astegolimab (RG6149) / Amgen, Roche - LARVOL DELTA

Updates in COPD Management: From Inflammatory Pathways to Targeted Therapies. (PubMed, Eur J Clin Invest) - "COPD management is evolving toward precision medicine, guided by inflammatory phenotypes, biomarkers, and individualised risk profiles. Continued investigation into targeted biologics, anti-inflammatory agents, and incorporating biomarkers into clinical practice may improve outcomes and reduce disease burden."

Biomarker • Journal • Review • Cardiovascular • Chronic Obstructive Pulmonary Disease • Cognitive Disorders • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL33

Tozorakimab restores epithelial dysfunction in COPD (ERS 2026) - "Tozorakimab is a human therapeutic mAb with a dual pharmacological profile that can inhibit both IL-33 activities with demonstrated ability to reverse epithelial dysfunction in COPD. Tozorakimab is under clinical investigation in COPD. Table."

Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • EGFR • IL33 • IL5 • MUC5AC

Efficacy of Biologics in Patients with Moderate to Very Severe COPD: A Systematic Review. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Sixteen publications were included, covering 12 studies of seven biologics (astegolimab, benralizumab, dupilumab, itepekimab, mepolizumab, tezepelumab and tozorakimab). Improvements in SGRQ total score were observed in patients with BEC ≥300 cells/µL (dupilumab and tezepelumab) and astegolimab improved SGRQ-C total score in patients with BEC >170 cells/µL. Overall, AECOPD reductions and improvements in lung function and health-related quality of life in patients with moderate to very severe COPD varied by biologic and baseline BEC subgroup; within studies, efficacy was generally greater in patients with an elevated baseline BEC, suggesting these patients may benefit most from biologic treatment."

Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Astegolimab reduces sedentary time in patients with COPD: post-hoc analyses from the ALIENTO wearable device–derived physical activity substudy (ERS 2026) - "These results suggest astegolimab may reduce daily sedentary time in patients with COPD. Due to the small sample size, results should be interpreted with caution but may be clinically meaningful in the context of the primary ALIENTO results."

Clinical • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Exploratory eosinophil biomarker analysis from the Phase IIb ALIENTO and Phase III ARNASA trials of astegolimab in COPD (ERS 2026) - P2, P3 | "STEPP and subgroup analyses of AERR indicated that astegolimab reduced the COPD annualised exacerbation rate regardless of baseline eosinophil count for both astegolimab Q2W and Q4W. These data highlight the efficacy of astegolimab across a range of baseline eosinophil counts."

Biomarker • P2b data • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

The efficacy of astegolimab on healthcare resource utilisation- (HCRU) and EXAcerbation of Chronic Pulmonary Disease Tool- (EXACT) defined COPD exacerbations (ERS 2026) - P2 | "A trend was observed for greater astegolimab Q2W efficacy with increased exacerbation severity, which was consistent across both HCRU-based and patient-reported symptom exacerbation definitions."

Clinical • HEOR • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

The efficacy of astegolimab on COPD hospitalisations: Data from the Phase IIb ALIENTO and Phase III ARNASA trials (ERS 2026) - "These analyses suggest a clinically meaningful impact of astegolimab on COPD exacerbation-related hospitalisations."

Clinical • P2b data • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P3 | N=2000 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2034 ➔ Jun 2027 | Trial primary completion date: Jul 2034 ➔ Jun 2027

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

ARNASA: A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P3 | N=1290 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Astegolimab in COPD: success or failure? (PubMed, Am J Respir Crit Care Med) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Epithelial alarmins TSLP, IL-33, and IL-25 in asthma pathogenesis: mechanistic roles and therapeutic implications. (PubMed, Mol Biol Rep) - "Epithelial alarmins represent critical upstream drivers of asthma pathogenesis, orchestrating diverse inflammatory pathways that determine disease endotypes and severity. Therapeutic targeting of TSLP, IL-33, and IL-25 offers a paradigm shift from downstream cytokine inhibition to source-directed intervention, with potential to reduce exacerbations, prevent airway remodelling, and improve disease control across different asthma phenotypes. The success of anti-TSLP therapy and ongoing clinical development of IL-33 and IL-25 inhibitors validate epithelial alarmins as essential molecular targets for precision medicine approaches in severe and refractory asthma."

