Roche provides update on two Phase III studies of lebrikizumab in asthma
Posted: 29 February 2016 | | No comments yet
LAVOLTA I and II are two identical, randomised, multicentre, placebo-controlled Phase III studies designed to evaluate the efficacy and safety of lebrikizumab…
Roche has announced top-line results from its LAVOLTA I & II studies that evaluated the efficacy and safety of lebrikizumab in people with severe asthma.
LAVOLTA I and II are two identical, randomised, multicentre, placebo-controlled phase III studies designed to evaluate the efficacy and safety of lebrikizumab in people with severe asthma that is uncontrolled despite standard-of-care treatment with an inhaled corticosteroid and a second controller medication. The studies together included more than 2,100 people across 28 countries. The primary endpoint of both studies was the rate of asthma exacerbations over 52 weeks. The evaluation of the primary and secondary endpoints was based on a subgroup of people with higher levels of serum periostin or blood eosinophils.
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. 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.
Data require ‘further interpretation’, says Roche
“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 at Roche. “These data require further interpretation and analyses are ongoing to better understand the results and determine next steps.”
Roche has said that results from the studies will be submitted for presentation at forthcoming medical meetings.