Latest news with #Tezepelumab
Yahoo
19-05-2025
- Health
- Yahoo
ATS 2025: Tezepelumab reduces COPD exacerbations in eosinophilic patients, despite CB
On 18 May 2025, at the American Thoracic Society International Conference, held in San Francisco, California, post hoc findings from the Phase IIa COURSE trial (NCT04039113) shed light on the potential for tezepelumab to reduce exacerbation rates in chronic obstructive pulmonary disease (COPD) patients with elevated blood eosinophil counts (BECs), regardless of chronic bronchitis (CB) status. Tezepelumab, a thymic stromal lymphopoietin (TSLP) inhibitor developed by AstraZeneca and Amgen, demonstrated clinically relevant benefits in specific inflammatory subtypes of COPD, re-inforcing the commercial opportunity for precision biologics in this historically underserved market. The double-blind, placebo-controlled COURSE study enrolled 337 patients aged 40 to 80 with moderate to very severe COPD and two or more exacerbations in the previous year, all on optimised triple inhaled therapy. Patients were randomised 1:1 to receive tezepelumab 420mg or placebo subcutaneously every four weeks for 52 weeks. This post hoc analysis evaluated treatment outcomes stratified by the presence of St George's Respiratory Questionnaire (SGRQ)-defined chronic bronchitis and baseline BEC (<150 vs. ≥150cells/μL). In patients with CB, tezepelumab reduced the annualised rate of moderate or severe exacerbations by 26% versus placebo. The effect was most pronounced in those with baseline BEC 150cells/μL or higher, where a 28% reduction was observed. Among patients without CB, no effect was seen in those with low BECs, but a 56% reduction was observed in the elevated eosinophil subgroup. These findings underscore the role of type 2 inflammation, particularly in the context of chronic bronchitis, in modulating biologic response. Additionally, improvements in pre-bronchodilator FEV₁ were observed in tezepelumab-treated patients with CB and BEC 150cells/μL or higher. Health-related quality of life, as measured by SGRQ total score, also improved more significantly in these groups — aligning with the drug's potential to target upstream inflammatory pathways beyond eosinophils alone. These findings re-inforce the growing clinical narrative that eosinophilic inflammation is a key modulator of response to biologic therapies in COPD, echoing similar subgroup-driven efficacy patterns seen with anti–IL-5 therapies such as GSK's Nucala (mepolizumab) and AstraZeneca's Fasenra (benralizumab). While tezepelumab missed its primary endpoint in the overall COURSE population, this subgroup data supports further targeted development and suggests potential for regulatory paths through biomarker enrichment strategies. From a commercial standpoint, this data has important implications. The global COPD market remains heavily dominated by inhaled therapies, with limited penetration of biologics due to historically poor trial outcomes in unstratified populations. However, the increasing focus on eosinophilic COPD opens the door for biologic differentiation, particularly in high-risk, high-exacerbation patients who fail standard inhaled triple therapy. If further validated in Phase III trials, tezepelumab could secure a foothold as a biomarker-driven add-on therapy, potentially capturing market share from other biologics with overlapping mechanisms. Moreover, AstraZeneca's existing respiratory portfolio, including Symbicort and Fasenra, positions it well to integrate tezepelumab into commercial pathways leveraging established prescriber networks. Still, payers will likely demand compelling value propositions and stratification criteria to justify premium pricing, especially as biologic competition intensifies. The trajectory of tezepelumab will be shaped by its ability to demonstrate differentiated, biomarker-driven efficacy in a clearly defined eosinophilic population. The data from COURSE strengthens the rationale for a precision medicine strategy, but meaningful commercial success will depend on validating these subgroup effects in a pivotal Phase III programme. In a competitive landscape that now includes Sanofi and Regeneron's Dupixent's (dupilumab) first-in-class approval and emerging IL-5 agents with broader datasets, tezepelumab must establish a compelling value proposition, both clinically and economically. Key opinion leaders interviewed by GlobalData have noted that while tezepelumab's upstream mechanism offers theoretical advantages across inflammatory endotypes, its success will ultimately hinge on clear evidence of clinical superiority or meaningful label differentiation. Without this, market access may remain limited. Experts emphasised that strategic deployment will require precise positioning, alignment with companion diagnostics, and competitive pricing to secure payer reimbursement and prescriber uptake in an increasingly crowded and cost-sensitive biologics landscape. Overall, tezepelumab's emerging COPD profile may represent a pivot point for the biologics market in respiratory disease, provided future trials continue to emphasise precision targeting over broad population efficacy. "ATS 2025: Tezepelumab reduces COPD exacerbations in eosinophilic patients, despite CB" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
15-05-2025
- Health
- Medscape
Tezepelumab Slashes Surgery Risk in Severe Nasal Polyposis
