Fasenra Eliminated Oral Corticosteroid Use in Majority of OCS-Dependent Asthma Patients in PONENTE Phase IIIb Trial

October 31, 2020 News /Bio ValleyBIOON/ --AstraZeneca(AstraZeneca) recently announced the top-line results of the open-label Phase 3b PONENTE study evaluating Fasenra (benralizumab), an anti-inflammatory agent, for the treatment of asthma. The data showed that in oral corticosteroid (OCS)-dependent patients with a broad range of blood eosinophil countsAsthmaFasenra eliminated the need for maintenance OCS use in most patients.

SevereAsthmaIt is a frequently debilitating disease affecting approximately 34 million people worldwide. More than one-third of these patients currently use chronic or intermittent oral corticosteroids (OCS), in addition to other therapies, to control their symptoms and acute exacerbations. However, frequent or long-term use of OCS can lead to serious adverse effects.

PONENTE is a multicenter, open-label, single-arm, phase IIIb trial in patients with severe eosinophilic asthma receiving high-dose inhaled corticosteroids (ICS), long-acting β2-agonists (LABA), and long-term oral corticosteroids (OCS), with or without additional asthma control medications.Asthmaconducted in patients to evaluate the efficacy and safety of reducing daily oral corticosteroid (OCS) use after initiating Fasenra 30 mg subcutaneous injection (SC).

The results showed that for the first primary endpoint, 62% of patients completely eliminated daily OCS use. For the second primary endpoint, 81% of patients achieved complete elimination, or were able to reduce their daily OCS dose to 5 mg or less when further reduction was not possible due to adrenal insufficiency. Both primary endpoints were maintained for at least 4 weeks, while maintainingAsthmaControl. PONENTE included nearly 600 patients from Europe, North America, South America, and Taiwan.

By employing a more rapid steroid tapering regimen in patients without adrenal insufficiency to reduce the use of high-dose oral corticosteroids (OCS), the PONENTE trial expands upon the data on OCS reduction previously observed in the Phase 3 ZONDA trial. The maintenance phase of the PONENTE trial was also longer, lasting approximately 24–32 weeks; compared with ZONDA and all other published biologic agent trials, PONENTE demonstrated more sustained OCS reduction andAsthmacontrol. In the PONENTE trial, the safety and tolerability of Fasenra were consistent with its known drug profile. The trial results will be presented at the upcoming medicalMeetingpublished above.

Professor Andrew Menzies Gow, Director of the Lung Clinic at the Royal Brompton Hospital in London, UK, and Principal Investigator of the PONENTE trial, stated: “These exciting results demonstrate the role of Fasenra in eliminating or reducing oral corticosteroids (OCS). The reductions achieved through personalized OCS tapering plans are particularly significant, as adrenal insufficiency may pose a barrier to safe and meaningful OCS reduction. These data will provide severeAsthma“Treatment guidelines provide information and enhance physicians’ confidence to more safely eliminate patients’ long-term OCS use.”

Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, stated: “Currently, 13.5 million patients with severe asthma worldwide rely on oral corticosteroids (OCS) to control disease exacerbations and prevent hospitalizations. However, overreliance on OCS also poses serious health risks to patients and places additional strain on healthcare systems. These data further support Fasenra in a broader range of severeAsthma"Clinical Profile of OCS Elimination in the Patient Population."

The active pharmaceutical ingredient of Fasenra is benralizumab, a monoclonal antibody that directly binds to the alpha subunit of the interleukin-5 receptor (IL-5Rα) on eosinophils and uniquely recruits natural killer (NK) cells throughApoptosis(Programmed cell death) induces rapid and nearly complete depletion of eosinophils.

Currently, Fasenra has been approved in the United States, the European Union, Japan, and other countries and regions as an add-on maintenance therapy for the treatment of severe eosinophilicAsthma. Additionally, the self-administration option for Fasenra (benralizumab) has been approved in the United States and the European Union, allowing patients to self-administer the medication using a new pre-filled, single-use autoinjector (Fasenra pen).

Fasenra was licensed to AstraZeneca from BioWa, a wholly-owned subsidiary of the Japanese pharmaceutical company Kyowa Hakko Kirin. In late March this year, AstraZeneca and Kyowa Hakko Kirin signed a new agreement, through which AstraZeneca obtained the Asian rights for all indications of Fasenra. In addition to the approved eosinophilicAsthmaBeyond its approved indications, AstraZeneca is also evaluating Fasenra for the treatment of eight eosinophil-driven diseases, including: severe nasal polyps, eosinophilic esophagitis (EoE), hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA), and chronic obstructive pulmonary disease (COPD). Previously,FDAFasenra Granted Orphan Drug Designation for the Treatment of EoE, HES, and EGPA. (Bioon.com)

Original Source: Fasenra Eliminated Oral Corticosteroid Use in a Majority of OCS-Dependent Patients with Asthma in PONENTE Phase IIIb Trial