Genentech has announced the results from two phase 3 studies that evaluated the efficacy and safety of lebrikizumab in people with severe asthma. In the LAVOLTA I trial, lebrikizumab reduced asthma exacerbations and improved lung function, but not as significantly as in its phase 2 trials. In the LAVOLTA II trial, lebrikizumab failed to produce statistically significant results for either endpoint, BioSpace reports.
LAVOLTA I and II included more than 2,100 people across 28 countries with severe asthma that was uncontrolled despite treatment with an inhaled corticosteroid and a second controller medication. The two identical, randomized, multicenter, placebo-controlled phase 3 studies had the primary endpoint of reducing the rate of asthma exacerbations over 52 weeks. The secondary endpoint of both was improvement in lung function as measured by forced expiratory volume in one second. Each of the endpoints was based on a subgroup of people with higher levels of serum periostin (a protein identified as a key biomarker of inflammation in certain types of asthma) or blood eosinophils (inflammatory cells sometimes present in increased numbers in the airways and blood of people with asthma).
“We were hopeful these identical studies would confirm the phase 2 results because there is still a significant unmet need for people with severe asthma,” said Sandra Horning, MD, 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.”
Lebrikizumab, a novel humanized monoclonal antibody, is designed to specifically block the action of the cytokine interleukin-13 (IL-13), a key contributor to airway inflammation and asthma in some patients. Ongoing clinical studies of the drug are being conducted in asthma, chronic obstructive pulmonary disease, atopic dermatitis, and idiopathic pulmonary fibrosis.
Source: BioSpace; February 29, 2016.