Roche Reports Mixed COPD Trial Results For Astegolimab: Phase IIb ALIENTO Positive, Phase III ARNASA Falls Short

Roche today announced topline results from two large-scale trials investigating astegolimab, a novel IL-33 inhibitor, in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The Phase IIb ALIENTO (n=1,301) and Phase III ARNASA (n=1,375) trials evaluated astegolimab versus placebo as an add-on to standard maintenance therapy in a broad COPD population, including current and former smokers regardless of eosinophil levels. The ALIENTO study met its primary endpoint, showing a statistically significant 15.4% reduction in the annualised exacerbation rate (AER) at 52 weeks with astegolimab given every two weeks. 

"While COPD remains the third leading cause of death worldwide, patients and families have limited treatment options for managing this debilitating and complex disease. 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," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. 

However, in contrast, the ARNASA trial failed in achieving its primary endpoint with a 14.5% reduction in AER that had failed to meet statistical significance. The number of total exacerbations in both studies was lower than anticipated, and that could have affected the statistical power of the ARNASA trial. Although the efficacy findings were mixed, there was no new safety concern to the previously reported profile of astegolimab.