Latest news with #multicenter
Medscape
2 days ago
- Health
- Medscape
Stereotactic RT Cuts Neurologic Deaths in SCLC, Brain Mets
TOPLINE: A phase 2 trial found that compared with whole brain radiation (WBRT), stereotactic radiation reduced neurologic deaths in patients with small cell lung cancer (SCLC) and 1-10 brain metastases. METHODOLOGY: SCLC carries a high risk for brain metastases and has traditionally been managed with WBRT or prophylactic cranial irradiation. Stereotactic radiosurgery/radiotherapy has become standard for patients with limited brain metastases from other solid tumors, but prospective data are lacking in those with SCLC. Researchers conducted a multicenter, phase 2 trial of 100 patients (median age, 68 years; 55% women) with SCLC or extrathoracic small cell primaries and 1-10 brain metastases. Participants received brain-directed stereotactic radiation — 20 Gy in a single fraction for lesions under 2 cm and fractionated schedules (30 Gy in five fractions) when necessary. Grossly resected cavities received 25-30 Gy in five fractions with a simultaneous integrated boost. The primary endpoint was neurologic death — defined as progressive radiographic brain disease with corresponding neurologic symptoms in the absence of systemic progression. The control group was a historical cohort of 35 patients with 1-6 brain metastases who underwent WBRT between 2008 and 2015. Secondary endpoints included overall survival, incidence of new brain metastases, leptomeningeal disease, and salvage brain-directed radiation. Median follow-up for survivors was 22 months. TAKEAWAY: Twenty neurologic deaths and 64 nonneurologic deaths occurred. The 1-year incidence of neurologic death was 11.0% among patients who received stereotactic radiation vs 17.5% in the WBRT group; 2–year rates were 20.3% and 35.2%, respectively. Median overall survival was 10.2 months. New brain metastases developed in 61% of patients (1-year estimate, 59.0%). Overall, 39% of the total population received salvage stereotactic radiation, while 22% required salvage WBRT, indicating that 78% avoided WBRT entirely. Looking at 2-year estimates, leptomeningeal disease occurred in 9% of patients (1-year estimate, 7%), systemic progression in 66% (1-year estimate, 58%), local recurrence in 17% (1-year estimate, 15%), radiographic radiation necrosis in 8% (1-year estimate, 6%), and symptomatic necrosis in 5.4% (1-year estimate, 3%). IN PRACTICE: 'Our phase 2 trial supports the viability of SRS/SRT [stereotactic radiation] in the management of patients with SCLC and a limited number of brain metastases who are naive to previous brain-directed radiation, including PCI [prophylactic cranial irradiation],' the authors wrote. Ongoing trials comparing stereotactic radiation to hippocampal-sparing WBRT will offer additional insights, the authors noted. SOURCE: This study, led by Ayal A. Aizer, MD, MHS, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Boston, was published online in the Journal of Clinical Oncology. LIMITATIONS: Limitations included a lack of concurrent WBRT control and reliance on data from a historical cohort from a single institution. The results might not be applicable to patients with more than 10 lesions. Additionally, frequent surveillance and early use of salvage stereotactic radiation mitigated the risk for neurologic death that might have otherwise been seen. DISCLOSURES: This study was supported by the Joint Center for Radiation Therapy, Boston. Several authors reported receiving research funding or honoraria or having ties with various sources. Additional disclosures are noted in the original article. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
3 days ago
- Health
- Medscape
Rituximab No Better Than Standard Therapy for EGPA Remission
TOPLINE: Rituximab did not show superiority over conventional therapy in inducing remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA). Both treatment groups had similar remission rates at 180 and 360 days, with no significant differences in relapse rates or adverse events. METHODOLOGY: A phase 3, multicenter, randomized, controlled superiority trial was conducted in France to compare rituximab with conventional therapy for EGPA remission induction. A total of 105 adult patients with active EGPA (mean age, 58.4 years; 52.4% women), defined by a Birmingham Vasculitis Activity Score (BVAS, version 3) ≥ 3, were enrolled between December 2016 and October 2019 and randomly assigned to receive either rituximab (n = 52) or conventional therapy on the basis of the five-factor score (n = 53). Patients in the rituximab group received 1 g of rituximab on days 1 and 15, along with glucocorticoids on a tapering schedule; those with a five-factor score ≥ 1 received placebo-cyclophosphamide and placebo-uromitexan. The conventional therapy group received glucocorticoids on a tapering schedule with or without cyclophosphamide on the basis of a five-factor score ≥ 1. The primary endpoint was the proportion of patients who achieved remission, defined as the absence of EGPA disease activity (indicated by a BVAS of 0 at a prednisone dose of ≤ 7.5 mg/d), at 180 days. Secondary endpoints included the duration of remission, glucocorticoid dose, and safety, with follow-up visits scheduled up to 360 days. TAKEAWAY: At 180 days, 63.5% of patients in the rituximab group and 60.4% in the conventional group achieved remission (relative risk, 1.05; P = .75). At 360 days, remission rates were similar between the groups: 59.6% in the rituximab group and 64.2% in the conventional group. The time to remission was a median of 2 weeks in both the groups. Among patients who achieved a BVAS of 0, the mean duration of remission was comparable — 48.5 weeks for rituximab and 49.1 weeks for conventional therapy. No significant differences were observed in relapse rates or serious adverse event rates between the rituximab and conventional therapy groups. Infections and cardiovascular events were the most common serious adverse events. IN PRACTICE: 'On the basis of the results of this trial, the role of rituximab in the therapeutic management of EGPA has been updated,' the authors of the study wrote. 