Selpercatinib

SAN FRANCISCO and SUZHOU, China, May 15, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that the first participant has been successfully dosed in GLORY-3, a Phase 3 clinical study of mazdutide (Innovent R&D Code: IBI362), a dual glucagon (GCG) and glucagon-like peptide 1 receptor (GLP-1) receptor agonist. The study targets adults in China with overweight or obesity accompanied metabolic dysfunction-associated fatty liver disease (MAFLD). GLORY-3 is a multicenter, randomized, open-label Phase 3 clinical study (NCT06884293) comparing the efficacy and safety of mazdutide versus semaglutide in Chinese adults with overweight or obesity accompanied MAFLD. This study plans to enroll approximately 470 participants with overweight or obesity (BMI ≥ 27 kg/m2) accompanied MAFLD, who will be randomized 1:1 to receive mazdutide 9 mg or semaglutide 2.4 mg. The primary endpoints are the percentage change in liver fat content (LFC) as measured by magnetic resonance proton density fat fraction (MRI-PDFF) and the percentage change in body weight from baseline to week 48. A Phase 2 study conducted in Chinese adults with obesity (BMI ≥ 30 kg/m2, NCT04904913) showed that after 48 weeks of treatment, mazdutide 9 mg achieved an 18.6% (17.8kg) placebo-adjusted mean percent reduction in body weight. Meanwhile, 51.2% and 34.9% of the subjects in the mazdutide 9 mg group achieved 15% or more and 20% or more weight loss from baseline, respectively. Among participants with baseline LFC≥ 5% (measured by MRI-PDFF), the percent change in LFC from baseline to week 24 was reduced by 73.3% in the mazdutide 9 mg group. This decrease was sustained during the 48-week extended treatment period, suggesting that mazdutide can effectively reduce body weight and liver fat in participants with overweight or obesity. Professor Lixin Guo, the Principal Investigator of the Study, Peking University People's Hospital, stated, "MAFLD is now the most common chronic liver disease in the world and has surpassed viral hepatitis as the leading chronic liver disease in China. Obesity is a key risk factor, with MAFLD affecting up to 81.8% people with obesity in China[1]. The latest Chinese guidelines recommended GLP-1 agents such as semaglutide for treating obesity and MAFLD ('Guideline for chronic weight management and clinical practice of anti-obesity medications'). As a dual GCG/GLP-1 receptor agonist, mazdutide 9 mg has shown strong weight loss effects and notable improvements in liver fat and enzyme levels, thanks to its additional GCG activity. GLORY-3 is the first clinical trial comparing a dual GCG/GLP-1 receptor agonist with a GLP-1R-only drug in Chinese adults with obesity. It will compare the efficacy and safety of mazdutide 9 mg versus semaglutide 2.4 mg in participants with overweight or obesity accompanied MAFLD. Together with our investigator team, I am committed to conducting this study to the highest standards and to delivering a better treatment option for the Chinese population with overweight or obesity accompanied MAFLD." Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent, stated, "Mazdutide, as a dual GCG/GLP-1 receptor agonist, enhances lipolysis and fatty acid oxidation by stimulating the GCG receptor, offering a series of comprehensive metabolic benefits compared to GLP-1 single receptor agonist drugs. In our Phase 2 study conducted in Chinese adults with obesity, participants with baseline LFC ≥ 5% had a 73.3% reduction in liver fat content after 24 weeks of treatment with mazdutide 9 mg, which preliminarily demonstrated the efficacy of mazdutide in reducing liver fat content. I am very confident that mazdutide will continue to show strong clinical efficacy in the GLORY-3 study, including in weight loss and liver metabolism, and provide a better treatment option for Chinese patients with overweight or obesity accompanied MAFLD." About Obesity China has the world's largest population of people with overweight or obesity[2], with the obesity rate likely to rise. Obesity contributes to multiple comorbidities, reducing life expectancy and quality of life. In 2019, overweight and obesity accounted for 11.1% of deaths related from chronic non-communicable diseases in China, a significant increase from 5.7% in 1990[3]. As obesity is a chronic disease, it requires long-term management, and China faces a lack of long-term effective and safe treatments. Despite lifestyle interventions being the first-line treatment, many patients fail to achieve their desired weight loss goals, underscoring the need for more effective and safer pharmacological interventions. About MAFLD MAFLD is the most common chronic liver disease worldwide, with a global prevalence estimated around 32.4% and increasing. Obesity is one of the risk factors for MAFLD, and the prevalence of MAFLD in those with obesity worldwide has reached 75.3%. In China, MAFLD has overtaken viral hepatitis as the leading chronic liver condition, affecting 81.8% of obese individuals[1]. China also has the world's highest incidence of MAFLD in both normal and obese populations. Treatment goals include reducing body weight and waist circumference, improving insulin resistance, preventing and treating metabolic-related syndromes, and reversing fibrosis. For patients with MAFLD and overweight or obesity, combining lifestyle and pharmacological interventions is considered the most effective strategy to improve health outcomes and quality of life. About Mazdutide (IBI362) Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, mazdutide may offer additional benefits beyond those of GLP-1 receptor agonists—such as promoting insulin secretion, lowering blood glucose and reducing body weight—by also activating the glucagon receptor to increase energy expenditure and improve hepatic fat metabolism. