AstraZeneca has reported that the PONENTE Phase IIIb trial showed Fasenra (benralizumab) eliminated the use of maintenance oral corticosteroids (OCS) in a majority of OCS-dependent asthma patients.
Developed by AstraZeneca and in-licensed from Kyowa Kirin subsidiary BioWa, Fasenra is a monoclonal antibody that attaches directly to IL-5 receptor alpha on eosinophils.
It attracts natural killer cells to induce rapid and near-complete depletion of eosinophils through apoptosis.
The multi-centre, open-label, single-arm trial was conducted on 600 patients in Europe, North America, South America, and Taiwan.
It evaluated the efficacy and safety of reducing daily OCS use after initiation of a 30mg dose of Fasenra administered subcutaneously (SC) in participants.
The subjects included adult patients with severe eosinophilic asthma on high-dose inhaled corticosteroids (ICS), plus long-acting beta2-agonist (LABA) and long-term use of OCS therapy with or without additional asthma controllers.
The treatment period had a four-week induction phase with no OCS adjustments, a variable OCS tapering phase, and an ongoing 24 to 32-week maintenance phase.
In the trial’s first primary endpoint, 62% of patients achieved complete elimination of daily OCS use.
About 81% of patients achieved complete elimination or were able to reduce their daily OCS dose to 5mg or less when the further reduction was not possible owing to adrenal insufficiency, thus meeting the second primary endpoint.
The results were sustained for at least four weeks while maintaining asthma control.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Around 13.5 million people worldwide with severe asthma currently rely on oral corticosteroids to control exacerbations and prevent hospitalisations.
“These data further support Fasenra’s clinical profile in eliminating oral corticosteroid use across a broader population of severe asthma patients.”
Frequent or chronic use of OCS can lead to serious adverse effects in asthma patients.
Last month, AstraZeneca reported positive results from the Phase III OSTRO trial of Fasenra to treat patients with chronic rhinosinusitis with nasal polyps.