'In most of the study population with nonsevere EGPA, the lack of a clinically meaningful effect of rituximab in addition to the conventional strategy of glucocorticoids alone may appropriately inform clinical decision-making,' they added. SOURCE: The study was led by Benjamin Terrier, MD, PhD, Université Paris Cité in Paris, France. It was published online on July 28, 2025, in Annals of Internal Medicine. LIMITATIONS: The study's design as a superiority trial may not adequately address the equivalence between rituximab and conventional therapy. The limited sample size, due to the rarity of EGPA, affected the precision of subgroup analyses. The focus on remission induction in the vasculitis phase may differ from other studies. DISCLOSURES: The study was funded by research grants from the French Ministry of Health and sponsored by Assistance Publique-Hôpitaux de Paris. Additional disclosures are noted in the original article online. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
4 days ago
- Health
- Medscape
Secukinumab in Early PsA Starts Fast vs Standard of Care
TOPLINE: More patients with recently diagnosed psoriatic arthritis (PsA) saw clinical improvement by 3 months in a treat-to-target strategy with secukinumab, a monoclonal antibody targeting interleukin-17, compared with those on standard-of-care treatment, but this difference was not seen at later 3-month intervals out to 1 year. METHODOLOGY: In a randomized, open-label, manufacturer-sponsored, multicenter trial, 120 patients (mean age, 49; 41% women) diagnosed with PsA within the prior 3 months were randomized to a treat-to-target approach of early treatment with secukinumab or standard of care in which treatment escalated according to predetermined steps if patients failed to respond. At the start, in the secukinumab arm, 60 patients received 300 mg monthly secukinumab, a single injection of 80 mg triamcinolone, and 15 mg/wk methotrexate plus 10 mg/wk folic acid. In the standard-of-care arm, 60 patients received 80 mg triamcinolone (single injection), methotrexate starting at 15 mg/wk and increasing to 25 mg/wk by 6 weeks, and 10 mg/wk folic acid. In the standard-of-care arm, treatment was escalated by adding sulfasalazine 1000 mg twice daily if needed, then switching if needed to a first or second TNF inhibitor with methotrexate. In the secukinumab arm, patients with poor response were escalated to a TNF inhibitor with 25 mg methotrexate per week, followed by a second TNF inhibitor plus methotrexate if needed. Outcomes were measured at 3, 6, 9, and 12 months, and the primary endpoint was the percentage of patients achieving 50% or greater improvement in American College of Rheumatology response criteria (ACR50) at 6 months. TAKEAWAY: At 6 months, both trial arms had similar ACR50 rates (around 41% in the secukinumab arm vs 37% in the standard-of-care arm). However, first-line secukinumab was associated with significantly more patients achieving ACR50 at 3 months (about 42% vs 22%; P < .05). Secondary endpoints of the percentage of patients meeting criteria for Minimal Disease Activity, 90% improvement in Psoriasis Area Severity Index, and resolution of enthesitis and dactylitis generally followed the same pattern of quicker responses in the secukinumab arm, followed by numerically greater but not statistically significant differences in the secukinumab vs standard-of-care arms at later timepoints. IN PRACTICE: 'Early response is very important to patients. They don't necessarily care whether they are eventually going to catch up. They want to know they'll feel much better at 3 months,' commented Dafna Gladman, MD, senior scientist at the Toronto Western Research Institute and professor in the Institute of Medical Science at the University of Toronto, both in Toronto, Ontario, Canada. She was not a part of the study. SOURCE: Gonul Hazal Koc, MD, of Erasmus MC in Rotterdam, the Netherlands, led the research and presented the 12-month results in a poster at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) 2025 Annual Meeting and Trainee Symposium in Bogotá, Colombia. LIMITATIONS: The study was not blinded, and a treat-to-target approach, while recommended by several guidelines, does not necessarily represent routine clinical practice in PsA. DISCLOSURES: Koc and her colleagues' research was supported by an unrestricted grant to her institution by Novartis, the manufacturer of secukinumab, which also supplied the study reported having no financial relationships outside the grant to her institution. Gladman has received research support and/or consultant fees from AbbVie, Amgen, Bristol-Myers Squibb, Johnson & Johnson, Eli Lilly, Fresenius Kabi, Novartis, Galapagos, UCB, Gilead, Janssen, Roche, and Pfizer.
