg orally for 21–28 days in 28-day cycles. The primary endpoint was overall response rate (ORR).

At a median follow-up of 18.3 months, the ORR was 64% in the frontline cohort and 46% in the relapsed or refractory cohort.

Three deaths, potentially treatment-related, occurred in patients in remission. The most common grade ≥3 treatment-emergent adverse events included febrile neutropenia in 18% of patients, pneumonia in 13%, respiratory failure in 8%, bacteremia in 6%, and sepsis in 6%.

“Our findings should be confirmed in larger multicentric studies,” Dr. Bazinet and colleagues concluded.

Funding for this study was provided by Taiho Oncology and Astex Pharmaceuticals.

Reference

Bazinet A, Garcia-Manero G, Short N, et al. Oral decitabine and cedazuridine plus venetoclax for older or unfit patients with acute myeloid leukaemia: a phase 2 study. Lancet Haematol. 2024. doi:10.1016/S2352-3026(24)00033-4

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