AstraZeneca’s attempt to push its respiratory biologic Fasenra (benralizumab) into the chronic obstructive pulmonary disease field has been foiled by a Phase III flop.
In the 56-week multi-center trial, Fasenra failed to spur a statistically significant reduction of exacerbations in patients with moderate to very severe COPD, the primary endpoint, compared to placebo.
Currently approved as an add-on treatment for severe eosinophilic asthma in the US, EU, Japan and several other countries, Fasenra was billed as a blockbuster in the making, with CEO Pascal Soriot estimating peak sales potential at $2 billion (Jefferies analysts gave it a more modest $1.5 billion).
To achieve that, AstraZeneca needed to navigate a market already staked by GlaxoSmithKline’s first-in-class Nucala, Teva’s Cinqair, and Novartis’ Xolair. It’s too early to tell whether its combination of lower pricing, dosing frequency and delivery method was enough to start winning over large numbers of physicians and patients, and its more entrenched rivals are planning moves of their own. Last September, GSK followed up with an NDA for Nucala in COPD — though the case was also built upon shaky data heavily reliant on a biomarker.
AstraZeneca went into the Phase III Galathea study (as well as another one dubbed Terranova) despite conceding defeat in a PhIIa study back in 2014, where Fasenra not only failed to improve the rate of acute exacerbations for severe COPD patients but also saw a higher rate of treatment-emergent adverse events. Execs at the UK pharma giant and its biologics unit MedImmune were betting that better trial design and patient selection would deliver a desperately needed win in this key disease target, but it proved elusive.
That said, no new safety or tolerability issues were reported in this trial — perhaps the only good news in the announcement.
While the team is still crunching the numbers for an upcoming medical meeting, CMO Sean Bohen has this to say:
COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies. We will now await the results of TERRANOVA and a full evaluation of both trials to determine next steps for Fasenra in COPD.
Terranova is scheduled to read out this quarter.
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