Dr. DiNardo on the Results of the VIALE-A Trial in AML

Courtney DiNardo, MD, MSCE, clinical researcher in the Department of Leukemia of the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, discusses the results of the phase 3 VIALE-A trial in acute myeloid leukemia (AML).

In VIALE-A, treatment-naïve patients who were ineligible for intensive therapy were randomized 2:1 to the combination of venetoclax (Venclexta) and azacitidine (n = 286) versus azacitidine alone (n = 145).

At a median follow-up of 20.5 months, the complete response (CR)/CR with incomplete hematologic recovery rates in the combination and azacitidine-alone arms were 66% and 28%, respectively (P <.001). The median time to first CR/CRi response was 1.3 and 2.8 months, respectively. The benefit with venetoclax was observed across all key subgroups, says DiNardo. The duration of CR/CRi was 17.5 months and 13.4 months respectively.

The median overall survival was 14.7 months in the combination arm versus 9.6 months in the azacitidine-alone arm (HR, 0.66; 95% CI, 0.52-0.85; P <.001), representing the first phase 3 trial to show such a clear survival advantage in this patient population, concludes DiNardo.