Journal • Review • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CRLF2 • IL17A • IL17RA • IL17RB • IL1RAP • IL33 • TSLP

ARNASA: A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P3 | N=1290 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Safety and efficacy of astegolimab for COPD with frequent exacerbations regardless of baseline blood eosinophil counts (ALIENTO and ARNASA): randomised, double-blind, placebo-controlled, phase 2b and 3 trials. (PubMed, Lancet) - P2, P3 | "In ALIENTO, astegolimab every 2 weeks was associated with a lower annual rate of exacerbations versus placebo in patients with COPD and a history of frequent exacerbations. In ARNASA, these findings did not meet statistical significance. Together, these findings suggest a role for targeting the ST2/IL-33 pathway to reduce the frequency of COPD exacerbations in patients with limited treatment options."

Journal • P2b data • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Inflammation • Pulmonary Disease • Respiratory Diseases • IL33

Astegolimab and the new era of biologics in COPD care. (PubMed, Lancet) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Astegolimab for COPD With Frequent Exacerbations: Pooled Analysis of the ALIENTO and ARNASA Trials. (PubMed, Am J Respir Crit Care Med) - P2, P3 | "Astegolimab every 2 weeks reduced the annualized rate of moderate/severe exacerbations in a clinically heterogeneous population of participants with COPD and frequent exacerbations."

Clinical • Journal • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P3 | N=2000 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jun 2027 ➔ Jul 2034 | Trial primary completion date: Jun 2027 ➔ Jul 2034

Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Astegolimab Decreases Exacerbation Risk in Patients With COPD With Frequent Exacerbations, Irrespective of Blood Eosinophil Count: Pooled Analysis of the Pivotal Randomized Trials ALIENTO and ARNASA (ATS 2026) - No abstract available

Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Astegolimab for Chronic Obstructive Pulmonary Disease (COPD) in Patients With a History of Frequent Exacerbations: The Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter ARNASA Trial (ATS 2026) - No abstract available

Clinical • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Astegolimab Improves HRQoL in Patients With COPD: Evaluating SGRQ-C Response in ALIENTO and ARNASA (ATS 2026) - No abstract available

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Serum Soluble ST2 and Blood Eosinophils Are Pharmacodynamic Biomarkers of Astegolimab Treatment in COPD (ATS 2026) - No abstract available

Biomarker • PK/PD data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Biologics in COPD: Current Status and Future Prospects. (PubMed, Tuberc Respir Dis (Seoul)) - "Subsequent Phase 3 trials have demonstrated substantial clinical benefits in defined patient subsets: dupilumab, which blocks interleukin (IL)-4 and IL-13 signaling, and mepolizumab, which targets IL-5, consistently reduced exacerbation frequency among patients with high blood eosinophil counts (≥300 cells/μL). In contrast, other biologics-benralizumab, tezepelumab, and IL-33/ST2 pathway inhibitors such as itepekimab, tozorakimab, and astegolimab-have shown variable efficacy, often dependent on biomarker profiles and patient characteristics. Together, these findings underscore the importance of precise patient stratification based on inflammatory endotypes. While biologics represent a major step forward for selected COPD populations, further research is required to clarify long-term outcomes, refine biomarker thresholds, and expand treatment options for non-eosinophilic COPD."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL33 • IL5

ARNASA: A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P3 | N=1290 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Mar 2027 ➔ Sep 2027

Trial completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

YAP Regulates Microglial Anti-Inflammatory Responses and Alleviates Cognitive Impairment Through the IL-33/ST2 Pathway after Traumatic Brain Injury. (PubMed, J Neurotrauma) - "These beneficial effects were effectively reversed by the administration of astegolimab, confirming the specificity of the YAP/IL-33/ST2 mechanism. Above all, we found that YAP produced by astrocytes regulates microglial anti-inflammatory responses through the IL-33/ST2 pathway, thereby improving cognitive function after TBI."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Inflammation • Vascular Neurology • IL33 • MRC1

Randomised, placebo-controlled trial of astegolimab for COPD with frequent exacerbations: ALIENTO (BTS WM 2025) - P2 | "Adverse events were balanced between treatment arms. Download figure Open in new tab Download powerpoint Abstract S1 Figure 1 Conclusions Astegolimab Q2W decreased annualised COPD exacerbation rate by 15% ( P =0.0494) vs placebo in the overall ALIENTO population (irrespective of smoking status or EOS level), with trends for improvement in some other clinical outcomes."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Safety and tolerability of astegolimab, an anti-ST2 monoclonal antibody: a narrative review. (PubMed, Respir Res) - "Astegolimab did not increase the risk of infection or major adverse cardiac events. Ongoing Phase IIb and Phase III trials of astegolimab in patients with COPD who have a history of frequent acute exacerbation(s) of COPD will provide a future opportunity to confirm the safety profile of astegolimab."

Journal • Review • Asthma • Atopic Dermatitis • Cardiovascular • Chronic Obstructive Pulmonary Disease • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • IL33