Latest news with #OASIS4
Medscape
3 days ago
- Health
- Medscape
Does Elinzanetant Reduce VMS in Younger Patients?
Another phase 3 trial has demonstrated the effectiveness of the dual-neurokinin receptor antagonist elinzanetant in controlling hot flashes in women on adjuvant endocrine therapy for hormone receptor-positive (HR+) breast cancer. This time, the sample included younger and older patients with less frequent and severe episodes than patients in the previously published trials had experienced. 'Elinzanetant is the first neurokinin-targeted therapy to demonstrate efficacy in reducing vasomotor symptoms (VMS)' — otherwise known as hot flashes — 'in women with breast cancer,' Fatima Cardoso, MD, MSc, said as she presented results from the OASIS 4 trial at the breast cancer oral abstracts session at the American Society of Clinical Oncology (ASCO) 2025 annual meeting. 'The effect [of the hormone-free dual neurokinin-1 and -3 receptor antagonist] is rapid at week 1,' Cardoso said. 'It is sustained throughout the duration of the study. It is also well-tolerated, which supports its use long term.' Trial results were also published simultaneously in The New England Journal of Medicine . 'It is important to treat VSM because they can negatively impact quality of life and lead to women prematurely stopping their breast cancer treatment,' Cardoso, director of the breast cancer unit at the Champalimaud Cancer Center and president of the ABC Global Alliance in Lisbon, Portugal, told Medscape Medical News. VMS Reduction Advantage Sustained for 12 Weeks OASIS 4 enrolled 474 women aged 18-70 years who were receiving endocrine therapy for HR+ breast cancer or as prevention in those at high risk for breast cancer and had 35 or more moderate-to-severe vasomotor symptoms a week. The trial assigned 316 participants to receive elinzanetant 120 mg daily for 52 weeks and 148 to receive a placebo daily for 12 weeks followed by elinzanetant 120 mg daily for 40 weeks. The average daily VMS frequency was 11.4 in the elinzanetant group and 11.5 in the placebo group. All participants were evaluated for 4 weeks after a year of treatment. Reductions in frequency of VMS were observed after 1 week of treatment, Cardoso said. The mean daily number of episodes was reduced by four in the patients receiving elinzanetant and 1.8 in those receiving placebo. By week 4, the daily reductions in VMS were 6.5 and 3.0 in the two groups, respectively. By week 12, the patients receiving elinzanetant had almost twice the reduction in overall frequency of VMS: 7.8 vs 4.2 fewer average daily episodes than baseline, respectively. Cardoso also noted 'a substantial improvement' in reducing the severity of VMS in patients receiving elinzanetant. She characterized the safety profile of elinzanetant as favorable, during her interview with Medscape Medical News. 'Most side effects were mild, and the most common were headache, fatigue, and somnolence,' she said. 'Very low rates of serious side effects were seen.' During the placebo-controlled period, the rates of treatment-emergent adverse events (TEAEs) were 70% in the patients receiving elinzanetant and 62% in the placebo group. Fewer TEAEs were reported in both groups after the 12-week placebo period ended, she said. Elinzanetant 'was very well tolerated,' Cardoso said as she presented the results. 'Perhaps the best factor to say that it was well tolerated and efficacious is that over 90% of the patients decided to go into the 2-year extension phase.' How OASIS 4 Compares With Other Elinzanetant Trials The OASIS 4 results are consistent with other phase 3 trials of elinzanetant in women on adjuvant endocrine therapy with VMS, JoAnn Pinkerton, MD, director of midlife health at the University of Virginia in Charlottesville, Virginia, told Medscape Medical News. Pinkerton was principal investigator of the OASIS 2 randomized trial of elinzanetant in postmenopausal participants with more frequent and severe VMS symptoms than those in OASIS 4. 'It is worth noting that the treatment did not have any adverse effects on the endometrium, and there were no significant changes in bone density that were not expected due to aging,' Pinkerton said. OASIS 4 is significant because it enrolled patients from 90 international sites, including Europe and Canada, and well as women aged 18-70 years with 35 or more moderate-to-severe VMS a week while on tamoxifen or aromatase inhibitors, Pinkerton added. 'OASIS 4 showed significant relief in menopausal symptoms in women with breast cancer, precisely the population that needs an effective, Food and Drug Administration-approved medication to treat their bothersome menopausal symptoms,' Pinkerton said. The trial was funded by Bayer. Cardoso reported financial relationships with Amgen, Astellas Pharma, AstraZeneca, Bayer, Celgene, Daiichi Sankyo, Eisai, GE Healthcare, Genentech, Gilead Sciences, GlaxoSmithKline, IQVIA, Macrogenics, Merck Sharp & Dohme, Merus, Mundipharma, Mylan, Novartis, Pfizer, Pierre Fabre, Prime Oncology, Roche, Samsung Bioepis, Sanofi, Seagen, Teva and touchIME. Pinkerton reported having financial relationships with Bayer, Pfizer, and Merck.
