Phase III LIBERTY ASTHMA QUEST study of dupilumab shows a reduction in severe asthma attacks.- Sanofi + Regeneron.

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the pivotal Phase III LIBERTY ASTHMA QUEST study of dupilumab in a broad population of patients with uncontrolled, persistent asthma met its two primary endpoints. Dupilumab, when added to standard therapies, reduced severe asthma attacks (exacerbations) and improved lung function. At 52 weeks, in the 300 mg dose group, dupilumab reduced severe asthma attacks by 46 percent in the overall population, 60 percent in patients with 150 eosinophilic cells/microliter or greater, and 67 percent in patients with 300 eosinophilic cells/microliter or greater (p less than 0.001 for all groups). At 12 weeks, in the 300 mg dupilumab dose group, mean improvement in lung function over placebo as assessed by forced expiratory volume over one second (FEV1) with dupilumab was 130 mL (9 percent) in the overall population, 210 mL (11 percent) in patients with 150 eosinophilic cells/microliter or greater, and 240 mL (18 percent) in patients with 300 eosinophilic cells/microliter or greater (p less than 0.001 for all groups).

The results for the 200 mg and 300 mg dupilumab dose groups were generally comparable on both exacerbations and FEV1. The extent of patient response correlated with allergic or atopic status as reflected by blood eosinophils and other markers. Less activity was observed in patients with less than 150 eosinophilic cells/microliter. The overall rates of adverse events, deaths, infections, conjunctivitis, herpes and discontinuations were comparable between the dupilumab and placebo groups. Injection site reactions were more common in the dupilumab groups occurring in 17 percent of dupilumab patients compared to 8 percent of placebo patients.

Detailed results from the QUEST study will be submitted for presentation at a future medical congress. QUEST is the second pivotal trial in uncontrolled persistent asthma following a positive Phase IIb pivotal study of dupilumab. Data from another Phase III study known as VENTURE examining the ability of dupilumab to reduce oral corticosteroid use in patients with severe steroid-dependent asthma are expected later this year. Also included in the LIBERTY ASTHMA clinical development program is the TRAVERSE trial, a long-term safety extension study.