EROS real-world outcomes data show prompt initiation of Breztri is associated
with a reduced risk of future exacerbations in people living with COPD1
EXACOS-CV US data highlights increased risk of severe cardiovascular events
following an acute COPD exacerbation2
Results from the EROS real-world retrospective study showed that initiating fixed-dose triple-combination therapy Breztri Aerosphere(budesonide/glycopyrronium/formoterol fumarate) within 30 days of a qualifying moderate or severe exacerbation in patients with COPD (chronic obstructive pulmonary disease) is associated with a decreased risk of future exacerbations by 24% vs. delaying treatment by one to six months, and by 34% vs. delaying treatment six months to one year.1
The EROS study is the first real-world evidence analysis of Breztri in more than 2,400 patients with COPD from a claims database registry, and was presented today as a late-breaking abstract at the ATS 2023 International Conference in Washington, DC, hosted by the American Thoracic Society. AstraZeneca's presence at ATS 2023 also includes new data from Tezspire and Fasenra.
Professor Charlie Strange, MD, Medical University of South Carolina, US and investigator in the EROS study, said: "A key treatment goal in COPD is to avoid exacerbations that may lead to increased risk of future exacerbations, possible hospitalisation or even death. The EROS real-world data build on the body of clinical evidence that Breztri is effective in reducing COPD exacerbation rates and can significantly reduce the risk of future exacerbations if used as soon as a patient’s COPD symptoms worsen.”
Another late-breaking presentation at ATS 2023, the EXACOS-CV US retrospective cohort study using the HealthCore Integrated Research Database of people with COPD showed the risk of an acute severe cardiovascular (CV) event (including stroke, heart failure, pulmonary embolism, arrhythmia, or heart attack) increased by 32% in the first 30 days following a single acute moderate or severe COPD exacerbation, compared to those without a prior COPD exacerbation. According to the results, the risk of CV events was highest in the first 90 days following the COPD exacerbation, the risk remained elevated for one year, and each subsequent COPD exacerbation was associated with an even higher risk of acute CV events (>2 times increased CV risk following two or three COPD exacerbations).2 These results suggest that patients with COPD should be considered at risk of cardiopulmonary events following an acute exacerbation, even those who are newly-diagnosed.
Robert Fogel, Vice President, Global Medical Affairs, Respiratory & Immunology, AstraZeneca, said: “As the third leading cause of death worldwide,3 improving outcomes for patients must be an urgent priority for physicians and healthcare systems. The EROS and EXACOS-CV studies increase our understanding of the significant cardiopulmonary risk COPD patients face as well as the opportunity to reduce COPD exacerbations through more proactive treatment with Breztri.”
AstraZeneca Respiratory & Immunology pipeline and portfolio highlighted in more than 50 abstracts at ATS 2023
Key additional data from AstraZeneca at ATS include:
- Two post hoc analyses from the NAVIGATOR Phase III trial demonstrating efficacy of Tezspire in patients with severe, uncontrolled asthma irrespective of prior omalizumab use; and in improvingrhinosinusitis symptoms measured with SNOT-22 in patients who also have a history of comorbid nasal polyps.4,5
- Real-world evidence from the retrospective RANS trial supporting the strong clinical efficacy of Fasenra specifically in patients with severe eosinophilic asthma and nasal polyps; and a post-hoc analysis of five Fasenra Phase III/IIIb trials showing an increased rate of achieving clinical remission in patients with severe eosinophilic asthma and concomitant nasal polyps.6,7
Notes
COPD
COPD refers to a group of lung diseases, including chronic bronchitis and emphysema, that cause airflow blockage and breathing-related problems.8It affects an estimated 391 million people around the world and is the third leading cause of death globally.3,9
EROS
The EROS (Exacerbations and Real-World Outcomes) study is a retrospective analysis of real-world outcomes in 2,409 COPD patients appearing in the MORE2Registry®claims database in the US to examine whether prompt initiation ofBreztrifollowing an exacerbation lowers risk of future exacerbations compared to delayed and very delayed initiation.1In the study, qualifying exacerbations included: one moderate exacerbation while on maintenance treatment, the second of two moderate events without any maintenance treatment, and severe events defined as COPD hospitalisations.
EXACOS-CV US
EXACOS-CV US (EXACerbations and their OutcomeS – CardioVascular)is a retrospective cohort study of 355,978 patients 40 years and older who were diagnosed with COPD between 1 January 2012 and 31 December 2019. The study used US administrative claims data from the Healthcare Integrated Research Database, managed by Carelon Research (formerly HealthCore), to investigate a correlation between cardiovascular events and moderate-to-severe COPD exacerbations.2
Breztri Aerosphere
Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate) is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a LABA, glycopyrronium bromide, a LAMA, with budesonide, an ICS, and delivered in a pressurised metered-dose inhaler.Breztri Aerosphereis approved to treat COPD in more than 50 countries worldwide including the US, EU, China and Japan, and is currently being studied in Phase III trials for asthma.