Tezepelumab (Tezspire) has shown significant clinical benefits in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP), including marked reductions in nasal congestion and polyp size and a near elimination of the need for surgical intervention. Findings from the phase 3 WAYPOINT trial were published in The New England Journal of Medicine and presented as a late-breaking oral presentation at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization annual meeting. Chronic rhinosinusitis with NP is a chronic inflammatory disorder characterized by persistent inflammation of the nasal mucosa and the presence of benign growths (NP). These polyps can obstruct nasal airflow and lead to symptoms such as nasal congestion, loss of smell, rhinorrhea, facial pressure or pain, sleep disturbances, and a substantial reduction in quality of life. Standard therapies include intranasal or systemic corticosteroids, surgical resection, and more recently, biologic agents. Adults With Severe Nasal Polyposis Tezepelumab, developed by AstraZeneca in collaboration with Amgen, is a first-in-class human monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), an upstream epithelial cytokine known to initiate and amplify various inflammatory pathways, including those involved in allergic and eosinophilic airway diseases. Preclinical and clinical data suggest that inhibiting TSLP could be an effective strategy for modulating inflammation in both upper and lower airway diseases. The WAYPOINT study was a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial designed to assess the efficacy and safety of subcutaneous tezepelumab in adults with severe CRSwNP. Participants received either tezepelumab or placebo for a 52-week treatment period, followed by a posttreatment follow-up phase lasting 12-24 weeks. Reduction in Polyp Severity Treatment with tezepelumab resulted in a significant reduction in NP severity, as demonstrated by the co-primary endpoints in the phase 3 WAYPOINT trial. The NP score improved by −2.065 ( P < .0001), and use of systemic corticosteroids was reduced by 88% ( P < .0001) compared with placebo. Improvements in NP score were observed as early as week 4, while improvements in nasal congestion score were noted by week 2, the first posttreatment assessment. These effects were sustained through week 52. Significant and clinically meaningful improvements were also observed across all key secondary endpoints in the overall trial population. Tezepelumab was associated with a 98% reduction in the need for NP surgery ( P < .0001) and again an 88% reduction in systemic corticosteroid use ( P < .0001) compared with placebo. 'The WAYPOINT study confirms the efficacy of tezepelumab in reducing the need for further surgery, systemic corticosteroid use, improving SNOT-22 scores, and restoring olfactory function,' said Geoffrey Mortuaire, MD, PhD, head of the Department of ENT and Head and Neck Surgery at Lille University Hospital, Lille, France. 'The rapid and consistent treatment response observed in patients supports the potential for making tezepelumab more broadly available. We hope to see its approval for this indication in France soon.' Favorable Safety Profile Tezepelumab was generally well tolerated in patients with severe nasal polyposis and demonstrated a safety profile consistent with its current indication for severe asthma. The most frequently reported adverse events in the WAYPOINT study were COVID-19, nasopharyngitis, and upper respiratory tract infections. There were no clinically meaningful differences in safety outcomes between the tezepelumab and placebo groups. Tezepelumab is currently approved as add-on maintenance therapy for severe asthma in adults and adolescents aged 12 years or older who remain uncontrolled despite high-dose inhaled corticosteroids and additional maintenance therapy. It is approved in the United States, Europe, Japan, and nearly 60 countries worldwide. Regulatory applications for tezepelumab in severe nasal polyposis are currently under review by health authorities in several regions, according to AstraZeneca.
The Independent
02-03-2025
- Health
- The Independent
Asthma drug showed positive results in trials for people with nasal polyps
An asthma drug has shown positive results when used to treat nasal polyps, researchers have said. Tezepelumab was first approved for treating asthma in 2021, but new research led by a University of Dundee professor has found it also reduces the size of nasal polyps and nasal blockages. The results, published in the New England Journal of Medicine, say significant results were reported by users in as little as two-to-four weeks, compared with those who were given a placebo. Other outcomes were reported, including improved smell and quality of life, and underlying sinus problems were also alleviated in some individuals. The global trial was co-led by Professor Brian Lipworth, of the University of Dundee's school of medicine, a practicing consultant physician working in the departments of respiratory medicine and ear, nose and throat clinics. Professor Lipworth, who is also head of the Scottish Centre for Respiratory Research, said: 'These results represent an important breakthrough in terms of therapy for patients suffering from severe chronic rhinosinusitis and nasal polyps. 'I treat patients who are already using this drug for asthma – around a third of patients who have severe asthma also have nasal polyps. 'Many of them were reporting that their nasal polyp symptoms and related quality of life were greatly improved shortly after taking this drug in the clinic, where we also noticed their polyps had shrunk. 'However that was just real-life clinical experience, so it's fantastic to confirm that it can treat this condition too in the setting of a proper placebo-controlled trial.' The drug, which has been approved in the UK for its use against asthma, is produced by pharmaceutical giants AstraZenica and Amgen. The trial marks the first time the drug has been tested for treating nasal conditions. Nasal polyps are thought to affect around 5% of the total population in the UK, and around 20% of patients with asthma. A total of 408 participants with severe chronic rhinosinusitis and nasal polyps, from ten different countries, were involved in the trial, named 'Waypoint', with 203 of those being given the active drug injections and the others being issued with a placebo. All participants received a monthly dose over 52 weeks and the nasal polyps were then inspected with a telescope and symptoms reported as well as sinus