[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on astegolimab in chronic obstructive pulmonary disease
Roche (OTCQX:RHHBY) has announced mixed results from two clinical trials evaluating astegolimab for chronic obstructive pulmonary disease (COPD). The pivotal phase IIb ALIENTO study (n=1,301) met its primary endpoint, showing a 15.4% reduction in annualized exacerbation rate (AER) at 52 weeks. However, the phase III ARNASA study (n=1,375) missed its primary endpoint, showing only a numerical 14.5% reduction in AER.
Both trials tested astegolimab against placebo on top of standard care in moderate to very severe COPD patients, including both current and former smokers. While the safety profile remained consistent with previous data, the total number of exacerbations was lower than anticipated in both trials. Roche plans to discuss these results with regulatory authorities to determine next steps.
Roche (OTCQX:RHHBY) ha annunciato risultati contrastanti da due studi clinici che valutano astegolimab per la broncopneumopatia cronica ostruttiva (BPCO). Lo studio pivotale di fase IIb ALIENTO (n=1.301) ha raggiunto l'endpoint primario, mostrando una riduzione del 15,4% nel tasso annualizzato di esacerbazioni (AER) a 52 settimane. Tuttavia, lo studio di fase III ARNASA (n=1.375) non ha raggiunto l'endpoint primario, evidenziando solo una riduzione numerica del 14,5% nell'AER.
Entrambi gli studi hanno confrontato astegolimab con placebo, aggiunto alla terapia standard, in pazienti con BPCO da moderata a molto grave, includendo sia fumatori attivi che ex fumatori. Il profilo di sicurezza 猫 rimasto coerente con i dati precedenti, ma il numero totale di esacerbazioni 猫 stato inferiore alle aspettative in entrambi gli studi. Roche intende discutere questi risultati con le autorit脿 regolatorie per definire i prossimi passi.
Roche (OTCQX:RHHBY) ha anunciado resultados mixtos de dos ensayos cl铆nicos que evaluaron astegolimab para la enfermedad pulmonar obstructiva cr贸nica (EPOC). El estudio pivotal de fase IIb ALIENTO (n=1,301) cumpli贸 con su objetivo principal, mostrando una reducci贸n del 15,4% en la tasa anualizada de exacerbaciones (AER) a las 52 semanas. Sin embargo, el estudio de fase III ARNASA (n=1,375) no alcanz贸 su objetivo principal, mostrando solo una reducci贸n num茅rica del 14,5% en la AER.
Ambos ensayos compararon astegolimab con placebo adem谩s del tratamiento est谩ndar en pacientes con EPOC de moderada a muy grave, incluyendo fumadores actuales y exfumadores. El perfil de seguridad se mantuvo consistente con datos previos, pero el n煤mero total de exacerbaciones fue menor de lo esperado en ambos estudios. Roche planea discutir estos resultados con las autoridades regulatorias para determinar los pr贸ximos pasos.
搿滌妶 (OTCQX:RHHBY)電� 毵岇劚 韽愳噭靹� 韽愳頇�(COPD)鞐� 雽�頃� 鞎勳姢韰岅敞毽鞚� 霊� 鞛勳儊鞁滍棙 瓴瓣臣臧� 鞐囮皥霠鸽嫟瓿� 氚滍憸頄堨姷雼堧嫟. 欷戩殧頃� 2b靸� ALIENTO 鞐瓣惮 (n=1,301)電� 52欤缄皠 鞐瓣皠 鞎呿檾鞙�(AER)鞚� 15.4% 臧愳唽鞁滍偆電� 1彀� 韽夑皜氤�靾橂ゼ 於╈”頄堨姷雼堧嫟. 攴鸽煬雮� 3靸� ARNASA 鞐瓣惮 (n=1,375)電� 1彀� 韽夑皜氤�靾橂ゼ 雼劚頃橃 氇豁晿瓿�, AER鞐愳劀 14.5% 臧愳唽 靾橃箻毵� 氤挫榾鞀惦媹雼�.
