AstraZeneca's Benralizumab Meets Primary Endpoint in Phase III MANDARA Study, Demonstrating Non-Inferiority to Mepolizumab in EGPA

On September 11, AstraZeneca announced that its benralizumab treatment for patients with eosinophilic granulomatosis with polyangiitis (EGPA) met the primary endpoint in the Phase III MANDARA study, with an overall response rate (ORR) not inferior to mepolizumab. These subjects were receiving oral corticosteroid (OCS) therapy with or without immunosuppressants. The MANDARA study is the first head-to-head Phase III clinical trial of biologics in the EGPA field.

MANDARA is a randomized, double-blind, parallel-group, active-controlled Phase III clinical trial designed to compare the efficacy and safety of Benralizumab versus Mepolizumab in treating EGPA over 52 weeks, enrolling 140 participants. The primary endpoint is the proportion of patients in remission at Weeks 36 and 48, with remission defined as a Birmingham Vasculitis Activity Score (BVAS) of 0 and an OCS dose ≤4mg/day. Specific results will be announced at an upcoming medical conference.

Benralizumab is an IL-5 receptor (IL-5Rα) monoclonal antibody that directly binds to IL-5Rα on eosinophils and recruits natural killer cells to induce rapid and nearly complete depletion of eosinophils through apoptosis (programmed cell death).

In November 2017, Benralizumab was first approved for marketing in the United States for add-on maintenance treatment in patients 12 years and older with severe eosinophilic asthma (SEA), under the trade name Fasenra. In October 2019, the FDA approved a pre-filled, single-use auto-injector pen (FASENRA Pen™) for self-administration by patients. Since its launch, the product's sales have soared, generating revenue of $1.396 billion in 2022.

Mepolizumab, an IL-5 monoclonal antibody developed by GSK, was first approved for marketing in the United States in November 2015 as an add-on maintenance treatment for SEA patients aged 12 years and above. Currently, mepolizumab has been approved globally for five indications: 1) Eosinophilic asthma; 2) Bronchial asthma; 3) Chronic rhinosinusitis with nasal polyps; 4) Chronic eosinophilic leukemia/hypereosinophilic syndrome; 5) Allergic granulomatous vasculitis. The product generated revenue of £1.423 billion in 2022.

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