分享好友 资讯首页 频道列表

Pimicotinib Demonstrates Best-in-Class Potential with Significant Efficacy and Clinically Meaningful Improvements in Patients with Tenosynovial Giant Cell Tumor

2025-06-03 09:2916440

Global Phase 3 MANEUVER study of pimicotinib in tenosynovial giant cell tumor (TGCT) met the primary endpoint, demonstrating objective response rate at week 25 of 54.0% versus 3.2% for placebo (p<0.0001)
MANEUVER met all five key secondary endpoints, with statistically significant and clinically meaningful improvements in pain, stiffness, range of motion, physical function, and decrease in tumor volume
Treatment was well-tolerated, with low incidence of treatment discontinuation and dose reductions
Not intended for Canada-, UK- or US-based media

DARMSTADT, Germany--(BUSINESS WIRE)--Merck, a leading science and technology company, today announced the presentation of detailed positive results from Part 1 of the global Phase 3 MANEUVER trial evaluating pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., in the treatment of patients with tenosynovial giant cell tumor (TGCT). Once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo (p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT. These findings will be presented Sunday, June 1 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #11500).

“The impact that TGCT has on patients goes far beyond the physical presence of the tumor. It affects their ability to work, to move freely, and to engage in everyday activities," said Prof. Niu Xiaohui, Director of the Bone and Soft Tissue Tumour Diagnosis and Research Centre at Beijing Jishuitan Hospital. “In MANEUVER, we observed the highest ORR seen to date with a systemic therapy, together with statistically significant improvements in measures of pain, stiffness, and range of motion. These improvements in outcomes that matter to patients with TGCT and the physicians who care for them show the potential of pimicotinib to allow patients to go about their daily lives with fewer negative effects of their disease.”

In MANEUVER, which enrolled patients from China, Europe and North America, the effect of pimicotinib had an early onset, with 41.3 % (26 of 63) of patients experiencing objective response to therapy after 13 weeks. By the data cutoff for primary analysis, nearly all patients in the pimicotinib group (58 of 63 patients; 92.1%) had a decrease in tumor size per BIRC based on RECIST v1.1; one patient achieved a complete response and 33 patients achieved a partial response. The median duration of response was not reached by the data cutoff. The analysis of tumor volume score (TVS, an endpoint designed specifically for TGCT) showed that nearly two-thirds of patients treated with pimicotinib experienced a reduction in tumor volume of at least 50% (61.9% vs. 3.2% for placebo, p<0.0001).

Pimicotinib also demonstrated statistically significant and clinically meaningful improvement across all additional secondary endpoints relevant to patients’ daily lives, and these improvements were seen regardless of achieving objective tumor response to pimicotinib. Pimicotinib improved active range of motion (p=0.0003) and physical function measured by PROMIS-PF scale (p=0.0074). Pimicotinib also reduced worst stiffness (p<0.0001) and worst pain (p<0.0001).

“TGCT, although rare, has a significant impact on the daily lives of the primarily working-age adults who live with the disease, due to swelling, pain, stiffness, and limited mobility caused by the growth of these tumors in and around the joints,” said Danny Bar-Zohar, appointed CEO Healthcare and current Global Head of R&D and Chief Medical Officer. “The landmark global Phase 3 MANEUVER study data will help redefine how TGCT is treated, and we plan regulatory submissions to start this year.”

Pimicotinib was well-tolerated, and the safety profile was consistent with previously reported data, with no evidence of cholestatic hepatotoxicity or hair/skin hypopigmentation. Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation occurred in one patient (1.6%) treated with pimicotinib; TEAEs leading to dose reduction occurred in 7.9% (n=5) of pimicotinib-treated patients.

About MANEUVER

The pivotal Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who require systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted by Abbisko Therapeutics in China (n=45), Europe (n=28), and the US and Canada (n=21).

In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint is objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review in the intent-to-treat (ITT) population. Secondary endpoints include tumor volume score, active range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS).

After the double-blind Part 1, eligible patients could continue to the open-label Part 2 for up to 24 weeks of dosing, results of which are expected in mid-2025. Patients who complete Part 2 may then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up.

