High-level results from the PONENTE Phase IIIb open-label trial showed FASENRA (benralizumab) eliminated the use of maintenance oral corticosteroids (OCS) in OCS-dependent asthma patients with a broad range of blood eosinophil counts.
On the first primary endpoint, 62 per cent of patients achieved complete elimination of daily OCS use. On the second primary endpoint, 81 per cent of patients achieved complete elimination or were able to reduce their daily OCS dose to 5mg or less when further reduction was not possible due to adrenal insufficiency. Both primary endpoints were sustained for at least four weeks while maintaining asthma control. PONENTE included nearly 600 patients in Europe, North America, South America, and Taiwan.
Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, the principal investigator of the PONENTE trial, said, “These exciting results demonstrate FASENRA’s impact in eliminating or reducing oral corticosteroid use. The reductions achieved with the personalized oral corticosteroid tapering schedule are particularly important because adrenal insufficiency can be a barrier to safe and meaningful oral corticosteroid reduction. These data should inform severe asthma treatment guidelines and strengthen physicians’ confidence to more safely eliminate chronic oral corticosteroid use in their patients.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said, “Around 13.5 million people worldwide with severe asthma currently rely on oral corticosteroids to control exacerbations and prevent hospitalizations. However, over-reliance on oral corticosteroids can also cause significant health risks for patients, as well as additional strain on health systems. These data further support FASENRA’s clinical profile in eliminating oral corticosteroid use across a broader population of severe asthma patients.”
The trial expands on OCS-sparing data previously seen in the ZONDA Phase III trial by using a faster steroid tapering schedule in patients who did not experience adrenal insufficiency to reduce OCS use from higher doses. The PONENTE trial also has a longer maintenance phase of approximately 24–32 weeks, which shows more durable OCS reduction and asthma control than was shown in ZONDA and all other published trials for biologic medicines. The safety profile and tolerability of FASENRA in PONENTE were consistent with the known profile of the medicine. The trial results will be presented at a forthcoming medical meeting.
FASENRA is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries, and is approved for self-administration in the US, EU and other countries. In January 2020, AstraZeneca announced FASENRA is being evaluated in eight eosinophil-driven diseases beyond severe asthma.