Seven-day Venetoclax Combined With Dose-adjusted Intensive Chemotherapy as Induction Treatment in Newly Diagnosed Acute Myeloid Leukemia

While venetoclax (VEN) combined with intensive chemotherapy (IC) has demonstrated efficacy in newly diagnosed acute myeloid leukemia (AML), the optimal duration of VEN administration remains uncertain, leading to variability in its application during induction therapy. Herein, we reported the data of 259 ND AML patients who received 7-day VEN combined with dose-adjusted IC (DA, HAA, or HAD) as induction treatment, to further validate the efficacy and explore the safety of this combination. This study evaluated a truncated 7-day VEN regimen combined with dose-adjusted IC (DA, HAA, or HAD) as induction therapy. The patients included in this study were derived from two clinical trials (VEN+DA: ChiCTR2200061524; VEN+HAA: NCT05893472) and one retrospective study (VEN+HAD). All induction regimens include a 7-day oral administration of VEN, in combination with either DA, HAA, or HAD regimen. The composite complete remission (CRc) rate was 90.3%, with a minimal residual disease (MRD) negativity rate of 92.2% as assessed by flow cytometry. After a median follow-up of 18 months, the median overall survival (OS) and event-free survival (EFS) were not reached. The estimated 24-month OS, EFS, and relapse-free survival (RFS) rates for the entire cohort were 72.9%, 69.3%, and 70.2%, respectively. No significant differences in survival outcomes were observed among the three treatment regimens (OS: p=0.68; EFS: p=0.73; RFS: p=0.34). The median time of the absolute neutrophil count recovered to≥0.5 × 10 9 /L and the platelet count to≥30 × 10 9 /L after induction therapy was 14(range: 5-52) days and 13 (range: 4-63) days, respectively. In conclusion, a 7-day VEN schedule maintains high efficacy while potentially reducing myelosuppressive risks of longer regimens.