About Pimicotinib (ABSK021)

Pimicotinib (ABSK021), which is being developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib was recently granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with tenosynovial giant cell tumor (TGCT) who require systemic therapy. Pimicotinib has been granted breakthrough therapy designation (BTD) for the treatment of unresectable TGCT by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds worldwide commercialization rights for pimicotinib.

Advancing the Future of Cancer Care

At Merck, we strive every day to improve the futures of people living with cancer. Building on our 350-year global heritage as pharma pioneers, we are focusing our most promising science to target cancer’s deepest vulnerabilities, pursuing differentiated molecules to strike cancer at its core. By developing new therapies that can help advance cancer care, we are determined to create a world where more cancer patients will become cancer survivors. Learn more at www.merckgroup.com.

About Merck

Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck, generated sales of € 21.2 billion in 65 countries.

The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

All Merck, press releases are distributed by e-mail at the same time they become available on the EMD Group website. In case you are a resident of the USA or Canada, please go to www.Merckgroup.com/subscribe to register for your online, change your selection or discontinue this service.

 

Contacts

Media Relations
gangolf.schrimpf@emdgroup.com
Phone: +49 151 1454 9591

Investor Relations
investor.relations@merckgroup.com
Phone: +49 6151 72-3321

反对 0
举报 0
收藏 0
打赏 0
评论 0
RAEOA与CMC开启新篇章:欧库西将引领东帝汶现代化进程
东帝汶欧库西--(美国商业资讯)--在一场具有里程碑意义的前瞻性公私合作中,欧库西-安贝诺特别行政区(RAEOA)与Core Management Corporation (CMC)公布了一项大胆的多领域发展战略,旨在将欧库西打造成东帝汶数字创新、可持续旅游和绿色能源的首要枢纽。 本新闻稿包含多媒体。此处查看新闻稿全文: https://www.businesswire.com/news/home/20250706060996/zh-CN/ 这一转型的核心是欧库西数字中心(ODC)智...

0评论2025-07-091723

IBA主席Umar Kremlev携手Terence Crawford与Tyson Fury,开启国际拳击协会黄金时代
Fury确认有意为争夺IBA职业赛头衔与Anthony Joshua对决:“让我看到诚意!” 伊斯坦布尔--(美国商业资讯)--拳击界一众重磅人物齐聚伊斯坦布尔,国际拳击协会(IBA)主席Umar Kremlev在此揭晓该运动“黄金时代”的规划。在拳坛名将Terence Crawford与重量级传奇Tyson Fury的共同见证下,Kremlev概述了IBA的愿景:构建支持业余、职业及裸拳拳击全层级选手的生态系统。 本新闻稿包含多媒体。此处查看新闻稿全文: http...

0评论2025-07-091724

CorFlow Therapeutics宣布MOCA-II IDE关键性试验获得FDA批准,旨在验证新型心脏病发作治疗技术
瑞士巴尔--(美国商业资讯)--专注于微血管疾病的心脏护理领域先驱企业CorFlow Therapeutics AG (CorFlow)今日宣布,该公司的技术已获得美国食品药品管理局(FDA)的研究性器械豁免(IDE)批准,这意味着关键性临床试验可在美国各医院启动。CorFlow目前正准备为这些临床试验中心配备CorFlow系统,开展相关培训,并开始招募接受心脏病治疗的患者。 这项名为MOCA-II的IDE关键性试验旨在前瞻性验证专有CorFlow CoFl系统在原发性经皮冠状动脉介入治...

0评论2025-07-091511

TH Global Capital四个月内在澳大利亚完成四项重大并购交易,包括Infosys收购The Missing Link
悉尼--(美国商业资讯)--足迹遍布13个国家的屡获殊荣的精品投资银行TH Global Capital于2025年前四个月完成了四笔备受瞩目的交易,其中包括以1.2亿澳元将The Missing Link售于Infosys。这是该公司在过去18个月内于澳大利亚完成的第十笔跨境交易,进一步巩固了其作为澳大利亚和新西兰中型市场并购精品投资银行的首选地位。 Infosys收购The Missing Link – 总部位于悉尼的The Missing Link是屡获殊荣的网络...