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies. It has also shown benefits in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, as well as improving insulin sensitivity. Mazdutide currently has two NDAs accepted for review by NMPA, including: For chronic weight management in adults with overweight of obesity; For glycemia control in adults with type 2 diabetes. Mazdutide is currently being evaluated in six Phase 3 clinical studies, including: GLORY-1: A Phase 3 trial in Chinese participants with overweight or obesity. GLORY-2: A Phase 3 trial in Chinese participants with moderate-to-severe obesity. GLORY-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese participants with overweight/obesity and metabolic dysfunction-associated fatty liver disease (MAFLD). DREAMS-1: A Phase 3 trial in treatment-naïve Chinese patients with T2D. DREAMS-2: A Phase 3 trial comparing mazdutide and dulaglutide in Chinese T2D patients with inadequate glycemic control on oral antidiabetic drugs. DREAMS-3: A Phase 3 trial comparing mazdutide and semaglutide in Chinese patients with T2D and obesity. Among these, GLORY-1, DREAMS-1 and DREAMS-2 studies have all met their endpoints. In addition, several new clinical studies of mazdutide are planned, including: A Phase 3 trial in adolescents with obesity. A Phase 3 trial in Chinese participants with moderate-to-severe obstructive sleep apnea (OSA) and obesity. New studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF). About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: (1)Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza) and Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. Forward-looking statement This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References [1] Chen K, Shen Z, Gu W, Lyu Z, Qi X, Mu Y, Ning Y; Meinian Investigator Group. Prevalence of obesity and associated complications in China: A cross-sectional, real-world study in 15.8 million adults. Diabetes Obes Metab. 2023 Nov;25(11):3390-3399. [2] Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373–92. [3] Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool. (accessed Jan 10, 2021). SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”ASCO 2025 微专辑扫描二维码可查看更多内容为了在2025年ASCO年会召开前了解专家们的兴趣，一些国际媒体在X平台上对肺癌专家进行了民意调查，以确定他们最渴望在ASCO年会期间了解哪些有影响力的演讲，结果显示LBA8010和LBA8000获得了最多的关注，其次是摘要8015、8639、8001、LBA8505、8500和8646。本文介绍这些摘要的标题、报告时间（美国中部夏令时间）和研究概况。LBA8010: Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: Updated survival and biomarker analyses from CheckMate 77T可切除非小细胞肺癌（NSCLC）患者围手术期纳武利尤单抗对比安慰剂：CheckMate77T的最新生存和生物标志物分析报告时间：6月1日星期一，下午4:36-4:42研究概况：III期CheckMate77T临床试验（NCT04025879）是一项关键性、随机、双盲、多中心研究，旨在评估在IIA-IIIB期可切除NSCLC患者中，将新辅助化疗联合铂类双药化疗随后进行手术和辅助化疗，对比新辅助化疗联合安慰剂随后进行手术和辅助安慰剂的疗效。[1]该研究先前报告的数据支持FDA于2024年10月批准围手术期使用纳武利尤单抗+含铂双药化疗治疗无EGFR突变或ALK重排的可切除NSCLC成年患者。先前数据显示，纳武利尤单抗组的中位无事件生存期（EFS）未达到（NR)，而化疗组为18.4个月（HR=0.58；95%CI: 0.43-0.78；P=0.00025）。在预设的中期分析时，尚未对总生存期（OS）进行正式的统计学显著性检验。LBA8000: Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816.CheckMate816试验中可切除NSCLC患者接受新辅助纳武利尤单抗联合化疗治疗后的总生存报告时间：6月2日星期二，下午3:00-3:12研究概况：III期CheckMate816试验（NCT02998528）评估了新辅助纳武利尤单抗联合化疗对比单纯化疗对IB-IIIA期可切除NSCLC患者（EGFR或ALK基因突变未知）的疗效；基于先前研究结果，该联合疗法于2022年3月4日获得FDA批准，用于可切除NSCLC患者的新辅助治疗。[2]初步数据显示，联合疗法的中位EFS为31.6个月（95%CI: 30.2-NR），而单纯化疗组为20.8个月（95%CI: 14.0-26.7）（HR=0.63；97.38%CI: 0.43-0.91；P=0.0052）。此外，纳武利尤单抗组的病理完全缓解率（pCR）为24%（95%CI: 18.0%-31.0%），而单纯化疗组为2.2%（95%CI: 0.6%-5.6%）。根据百时美施贵宝公司2025年2月发布的新闻稿，对于可切除的NSCLC患者，与单纯新辅助化疗相比，该方案治疗可显著提高患者的OS，且具有临床意义。[3]LBA8505: Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study.