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ASH 2021 | ASTX727 plus venetoclax: Phase I study of total oral therapy for high-risk MDS/CMML

Sangeetha Venugopal, MD, University of Texas MD Anderson Cancer Center, Houston, TX, discusses a single arm Phase I/II study (NCT04655755) of ASTX727 in combination with venetoclax to treat patients with treatment-naïve higher risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) with excess blasts ≥5%. ASTX727, an oral formulation of decitabine and cedazuridine, was recently approved for the treatment of MDS and CMML. Based on observations of strong activity using venetoclax in combination with azacitidine, it was hypothesized that the addition of venetoclax to ASTX727 would improve clinical outcomes and quality of life, due to the total oral route of administration of the regimen. During the 6-patient safety lead-in, 3 patients were treated at dose level 0 and 3 patients at dose level 1. No dose-limiting toxicities were observed and the 30- and 60-day mortality rates were 0%. A total of 9 patients were enrolled in the Phase I portion and the response rate was 100%. The combination appears safe and well tolerated, with encouraging preliminary efficacy findings. This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.

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