AstraZeneca says benralizumab met primary endpoint of MANDARA trial

Results from the MANDARA Phase III trial for Fasenra, or benralizumab, in patients with EGPA were published in the New England Journal of Medicine, as the first head-to-head trial of biologics in patients with EGPA, and the first to demonstrate that more than half of patients achieved remission with eosinophil-targeting biologic therapies, AstraZeneca reported. These findings were also presented as a late-breaking poster at the American Academy of Allergy Asthma & Immunology, or AAAAI, Annual Meeting in Washington, DC, February 23-26. MANDARA compared benralizumab to mepolizumab in patients with EGPA receiving oral corticosteroids with or without stable immunosuppressive therapy. Patients were randomized to receive either a single 30 mg subcutaneous injection of benralizumab, or three separate 100 mg subcutaneous injections of mepolizumab, once every four weeks. Full results showed that benralizumab met the primary endpoint of the trial and demonstrated non-inferior rates of remission compared to mepolizumab. The primary endpoint of adjusted rate of remission was 59% for benralizumab-treated patients at weeks 36 and 48, compared with 56% for mepolizumab. Remission in EGPA is defined as Birmingham Vasculitis Activity Score=0 and OCS dose less than or equal to 4 mg/day. A higher proportion of Fasenra-treated patients were able to fully taper off OCS during weeks 48 through 52. Additionally, 86% of benralizumab patients vs. 74% in the comparator arm had at least a 50% reduction in OCS dose during weeks 48 through 52. Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said, “The results from this trial are an important step forward for the EGPA community, as this is the first trial to demonstrate that remission from EGPA with an eosinophil-targeting biologic is achievable for the majority of patients. This is a significant advancement and shows that benralizumab helped patients achieve remission and reduce chronic OCS usage, in a convenient, single, monthly subcutaneous injection, and could alleviate some of the impact of this debilitating disease.”