赛沃替尼联合奥希替尼vs化疗治疗EGFR酪氨酸激酶抑制剂（TKI）治疗后病情进展的EGFR突变、MET扩增晚期NSCLC：一项随机III期SACHI研究的结果报告时间：6月1日星期一，上午9:48-10:00研究概况：这项多中心、开放标签、III期SACHI试验（NCT05015608）评估了赛沃替尼（Orpathys）联合奥希替尼（Tagrisso）对比铂类化疗治疗EGFR突变、MET扩增的晚期NSCLC，且该患者在接受EGFR-TKI治疗后病情进展。[4]主要终点是研究者评估的无进展生存期（PFS)，次要终点包括OS、客观缓解率（ORR)、缓解持续时间（DOR)、疾病控制率（DCR)等。SACHI试验的中期结果表明，联合疗法达到了其预设的PFS终点。[5]8015: Alectinib as neoadjuvant treatment in potentially resectable stage III ALK-positive NSCLC: Final analysis of ALNEO phase II trial (GOIRC-01-2020-ML42316).阿来替尼作为潜在可切除III期ALK阳性NSCLC的新辅助治疗：II期ALNEO试验（GOIRC-01-2020-ML42316）的最终分析报告时间：6月1日星期一，下午5:30-5:36研究概况：这项开放标签、单组、多中心II期ALNEO试验（NCT05015010）探讨了阿来替尼（Alecensa）作为新辅助治疗在先前未接受过治疗的潜在可切除III期ALK阳性非小细胞肺癌患者中的应用。[6]主要终点是主要病理缓解（MPR)，次要终点包括pCR率、ORR、EFS、DFS、OS和安全性。8639: Amivantamab plus chemotherapy vs chemotherapy in EGFR-mutant advanced NSCLC after disease progression on osimertinib: Outcomes by osimertinib resistance mechanisms in MARIPOSA-2.埃万妥单抗联合化疗vs化疗用于奥希替尼治疗疾病进展的EGFR突变型晚期NSCLC：MARIPOSA-2研究中根据奥希替尼耐药机制的分析结果壁报展示：5月31日星期日，下午1:30研究概况：III期MARIPOSA-2临床试验（NCT04988295）评估了埃万妥单抗（Rybrevant）联合化疗对比单纯化疗在奥希替尼耐药晚期EGFR突变NSCLC患者中的效果。试验的主要终点为PFS，次要终点包括ORR、OS和安全性。[7]该试验的先前数据促使FDA于2024年9月批准埃万妥单抗联合化疗用于此类患者。[8]此前发布的MARIPOSA-2研究结果表明，对于EGFR突变型晚期NSCLC患者，埃万妥单抗联合化疗在数值上改善了OS，并且与单用化疗相比显著改善疾病进展后的结果。[7]8001: Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.新辅助奥希替尼±化疗对比单纯化疗治疗可切除EGFR突变NSCLC患者：NeoADAURA研究报告时间：6月2日星期二，下午3:12CDT 研究概况：NeoADAURA III期临床试验（NCT04351555）是一项随机、多中心研究，评估奥希替尼联合或不联合化疗vs单独化疗治疗可切除II-IIIB期EGFR突变NSCLC患者的效果。[9]主要终点为MPR，次要终点包括EFS、pCR和淋巴结降期等。先前研究发现，在接受手术切除的24例患者中，MPR率为14.8%（95%CI: 4.2%-33.7%），未达到预设的50%阈值。未观察到pCR。客观缓解率为52%，中位无病生存期（DFS）为40.9个月。重要的是，没有患者因毒性反应而出现手术延误或不适合手术。8500: First-line adagrasib (ADA) with pembrolizumab (PEMBRO) in patients (pts) with advanced/metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) from the phase 2 portion of the KRYSTAL-7 studyKRYSTAL-7研究II期部分中，一线治疗阿达格拉西联合帕博利珠单抗治疗晚期/转移性KRAS G12C突变NSCLC患者报告时间：6月1日星期一，上午8:00-8:12研究概况：II期KRYSTAL-7研究（NCT04613596）是一项多中心试验，评估阿达格拉西（Krazati）联合帕博利珠单抗（Keytruda）作为晚期或转移性KRAS G12C突变NSCLC患者的一线治疗效果。[10]该研究的主要终点是研究者根据RECIST1.1标准评估的ORR；次要终点包括研究者评估的DOR、PFS、OS和安全性。2025年欧洲肺癌大会上公布的研究结果表明，在II期KRYSTAL-7队列中，ORR为59.3%（95%CI: 45.0%-72.4%），中位DOR为26.3个月（95%CI: 26.3-不可评估[NE]）。此外，在中位随访期22.6个月时，中位PFS为27.7个月（95%CI: 8.1-NE）。8646: Rechallenge with first-generation RET inhibitors in RET-rearranged NSCLC pre-treated with selpercatinib or pralsetinib: Results from the RET MAP registry.第一代RET抑制剂用于经selpercatinib或pralsetinib治疗的RET重排NSCLC患者的再次治疗：来自RET MAP注册研究的结果壁报展示：5月31日星期日，下午1:30 研究概况：RET MAP注册研究是一项国际多中心回顾性研究，收集了2012年2月-2022年4月期间确诊的218例RET融合基因NSCLC患者的真实数据。[11]本分析将评估经第二代RET抑制剂selpercatinib（Retevmo）或pralsetinib（Gavreto）治疗后病情进展的RET融合基因阳性NSCLC患者再次进行第一代RET抑制剂治疗的疗效和安全性。研究分析了包括手术、化疗（CT)、免疫检查点抑制剂（ICI)、CT-ICI联合治疗、多种TKI和RET抑制剂在内的多种疗法的临床生物学特征和治疗结果。