Roche’s IgG2 monoclonal antibody (mAb) astegolimab has yielded mixed results in chronic obstructive pulmonary disease (COPD), succeeding in a Phase IIb trial but failing in a Phase III study.
The Swiss biotech reported that the drug met its primary endpoint – a significant reduction in the annualised exacerbation rate (AER) at 52 weeks – in the Phase IIb ALIENTO study (NCT05037929). However, the same primary endpoint was not achieved in the Phase III ARNASA (NCT05595642) trial.
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The randomised studies evaluated the drug versus placebo on top of standard of care (SoC) therapy in patients with severe COPD, including patients who are both former and current smokers, of any blood eosinophil count, and who have a history of frequent exacerbations. SoC included inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); long-acting muscarinic antagonist (LAMA) plus LABA; or ICS plus LAMA plus LABA.
In the Phase IIb ALIENTO study, AER was reduced by a statistically significant 15.4% at 52 weeks, when given every two weeks. In the ARNASA study, statistical significance was not met, with a 14.5% reduction, also on a two-weekly dosing schedule.
Roche added that the total number of exacerbations was lower than anticipated, and secondary endpoints were generally consistent in both studies. The safety profile of astegolimab remained consistent with previous trials, with no new safety signals identified.
Roche’s chief medical officer Dr Levi Garraway, said: “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.”
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By GlobalDataAstegolimab is an investigational, fully human anti-ST2 monoclonal antibody that binds with high affinity to the ST2 receptor to block interleukin (IL)-33 signalling. Roche licensed the drug from Amgen in 2016.
COPD mAb race heats up
The biologics race is intensifying in COPD, with a number of therapies having been recently approved or showing promise in late-stage studies.
In October 2024, the US Food and Drug Administration (FDA) approved the first mAb for the treatment of COPD – Regeneron and Sanofi’s Dupixent (dupilumab). It has also received approval in the UK and Europe. The therapy acts similarly to astegolimab, but instead blocks signalling of IL-4 and IL-13.
GSK’s Nucala (mepolizumab) has also recently been approved by the FDA, in May 2025, after it met the primary endpoint in a Phase III trial in COPD in September 2024. Nucala is an IL-5/IL-5Rα targeting antibody.
Regeneron and Sanofi’s therapy, as well as GSK’s therapy, have previous approvals in asthma before the companies decided to investigate their efficacy in COPD.
Roche is the outlier to this, however, with astegolimab currently more advanced in COPD trials than in asthma.
AstraZeneca’s drug, tozorakimab, also blocks IL-33 and failed to meet the primary endpoint in a Phase II study in COPD in September 2024.
GlobalData predicts the COPD market across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan) will grow from $11.6bn in 2023 to $30.2bn in 2033, driven in part by the entry of biologics into the treatment landscape.
GlobalData is the parent company of Clinical Trials Arena.
