A Single-Arm, Open-Label Phase II Clinical Study of Fruquintinib Combined With Sintilimab and Stereotactic Body Radiation Therapy (SBRT) for the Second-Line and Higher-Line Treatment of Gastric or Gastroesophageal Junction Adenocarcinoma With Oligometastatic Progression

Efficacy and safety of fruquintinib in combination with sintilizumab and SBRT in the treatment of oligonadenocarcinoma progression in the stomach or gastroesophageal junction

开始日期2025-06-01

申办/合作机构

南昌大学第二附属医院

NCT06900218

/ Not yet recruiting临床3期IIT

A Multicenter, Randomized Controlled Phase III Trial of Sintilimab Combined With Capecitabine Versus Capecitabine Alone as Adjuvant Therapy for High-Risk Locoregionally-advanced Nasopharyngeal Carcinoma

This study will enroll 664 patients who had completed induction chemotherapy combined with the PD-1 antibody sintilimab treatment followed by concurrent cisplatin-based chemoradiotherapy (no concurrent sintiliamb). Patients will be randomly divided into two groups. One group will receive 9 cycles of sintilimab therapy, while the other group will receive an additional year of capecitabine chemotherapy on top of the sintilimab treatment. The primary endpoints will be event-free survival and overall survival.

开始日期2025-05-01

申办/合作机构

中山大学

NCT06973330

/ Not yet recruiting临床2期IIT

Sintilimab Plus Apatinib and SOX as First-line Treatment in Patients With AFP Gastric or Gastroesophageal Junction Adenocarcinoma: a Single-arm, Multi-center, Phase II Trial

This is a multi-center, prospective, open label phase II study evaluating the safety and efficacy of standard first-line chemotherapy SOX regimen combined with Sintilimab (anti-PD-1 antibody) and Apatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Anhui Provincial Cancer Hospital. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with SOX regimen combined with Sintilimab plus Apatinib every 3 weeks(4 cycles) followed by sintilimab+apatinib until disease progression or intolerable adverse reactions or death(up to 24 months).Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.

开始日期2025-05-01

申办/合作机构

安徽省肿瘤医院

100 项与信迪利单抗相关的临床结果

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100 项与信迪利单抗相关的转化医学

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100 项与信迪利单抗相关的专利（医药）

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1,099

项与信迪利单抗相关的文献（医药）

2025-12-31·Hematology

Sintilimab for treating progressive multifocal leukoencephalopathy caused by human polyomavirus 2 virus infection following allogeneic hematopoietic cell transplantation: a case report

Article

作者: Zhong, Xushu ; Liu, Qinyu ; Jin, Xuelian ; Chen, Xinchuan

BACKGROUND:

Progressive multifocal leukoencephalopathy (PML) is characterized by demyelination in the central nervous system. It is caused by infection with human polyomavirus 2 and has a poor prognosis. Therapeutic strategies involve restoring immune function and/or discontinuing immunosuppressive treatment. Immune checkpoint inhibitors such as those targeting programmed death receptor-1 (PD-1) can alleviate PML by restoring T cell function. There are no case reports on the use of the PD-1 inhibitor, Sintilimab, for treating PML. Here, we report a case of successful treatment of PML with sintilimab following allogeneic hematopoietic stem cell transplantation.

CASE PRESENTATION:

A 35-year-old woman with high-risk acute myeloid leukemia underwent allogeneic hematopoietic stem cell transplantation after induced remission and developed PML 12 months after transplantation. She received five courses of 100 mg every 4 weeks with monitoring by magnetic resonance imaging (MRI) and viral load in the cerebrospinal fluid, showing clinical improvement, resolution of neurological symptoms, and reduced viral load. MRI showed initial exacerbation of lesions but significant improvement after five courses of treatment. No graft-versus-host disease occurred, but manageable immune reconstitution inflammatory syndrome was observed.

CONCLUSION:

Sintilimab, a PD-1 inhibitor, might be used to treat PML in patients with hematologic malignancies undergoing allo-HSCT, which needs further investigation.

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Hedgehog pathway inhibitors (HHI) combined with radiotherapy and immunotherapy for advanced basal cell carcinoma: a case report

Article

作者: Yao, Zhijian ; Wei, Gao ; Li, Longshan ; Zhao, Chen ; Li, Xianghui ; Ruan, Zhuren

PURPOSE:

Basal cell carcinoma (BCC) is one of the most common skin cancers. Most BCCs can be treated with surgery excision. For advanced BCC unsuitable for curative surgery, the combination of radiotherapy and Hedgehog pathway inhibitors (HHI) are effective systemic treatment options. However, there is a scarcity of evidence-based guidelines for the management of patients with advanced or metastatic BCC, particularly those who develop resistance to HHI therapy.

MATERIALS AND METHODS:

We report the case of a patient with advanced BCC of the head and neck, which originated from a nevus sebaceous.

