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AstraZeneca’s TERRANOVA trial has not met the primary endpoint

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The trial, the second of two pivotal Phase III trials for Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), did not meet the primary endpoint of a statistically-significant reduction of exacerbations.

This news follows 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. We will now analyse the complete data sets from the GALATHEA and TERRANOVA trials to further understand these results,” says Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer.

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.

The safety and tolerability findings in TERRANOVA were consistent with those observed in previous trials with Fasenra. A full evaluation of the data is ongoing, and the results will be submitted for presentation at a forthcoming medical meeting. The company does not currently intend to make a regulatory submission.

Fasenra is AstraZeneca’s first respiratory biologic and is 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 do not impact the approved indication in severe eosinophilic asthma.