霊� 鞐瓣惮 氇憪 欷戨摫霃勳棎靹� 毵れ毎 欷戩 COPD 頇橃瀽(順勳灛 氚� 鞚挫爠 頋§棸鞛� 韽暔)毳� 雽�靸侅溂搿� 響滌 旃橂鞐� 鞎勳姢韰岅敞毽 霕愲姅 鞙勳暯鞚� 於旉皜頃� 牍勱祼頄堨姷雼堧嫟. 鞎堨爠靹� 頂勲韺岇澕鞚� 鞚挫爠 雿办澊韯办檧 鞚检箻頄堨溂雮�, 霊� 鞐瓣惮 氇憪 旮半寑氤措嫟 鞎呿檾 須熿垬臧� 鞝侅棃鞀惦媹雼�. 搿滌妶電� 攴滌牅 雼龟淡瓿� 鞚� 瓴瓣臣毳� 雲检潣頃橃棳 頄ロ泟 瓿勴殟鞚� 瓴办爼頃� 鞓堨爼鞛呺媹雼�.
Roche (OTCQX:RHHBY) a annonc茅 des r茅sultats mitig茅s issus de deux essais cliniques 茅valuant l'astegolimab pour la maladie pulmonaire obstructive chronique (MPOC). L'茅tude pivot de phase IIb ALIENTO (n=1 301) a atteint son crit猫re principal, montrant une r茅duction de 15,4% du taux annualis茅 d'exacerbations (AER) 脿 52 semaines. Cependant, l'茅tude de phase III ARNASA (n=1 375) n'a pas atteint son crit猫re principal, ne montrant qu'une r茅duction num茅rique de 14,5% de l'AER.
Les deux essais ont compar茅 l'astegolimab au placebo en compl茅ment des soins standards chez des patients atteints de MPOC mod茅r茅e 脿 tr猫s s茅v猫re, incluant des fumeurs actuels et anciens. Le profil de s茅curit茅 est rest茅 conforme aux donn茅es pr茅c茅dentes, mais le nombre total d'exacerbations a 茅t茅 inf茅rieur aux attentes dans les deux 茅tudes. Roche pr茅voit de discuter de ces r茅sultats avec les autorit茅s r茅glementaires afin de d茅terminer les prochaines 茅tapes.
Roche (OTCQX:RHHBY) hat gemischte Ergebnisse aus zwei klinischen Studien zur Bewertung von Astegolimab bei chronisch obstruktiver Lungenerkrankung (COPD) bekannt gegeben. Die entscheidende Phase-IIb-Studie ALIENTO (n=1.301) erreichte den prim盲ren Endpunkt und zeigte eine 15,4%ige Reduktion der annualisierten Exazerbationsrate (AER) nach 52 Wochen. Die Phase-III-Studie ARNASA (n=1.375) verfehlte jedoch den prim盲ren Endpunkt und zeigte nur eine numerische 14,5%ige Reduktion der AER.
Beide Studien testeten Astegolimab gegen Placebo zus盲tzlich zur Standardbehandlung bei Patienten mit mittelschwerer bis sehr schwerer COPD, darunter sowohl aktuelle als auch ehemalige Raucher. Das Sicherheitsprofil blieb konsistent mit fr眉heren Daten, jedoch war die Gesamtzahl der Exazerbationen in beiden Studien niedriger als erwartet. Roche plant, diese Ergebnisse mit den Zulassungsbeh枚rden zu besprechen, um die n盲chsten Schritte festzulegen.
- Phase IIb ALIENTO trial met primary endpoint with 15.4% reduction in exacerbation rate
- Safety profile remained consistent with no new safety signals
- Results were consistent across secondary endpoints in both studies
- Phase III ARNASA trial failed to meet primary endpoint
- Total number of exacerbations was lower than anticipated in both trials
- Mixed results may impact regulatory pathway for astegolimab in COPD
- The pivotal phase IIb ALIENTO study met the primary endpoint of a statistically significant reduction in the annualised 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
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
"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鈥檚 Chief Medical Officer and Head of Global Product Development. "This was the first set of studies in an 鈥榓ll-comers鈥� COPD population, and we will discuss these data with regulatory authorities to evaluate next steps for astegolimab.鈥�
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.听 Standard of care maintenance therapy for both studies was one of the following combinations 鈥� 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鈥檚 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.
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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鈥�8.
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