LATE-BREAKING ABSTRACT: LAVOLTA I and II: Results of 2 phase III studies to assess the efficacy and safety of lebrikizumab in patients with uncontrolled asthma

Introduction In Phase II trials, lebrikizumab, an anti-IL-13 mAb, improved exacerbation rates and FEV 1 in patients with uncontrolled asthma, particularly in patients with higher levels of Type 2 biomarkers. Aims LAVOLTA I (NCT01867125) and II (NCT01868061) are replicate Phase III studies designed to assess the efficacy and safety of lebrikizumab in patients with uncontrolled asthma despite ICS and at least a second controller. Methods Adult patients with uncontrolled asthma, pre-bronchodilator FEV 1 40–80% predicted, and stable background therapy were randomized to receive lebrikizumab 37.5 mg or 125 mg, or placebo SC, Q4W. The primary efficacy endpoint was rate of asthma exacerbations during the 52-week placebo-controlled period in biomarker-high patients (periostin ≥50 ng/mL or blood eosinophils ≥300 cells/µL). Secondary endpoints included change in FEV 1 and ACQ-5. Results 1081 and 1067 patients were randomized and treated in LAVOLTA I and II. Over 52 weeks, lebrikizumab treatment reduced exacerbation rates in biomarker-high patients by 51% for the 37.5 mg dose ( p p 1 improved vs placebo ( p Conclusion In these replicate Phase III trials, LAVOLTA I met its primary endpoint and LAVOLTA II did not. Further work is ongoing to understand the trial results in more detail.