Roche said Monday that a late-stage study of the experimental therapy lebrikizumab in people with severe asthma met its primary endpoint, although the company noted that an identical trial failed to meet the same main goal. "We were hopeful these identical studies would confirm the Phase II results," remarked chief medical officer Sandra Horning, adding "these data require further interpretation and analyses are ongoing to better understand the results and determine next steps."
The LAVOLTA I and II trials examined the efficacy and safety of lebrikizumab in patients with severe asthma that remains uncontrolled despite standard-of-care treatment with an inhaled corticosteroid and a second controller medication. The primary endpoint of the two studies, which included more than 2100 people, was the rate of asthma exacerbations over 52 weeks, while both the primary and secondary goals were evaluated in a subgroup of patients with higher levels of serum periostin or blood eosinophils.
Roche noted that the LAVOLTA I trial showed a significant reduction in the rate of asthma exacerbations in people with higher levels of serum periostin or blood eosinophils among patients treated with lebrikizumab. The company also recorded a significant improvement in lung function as measured by forced expiratory volume in one second.
The drugmaker cautioned that the observed effects in both the primary and secondary endpoints were weaker than those reported in mid-stage studies. Specifically, in the MILLY study, the results of which were reported  in 2011, treatment with lebrikizumab was associated with a 5.5-percent increase in lung function versus placebo, as well as an 8.2-percent improvement among patients with high levels of periostin.
Meanwhile, Roche said that the exacerbation reduction results observed in LAVOLTA II did not meet significance. The drugmaker said that no new safety signals were observed in either study, adding that results from both trials will be submitted for presentation at future medical meetings.
Lebrikizumab is a humanised monoclonal antibody designed to specifically block the action of interleukin-13. Roche is also conducting clinical studies of the injectable therapy in chronic obstructive pulmonary disease, atopic dermatitis and idiopathic pulmonary fibrosis.
For related analysis, see ViewPoints: Roche's lebrikizumab takes another unexpected clinical detour , and for more information on dugs in development for asthma, see Targeted Therapies In Asthma: KOL Insight .