Medscape
6 days ago
- Health
- Medscape
Early Breast Cancer Highlights From ASCO 2025
Reporting on studies in early breast cancer presented at ASCO 2025, Dr Ian Krop of Yale Cancer Center discusses potential refinements in treatment across all subtypes as well as a significant study in supportive care. Dr Krop begins with the neoCARHP trial, which reevaluated the role of carboplatin, a component of standard neoadjuvant therapy for patients with early HER2-positive breast cancer. Omitting carboplatin yielded comparable pathologic complete response results confirming noninferiority of the carboplatin-free regimen. Carboplatin was also reexamined in the context of triple-negative breast cancer in the phase 3 NRG-BR003 trial. Invasive disease-free survival rates at 5 years were slightly higher among patients taking carboplatin, although patients who had BRCA mutations appeared to experience more benefit. In hormone receptor (HR)-positive disease, Dr Krop discusses 15-year updated data from the SOFT and TEXT trials assessing the benefit of adjuvant exemestane with ovarian function suppression (OFS) vs tamoxifen plus OFS. Results confirmed the benefit of adding OFS and switching to exemestane, particularly for higher-risk patients. Vasomotor symptoms can compromise quality of life for patients with breast cancer and can lead to nonadherence. Dr Krop highlights the OASIS 4 trial, which evaluated elinzanetant in patients with HR-positive disease. Promising results in this trial are helping to move this therapy toward FDA approval.
Medscape
09-06-2025
- Health
- Medscape
ASCO 2025: Key Updates in Early Breast Cancer Care
Mariana Chavez MacGregor, MD, MSc, comments on how the ASCO 2025 meeting delivered a wealth of impactful data, particularly in the early-stage breast cancer setting. Trials like neoCARHP and CompassHER2 raised important questions about de-escalating therapy for HER2-positive patients, challenging the role of carboplatin and demonstrating strong pathologic complete response rates with shorter regimens. Long-term data from SOFT and TEXT reinforced the survival benefits of ovarian suppression plus an aromatase inhibitor in high-risk premenopausal patients, and the OASIS 4 study showed promise with elinzanetant in managing vasomotor symptoms. Across subtypes, including triple-negative disease, and with the growing role of AI and circulating tumor DNA, the meeting emphasized more personalized, less toxic approaches to care.
Yahoo
05-05-2025
- Health
- Yahoo
FDA accepts Novo Nordisk's NDA submission for weight management therapy
The US Food and Drug Administration (FDA) has accepted Novo Nordisk's new drug application (NDA) submission for the 25 mg oral formulation of Wegovy (semaglutide) intended for chronic weight management in adult obese or overweight patients with one or more comorbid conditions. This investigational one-time-a-day treatment aims to minimise the risk of major adverse cardiovascular events in this population and established cardiovascular disease. The agency's decision on the NDA is expected in the fourth quarter of this year. The application for Wegovy is supported by outcomes from the 64-week, controlled, randomised Phase III OASIS 4 trial. This trial assessed the safety and efficacy of a 25 mg dose of oral semaglutide against a placebo in 307 adults without diabetes who were either obese or overweight with at least one comorbidity. The trial participants underwent a 12-week dose escalation period, with 64 weeks of treatment and a follow-up period of a seven-week off-treatment. Novo Nordisk noted that, on approval, the therapy would mark the first oral glucagon-like peptide-1 (GLP-1) medication for chronic weight management. Recently, the company announced that starting July 1 of this year, Wegovy will be the preferred GLP-1 receptor agonist (RA) on the template formularies of CVS Caremark, the US pharmacy benefit manager (PBM). Currently, the therapy is approved as a 2.4 mg dosage injection for use alongside a low-calorie diet and increased physical activity in the adult and paediatric population aged 12 and above with obesity or overweight with weight-related medical problems. Additionally, in adults with a history of heart disease who are either obese or overweight, it is used to diminish the risk of cardiovascular incidents, such as heart attacks, strokes, or mortality. Novo Nordisk Clinical Development, Medical & Regulatory Affairs senior vice president Anna Windle said: "We are entering a new era of obesity care where patients want individualised treatment plans that address their needs and provide choices, including oral formulations. "We are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral GLP-1 treatment for obesity." Last month, the company invested $1.09bn to expand its production facility in Brazil as a part of the company's strategy to increase the production capacity of its GLP-1 receptor agonist products. "FDA accepts Novo Nordisk's NDA submission for weight management therapy" 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. Sign in to access your portfolio
