AstraZeneca provides update on GALATHEA Phase III trial for Fasenra in chronic obstructive pulmonary disease

AstraZenecaAstraZeneca and MedImmune, its global biologics research and development arm, today announced top-line results from the GALATHEA Phase III trial for Fasenra (benralizumab) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD.

Dr. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: "COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies. We will now await the results of TERRANOVA and a full evaluation of both trials to determine next steps for Fasenra in COPD."

The pivotal Phase III trials GALATHEA and TERRANOVA are randomised, double-blinded, 56-week placebo-controlled, multi-centre trials assessing the safety and efficacy of Fasenra as an add-on to dual or triple inhaled therapy compared to placebo in patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils.(1)

The safety and tolerability findings in GALATHEA were consistent with those observed in previous trials with Fasenra. A full evaluation of the data is ongoing and the results will be submitted for presentation at a forthcoming medical meeting.

Fasenra is AstraZeneca's first respiratory biologic and is currently approved as an add-on treatment for severe eosinophilic asthma in the US, EU, Japan and several other countries.

The results of the GALATHEA trial do not impact the approved indication in severe eosinophilic asthma.

About COPD

COPD is a progressive disease which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.2 It affects an estimated 384 million people worldwide and is predicted to be the third-leading cause of death by 2020.(2,3) At initial diagnosis, approximately one-third of COPD patients have severe or very severe forms of this disease.(4) Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important to the management of COPD.(2)

About 30-40% of moderate to severe COPD patients on triple inhaled therapy (ICS/LAMA/LABA) remain uncontrolled and continue to experience exacerbations.(5,6) COPD exacerbations significantly impair quality of life and are linked to disease progression, accelerated decline in lung function, and increased hospitalisations and mortality.(7,8,9)

About Fasenra

Fasenra (benralizumab) is a monoclonal antibody that recruits natural killer cells to induce rapid and near-complete depletion of eosinophils, a type of white blood cell that are a normal part of the body's immune system.(10,11) Depletion of circulating eosinophils is rapid, with an onset of action within 24 hours as confirmed in Phase I/II severe asthma trials.(10,11,12)

Fasenra is AstraZeneca's first respiratory biologic now approved in severe eosinophilic asthma in the US, EU, Japan, Canada and Australia and under regulatory review in several other jurisdictions.

Fasenra was developed by AstraZeneca with MedImmune, the company’s global biologics research and development arm and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd., Japan.

About the VOYAGER Programme

VOYAGER is AstraZeneca's Phase III Fasenra clinical trial programme in COPD and, with close to 4,000 patients, it is currently the largest COPD biologics development programme in the world.(13) The VOYAGER programme includes two trials, GALATHEA and TERRANOVA, evaluating Fasenra in patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils.(13)

About AstraZeneca in Respiratory Disease

Respiratory disease is one of AstraZeneca's main therapy areas, and the Company has a growing portfolio of medicines that reached more than 18 million patients in 2017. AstraZeneca's aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification.

The Company is building on a 40-year heritage in respiratory disease and AstraZeneca’s capability in inhalation technology spans pressurised metered-dose inhalers and dry powder inhalers, as well as the Aerosphere Delivery Technology. The company also has a growing portfolio of respiratory biologics, including Fasenra (anti-eosinophil, anti-IL-5rɑ), now approved for severe eosinophilic asthma, and tezepelumab (anti-TSLP), which achieved its Phase IIb primary and secondary endpoints and is continuing development in the Phase III PATHFINDER clinical trial programme. AstraZeneca's research is focused on addressing underlying disease drivers focusing on the lung epithelium, lung immunity and lung regeneration.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology, Respiratory, Cardiovascular & Metabolic Diseases, and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK and Mountain View, Calif.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

