Venclexta misses Phase III endpoint in AML combo trial

The VIALE-C (M16-043) trial of  Venclexta (venetoclax) in combination with low-dose cytarabine (LDAC) versus LDAC in combination with placebo did not meet its primary endpoint of statistically-significant improvement of overall survival (OS) for patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy at the time of the planned analysis.

AML is one of the most difficult-to-treat blood cancers, says AbbVie (NYSE: ABBV), which is 0developing and marketing the already approved drug to treat certain patients with chronic lymphocytic leukemia and acute myeloid leukemia in partnership with Roche (ROG: SIX) subsidiary Genentech.

Treatment with the venetoclax combination showed a 25% reduction in the risk of death compared to LDAC with placebo (Hazard Ratio [HR]=0.75 [95% CI 0.52–1.07], p=0.11). The venetoclax with LDAC arm also showed a median OS of 7.2 months versus 4.1 months in the LDAC arm alone. A post-hoc analysis after an additional six months of follow up showed an increase in median OS of 8.4 months in the venetoclax plus LDAC arm and 4.1 months in the placebo plus LDAC arm (HR=0.70 [95% CI 0.50-0.99]). Select secondary endpoints are included in the following table.