Genentech Updates on Astegolimab for COPD

07/21/2025 – 01:05 AM

– The pivotal Phase IIb ALIENTO study met the primary endpoint of a statistically significant reduction in the annualized exacerbation rate (AER) at 52 weeks when astegolimab was given every two weeks –

– The Phase III ARNASA study did not meet the primary endpoint of a statistically significant reduction in the AER at 52 weeks –

– The safety profile of astegolimab was consistent with previously reported data, with no new safety signals identified –

– Analysis of the ALIENTO and ARNASA data will be discussed with regulatory authorities and shared at an upcoming medical meeting –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today released topline results from its Phase IIb ALIENTO (n=1,301) and Phase III ARNASA (n=1,375) trials. The studies investigated astegolimab, compared to a placebo, in conjunction with standard of care maintenance therapy for individuals battling moderate to very severe chronic obstructive pulmonary disease (COPD). The trial participants represented a diverse COPD group, including both former and current smokers with varying blood eosinophil counts, all with histories of frequent exacerbations.

The ALIENTO study achieved its primary endpoint, demonstrating that astegolimab, administered every two weeks, resulted in a statistically significant 15.4% reduction in the annualized exacerbation rate (AER) over a 52-week period. However, the ARNASA study, while showing a numerical reduction of 14.5% in AER with the same bi-weekly astegolimab administration, did not reach statistical significance for its primary endpoint. Secondary endpoints in both studies generally aligned with these findings. Notably, both trials registered fewer exacerbations than initially projected. A positive note: the safety profile of astegolimab remained consistent with previous data, with no new safety concerns emerging.

“COPD tragically remains the third leading cause of death globally, placing a massive burden on patients and families. Current treatment options are limited in managing this complex and debilitating disease,” commented Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development at Genentech. “These trials marked the first comprehensive studies encompassing an ‘all-comers’ COPD population. We intend to engage with regulatory bodies to thoroughly evaluate this data and determine the appropriate next steps for astegolimab.”

Genentech plans to present detailed findings from the ALIENTO and ARNASA studies at an upcoming medical conference.

About the ALIENTO and ARNASA studies

Astegolimab represents a novel investigational approach: a fully human anti-ST2 monoclonal antibody. Its design enables it to bind with high affinity to the ST2 receptor, effectively blocking the signaling pathway of IL-33. Genentech’s COPD pivotal program for astegolimab centers around the Phase IIb ALIENTO (NCT05037929) and Phase III ARNASA (NCT05595642) studies, both designed as double-blinded, placebo-controlled, multi-center trials. These studies assess the efficacy and safety of astegolimab when administered either every two or every four weeks, on top of standard of care maintenance therapy, in COPD patients. Crucially, these patients included former and current smokers, irrespective of blood eosinophil count, all with a history of frequent exacerbations. The primary analysis focuses on the initial phase of the studies, involving 1,301 patients in ALIENTO and 1,375 in ARNASA. The primary endpoint is the reduction in the annualized rate of moderate and severe COPD exacerbations (AER) over the 52-week treatment period. AER is calculated as the total number of exacerbations (a sudden worsening of airway function and respiratory symptoms) during the relevant period, divided by the total number of patient years. Standard of care maintenance therapy included inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); long-acting muscarinic antagonist (LAMA) plus LABA; or ICS plus LAMA plus LABA.

About Genentech

For over four decades, Genentech has stood as a leading biotechnology innovator, dedicated to discovering, developing, manufacturing, and commercializing transformative medicines for patients facing serious and life-threatening conditions. As a member of the Roche Group, Genentech is headquartered in South San Francisco, California. For more about Genentech, visit http://www.gene.com.

Genentech Updates on Astegolimab for COPD