Genentech, a member of the Roche Group, has announced top-line results from two Phase III studies. The LAVOLTA I-II studies were identical, double-blind, randomized, multicenter, placebo-controlled studies that evaluated the efficacy and safety of lebrikizumab in people with severe asthma.
LAVOLTA I met its primary endpoint, showing a significant reduction in the rate of asthma exacerbations in people with higher levels of serum periostin or blood eosinophils, both biomarkers of airway inflammation. In addition, this study demonstrated a significant improvement in lung function as measured by forced expiratory volume in one second (FEV1). The observed effect in the primary and secondary endpoints, however, was less than seen in the lebrikizumab Phase II trials. In contrast, the exacerbation reduction results observed in LAVOLTA II did not meet statistical significance. No new safety signals were observed in either study.
“We were hopeful these identical studies would confirm the Phase II results because there is still a significant unmet need for people with severe asthma,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “These data require further interpretation and analyses are ongoing to better understand the results and determine next steps.”
Results from the studies will be submitted for presentation at upcoming medical meetings.