Globe and Mail
6 days ago
- Business
- Globe and Mail
AstraZeneca's Osimertinib Study: A Potential Game-Changer for NSCLC Treatment
AstraZeneca ((AZN)), AstraZeneca plc ((GB:AZN)), AstraZeneca ((DE:ZEGA)), AstraZeneca plc US ((AZNCF)) announced an update on their ongoing clinical study. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. AstraZeneca is conducting a study titled 'Positioning, Utilization and Effectiveness of Osimertinib in First Line in Real-life Therapeutic Strategy in France' to evaluate the effectiveness of osimertinib in treating locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with activating EGFR mutations. The study aims to assess the 36-month overall survival rate, patient characteristics, disease progression, treatment patterns, and quality of life. The intervention being tested is osimertinib, a drug used as a first-line treatment for NSCLC patients with specific genetic mutations. It is designed to target and inhibit the growth of cancer cells. This observational study employs a multicenter design, combining a cross-sectional survey and a prospective cohort model. It focuses on real-life treatment scenarios to gather comprehensive data on patient outcomes and treatment efficacy. The study began on May 12, 2021, with an estimated completion date in July 2025. These timelines are crucial for tracking the progress and ensuring timely analysis of the data collected. The study's findings could significantly impact AstraZeneca's stock performance by demonstrating the effectiveness of osimertinib, potentially boosting investor confidence. It also positions AstraZeneca competitively within the oncology market, particularly against other companies developing treatments for NSCLC. The study is ongoing, with further details available on the ClinicalTrials portal.
Globe and Mail
21-07-2025
- Business
- Globe and Mail
Type 2 Diabetes Pipeline Appears Promising With 75+ Leading Biotech and Pharma Companies Driving Innovation in the Therapeutics Segment
DelveInsight's, 'Type 2 Diabetes Pipeline Insight, 2025' report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Type 2 Diabetes pipeline landscape. It covers the Type 2 Diabetes pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Type 2 Diabetes pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore our latest breakthroughs in Type 2 Diabetes Research. Learn more about our innovative pipeline today! @ Type 2 Diabetes Pipeline Outlook Key Takeaways from the Type 2 Diabetes Pipeline Report In July 2025, AstraZeneca announced a Phase II study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy. In July 2025, Novo Nordisk A/S conducted a study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. In July 2025, Sanofi organized a Phase IV Single Arm Clinical Trial to Evaluate the Safety and Efficacy of a Fixed Ratio Combination of Insulin Glargine and Lixisenatide in Adult Patients With Type 2 Diabetes Who Are Sub Optimally Controlled on Oral Anti-hyperglycemic Drugs and/or Basal Insulin/GLP-1 RA. In July 2025, Getz Pharma announced a study Objective To evaluate the safety and tolerability of Empagliflozin with or without metformin in patients with Type II Diabetes Mellitus in the Pakistani population. DelveInsight's Type 2 Diabetes pipeline report depicts a robust space with 75+ active players working to develop 80+ pipeline therapies for Type 2 Diabetes treatment. The leading Type 2 Diabetes Companies such as Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Rivus Pharmaceuticals, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. Promising Type 2 Diabetes Pipeline Therapies such as Empagliflozin, Subetta, AZD6234, AZD1656, Glipizide, iGlarLixi (insulin glargine/lixisenatide), GFT505 80mg, Pioglitazone, Metformin, Sulfonylurea and others. Stay informed about the cutting-edge advancements in Type 2 Diabetes treatments. Download for updates and be a part of the revolution in Endocrinology and Metabolic Disorders Care @ Type 2 Diabetes Clinical Trials Assessment Type 2 Diabetes Emerging Drugs Profile LY-3209590: Eli Lilly and Company Insulin efsitora alfa (LY3209590) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. Efsitora is in phase III development for adults with type 1 and 2 diabetes. THDB0206: Tonghua Dongbao Pharmaceutical BC Lispro (THDB0206) is an ultra-rapid-acting insulin analog developed by Tonghua Dongbao Pharmaceutical Co., Ltd. for the treatment of type 2 diabetes. BC Lispro is designed to restore early-phase insulin secretion, which is often impaired in diabetic patients. This insulin analog utilizes a new formulation technology that allows for rapid absorption and action, mimicking the physiological pattern of insulin secretion after meals. Such characteristics are expected to reduce the risk of late postprandial hypoglycemia, providing patients with greater flexibility in managing their insulin injections. