Roche announces ALIENTO trial meets, ARNASA study misses primary endpoint

Genentech, a member of the Roche (RHHBY), announced topline results from the pivotal Phase IIb ALIENTO and the Phase III ARNASA 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. 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 annualized exacerbation rate 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. Detailed results from ALIENTO and ARNASA will be shared at an upcoming medical meeting.