AbbVie has reported that the Phase III VIALE-C clinical trial of venetoclax (Venclexta) plus low-dose cytarabine (LDAC) failed to reach the primary goal in patients with acute myeloid leukaemia (AML).
Venetoclax specifically binds to and inhibits the B-cell lymphoma-2 (BCL-2) protein, which blocks some cancer cells from undergoing their natural death.
The randomised, double-blind, placebo-controlled Phase III trial compared the safety and efficacy of venetoclax combination to placebo plus LDAC, in a total of 210 treatment-naïve AML patients.
Primary efficacy endpoint of the study was overall survival (OS). The trial also assessed secondary endpoints such as remission rates, transfusion independence and event-free survival.
AbbVie’s drug combination did not show statistically significant improvement in OS, where the treatment led to a 25% decrease in the risk of death versus to LDAC with placebo.
The venetoclax arm demonstrated a median OS of 7.2 months compared to 4.1 months in the LDAC arm.
Data from a posthoc analysis after an additional six months of follow up revealed 8.4 months of increase in median OS with the venetoclax combination and 4.1 months with the placebo combination.
The safety profile of the combination is said to be consistent with the Phase I / II data, which supported the US Food and Drug Administration (FDA) approval of the combination in other indications.
AbbVie chief medical officer and development vice-president Neil Gallagher said: “We remain committed to AML patients and our research in AML and other blood cancers.
“The study results, while not statistically significant, are indicative of the clinical activity of venetoclax in combination with low-dose cytarabine.”
AbbVie is developing the drug in alliance with Roche. It is co-commercialised by AbbVie and Roche unit Genentech in the US and by AbbVie alone outside of the US.
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