Latest news with #OASIS4
Medscape
08-07-2025
- Health
- Medscape
Oral Semaglutide: Will Injectors Switch?
With a GLP-1 in pill form for weight loss expected to be FDA-approved by year's end, obesity medicine physicians said they are gearing up for higher demand and already answering questions about the anticipated new option. Predictions are mixed about how many people may dump the shots in favor of the pill, and some physicians worry about misuse, mostly patients skipping or double dosing. While doctors welcome the new option, many also pointed to a host of other medications in the pipeline that they say look as good or better than the anticipated new pill. Semaglutide in a Weight-Loss Pill The FDA accepted the New Drug Application submission from Novo Nordisk in May for an investigational, once-daily, 25-mg oral form of Wegovy (semaglutide) for chronic weight management in adults with obesity or overweight with one or more comorbid conditions and to reduce the risk for major adverse cardiovascular events in adults with overweight or obesity and cardiovascular disease. The decision is expected in the fourth quarter of 2025. No information is available at this point on costs, a Novo Nordisk spokesperson said in late June. OASIS 4 Results: 13.6% vs 2.2% Loss The FDA filing is based on results of the phase 3 OASIS 4 trial, presented in November at Obesity Week in San Antonio. Tanna Donalson, PA-C That trial suggested that a dose of 25 mg may be the sweet spot. The double-blind, placebo-controlled 64-week multicenter trial randomized 307 participants with overweight or obesity 2:1 to the 25 mg semaglutide or to placebo. In all, 167 in the intervention group and 76 in the placebo group completed the trial. The average age was 48 years, and body weight was 105.9 kg. The semaglutide group lost an average of 13.6% of weight vs 2.2% in the placebo group. All adverse events (AEs) were comparable between groups — 93.1% in the semaglutide group and 85.3% in the placebo group; the incidence of serious AEs was lower in the semaglutide group (3.9%) than in the placebo group (8.8%). While 79.2% of the intervention group lost 5% or more of their body weight, 31.1% of the placebo group did so as well. Physical functioning improved more in the semaglutide group; improvements in cardiometabolic risk factors were also greater in the semaglutide group. Doctors Gear Up for Demand The pill form of semaglutide for weight management will definitely be in demand, doctors told Medscape Medical News, although experts disagreed on how big that demand would be and cited unknown factors such as insurance coverage and costs that would affect people's decisions. 'Coverage and cost are important and determine who can use the medication,' said Delilah Strother, MD, DABOM, an obesity medicine physician at Providence Swedish Weight Loss Services in Seattle. While many people have gotten used to injecting themselves, not everyone has. 'We actually have people come into our office every week to have us inject them,' said Supriya Rao, MD, DABOM, DABLM, a gastroenterology and obesity medicine physician in Lowell, Massachusetts. 'They're scared of needles. People are able to wrap their head around taking a pill.' Supriya Rao, MD, DABOM, DABLM However, Rao thinks those on injectables and happy with them will stay on them. Yet, even then, she said, the unknown, as always, is insurance. 'Already we've heard rumblings about some [plans] not covering injectables [for weight loss] starting next year,' she said. While cost is an unknown, Rao predicted the pills will be cheaper than insurance and speculated: 'Insurance might be more willing to take those on, as opposed to injectables.' Doctors say they regularly get the 'When's the pill coming out?' question and have for years. 'Many are curious whether the oral version will be as effective, how it compares in term of side effects, and if switching would make sense for them,' said Urvi Vyas, MD, an endocrinologist at Hoag, a healthcare system in Southern California. 'There's enthusiasm, especially among those who have struggled with the logistics or discomfort of weekly injections.' Right now, 'less than 5% of my patients are requesting oral options,' Strother said, 'but once an oral option is advertised, I suspect all patients would be more interested in an oral as first line.' Pills will be a boon for those who travel, said Tanna Donalson, PA-C, a physician assistant in Denver who directs a medical spa because popping a pill is easier than injecting. It will also help those with an issue with refrigeration. (Novo advises storing Wegovy pens in the refrigerator and discarding any that have been out of refrigeration for 28 days or more.) 'It opens the door for those who wouldn't consider GLP-1s [in injectable form],' Donalson said of the expected pill option. Donalson said it's difficult to guess who else will switch to oral. She suspects some may actually prefer the weekly injection. For instance, some may do an injection every Sunday, and it's become kind of a ritual, and they just prefer to keep it that way and not have to think about remembering a dose the rest of the week. She estimates maybe 25% of people on injected GLP-1s would want to switch to a pill. Misuse and Misconceptions Concerns? Pill sharing probably isn't a concern, most doctors interviewed said. Most patients are so grateful to be on the medication they're not about to share with friends, doctors said. But misconceptions about pills may need to be cleared up, Rao said. 'People think pills don't have as many side effects as injecting,' and that they can go on and off, which she will advise against. Pills are easier to misuse, such as by skipping a day, and that could affect results, she said. Setting Expectations In the phase 3 trial, patients lost an average of 13.6% of body weight. 'That's a substantial amount and is comparable to results seen with injectable GLP-1 medications,' said Vyas. 'Of course, real-world results can vary depending on individual factors like adherence, diet, physical activity, and metabolic profile.' She emphasizes to patients the medications are part of an overall strategy for health. Coming Up Numerous other medications are in development for both weight loss and diabetes. Two that doctors often mentioned they are tracking: Orforglipron: Studied in a phase 3 trial to reduce A1C, Lilly's small-molecule GLP-1 lowered A1C by an average of 1.3%-1.6% from a baseline of 8%. In a secondary endpoint, those randomly assigned to orforglipron lost an average of 16 lb, or 7.9% of weight, at the highest dose at 40 weeks, and the weight loss had not plateaued when the study ended. Lilly is studying it in the ATTAIN trial as a weight-loss medication for people with obesity or overweight; results are expected late in 2025. Amycretin: In early-stage research, Novo Nordisk's obesity medication includes subcutaneous and oral formulations; results were published here and here. 'I do believe there will be quite a host of different medicines coming out that will be able to benefit our patients,' Rao said. Her hope, shared by other physicians and patients hoping to benefit, is that insurance will understand those benefits and put them within reach.
Medscape
27-06-2025
- 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
24-06-2025
- 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
