Roche announces topline results from trials investigating astegolimab compared to placebo in COPD patients
Basel: Roche has announced topline results from the pivotal phase IIb ALIENTO (n=1,301) and the phase III ARNASA (n=1,375) trials investigating astegolimab compared to placebo, on top of standard of care maintenance therapy in people with moderate to very severe chronic obstructive pulmonary disease (COPD).
The studies included a broad population: both former and current smokers, regardless of blood eosinophil count, who have a history of frequent exacerbations.
The pivotal phase IIb ALIENTO study met its primary endpoint and showed that astegolimab reduced the annualised exacerbation rate (AER) by a statistically significant 15.4% at 52 weeks, when given every two weeks. However, the phase III ARNASA study did not meet its primary endpoint of a statistically significant reduction in the AER, demonstrating a numerical 14.5% reduction, at 52 weeks when astegolimab was given every two weeks. The results were generally consistent across secondary endpoints in both studies. The total number of exacerbations was lower than prospectively anticipated in both trials. The safety profile of astegolimab was consistent with previously reported data, with no new safety signals identified.
"While COPD remains the third leading cause of death worldwide, patients and families have limited treatment options for managing this debilitating and complex disease," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "This was the first set of studies in an ‘all-comers’ COPD population, and we will discuss these data with regulatory authorities to evaluate next steps for astegolimab.”
Detailed results from ALIENTO and ARNASA will be shared at an upcoming medical meeting.
