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[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on astegolimab in chronic obstructive pulmonary disease
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
Basel, 21 July 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today topline results from the pivotal phase IIb ALIENTO (n=1,301) and the phase III ARNASA (n=1,375) 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 (COPD). 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 annualised exacerbation rate (AER) 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.
'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.'
Detailed results from ALIENTO and ARNASA will be shared at an upcoming medical meeting.
About the ALIENTO and ARNASA studies1,2
Astegolimab is an investigational, fully human anti-ST2 monoclonal antibody designed to bind with high affinity to the ST2 receptor, thereby blocking the signalling of IL-33.3 The astegolimab COPD pivotal programme consists of two registrational studies, the phase IIb ALIENTO (NCT05037929) and phase III ARNASA (NCT05595642) studies. Both ALIENTO and ARNASA are double-blinded, placebo-controlled, multicentre studies that evaluate the efficacy and safety of astegolimab administered every two or every four weeks in patients with COPD on top of standard of care maintenance therapy. Patients in the studies included former and current smokers, regardless of blood eosinophil count, who have a history of frequent exacerbations. The primary analysis is based on the initial phase of the study, which consisted of 1,301 patients for ALIENTO and 1,375 patients for ARNASA. The primary endpoint is the reduction in the annualised rate of moderate and severe COPD exacerbations (AER) over the 52-week treatment period. AER is the total number of exacerbations (a sudden worsening in airway function and respiratory symptoms) occurring over the relevant treatment period, divided by the total number of patient years. Standard of care maintenance therapy for both studies was one of the following combinations – inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References[1] A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (ARNASA). [Internet; cited March 2025]. Available from: https://clinicaltrials.gov/study/NCT05595642. [2] A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease. [Internet; cited March 2025]. Available from: https://clinicaltrials.gov/study/NCT05037929.
[3] Kelsen SG, Agache O, Soong W, Israel E, Chupp GL, Cheung DS, et al. Astegolimab (anti-ST2) efficacy and safety in adults with severe asthma: A randomized clinical trial. Journal of Allergy and Clinical Immunology. 2021 Sep;148(3):790–8.
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About the Archway study and its open-label extension study (Portal)1,2Archway (NCT03677934) was a randomised, multicentre, open-label phase III study evaluating the efficacy and safety of Susvimo refilled every six months at fixed intervals, compared to monthly IVT ranibizumab 0.5 mg in 415 people living with nAMD. Patients were randomized 3:2 to Susvimo (n = 248) or IVT ranibizumab injections (n = 167). Patients enrolled in Archway were responders to prior treatment with anti-VEGF therapy. In both study arms, patients were treated with at least three anti-VEGF injections within the six months prior to their Archway screening visit, with an average of five anti-VEGF injections before randomization. The primary endpoint of the study was the change in BCVA score from baseline at the average of Week 36 and Week 40. Secondary endpoints include safety, overall change in vision (BCVA) from baseline and change from baseline in centre point thickness over time. 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About neovascular age-related macular degenerationAge-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading.3 Neovascular or 'wet' AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.4,5 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.5 Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.3,6,7 About Susvimo® (Port Delivery System with ranibizumab)Approved in the United States by the Food and Drug Administration (FDA) for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR), Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure.8,9 Susvimo continuously delivers a customised formulation of ranibizumab over time.8,9 Ranibizumab is a VEGF inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.8-10The customised formulation of ranibizumab delivered by Susvimo is different from the ranibizumab IVT injection, a medicine marketed as Lucentis® (ranibizumab injection)*, which is approved to treat nAMD and other retinal diseases.11 About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. *Lucentis® (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. References[1] Kitchens J, et al. Five Year Outcomes in nAMD Patients Enrolled in the Archway Study and Treated With the PDS. Presented at: The American Society of Retina Specialists (ASRS) 2025 Annual Meeting; 2025 August 01; Long Beach, California, United States.[2] Regillo C, et al. Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results. Ophthalmology. 2023;130(7):735-747.[3] Bright Focus Foundation. Age-related macular degeneration (AMD): facts & figures. [Internet; cited July 2025]. Available from: [4] Pennington KL, et al. Epidemiology of AMD: associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.[5] Little K, et al. Myofibroblasts in macular fibrosis secondary to nAMD - the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.[6] Connolly E, et al. Prevalence of AMD associated genetic risk factors and four-year progression data in the Irish population. British Journal of Ophthalmology. 2018 Feb;102:1691-95.[7] Wong WL, et al. Global prevalence of AMD and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health. 2014 Feb;2:106-16.[8] US Food and Drug Administration (FDA). Highlights of prescribing information, Susvimo. 2021. [Internet; cited July 2025]. Available from: [9] Holekamp N, et al. Archway randomised phase III trial of the PDS with ranibizumab for neovascular age-related macular degeneration (nAMD). Ophthalmology. 2021.[10] Heier JS, et al. The angiopoietin/tie pathway in retinal vascular diseases: A review. The Journal of Retinal and Vitreous Diseases. 2021;41:1-19.[11] US FDA. Highlights of prescribing information, Lucentis. 2012. [Internet; cited April 2025]. Available from: [12] US FDA. Highlights of prescribing information, Vabysmo. 2024. [Internet; cited April 2025]. Available from: [13] European Medicines Agency. Summary of product characteristics, Vabysmo. [Internet; cited April 2025]. Available from: Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: Attachment Media Investor Release Susvimo Archway study english