1. U.S. National Institutes of Health. “Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History (GALATHEA).” NCT02138916. 2018. Last Accessed May 2018. https://clinicaltrials.gov/ct2/show/NCT02138916?term=GALATHEA&rank=1.
2. GOLD. Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018. [Online]. Available at: http://goldcopd.org. Last accessed January 2018.
3. Bereza BG, Nielsen AT, Valgardsson S et al. Patient preferences in severe COPD and asthma: a comprehensive literature review. International Journal of COPD. 2015: 10: 739-744.
4. Mapel DW, Anand AD, Blanchette CM et al. Severity of COPD at initial spirometry-confirmed diagnosis: data from medical charts and administrative claims. Int J Chron Obstruct Pulmon Dis. 2011;6:573-81. doi: 10.2147/COPD.S16975.
5. Vestbo J, Papi A, Corradi M, et al. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet 2017; 389: 1919-29.
6. Mullerova H, Maskell J, Meeraus WH, Galkin D, Albers FC, Gait C. Characterization of COPD patients treated with inhaled triple therapy containing inhaled corticosteroids [ICS], long-acting beta2- agonists [LABA], and long-acting muscarinic antagonists [LAMA] in the UK. Am J Respir Crit Care Med 2017; 195: A4986. abstract.
7. Hurst JR, Vestbo J, Anzueto A, et al. Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints(ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-38.
8. Lange P, Halpin DM, O'Donnell DE, MacNee W. Diagnosis, assessment, and phenotyping of COPD: beyond FEV₁. Int J Chron Obstruct Pulmon Dis. 2016 Feb 19;11 Spec Iss:3-12.
9. Soler-Cataluna JJ et al. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005 Nov; 60: 925-31.
10. Kolbeck R, Kozhich A, Koike M, et al. MEDI-563, a humanized anti–IL-5 receptor a mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010 Jun;125(6):1344-1353.e2.
11. Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016; 111:21-29.
12. Laviolette M, Gossage DL, Gauvreau G, et al. Effects of benralizumab on airway eosinophils in asthmatic patients with sputum eosinophilia. J Allergy Clin Immunol. 2013 Nov; 132(5): 1086 - 1096.e5.
13. AstraZeneca. Clinical Trials Appendix Full-Year and Q4 2017 Results Update. Available at https://www.astrazeneca.com/content/dam/az/PDF/2017/Full-Year/Full-Year%202017%20Results%20Clinical%20trials%20appendix.pdf. Last Accessed May 2018.

Most Popular Now

Chemists characterize the fatal fungus among us

Life-threatening fungal infections affect more than two million people worldwide. Effective antifungal medications are very limited. Until now, one of the major challenge...

FDA approves first cancer drug through new oncolog…

The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopa...

Discovery of kidney cancer driver could lead to ne…

University of North Carolina Lineberger Comprehensive Cancer Center scientists have uncovered a potential therapeutic target for kidney cancers that have a common genetic...

The immune system: T cells are built for speed

Without T cells, we could not survive. They are a key component of our immune system and have highly sensitive receptors on their surface that can detect pathogens. The e...

Pfizer initiates pivotal Phase 3 program for inves…

Pfizer Inc. (NYSE:PFE) and Spark Therapeutics (NASDAQ:ONCE) announced today that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evalu...

FDA approves first targeted treatment for patients…

The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (...

Sanofi and REVOLUTION Medicines launch global part…

Sanofi and REVOLUTION Medicines, Inc. today announced an exclusive worldwide partnership to develop and commercialize targeted therapies, based on the biology of the cell...

Novartis renews drug donation of Egaten® (triclabe…

Novartis reaffirms its commitment to the fight against liver fluke (fascioliasis), signing a renewed memorandum of understanding with the World Health Organization (WHO) ...

Women and older people under-represented in drug t…

Trying to determine how best to treat a patient, doctors often look to randomized clinical trials to guide their choice of what drug to prescribe. One of the most common ...

New findings suggest allergic responses may protec…

The components of the immune system that trigger allergic reactions may also help protect the skin against cancer, suggest new findings. The research, led by Imperial Col...

FDA grants Breakthrough Therapy Designation for Ro…

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq® (atezolizumab) i...

Novartis marks a new era for migraine patients wit…

Novartis announced today that the European Commission (EC) approved Aimovig® (erenumab) for the prevention of migraine in adults experiencing four or more migraine days p...