RESULTS:

The patient initially responded well to sonidegib, an HHI, but resistance emerged within a month. We then modified the systemic therapy to include a combination of radiotherapy and the anti-PD-1 agent sintilimab.

CONCLUSIONS:

This adjusted treatment regimen led to effective long-term clinical responses without significant adverse events.

2025-12-31·ANNALS OF MEDICINE

Cost-effectiveness of PD-1 inhibitors combined with chemotherapy for first-line treatment of oesophageal squamous cell carcinoma in China: a comprehensive analysis

Article

作者: Xu, Kai ; Zhang, Lingli ; Yu, Man ; Lin, Yingtao ; Li, Xin ; Su, Dan ; Shang, Jingjing ; Sun, Qingli ; Gong, Jinhong ; Qian, Xiaodan

BACKGROUND:

Programmed death-1 (PD-1) inhibitors combined with chemotherapy have become a standard first-line treatment for advanced oesophageal squamous cell carcinoma (ESCC). Given the high costs associated with immunotherapy, evaluating the cost-effectiveness of different PD-1 inhibitors in the Chinese healthcare setting is essential for guiding treatment decisions and policy development.

METHODS:

A cost-effectiveness analysis was conducted comparing six PD-1 inhibitors-sintilimab, toripalimab, tislelizumab, camrelizumab, serplulimab, and pembrolizumab-combined with chemotherapy for first-line treatment of advanced ESCC. A partitioned survival model was used to calculate incremental cost-effectiveness ratios (ICERs) from healthcare system perspective, with a willingness-to-pay (WTP) threshold set at $36,598.19 per quality-adjusted life year (QALY). Sensitivity analyses were performed to evaluate the robustness of the results.

RESULTS:

The ICERs for toripalimab, camrelizumab, pembrolizumab, serplulimab, sintilimab, and tislelizumab were $32,356.79/QALY, $48,410.64/QALY, $312,743.54/QALY, $121,200.84/QALY, $29,663.42/QALY, and $35,304.33/QALY, respectively. Sintilimab, toripalimab, and tislelizumab were below the WTP threshold. Among all regimens, the top three in life years (LYs) gained were toripalimab, serplulimab, and tislelizumab. Sensitivity analysis showed that utility values and drug prices were key factors influencing ICERs. Probabilistic analysis indicated that toripalimab, sintilimab, and tislelizumab had the highest probabilities of being cost-effective, at 83.1%, 81.4%, and 70.0%, respectively.

CONCLUSION:

Sintilimab, toripalimab, and tislelizumab are the most cost-effective PD-1 inhibitors when combined with chemotherapy for the first-line treatment of advanced ESCC in China, with ICERs below the WTP threshold. While all six PD-1 inhibitors demonstrated clinical benefits, pembrolizumab and serplulimab were less favourable from a cost-effectiveness standpoint. Sensitivity analysis confirmed that drug prices and utility values are significant determinants of cost-effectiveness.

