Genentech announced top-line results from two Phase 3 studies, LAVOLTA I and II, of lebrikizumab for the treatment of patients with severe asthma.
LAVOLTA I and II are two identical, randomized, multicenter, placebo-controlled Phase 3 studies evaluating the efficacy and safety of lebrikizumab in more than 2,100 patients with severe asthma that is uncontrolled despite standard-of-care treatment with an inhaled corticosteroid and a second controller medication. Their primary endpoint was the rate of asthma exacerbations over 52 weeks, based on a subgroup of patients with higher levels of serum periostin or blood eosinophils.
A significant reduction in the rate of asthma exacerbations in patients with higher levels of serum periostin or blood eosinophils was seen in LAVOLTA I, meeting its primary endpoint. Additionally, patients treated with lebrikizumab demonstrated a significant improvement in lung function as measured by forced expiratory volume in one second (FEV1). However, the observed effect in the primary and secondary endpoints was less than that seen in the lebrikizumab Phase 2 trials. In contrast, LAVOLTA II did not meet statistical significance in the reduction of asthma exacerbation endpoint. Detailed study results will be presented at upcoming medical meetings.
Lebrikizumab is a novel humanized monoclonal antibody that specifically inhibits the action of interleukin-13 (IL-13).
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