AstraZeneca and its global biologics research and development arm MedImmune announced top-line results from TERRANOVA, the second of two pivotal Phase III trials for Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), on Wednesday.
The FTSE 100 pharmaceutical giant said the trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations.

That news followed the announcement earlier this month that the first pivotal Phase III trial, GALATHEA, did not meet its primary endpoint.

"These results are disappointing because uncontrolled COPD patients already on dual or triple inhaled therapy need new treatment options," said AstraZeneca chief medical officer Dr Sean Bohen.

"We will now analyse the complete data sets from the GALATHEA and TERRANOVA trials to further understand these results."

The pivotal Phase III trials GALATHEA and TERRANOVA were randomised, double-blinded, 56-week placebo-controlled, multicentre trials assessing the safety and efficacy of Fasenra as an add-on to dual or triple inhaled therapy compared to placebo in patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils.

AstraZeneca said the safety and tolerability findings in TERRANOVA were consistent with those observed in previous trials with Fasenra.

A full evaluation of the data was ongoing, and the results would be submitted for presentation at a forthcoming medical meeting.

The company confirmed it did not currently intend to make a regulatory submission.

Fasenra was described as AstraZeneca's first respiratory biologic and was currently approved as an add-on treatment for severe eosinophilic asthma in the US, EU, Japan and several other countries.

The results of the GALATHEA and TERRANOVA trials did not impact the approved indication in severe eosinophilic asthma.

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