Roche has unveiled top-line results from two late-stage studies assessing its humanised monoclonal antibody lebrikizumab in people with severe asthma, showing a mixed performance on exacerbations.
The LAVOLTA I and II studies were identical, double-blind, randomised, multicentre, placebo-controlled studies evaluating the drug’s efficacy and safety in patients, after Phase II data showed that the drug cut asthma exacerbations by 60%.
Lebrikizumab is designed to specifically block the action of interleukin-13 (IL-13), a cytokine that contributes to airway inflammation and asthma disease process in some patients. Roche is exploring whether blocking this cytokine and measuring levels of the biomarker periostin with a blood test could predict which patients with severe uncontrolled asthma might benefit.
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, as well as a significant improvement in lung function. However, in direct contrast, exacerbation reduction results observed in LAVOLTA II did not meet statistical significance.
The Swiss drugs giant failed to expand on the findings, with chief medic officer and head of global product development Sandra Horning saying only that the data “require further interpretation and analyses are ongoing to better understand the results and determine next steps.”
No new safety signals were observed in either study, Roche said.