0评论2025-07-091070

Lubrizol的Apinovex聚合物荣获2025年世界制药原料中国展药用辅料奖
克利夫兰--(美国商业资讯)-- Lubrizol的Apinovex™聚合物在6月24日至26日于上海举办的世界制药原料中国展(CPhI China)上荣获药用辅料奖类别的表彰奖。CPhI通过多渠道活动和各地区数字平台为全球制药供应链提供支持,行业专业人士可在此就原料药(API)、合同开发与生产组织(CDMO)、辅料等进行交流、学习与合作。 本新闻稿包含多媒体。此处查看新闻稿全文: https://www.businesswire.com/news/home/20250707...

0评论2025-07-091629

Tecnotree入选两份2025年Gartner技术成熟度曲线(Hype Cycle)报告
芬兰埃斯波--(美国商业资讯)--全球领先的AI、5G及云原生技术数字平台与服务提供商Tecnotree已入选两份2025年Gartner®技术成熟度曲线报告。 本新闻稿包含多媒体。此处查看新闻稿全文: https://www.businesswire.com/news/home/20250707756622/zh-CN/ Tecnotree入选的2025年Gartner技术成熟度曲线报告如下: 《2025年企业通信服务技术成熟度曲线》(针对通信服务提供商(CSP)...

0评论2025-07-092027

泰雷兹 2025年全球云安全研究:企业在保护不断扩展的AI驱动云环境方面困难重重
52%的企业报告称,AI安全支出正在挤占传统安全预算 55%的企业报告称,云环境比本地基础设施更难保障安全 企业平均使用85个SaaS应用,导致安全工具过度分散 法国默东--(美国商业资讯)--近日,全球科技与网络安全领域的领先企业之一泰雷兹宣布发布《2025年泰雷兹云安全研究报告》。该报告由S&P Global Market Intelligence旗下的451 Research开展的一项年度调查。研究显示,针对AI的专项安全保护已迅速成为企业的首要任务,其重要性仅次于云安...

0评论2025-07-091756

村田在市场上抢先推出采用XBAR技术的商品化高频滤波器 -该产品可在 3GHz 以上的频段实现高衰减和低损耗信号检测-
主要特性 市面上居先采用XBAR技术的高频滤波器产品 在3GHz以上的频段中实现了低插损、高衰减和高带宽 结合了村田的声表面波滤波器(SAW)专有技术,同时实现了高质量和高性价比 日本京都--(美国商业资讯)--株式会社村田制作所(TOKYO: 6981)今日宣布,公司已开始批量生产和付运市面上居先(1)采用 XBAR 技术(2)的高频滤波器(以下简称“该产品”)。该产品的开发结合了Resonant公司的XBAR技术与村田的专有滤波器技术,村田于2022年收...

0评论2025-07-091962

马萨诸塞州联邦法院驳回维梧资本就科兴生物控股事宜的救济申请
法院驳回维梧资本有关股东投票和公司治理的救济措施申请,为每股55.00美元特别现金股息派发再次扫清法律障碍 尚珹资本/Prime和维梧资本针对现任董事会及董事会主席发起的法律诉讼行动连续失败,其蓄意发布误导性和毁誉性言论的宣传徒然无功 Glass Lewis与ISS两家国际知名公司治理研究与股东投票独立咨询机构发布新报告,一致建议股东投票支持由李嘉强博士领导的现任董事会留任 北京--(美国商业资讯)--中国领先的生物制药公司科兴控股生物技术有限公司(Sinovac Biotech Ltd....

0评论2025-07-091199

Omdia:BOE有望在2025年成为苹果MacBook显示面板的最大供应商
伦敦--(美国商业资讯)-- Omdia的 “平板电脑和笔记本显示面板及OEM研究服务”最新分析显示,2025年京东方(BOE)将占据苹果MacBook显示面板供应量的51%。苹果的MacBook系列以其最先进的LCD显示面板而著称,其具备高分辨率、氧化物背板、Mini LED背光和低功耗等特性。笔记本电脑厂商也计划在未来几年内从LCD过渡到OLED。 本新闻稿包含多媒体。此处查看新闻稿全文: https://www.businesswire.com/news/h...

0评论2025-07-081558