According to findings published in Lancet Haematology, the addition of the BCL2 inhibitor venetoclax to intensive chemotherapy in younger patients with newly diagnosed acute myeloid leukemia (AML) was safe and active.
The study enrolled 50 patients with a median age of 48 years (range = 18-65). Patients received cladribine (5 mg/m2) and cytarabine (1.5 g/m2 for patients aged <60 years, 1 g/m2 for patients aged ≥60 years). Consolidation consisted of cladribine (5 mg/m2), cytarabine (1 g/m2 for patients aged <60 years and 0.75 g/m2 for patients aged ≥60 years), and idarubicin (8 mg/m2). Venetoclax 400 mg was given on days two through eight of each course.
A total of 47 patients (94%) patients had composite complete response (defined as complete response plus complete response with incomplete blood count recovery). The same number of patients also had an overall response. At a median follow-up of 13.5 months, the median durations of response, event-free survival, and overall survival were not reached.
Thirty-seven patients (82%) had undetectable measurable residual disease (MRD).
The most common grade ≥3 adverse events were febrile neutropenia (84%), infection (12%), and alanine aminotransferase elevations (12%). One patient died during induction in a patient who was also receiving an FLT3 inhibitor. Another two patients died during consolidation, but no deaths were deemed to be treatment related.