NEW DATA PRESENTED AT ATS 2024 SHOW THE POTENTIAL OF TEZSPIRE® TO HELP PATIENTS LIVING WITH COPD

PR Newswire05-20

Late-Breaking Results From the Phase 2a COURSE Trial Illustrate Tezspire's Impact on COPD Exacerbations in Patients With a Broad Range of Eosinophil Levels THOUSAND OAKS, Calif., May 19, 2024 /...

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Importantly, this proof-of-concept study showed that, in patients with BEC ≥150 cells/L, tezepelumab led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo. Studies suggest that approximately 65% of bio-eligible patients with COPD have a BEC ≥150 cells/μL. Among patients with BEC ≥300 cells/L, tezepelumab led to a numerical reduction of 46% in the rate of moderate or severe exacerbations . Trends towards improved outcomes were also seen with tezepelumab use for pre-bronchodilator FEV1 and SGRQ total score.\"I believe biologics will play a critical role in the future care of COPD, and trials such as the tezepelumab COURSE trial are central to understanding and shaping the treatment landscape,\" said Dr. Dave Singh, professor of respiratory pharmacology at the University of M","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","LU0122379950.USD":"贝莱德世界健康科学A2","TSLP":"Kurv Yield Premium Strategy Tesla (TSLA) ETF","BK4581":"高盛持仓","SG9999001440.SGD":"United Global Dividend Equity Fund A SGD Dist","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","LU1571399168.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"IP\" (USD) ACC","LU2242652126.USD":"FIDELITY FUNDS GLOBAL DIVIDENDS PLUS \"A\" (USD) INC","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","AMGN":"安进","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU2242646821.SGD":"Fidelity Global Dividend Plus A-MINCOME(G)-SGD","BK4161":"工业机械","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","BK4534":"瑞士信贷持仓","BK4585":"ETF&股票定投概念","BK4139":"生物科技","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","ATS":"ATS Corp.","BK4533":"AQR资本管理(全球第二大对冲基金)","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","BK4566":"资本集团","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","LU0058720904.USD":"联博国际健康护理基金A","BK4588":"碎股"},"translate_title":"ATS 2024上展示的新数据显示了TEZSPIRE®在帮助COPD患者方面的潜力","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ATS":1,"TSLP":1,"AMGN":0.9},"content_text":"Late-Breaking Results From the Phase 2a COURSE Trial Illustrate Tezspire's Impact on COPD Exacerbations in Patients With a Broad Range of Eosinophil Levels \nTHOUSAND OAKS, Calif., May 19, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced the results of the Phase 2a COURSE trial evaluating Tezspire® (tezepelumab-ekko) in people with moderate to very severe chronic obstructive pulmonary disease (COPD) with a broad range of baseline blood eosinophil counts (BEC) irrespective of emphysema, chronic bronchitis or smoking status. The primary results showed that treatment with Tezspire led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, which was not statistically significant (90% CI: -6, 36; p[1-sided]=0.1042). The results will be featured in presentations at the American Thoracic Society (ATS) International Conference, May 17-22, in San Diego.\nImportantly, this proof-of-concept study showed that, in patients with BEC ≥150 cells/µL, tezepelumab led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo. Studies suggest that approximately 65% of bio-eligible patients with COPD have a BEC ≥150 cells/μL. Among patients with BEC ≥300 cells/µL, tezepelumab led to a numerical reduction of 46% in the rate of moderate or severe exacerbations (Table 1). Trends towards improved outcomes were also seen with tezepelumab use for pre-bronchodilator FEV1 and SGRQ total score.\n\"Despite advances in treatments for patients with COPD, there is still a pressing need for effective therapies that can improve their clinical outcome, especially for those with eosinophil counts above 150 cells/µL,\" said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. \"We are now actively planning a Phase 3 clinical program evaluating tezepelumab in patients with COPD.\"\nA subgroup analysis of the COURSE trial also showed treatment with tezepelumab resulted in numerical improvements in lung function as measured by forced expiratory volume (FEV1) (improvement of 63 mL and 146 mL in BEC ≥150 and ≥300 cells/μL respectively, compared to placebo) and in quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ) score (reduction of 4.2 points and 9.5 points in BEC ≥150 and ≥300 cells/μL respectively). The safety and tolerability profile for tezepelumab was consistent with its approved severe asthma indication; the most frequently reported (>10%) adverse events for tezepelumab were worsening of COPD (12.1%) and incidents of COVID-19 infections (14.5%) (this trial commenced in July 2019) (Table 2).\n\"I believe biologics will play a critical role in the future care of COPD, and trials such as the tezepelumab COURSE trial are central to understanding and shaping the treatment landscape,\" said Dr. Dave Singh, professor of respiratory pharmacology at the University of Manchester and lead investigator on the trial. \"The tezepelumab COURSE results are particularly important as they show activity in COPD across a broad patient population including those with baseline blood eosinophil counts greater than 150 cells/μL.