▎WuXiEdited by Kant Content Team

Recently, The New England Journal of Medicine published positive results from AstraZeneca's Phase 3 trial MANDARA of Fasenra (benralizumab), an IL-5 receptor α (IL-5Rα) inhibitor, for the treatment of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).According to the press release, this is the first head-to-head trial of a biologic for the treatment of EGPA patients, and it is also the first trial result demonstrating that a biologic targeting eosinophils can lead to remission in more than half of the patients.

The MANDARA trial compared benralizumab with the IL-5 monoclonal antibody Nucala (mepolizumab) for the treatment of EGPA patients using oral corticosteroids (OCS), with or without stable immunosuppressive therapy. Patients were randomly assigned to receive a single 30 mg subcutaneous injection of benralizumab or a 300 mg subcutaneous injection of the active control drug. The results showed,The trial met its primary endpoint, with benralizumab demonstrating non-inferiority to the active control group in the treatment of EGPA patients.At weeks 36 and 48, the adjusted remission rate for the primary endpoint was 59% in the benralizumab group versus 56% in the active comparator group (rate difference: 3%; 95% CI: –13, 18).

In addition,A significantly higher proportion of patients treated with benralizumab were able to taper off oral OCS completely between Weeks 48 and 52, with 41% in the benralizumab group achieving this compared to 26% in the control group, a difference of 16% (95% CI: 1, 31).Meanwhile, during this period, the proportion of patients who reduced OCS dosage by at least 50% was 86% in the benralizumab group and 74% in the control group, with a difference of 12% (95% CI: -1, 25).

Benralizumab is a monoclonal antibody that binds to IL-5Rα expressed on the surface of eosinophils.By binding to IL-5Rα, it is able to recruit natural killer cells and rapidly eliminate these cells by inducing the apoptosis process of eosinophils.BenralizumabIt is the first biologic developed by AstraZeneca for the treatment of respiratory diseases and has been approved as an add-on therapy for severe eosinophilic asthma.

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References:

[1] MANDARA Phase III data published in New England Journal of Medicine show remission is an achievable goal in eosinophilic granulomatosis with polyangiitis (EGPA) with FASENRA. Retrieved February 24, 2024 from https://www.businesswire.com/news/home/20240223997402/en/

[2] Wechsler ME, Nair P, Terrier B, Walz B, Bourdin A, Jayne DRW, Jackson DJ, Roufosse F, Börjesson Sjö L, Fan Y, Jison M, McCrae C, Necander S, Shavit A, Walton C, Merkel PA; MANDARA Study Group. Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2024 Feb 23. doi: 10.1056/NEJMoa2311155. Epub ahead of print. PMID: 38393328.

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