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On July 16, 2020, it was announced that the phase I trial (NCT04214860), evaluating eprenetapopt in combination with venetoclax and azacitidine in patients with TP53 mutations, was expanded and will include the addition of another cohort of patients who will be treated with eprenetapopt in combination with azacitidine as a frontline treatment. The decision to expand was based upon the results from two independent phase Ib/II clinical trials (NCT03588078 and NCT03072043).1
The lead-in safety portion of these studies demonstrated that both treatment regimens, eprenetapopt + venetoclax + azacitidine, and eprenetapopt + azacitidine, were well tolerated, and no dose-limiting toxicities were experienced. The expansion cohort will treat patients with TP53-muted AML with the triplet therapy of eprenetapopt + venetoclax + azacitidine (~ n = 30) and with the doublet therapy of eprenetapopt + azacitidine (~ n = 30) as frontline therapies. Safety and efficacy will be evaluated in both cohorts.1
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