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In February 2018, the AGP reported data as of cut-off date of June 2016 from a dual-stage, non-randomized phase Ib study (NCT02203773), which is assessing the safety and efficacy of venetoclax (VEN), a BCL2 inhibitor, in combination with decitabine (DEC) or azacitidine (AZA) in previously untreated older acute myeloid leukemia (AML) patients who are ineligible for standard induction therapy. Preliminary findings of this study demonstrated that VEN plus AZA or DEC was “well tolerated” in newly diagnosed patients with AML who are unfit for standard chemotherapy with promising preliminary efficacy and low early mortality rate.1
The updated data from this phase Ib study was presented by Courtney DiNardo at the 2018 American Society of Oncology (ASCO) Annual Meeting. Overall, 145 patients (median age = 74 years, range: 65–86) were enrolled and administered either VEN at a dose of 400 mg (n = 60), 800 mg (n = 74) or 1200 mg (n = 11) co-administered daily with 20 mg/m2 of DEC on days 1–5 or 75 mg/m2 of AZA on days 1–7, each 28-day cycle.2
The speaker concluded by stating that the “preliminary data suggest that 400 mg of VEN has the optimal benefit-risk profile in combination with DEC or AZA, which demonstrated a tolerable safety profile with deep responses and durable outcomes in elderly patients with AML”. Courtney DiNardo discusses this study in an interview with the AML Global Portal.
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