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Roche finds contradictory results in identical Phase III asthma trials

pharmafile | February 29, 2016 | News story | Manufacturing and Production, Research and Development Roche, lebrikizumab asthma 

Roche has reported contradictory results from two identical Phase III studies of lebrikizumab in severe asthma, with one showing the drug significantly reduced exacerbations of the condition; and the second study failing to meet this primary endpoint.

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. This study also demonstrated a significant improvement in lung function, although both observed effects in the primary and secondary endpoints were less than those seen in the lebrikizumab phase II trials. Even worse was the news from the identical LAVOLTA II trial, in which the exacerbation reduction results observed failed to meet statistical significance.

Sandra Horning, chief medical officer and head of Global Product Development at Roche, said the company would examine the results before deciding on a path forward. She comments: “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. These data require further interpretation and analyses are ongoing to better understand the results and determine next steps.”

Joel Levy

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