Results of a phase-2 clinical study report an effective first-line treatment option (DAV regimen: daunorubicin, cytarabine and venetoclax) for patients with acute myeloid leukaemia (AML), with high rates of complete remission. The findings of the clinical trial were recently published in The Lancet Haematology.
The currently available treatment regimens for adults with AML have unsatisfactory clinical outcomes. Earlier studies have reported the efficacy of combining venetoclax with azacytidine or cytarabine for AML patients. The trial aimed to investigate the effectiveness of combining all three drugs.
Phase-2, two-stage, single-arm enrolled 33 untreated AML patients (Eastern Cooperative Oncology Group performance status of 0-2) from three public hospitals in China. The participants received induction treatment with daunorubicin (intravenous, 60 mg/m2, days 1–3), cytarabine (intravenous, 100 mg/m2 on days 1–7), and venetoclax (oral,100 mg on day 4, 200 mg on day 5, and 400 mg on days 6–11; DAV regimen) for 28-35 days per cycle. The study’s primary endpoint was the composite complete remission rate after one induction treatment cycle. The secondary endpoints were residual disease, event-free survival (EFS), overall survival (OS), and adverse events.
Ninety-one percent of patients (29/30) showed undetectable measurable residual disease after one treatment cycle. After a median follow up of 11 months, the OS and EFS were 97% and 72%, respectively. Grade 3 or worse adverse events were observed in all the patients, including neutropenia (55%), pneumonia (21%), and sepsis (12%).
The results demonstrate the clinical benefits of first-line treatment with daunorubicin plus cytarabine and venetoclax for adult AML patients.
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