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ASCO 2022: Phase II Study of Total Oral Triplet Regimen in Older Patients With AML

By: Vanessa A. Carter, BS
Posted: Tuesday, June 21, 2022

Farhad Ravandi, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues assessed whether total oral therapy consisting of cedazuridine/decitabine (ASTX727) plus venetoclax was safe and effective in older patients with acute myeloid leukemia (AML) who are not candidates for chemotherapy. Presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 7037), the results of this study demonstrated the potential benefit of this combination therapy for this patient population in both the first-line and relapsed or refractory settings.

The study authors focused on 13 adults with relapsed or refractory AML and 15 elderly patients with previously untreated AML who were ineligible for intensive chemotherapy. ASTX727 was administered daily on days 1 through 5 of each cycle, along with venetoclax on days 1 through 28 of the first cycle. Cycles were repeated every 4 to 8 weeks, and venetoclax was administered for 21 days in subsequent cycles.

Among those given front-line treatment, mutations of interest resided in genes TET2, ASXL1, RUNX1, and TP53. The overall response rate in the front-line cohort was 61%, comprising four complete responses, four complete responses with incomplete blood cell count recovery, and one morphologic leukemia-free state. Severe adverse events, such as ischemic stroke, debilitation, and septic shock, were deemed unrelated to therapy and affected one patient each.

The objective response rate in the relapsed/refractory cohort was 45%, with two complete responses, two complete responses with incomplete blood cell count recovery, and two morphologic leukemia-free states. Although the median overall survival for patients given first-line treatment was not reached, it was 7.2 months for those with relapsed or refractory disease. Of note, common grade 3 or higher treatment-related adverse events were neutropenic infections and liver enzyme elevation.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.


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