Regeneron (REGN) SanoSNY) Reports New Results from Dupixent (dupilumab) Phase 3 Open-Label Extension Trial
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NYSE: SNY) today announced new results from a Dupixent® (dupilumab) Phase 3 open-label extension trial that showed the safety and efficacy profile observed in previous Dupixent trials was maintained for up to three years in adults and adolescents with moderate-to-severe asthma. Data from the trial will be presented during a live session at the virtual 2020 European Respiratory Society (ERS) International Congress.
"These data suggest Dupixent may slow the progressive decline in lung function that many patients with moderate-to-severe asthma experience, as shown by the sustained improvement in lung function for up to three years. Further, patients on Dupixent maintained asthma control and reduced rates of severe asthma attacks that may result in hospitalizations," said Michael Wechsler, M.D., M.M.Sc., Director of the National Jewish Cohen Family Asthma Institute in Denver, Colorado, and principal investigator of the trial. "This reinforces the importance of Dupixent as a continuous, long-term treatment option to improve patients' ability to breathe and maintain control of their asthma, particularly in those with higher markers of underlying type 2 inflammation."
The analyses to be presented at ERS included more than 2,200 patients who previously participated in Dupixent asthma trials, including three pivotal trials that lasted between 24 and 52 weeks. Patients entered the extension trial after finishing active treatment or placebo in the initial trials and were treated for up to an additional two years, providing up to three years of treatment data in total. The safety analyses included patients from all three pivotal asthma trials, and the efficacy and biomarker analyses included patients who were not dependent on oral corticosteroids (OCS) from the pivotal Phase 2b and Phase 3 QUEST trials. Additional long-term efficacy data in OCS-dependent patients will be presented at a later congress. Results showed:
Efficacy:
- Lung function: Patients continued to experience improvement in lung function by 13-22% at 96 weeks, as measured by the average change in forced expiratory volume over one second (FEV1) compared to baseline for the initial asthma trials.
- Asthma attacks: Patients maintained a low rate of severe asthma attacks (unadjusted annualized severe exacerbation rate) with an average of 0.31-0.35 events per year. In the year prior to commencing Dupixent trials, the rate of severe asthma attacks was 2.09-2.17 events per year.
- Type 2 inflammation: Improvements in lung function and asthma attacks were greater in those with elevated baseline blood eosinophils or fractional exhaled nitric oxide (FeNO), which are markers of type 2 inflammation. In these long-term results, patients showed reductions in blood eosinophils (23-35%) and in blood IgE for patients from the pivotal Phase 2b trial (82%) compared to baseline for the initial asthma trials.
Safety:
- The proportion of patients with adverse events (AEs) in the open label extension trial was similar to that seen in prior pivotal trials of Dupixent in asthma. Over the 96-week treatment period, overall AE rates were 76-88%, and the most common AEs were nasopharyngitis (18-26%) and injection-site erythema (2-23%). Overall serious AEs were experienced by 9-13% of patients.
Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis. Across all approved indications globally, more than 170,000 patients have been treated with Dupixent.