Astegolimab Fails to Meet Primary Endpoint in COPD Trials, Despite Numerical Reduction in Exacerbations.

Genentech announced topline results from two pivotal trials investigating astegolimab in chronic obstructive pulmonary disease (COPD). The Phase IIb ALIENTO study met its primary endpoint, reducing exacerbation rates by 15.4%, while the Phase III ARNASA study did not meet its primary endpoint, with a numerical reduction of 14.5%. The results were generally consistent across secondary endpoints in both studies, with a consistent safety profile. The company will discuss the data with regulatory authorities to evaluate next steps for astegolimab.

Basel, July 2, 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced topline results from two pivotal trials investigating astegolimab, an investigational anti-ST2 monoclonal antibody, in chronic obstructive pulmonary disease (COPD). The Phase IIb ALIENTO study met its primary endpoint, reducing exacerbation rates by 15.4%, while the Phase III ARNASA study did not meet its primary endpoint, showing a numerical reduction of 14.5%.

The ALIENTO study, which included 1,301 patients, demonstrated a statistically significant reduction in the annualized exacerbation rate (AER) over 52 weeks when astegolimab was administered every two weeks. In contrast, the ARNASA study, which enrolled 1,375 patients, showed a numerical reduction of 14.5% in AER over the same period. Both studies included a broad population of former and current smokers, regardless of blood eosinophil count, who had a history of frequent exacerbations.

The safety profile of astegolimab was consistent with previously reported data, with no new safety signals identified. The total number of exacerbations was lower than prospectively anticipated in both trials. Detailed results from ALIENTO and ARNASA will be shared at an upcoming medical meeting.

"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."

Roche is committed to transforming healthcare and has a long history of developing innovative medicines and diagnostics. The company is also dedicated to sustainability and is part of the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

References:
[1] https://www.stocktitan.net/news/RHHBY/ad-hoc-announcement-pursuant-to-art-53-lr-roche-provides-update-on-7ac9l5xkw9zv.html
[2] https://finance.yahoo.com/news/ad-hoc-announcement-pursuant-art-050000426.html