AstraZeneca and Amgen asthma drug shows positive results in Phase III trial

AstraZeneca and Amgen’s new tezepelumab drug for the treatment of severe asthma has shown superiority across all primary and secondary endpoints in a Phase III trial.

The NAVIGATOR study treated patients with standard of care with either tezepelumab or a placebo over 52 weeks. Tezepelumab was found to reduce annualised asthma exacerbation rates by 77%, and hospitalisation by 85%, as compared to those on placebo.

Tezepelumab also showed statistically significant improvements in key secondary endpoints in lung function, asthma control, and health-related quality of life. 

Improvements were observed in tezepelumab-treated patients as early as week two of the study and were sustained throughout the treatment period.

The trial involved 1,061 participants, aged between 12 and 80 years old, with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose inhaled corticosteroids (ICS), plus at least one additional controller medication.

Globally, there are approximately 2.5 million severe asthma patients who are uncontrolled or eligible for treatment with biologics, with approximately 1 million in the US and 200,000 in the UK.

Uncontrolled asthma occurs when symptoms persist despite treatment. Severe, uncontrolled asthma can cause patients to experience frequent exacerbations, significant limitations on lung function, and a reduced quality of life.

Professor Andrew Menzies-Gow, Principal investigator of the NAVIGATOR Phase III trial, said:

"Managing severe asthma is challenging with multiple inflammatory pathways often contributing to the complexity of a patient's disease. These latest results underscore the potential of tezepelumab to transform treatment for a broad population of severe asthma patients regardless of their type of inflammation.”

Dr David M Reese, Executive Vice President of Research and Development at Amgen, added: ”Severe, uncontrolled asthma is debilitating, with patients experiencing frequent exacerbations that lead to hospitalisation. For this reason, we were incredibly pleased to see that patients who received tezepelumab during the trial had a reduction in both ER visits and hospitalizations.

”Advancing the science to address unmet patient needs such as these has been the driving force behind Amgen's inflammation research for more than two decades. Along with our partner AstraZeneca, we are incredibly proud of these results and tezepelumab's potential for a broad population of patients with asthma."

Jack Goddard