参考文献（上下滑动可查看）1.FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer. FDA. October 3, 2024. Accessed May 9, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvantadjuvant-nivolumab-resectable-non-small-cell-lung-cancer2.FDA approves neoadjuvant nivolumab and platinum-doublet chemotherapy for early-stage non-small cell lung cancer. FDA. March 4, 2022. Accessed May 9, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-nivolumab-and-platinum-doublet-chemotherapy-early-stage-non-small-cell-lung3.Bristol Myers Squibb announces Opdivo plus chemotherapy as the first and only neoadjuvant-only immuno-oncology therapy to demonstrate statistically significant and clinically meaningful overall survival in resectable non-small cell lung cancer. News release. Bristol Myers Squibb. February 19, 2025. Accessed May 9, 2025. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Announces-Opdivo-Plus-Chemotherapy-as-the-First-and-Only-Neoadjuvant-Only-Immuno-Oncology-Therapy-to-Demonstrate-Statistically-Significant-and-Clinically-Meaningful-Overall-Survival-in-Resectable-Non-Small-Cell-Lung-Cancer/default.aspx4.Study on savolitinib combined with osimertinib in treatment of advanced NSCLC with MET amplification (SACHI). ClinicalTrials.gov. Updated March 30, 2023. Accessed May 9, 2025. https://clinicaltrials.gov/study/NCT050156085.HUTCHMED Announces NDA acceptance in China with priority review status for Orpathys and Tagrisso combination in lung cancer patients with MET amplification after progression on first-line EGFR inhibitor therapy. News release. HUTCHMED. January 2, 2025. Accessed May 9, 2025. https://www.hutch-med.com/orpathys-tagrisso-nda-acceptance-in-china-with-priority-review-status-for-lung-cancer-after-egfri/6.Leonetti A, Boni L, Gnetti L, et al. Neoadjuvant alectinib in potentially resectable stage III ALK-Positive NSCLC: Interim analysis of ALNEO-GOIRC-01-2020 phase II trial. J Thor Oncol. 2024;19(10):S52. doi:10.1016/j.jtho.2024.09.091.7.S. Popat, et al. Amivantamab plus chemotherapy vs chemotherapy in EGFR-mutated, advanced non-small cell lung cancer after disease progression on osimertinib: Second interim overall survival from MARIPOSA-2. 2024 ESMO, LBA54.8.Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) approved in the U.S. as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer. News release. Johnson & Johnson. August 20, 2024. Accessed May 9, 2025. https://www.investor.jnj.com/news/news-details/2024/RYBREVANT-amivantamab-vmjw-plus-LAZCLUZE-lazertinib-approved-in-the-U.S.-as-a-first-line-chemotherapy-free-treatment-for-patients-with-EGFR-mutated-advanced-lung-cancer/default.aspx9.Blakely CM, Urisman A, Gubens MA, et al. Neoadjuvant Osimertinib for the Treatment of Stage I-IIIA Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: A Phase II Multicenter Study. J Clin Oncol. 2024;42(26):3105-3114. doi:10.1200/JCO.24.0007110.First-line adagrasib (ADA) with pembrolizumab (PEMBRO) in patients with advanced/metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) and PD-L1 ≥ 50% from the phase 2 portion of KRYSTAL-7. Presented at: 2025 European Lung Cancer Congress; March 26-29, 2025; Paris, France. Abstract 5MO.11.Aldea M, Marinello A, Duruisseaux M, et al. RET-MAP: An International Multicenter Study on Clinicobiologic Features and Treatment Response in Patients With Lung Cancer Harboring a RET Fusion. J Thorac Oncol. 2023;18(5):576-586. doi:10.1016/j.jtho.2022.12.018（来源：《肿瘤瞭望》编辑部）声 明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。