Mepolizumab Demonstrates Positive Results in Phase III Trial for Severe Eosinophilic Asthma in Chinese Population

ShanghaiMay 23, 2023PR Newswire -- Recently, the American Thoracic Society (ATS) annual meeting announced in poster formBiological agents from GlaxoSmithKline (GSK)Mepolizumab (trade name: Nucala)^®) Positive results from the Phase III randomized controlled trial in China (201536; NCT03562195). This trial evaluated the efficacy and safety of Mepolizumab in Chinese patients with severe eosinophilic asthma. The results showed that Mepolizumab significantly reduced the rate of asthma exacerbations, improved patients' quality of life scores, and enhanced lung function.

"Previous studies have found that in patients with bronchial asthma, the eosinophilic inflammatory phenotype accounts for about two-thirds. Elevated blood eosinophils in asthma patients are closely related to the cytokine interleukin-5 (IL-5). Mepolizumab targets and binds to IL-5, blocking its interaction with receptors on the surface of eosinophils, which can continuously reduce the number of blood eosinophils in severe asthma patients to normal levels. It decreases eosinophil-mediated inflammation and tissue damage, improves asthma symptoms, and reduces acute exacerbations while having minimal effects on other parts of the immune system. The data from this Phase III randomized controlled trial completed in China is encouraging. As a combination maintenance therapy, mepolizumab is expected to offer a new treatment option for Chinese patients with severe eosinophilic asthma," said Professor Chen Ruchong from the First Affiliated Hospital of Guangzhou Medical University, National Center for Respiratory Medicine, and Guangzhou Institute of Respiratory Health.

"We are pleased to see that Mepolizumab continues to significantly reduce the exacerbation rate of severe eosinophilic asthma, while improving patients' quality of life and lung function. As the world's first approved targeted IL-5 monoclonal antibody biologic, Mepolizumab has been recommended by the Global Initiative for Asthma (GINA).^[1]As recommended by the "Chinese Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition)" for patients with severe eosinophilic asthma.^[2]"We look forward to the near future where mepolizumab can meet the unmet needs of more Chinese asthma patients," said Dr. Pauline Ng, Vice President and Head of Medical Affairs, GSK China.

This multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III randomized controlled trial with a 52-week treatment period adopted a similar study design to the global pivotal Phase III study MEA115588. In the intention-to-treat population, compared with the placebo group at week 52, mepolizumab significantly reduced the asthma exacerbation rate by 65% (posterior probability of rate ratio <1: >0.999, p<0.001), significantly extended the time to first asthma exacerbation (p<0.001), and significantly reduced the rate of asthma exacerbations requiring hospitalization/emergency department visits by 70% (p=0.012). Additionally, the mepolizumab group showed a greater average reduction in Saint George's Respiratory Questionnaire score from baseline (mean difference -7.1, p=0.001) and a greater increase in pre-bronchodilator forced expiratory volume in one second from baseline (mean difference 137.1ml, p=0.006). In terms of safety, no significant differences were observed between the mepolizumab group and the placebo group in laboratory parameters, electrocardiogram, or vital signs, and the observed adverse events were consistent with the known safety profile.

Mepolizumab has been approved in many countries or regions for the treatment of severe eosinophilic asthma. Currently, China's National Medical Products Administration has officially accepted the registration application for the severe eosinophilic asthma indication of mepolizumab.^[3]If approved, mepolizumab will become the first targeted IL-5 monoclonal antibody biologic in China for adult and adolescent patients with severe eosinophilic asthma.

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