Results from the Phase III VIALE-A clinical study of Venclexta with Vidaza in acute myeloid leukemia (AML) in NEJM.- AbbVie

AbbVie announced the publication of results from the Phase III VIALE-A clinical study in patients with AML in the New England Journal of Medicine (NEJM). The study, which evaluated newly-diagnosed AML patients who had not yet been treated and were unable to tolerate traditional intensive chemotherapy, found that Venclexta (venetoclax) in combination with Vidaza (azacitidine) extended overall survival (OS) compared to azacitidine plus placebo. In the VIALE-A study, OS was the sole primary study endpoint in the U.S. OS and composite complete remission rate (CR+CRi) were co-primary endpoints in China, Japan, the European Union (EU) and EU reference countries. CR+CRi is a composite score reflecting the complete remission (CR) and CR with incomplete hematologic recovery (CRi), which is an incomplete CR with blood counts not fully recovered. Treatment with venetoclax plus azacitidine reduced the risk of death by 34% compared to azacitidine in combination with placebo (Hazard Ratio [HR]=0.66 [95% CI: 0.52-0.85], p<0.001). patients in the venetoclax combination arm had a median os of 14.7 months (95% ci: 11.9-18.7) versus 9.6 months for patients in the placebo arm (95% ci: 7.4-12.7). additionally, 66.4% (95% ci: 60.6-71.9) of patients treated with venetoclax plus azacitidine achieved cr+cri versus 28.3% (95% ci: 21.1-36.3) of patients treated with azacitidine plus placebo (p><0.001). other secondary endpoints that were published in nejm include cr and cr with partial hematologic recovery (cr+crh). the observed safety profile in the viale-a trial is generally consistent with the known safety profiles of venetoclax combined with azacitidine.>