PATHWAY Phase II trial of tezepelumab shows reduction in annual asthma exacerbation rate and is published in NEJM.- Medimmune/AstraZeneca + Amgen.

AstraZeneca and Amgen Inc.announced results from the PATHWAY Phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. Tezepelumab is a first-in-class anti-TSLP monoclonal antibody being developed by MedImmune, AstraZeneca’s global biologics research and development arm, in collaboration with Amgen.

The trial results are published in the New England Journal of Medicine on 7 September and will be followed by an oral presentation on 12 September at the ERS International Congress 2017 in Milan. The PATHWAY trial achieved its primary efficacy endpoint, showing annual asthma exacerbation rate reductions of 61%, 71% and 66% in the tezepelumab arms receiving either 70mg or 210mg every four weeks or 280mg every two weeks, respectively (p<0.001 for all comparisons to placebo). In the trial, tezepelumab was given as an add-on therapy to patients with a history of asthma exacerbations and uncontrolled asthma despite receiving inhaled corticosteroids/long-acting beta-agonists with or without oral corticosteroids and additional asthma controllers. Significant and clinically-meaningful reductions in the exacerbation rate were observed independent of baseline blood eosinophil count or other type 2 (T2) inflammatory biomarkers. Tezepelumab also demonstrated improvements in lung function at all doses and in asthma control at the two higher doses (p<0.05 for all comparisons to placebo).

The incidence of adverse events was similar between the tezepelumab and placebo groups. The most common adverse events in tezepelumab-treated patients were asthma, nasopharyngitis, headaches and bronchitis.