scans, nasal flow measurement and formal smell testing. John Ellerby, 70, of Tayport, Fife, has suffered from nasal polyps for nearly 40 years and has undergone three surgical procedures to remove growths from his sinuses. He describes his condition as being akin to a 'one-way valve' through which he can breathe in but not out. His symptoms include a constantly blocked nose, headaches, earaches, breathlessness to the point of needing an inhaler, coughing and mucus coming from his nose unnoticed. The condition also affects his sleep and his moods, leading to irritability. Despite not being initially told if he was given the active drug Tezepelumab or the placebo, Mr Ellerby says it became very clear to him when his sense of smell returned, around three months into the trial. He said: 'I was going around the house sniffing everything – coffee, perfume, the flowers in the garden. It was fantastic. 'I walked along the beach enjoying the smell of the sea, I started playing squash again, and I was out with the dog doing 14,000 steps a day. 'I was doing things I hadn't been able to do since my 30s, I felt like a new man.' Professor Lipworth says medicinal organisations such as the Scottish Medicines Consortium (SMC) and the National Institute for Health and Care Excellence (Nice) will ultimately advise the NHS on whether the drug should be rolled out on prescription. The NHS will then decide if the drug is cost-effective and fit for purpose. Hopeful the drug will be approved for treating nasal polyps, he said: 'All being well, if the price is right, Nice and SMC will decide on whether it's cost effective. 'Other drugs have gone through the same process but have been rejected on cost-effectiveness, so that's the problem, so we'll have to wait and see.'
Yahoo
02-03-2025
- Health
- Yahoo
Asthma drug showed positive results in trials for people with nasal polyps
An asthma drug has shown positive results when used to treat nasal polyps, researchers have said. Tezepelumab was first approved for treating asthma in 2021, but new research led by a University of Dundee professor has found it also reduces the size of nasal polyps and nasal blockages. The results, published in the New England Journal of Medicine, say significant results were reported by users in as little as two-to-four weeks, compared with those who were given a placebo. Other outcomes were reported, including improved smell and quality of life, and underlying sinus problems were also alleviated in some individuals. The global trial was co-led by Professor Brian Lipworth, of the University of Dundee's school of medicine, a practicing consultant physician working in the departments of respiratory medicine and ear, nose and throat clinics. Professor Lipworth, who is also head of the Scottish Centre for Respiratory Research, said: 'These results represent an important breakthrough in terms of therapy for patients suffering from severe chronic rhinosinusitis and nasal polyps. 'I treat patients who are already using this drug for asthma – around a third of patients who have severe asthma also have nasal polyps. 'Many of them were reporting that their nasal polyp symptoms and related quality of life were greatly improved shortly after taking this drug in the clinic, where we also noticed their polyps had shrunk. 'However that was just real-life clinical experience, so it's fantastic to confirm that it can treat this condition too in the setting of a proper placebo-controlled trial.' The drug, which has been approved in the UK for its use against asthma, is produced by pharmaceutical giants AstraZenica and Amgen. The trial marks the first time the drug has been tested for treating nasal conditions. Nasal polyps are thought to affect around 5% of the total population in the UK, and around 20% of patients with asthma. A total of 408 participants with severe chronic rhinosinusitis and nasal polyps, from ten different countries, were involved in the trial, named 'Waypoint', with 203 of those being given the active drug injections and the others being issued with a placebo. All participants received a monthly dose over 52 weeks and the nasal polyps were then inspected with a telescope and symptoms reported as well as sinus scans, nasal flow measurement and formal smell testing. John Ellerby, 70, of Tayport, Fife, has suffered from nasal polyps for nearly 40 years and has undergone three surgical procedures to remove growths from his sinuses. He describes his condition as being akin to a 'one-way valve' through which he can breathe in but not out. His symptoms include a constantly blocked nose, headaches, earaches, breathlessness to the point of needing an inhaler, coughing and mucus coming from his nose unnoticed. The condition also affects his sleep and his moods, leading to irritability. Despite not being initially told if he was given the active drug Tezepelumab or the placebo, Mr Ellerby says it became very clear to him when his sense of smell returned, around three months into the trial. He said: 'I was going around the house sniffing everything – coffee, perfume, the flowers in the garden. It was fantastic. 'I walked along the beach enjoying the smell of the sea, I started playing squash again, and I was out with the dog doing 14,000 steps a day. 'I was doing things I hadn't been able to do since my 30s, I felt like a new man.' Professor Lipworth says medicinal organisations such as the Scottish Medicines Consortium (SMC) and the National Institute for Health and Care Excellence (Nice) will ultimately advise the NHS on whether the drug should be rolled out on prescription. The NHS will then decide if the drug is cost-effective and fit for purpose. Hopeful the drug will be approved for treating nasal polyps, he said: 'All being well, if the price is right, Nice and SMC will decide on whether it's cost effective. 'Other drugs have gone through the same process but have been rejected on cost-effectiveness, so that's the problem, so we'll have to wait and see.'