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Type 2 Diabetes. HU6: Rivus Pharmaceuticals Rivus Pharmaceuticals is developing HU6, a novel oral medication classified as a Controlled Metabolic Accelerator (CMA), aimed at treating various metabolic diseases, including type 2 diabetes. HU6 works by leveraging mitochondrial uncoupling to increase the body's resting metabolic rate, promoting fat loss while preserving lean muscle mass. Currently, the drug is in the Phase II stage of development to treat Type 2 Diabetes. AZD-5004, also known as ECC5004, is an investigational small molecule glucagon-like peptide-1 receptor agonist (GLP-1RA) developed by AstraZeneca in collaboration with Eccogene. It is primarily aimed at treating obesity, type 2 diabetes, and related cardiometabolic conditions. AZD-5004 works by mimicking the effects of GLP-1, a hormone that regulates appetite and insulin secretion. This mechanism is crucial for managing weight and improving glucose metabolism, making it a potential therapeutic option for individuals with obesity and type 2 diabetes. Currently, the drug is in the Phase II stage of development to treat Type 2 Diabetes. XW014: Sciwind Biosciences XW014 is an oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist developed by Sciwind Biosciences for the treatment of obesity and type 2 diabetes (T2D). XW014 functions as a GLP-1 receptor agonist, which means it mimics the action of the GLP-1 hormone that is released after meals. This hormone plays a key role in regulating glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, and promoting satiety. As an oral small molecule, XW014 offers advantages over traditional peptide-based GLP-1 therapies, such as ease of administration and the potential for combination therapies with other oral medications. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Type 2 Diabetes. KN056: Suzhou Alphamab Co., Ltd. KN-056 is a glucagon-like peptide-1 receptor (GLP-1R) modulator developed by Suzhou Alphamab Co., Ltd. for the treatment of type 2 diabetes. KN-056 functions as a GLP-1R modulator, which means it targets the glucagon-like peptide-1 receptor. GLP-1 is a hormone that plays a key role in regulating glucose metabolism by stimulating insulin secretion, inhibiting glucagon release, and promoting satiety. By modulating the GLP-1 receptor, KN-056 aims to improve glycemic control in patients with type 2 diabetes. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Type 2 Diabetes. The Type 2 Diabetes Pipeline Report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Type 2 Diabetes with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Type 2 Diabetes Treatment. Type 2 Diabetes Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Type 2 Diabetes Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Type 2 Diabetes market. Learn more about Type 2 Diabetes Drugs opportunities in our groundbreaking Type 2 Diabetes research and development projects @ Type 2 Diabetes Unmet Needs Type 2 Diabetes Companies Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Rivus Pharmaceuticals, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. Type 2 Diabetes pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Type 2 Diabetes Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Discover the latest advancements in Type 2 Diabetes treatment by visiting our website. Stay informed about how we're transforming the future of Endocrinology and Metabolic Disorders @ Type 2 Diabetes Market Drivers and Barriers, and Future Perspectives Scope of the Type 2 Diabetes Pipeline Report Coverage- Global Type 2 Diabetes Companies- Tonghua Dongbao Pharmaceutical, Eli Lilly and Company, Rivus Pharmaceuticals, Celon Pharma, Sciwind Biosciences, AstraZeneca, Suzhou Alphamab Co., Ltd., Neurodon, Abarceo Pharma, Chong Kun Dang Pharmaceutical and others. Type 2 Diabetes Pipeline Therapies- Empagliflozin, Subetta, AZD6234, AZD1656, Glipizide, iGlarLixi (insulin glargine/lixisenatide), GFT505 80mg, Pioglitazone, Metformin, Sulfonylurea and others. Type 2 Diabetes Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Type 2 Diabetes Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III For a detailed overview of our latest research findings and future plans, read the full details of Type 2 Diabetes Pipeline on our website @ Type 2 Diabetes Emerging Drugs and Companies Table of Contents Introduction Executive Summary Type 2 Diabetes: Overview Pipeline Therapeutics Therapeutic Assessment Type 2 Diabetes– DelveInsight's Analytical Perspective Late Stage Products (Phase III) LY-3209590: Eli Lilly and Company Mid Stage Products (Phase II) HU6: Rivus Pharmaceuticals Early Stage Products (Phase I) KN056: Suzhou Alphamab Co., Ltd. Preclinical and Discovery Stage Products Drug name: Company name Inactive Products Type 2 Diabetes Key Companies Type 2 Diabetes Key Products Type 2 Diabetes- Unmet Needs Type 2 Diabetes- Market Drivers and Barriers Type 2 Diabetes- Future Perspectives and Conclusion Type 2 Diabetes Analyst Views Type 2 Diabetes Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. 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