Roche/AbbVie’s Venclexta extends survival in leukemia study

Following up on their initial announcement in March, Roche (OTCQX:RHHBY) unit Genentech and U.S. commercialization partner AbbVie (NYSE:ABBV) announce positive results from a Phase 3 clinical trial, VIALE-A, evaluating Venclexta (venetoclax) and chemo agent azacitidine in previously untreated acute myeloid leukemia (AML) patients ineligible for intensive chemo.

The study met both primary endpoints, demonstrating statistically significant improvements in overall survival (OS) (sole U.S. efficacy endpoint) and the proportion of patients achieving complete remission (CR) and CR with incomplete blood count recovery (CRi) compared to azacitidine + placebo.

Specifically, OS in the Venclexta + azacitidine (V+a) arm was 14.7 months compared to 9.6 months in the azacitidine alone arm (p<0.001). 64% of patients receiving V+a achieved CR + CRi versus 28.3% of patients in the azacitidine group (p<0.001).

The companies are co-commercializing Venclexta in the U.S. while AbbVie has sole rights ex-U.S.

https://seekingalpha.com/news/3582827-roche-abbvies-venclexta-extends-survival-in-aml-study