Phase 2 study of venetoclax plus intensive chemotherapy for newly diagnosed AML or high-risk MDS

Addition of the BCL2 inhibitor venetoclax to lower intensity therapy has been shown to improve overall survival in older (aged 75 years or older) and unfit patients with newly diagnosed AML. A cohort from a phase 2 study at MD Anderson Cancer Center (Houston, TX) evaluated the combination of venetoclax and intensive chemotherapy (cladribine, idarubicin, and cytarabine) for newly diagnosed AML or high-risk MDS. The treatment was safe. Complete response or complete response with incomplete blood count recovery was seen in 94% of patients, and 82% had undetectable MRD. At median 13.5 months of follow-up median DOR, EFS and OS were not reached.