Tezspire
Tezspire(tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.10,11Tezspireis approved in the US, EU, Japan and other countries for the treatment of severe asthma.12-14
NAVIGATOR
NAVIGATOR is a Phase III, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy and safety ofTezspire(210mg every four weeks) compared to placebo added to SoC in adults and adolescents with severe, uncontrolled asthma.15Two post hoc analyses from the NAVIGATOR trial evaluated the effect ofTezspireon the annualized asthma exacerbation rate (AAER) over 52 weeks with and without prior omalizumab, and changes in total and domain SNOT-22 scores from baseline to week 52 in patients with a history of nasal polyps.4,5
Amgen collaboration
In 2020, Amgen and AstraZeneca updated a2012 collaboration agreementforTezspire. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement, Amgen and AstraZeneca will jointly commercialiseTezspirein North America. Amgen will record product sales in the US, with AZ recording its share of US profits as Collaboration Revenue. Outside of the US, AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue.
Fasenra
Fasenra(benralizumab) is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).16Fasenrais currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries,and is approved for self-administration in the US,EUand other countries.
Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd., Japan.
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals is a key disease area and growth driver to the Company.
AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visitastrazeneca.comand follow the Company on Twitter@AstraZeneca.
Contacts
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References
1. Pollack, M, Tkacz, J, Schinkel, J. et al. Exacerbations and real-world outcomes (EROS) among patients with COPD receiving single inhaler triple therapy of budesonide/glycopyrrolate/formoterol fumarate [Poster Discussion]. Presented at the American Thoracic Society International Conference 2023 (19-24 May)
2. Daniels, K, Tave, A., Neikirk, A., et al. Incidence of acute cardiovascular events following acute exacerbation of chronic obstructive pulmonary disease in a large US claims database [Thematic Poster Session]. Presented at the American Thoracic Society International Conference 2023 (19-24 May).
3. World Health Organization. The Top 10 Causes of Death. Accessible at: https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death [last accessed May 2023]
4. Menzies-Gow, A, Colice, G, Ambrose, C, et al. Efficacy of tezepelumab in patients with severe, uncontrolled asthma by prior omalizumab use: a post hoc analysis of the phase 3 NAVIGATOR study. [Mini Symposium] Presented at the American Thoracic Society International Conference 2023 (19-24 May)
5. Spahn, J, Jacobs, J, Hoyte, F, et al. Tezepelumab efficacy by SNOT-22 domain scores in patients with severe, uncontrolled asthma and comorbid nasal polyps in the phase 3 NAVIGATOR study. [Poster Discussion] Presented at the American Thoracic Society International Conference 2023 (19-24 May)
6. Le TT, et al. Real-World Evidence of Benralizumab in Patients with Severe Eosinophilic Asthma and Nasal Polyps: Initial Results of the RANS Study. [Poster discussion]. Presented at the American Thoracic Society International Conference 2023, 23 May 2023, 14:15-16:15 EST
7. Louis R, et al. Approaching clinical remission in severe asthma: An analysis of patients with chronic rhinosinusitis with nasal polyps (CRSwNP) treated with benralizumab across five clinical trials. [Poster discussion]. Presented at the American Thoracic Society International Conference 2023, 23 May 2023, 9:00-16:15 EST
8. GOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023. [Online]. Available at: https://goldcopd.org/2023-gold-report-2/ [last accessed May 2023]
9. Adeloye D, Song P, Zhu Y, et al. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. (2022) Vol 10(5); 447-458
10. Corren J,et al. Tezepelumab in adults with uncontrolled asthma [supplementary appendix; updated April 18, 2019].N Engl J Med. 2017;377:936-946.
11. Varricchi G,et al.Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer.Front Immunol. 2018;9:1595.
12. AstraZeneca plc. Tezspire (tezepelumab) approved in the US for severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2021/Tezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html. [Last accessed: May 2023].
13. AstraZeneca plc. Tezspire approved in the EU for the treatment of severe asthma. 2022. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/tezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html. [Last accessed: May 2023].
14. AstraZeneca plc. Tezspire approved in Japan for the treatment of severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html. [Last accessed: May 2023].
15. Menzies-Gow A,et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma.N Engl J Med.2021;384: 1800-1809. DOI: 10.1056/NEJMoa2034975.
16. AstraZeneca. Fasenra Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/fasenra-epar-product-information_en.pdf [Last accessed: May 2023].
Veeva ID: Z4-53229
Date of preparation: May 2023