Yahoo
02-05-2025
- Health
- Yahoo
FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity
Novo Nordisk hopes to expand Wegovy® label by becoming the first GLP-1 treatment for obesity in a pill The FDA filing is based on the results of the phase 3 OASIS 4 trial that evaluated oral semaglutide 25 mg in adults with obesity or overweight1 Novo Nordisk continues to build on 100-year-plus legacy of science and innovation PLAINSBORO, N.J., May 2, 2025 /PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational once-daily, 25 mg oral formulation of Wegovy® (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease.2 If approved, Wegovy® would become the first oral formulation of a GLP-1 indicated for chronic weight management. "We are entering a new era of obesity care where patients want individualized treatment plans that address their needs and provide choices, including oral formulations," said Anna Windle, PhD, Senior Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc. "Novo Nordisk's strong legacy in obesity care and decades of scientific research and innovation have brought us to this moment. We are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral GLP-1 treatment for obesity." The FDA application is based on results from OASIS 4, a 64-week phase 3 randomized, controlled trial evaluating the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity (BMI >/= 30 kg/m2) or overweight (BMI >/= 27 kg/m2) with one or more comorbidities.1,3 Patients with diabetes were excluded.1,3 OASIS 4 included a 64-week treatment period including a 12-week dose escalation, and a 7-week off-treatment follow-up period.1,3 In total, 307 participants were randomized 2:1 ratio to once-daily oral semaglutide 25 mg or placebo, as an adjunct to lifestyle intervention for 64 weeks.1,3 The FDA action date to decide on the Wegovy® oral formulation NDA will be in Q4 2025.2 About Wegovy®Wegovy® (semaglutide) injection 2.4 mg is currently approved along with a reduced calorie diet and increased physical activity, for adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off and to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight.4 About obesityObesity is a serious chronic, progressive, and misunderstood disease that requires long-term management.5-7 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.5,7 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.8,9 The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.10,11 In the U.S., about 40% of adults live with obesity.12 About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit Facebook, Instagram, and X. Contacts for further information Media:Liz Skrbkova (US)+1 609 917 0632NNIMediaTeam@ Ambre James-Brown (Global)+45 3079 9289Globalmedia@ Investors:Frederik Taylor Pitter (US) +1 609 613 0568fptr@ Jacob Martin Wiborg Rode (Global)+45 3075 5956jrde@ Sina Meyer (Global) +45 3079 6656 azey@ Ida Schaap Melvold (Global) +45 3077 5649 idmg@ Max Ung (Global)+45 3077 6414mxun@ References Garvey W, Duque do Vale R, Karlsson T, et al. Efficacy and Safety of Oral Semaglutide 25 mg in Adults With Overweight/Obesity: The OASIS 4 RCT. Oral presentation presented at ObesityWeek® 2024; 3-6 November 2024; Henry B. Gonzalez Convention Center, San Antonio, US. Presentation Oral-108. Oral Semaglutide 25 mg FDA NDA filing; Novo Nordisk data on file. Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Works in People Who Have a Body Weight Above the Healthy Range (OASIS 4). Last accessed: May 2025. Available at: Wegovy® (semaglutide) injection 2.4 mg Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.; 2025. Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev. 2017;18(7):715-723. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: May 2025. Available at: Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: May 2025. Available at: World Obesity Federation. World Obesity Atlas 2023. Last accessed: May 2025. Available at: Centers for Disease Control and Prevention. Why it matters. Last accessed: May 2025. Available at: Centers for Disease Control and Prevention. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021–August 2023. Last accessed May 2025. Available at: © 2025 Novo Nordisk All rights reserved. US25SEMO00927 May 2025 View original content to download multimedia: SOURCE NOVO NORDISK INC. Sign in to access your portfolio
