Key clinical point: Combination of low-dose cytarabine (LDAC) with venetoclax vs. placebo improved survival and treatment response in treatment-naive patients with acute myeloid leukemia (AML) ineligible for intensive chemotherapy (IC).
Major finding: LDAC+venetoclax vs. LDAC+placebo improved median overall survival (hazard ratio 0.70; P = .04), along with higher rates of complete response (CR) or CR with incomplete hematologic recovery (48.3% vs. 13.2%; P < .001) and postbaseline red blood cell and platelet transfusion independence (39.2% vs. 17.6%; P = .002).
Study details: This was a post hoc analysis performed after an additional 6 months of follow-up of the phase 3 VIALE-C trial, including 211 adult patients with AML who were treatment-naive and unsuitable for IC. Patients were randomly assigned to receive LDAC with venetoclax (n = 143) or placebo (n = 68).
Disclosures: This study was sponsored by AbbVie. Some investigators, including the lead author, reported receiving research and financial support from, being on advisory boards or boards of directors for, being a current or former employee of, holding stocks in, or receiving patents and royalties from various pharmaceutical companies, including AbbVie.
Source: Wei AH et al. Blood Cancer J. 2021;11:163. doi: 10.1038/s41408-021-00555-8.