\"\nCOURSE Phase 2a analysis:Table 1: Tezepelumab impact on COPD exacerbations versus placebo over 52 weeks\n\n\n\n\n\nReduction in exacerbations compared to placebo \nAnnualized rate of exacerbations \n\n\nModerate or severe exacerbations  \n\n\nOverall population (n=333) \n17% (90% CI: -6, 36)  \n1.75 in tezepelumab group versus 2.11 in placebo group  \n\n\nBEC less than 150 cells/μL (n=137) \n-19% (95% CI: -90, 25) \n2.04 in tezepelumab group versus 1.71 in placebo group  \n\n\nBEC greater than or equal to 150 cells/μL (n-196) \n37% (95% CI: 7, 57) \n1.52 in tezepelumab group versus 2.40 in placebo group  \n\n\nBEC greater than or equal to 300 cells/μL (n=56) \n46% (95% CI: -15, 75) \n1.20 in tezepelumab group versus 2.24 in placebo group  \n\n\nSevere exacerbations \n\n\nOverall population (n=333) \n48% (95% CI: -11, 76) \n0.13 in tezepelumab group versus 0.25 in placebo group  \n\n\n\n\nTable 2: Tezepelumab impact on quality of life and lung function versus placebo over 52 weeks\n\n\n\n\n\nLung function as measured by pre-bronchodilator forced expiratory volume (FEV1, µL) \nQuality of life improvement as measured by St. George's Respiratory Questionnaire (SGRQ) score \n\n\nTezepelumab (n)/LS Mean \nPlacebo (n)/LS Mean \nLS mean difference (95% CI) \nTezepelumab (n)/LS Mean \nPlacebo (n)/LS Mean \nLS mean difference (95% CI) \n\n\nBEC less than 150 cells/μL \n73/-0.002 \n63/-0.053 \n0.051 (-0.012,0.114) \n69/-1.91 \n60/-0.30 \n-1.62  (-6.69, 3.45) \n\n\nBEC greater than or equal to 150 cells/μL \n90/0.049 \n103/-0.014 \n0.063 (0.009, 0.116) \n88/-7.08 \n96/-2.85 \n-4.23 (-8.51, 0.06) \n\n\nBEC greater than or equal to 300 cells/μL \n24/0.160 \n31/0.013 \n0.146 (0.044, 0.248) \n22/-10.22 \n27/-0.68 \n-9.53  (-18.11, -0.96) \n\n\n\n\nAbout the COURSE Phase 2a TrialCOURSE was a Phase 2a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe COPD receiving triple inhaled maintenance therapy, and having had two or more documented COPD exacerbations in the 12 months prior to Visit 1. A total of 337 patients were randomized globally, with patients stratified by region and prior number of exacerbations (two vs. three or more). Patients received tezepelumab 420 mg or placebo administered via subcutaneous injection at the trial site every four weeks over a 52-week treatment period. The trial included a post-treatment follow-up period of 12 weeks.\nAbout Chronic Obstructive Pulmonary Disease (COPD)COPD refers to a group of lung diseases, including chronic bronchitis and emphysema, that cause airflow blockage and breathing-related problems. COPD is a major public health threat that affects an estimated 391 million people around the world, with global costs connected to the disease expected to rise to US $4.8 trillion by 2030. COPD is a highly complex disease with multiple pathways and disease drivers, and a single COPD exacerbation can increase the risk of hospitalization. Baseline blood eosinophil counts are a key factor in how physicians select optimal treatments for COPD. Approximately 65% of patients with COPD who are eligible for biologic treatment have a BEC >150 cells/µL, 20-40% have a BEC >300 cells/µL.\nAbout TEZSPIRE® (tezepelumab-ekko)TEZSPIRE is a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. Specifically, TEZSPIRE targets and blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. \nExpression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. By working at the top of the cascade, TEZSPIRE helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.\nBeyond severe asthma, TEZSPIRE is also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE). In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE.\nAbout the Amgen and AstraZeneca CollaborationIn 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for TEZSPIRE. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit 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 commercialize TEZSPIRE in North America. Amgen will record product sales in the U.S., with AstraZeneca recording its share of U.S. profits as Collaboration Revenue. Outside of the U.S., AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue.\nTEZSPIRE® (tezepelumab-ekko) U.S. Indication\nTEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.\nTEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.\nTEZSPIRE® (tezepelumab-ekko) Important Safety Information \nCONTRAINDICATIONS\nKnown hypersensitivity to tezepelumab-ekko or excipients.\nWARNINGS AND PRECAUTIONS\nHypersensitivity Reactions\nHypersensitivity reactions were observed in the clinical trials (e.g., rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.\nAcute Asthma Symptoms or Deteriorating Disease\nTEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.\nAbrupt Reduction of Corticosteroid Dosage\nDo not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.\nParasitic (Helminth) Infection\nIt is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.\nLive Attenuated Vaccines\nThe concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.\nADVERSE REACTIONS\nThe most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.\nUSE IN SPECIFIC POPULATIONS\nThere are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.\nPlease see the full Prescribing Information including Patient Information and Instructions for Use.\nYou may report side effects related to AstraZeneca products by clicking here.\nAbout Amgen  Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.\nIn 2024, Amgen was named one of the \"World's Most Innovative Companies\" by Fast Company and one of \"America's Best Large Employers\" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.\nFor more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads. \nAmgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. 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We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.\nThe scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.\nCONTACT: Amgen, Thousand Oaks Kate Meyer, 872-867-0754 (media)Elissa Snook, 609-251-1407 (media) Justin Claeys, 805-313-9775 (investors) \n\n\n\n\n\n View original content to download multimedia:https://www.prnewswire.com/news-releases/new-data-presented-at-ats-2024-show-the-potential-of-tezspire-to-help-patients-living-with-copd-302149584.html\nSOURCE Amgen","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.27.0","shortVersion":"4.27.0","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2436719258"}