AstraZeneca’s Fasenra Fails a Second Phase III COPD Trial


AstraZeneca’s add-on asthma treatment Fasenra has failed a second Phase III trial this month. This morning the company said the medication did not hit its primary endpoint in a trial of patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

The U.K. pharma giant and its biologics research-and-development arm, MedImmune, were studying the efficacy of Fasenra (benralizumab) as a potential therapeutic to reduce exacerbations in the COPD patients. Last year Fasenra scored approval from the U.S. Food and Drug Administration as an add-on treatment for asthma patients due to the clinical evidence that it demonstrated significant reductions in the annual asthma exacerbation rate.

COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 384 million people worldwide and is predicted to be the third-leading cause of death by 2020. About 30 to 40 percent of moderate to severe COPD patients on triple inhaled therapy remain uncontrolled and continue to experience exacerbations.

Fasenra is a monoclonal antibody that stimulates natural killer cells to cause rapid and near-complete depletion of eosinophils, a type of white blood cell.

Fasenra’s failure to achieve a statistically significant reduction of exacerbations in the TERRANOVA trial came hard on the heels of its failure in the Phase III GALATHEA trial. In that trial, Fasenra also failed to achieve a statistically-significant decrease of exacerbations in COPD patients.

AstraZeneca’s Chief Medical Officer Sean Bohen said the company will analyze the complete data sets from both Phase III trials in order to fully understand the results. He added that the results from both trials are disappointing “because uncontrolled COPD patients already on dual or triple inhaled therapy need new treatment options.” But what this means for the future of Fasenra in COPD is not yet known. Following the failure of the GALATHEA trial, Bohen said the company would have to wait for the TERRANOVA results to determine the next steps for Fasenra in COPD. A full evaluation of the data is ongoing, and the results will be submitted for presentation at a forthcoming medical meeting, AstraZeneca said. It is possible the trial could be redesigned, or the company could scrap the Fasenra COPD program altogether. One thing AstraZeneca made clear is it does not currently intend to make a regulatory submission.

Both the GALATHEA and TERRANOVA trials were randomized, double-blinded, 56-week placebo-controlled, multicenter 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.

A focus on respiratory drugs has been key to AstraZeneca’s strategy, particularly since the $575 million acquisition of Takeda Pharmaceutical Company’s core respiratory business, including global rights to roflumilast, a treatment for chronic obstructive pulmonary disease (COPD). The company is also banking on its new COPD drug, Bevespi Aerosphere, to boost sagging revenue due to stiffer competition from other companies, including GlaxoSmithKline.

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