1,497

项与信迪利单抗相关的新闻（医药）

2025-05-26

·信达生物

荣耀登顶 | 全球首款申报上市的GCG/GLP-1双受体激动减重降糖药物玛仕度肽的临床研究结果在《新英格兰医学杂志》发布

2025年5月26日，美国旧金山和中国苏州——信达生物制药集团（香港联交所股票代码：01801），一家致力于研发、生产和销售肿瘤、自身免疫、代谢及心血管、眼科等重大疾病领域创新药物的生物制药公司，今日宣布：胰高血糖素（GCG）/胰高血糖素样肽-1（GLP-1）双受体激动剂，玛仕度肽，在中国超重或肥胖受试者中的III期临床研究（GLORY-1）结果近日在国际知名期刊《新英格兰医学杂志》（The New England Journal of Medicine, NEJM）全文在线发表（点击文末阅读原文查看文章），并特配专家评述。本文第一作者分别为北京大学人民医院纪立农教授和河南科技大学附属第一医院姜宏卫教授，另外纪立农教授和信达生物制药集团钱镭博士为本文共同通讯作者。这是全球首个且唯一申报上市的GCG/GLP-1双受体激动减重降糖药物的临床研究第一次登顶医学权威学术期刊，将改写国内外超重和肥胖疾病的临床治疗和指南。在中国代谢和内分泌疾病领域，第一次有创新药临床研究结果发表在全球最权威期刊上，代表了中国药物研发能力与生物科技创新水平迈上了新台阶。针对这项最新发布的重磅研究，哈佛大学医学院波士顿布莱根妇女医院 Vanita R. Aroda 教授与科罗拉多大学安舒茨医学院 Leigh Perreault 教授同步在《新英格兰医学杂志》发布评论指出，GLORY-1研究中展现出的中国人特点与西方人不同，在更加年轻的人群中，代谢异常比例不低甚至更高，而GCG/GLP-1双受体激动剂治疗不仅能显著降低体重和BMI，更能全面改善肥胖相关全身性健康风险；此外中国肥胖干预需结合本土人群特征实施差异化策略，重点关注肝脏健康与血脂管理。中国肥胖日益年轻化，社会负担更重，因此要更早干预，并且从早期干预也会带来更大获益。对于肥胖领域不断涌现的新疗法，两位专家认为药物疗法仅是肥胖防控的一环，需与公共卫生政策协同构建综合防治体系，以更有效应对全球肥胖负担。玛仕度肽预计今年在国内上市，将获批减重降糖两项适应症。因出色的减重疗效和全面的代谢获益，玛仕度肽获评2025年全球十大最受期待药物之一（FIERCE Pharma 2025）。此前临床研究表明i,ii：使用玛仕度肽体重降幅达21%，降低肝脏脂肪含量超 80%，腰围减少达11cm，颈围减少接近3cm，兼顾改善血压、血脂、血尿酸和转氨酶水平等多重代谢指标。玛仕度肽还能有效降低糖化血红蛋白达2.15%，且耐受性良好。此次入选《新英格兰医学杂志》的研究为玛仕度肽一项低剂量减重注册临床研究GLORY-1。GLORY-1研究共入组610例肥胖（BMI≥28 kg/m2）或超重（24kg/m2≤ BMI ＜28 kg/m2）并伴有至少一种肥胖相关并发症的受试者，随机接受玛仕度肽 4 mg、6 mg和安慰剂，每周一次、皮下注射给药48周。研究主要终点为第32周时体重较基线的百分比变化和体重较基线降幅≥5%的受试者比例。受试者基线平均体重为87.2 kg，基线平均BMI为31.1 kg/m2。研究结果显示，各剂量玛仕度肽相较安慰剂均可显著降低体重。基于疗效估计目标:第32周时，玛仕度肽4 mg、6 mg和安慰剂组体重较基线百分比变化的均值分别为−10.97%、−13.38%和−0.24%；第48周时分别为−12.05%、−14.84%和−0.47%。第32周时，玛仕度肽4 mg、6 mg和安慰剂组体重较基线降幅≥5%的受试者比例分别达76.3%、84.0%和10.9%。第48周时，玛仕度肽4 mg、6 mg和安慰剂组体重较基线降幅≥15%的受试者比例分别达37.0%、50.6%和2.1%。研究的主要终点及所有关键次要终点结果均显示了玛仕度肽任一剂量组相较安慰剂组具有统计学意义的优效性，p值均小于0.001(主要结果如下)。玛仕度肽显著降低血压、血脂（甘油三酯、总胆固醇和低密度脂蛋白胆固醇）、血尿酸、转氨酶水平等心血管代谢指标。此外，玛仕度肽显著降低了超重或肥胖受试者的肝脏脂肪含量。在基线肝脏脂肪含量≥5%的受试者中，第48周时，玛仕度肽4 mg、6 mg和安慰剂组受试者全肝平均脂肪含量相对基线的百分比变化均值分别为−63.26%、−73.18%和+8.20%；在基线肝脏脂肪含量≥10%的受试者中，第48周时，玛仕度肽4 mg、6 mg和安慰剂组受试者全肝平均脂肪含量相对基线的百分比变化均值分别为−65.85%、−80.24%和−5.27%。玛仕度肽总体耐受性和安全性良好。玛仕度肽组整体安全性特征与玛仕度肽的既往研究和其他GLP-1受体激动剂类药物相似。最常报告的治疗期不良事件包括恶心、腹泻和呕吐，大多为轻度或中度。研究期间未见心血管风险增加的安全性信号。该研究的牵头研究者、北京大学人民医院纪立农教授表示：“长期以来，全球肥胖诊疗指南主要基于白人人群数据，对亚洲人群的适用性存在偏差。与此同时，相比欧美人群，中国超重肥胖人群有着独特的疾病特点及治疗需求，亟需以中国证据，指导中国超重肥胖人群的体重管理。对于中国大多数超重和轻度肥胖症患者，减重目标应设定为：在3-6个月之内至少将体重降低5%-15%并维持；对于中、重度肥胖症患者则可设定更高的减重目标。GLORY-1研究人群全部来自中国人群，符合上述中国人群减重目标的设定，研究中玛仕度肽的减重数据十分令人振奋，近半数患者减重幅度＞15%，这提示，对于超重、轻度和中重度肥胖患者，玛仕度肽均能够帮助其显著控制体重，完成减重目标。玛仕度肽GLORY-1研究见刊于全球最权威的临床医学期刊《新英格兰医学杂志》，不仅代表了中国在内分泌代谢领域的创新研究成果得到了国际认可，也再次证实中国创新药物的研发能力与生物科技创新水平已走在了全球前列。玛仕度肽的研发成功将加速本土企业在肥胖管理领域的布局，为中国超重肥胖患者提供更具个性化的全周期管理方案。”信达生物制药集团钱镭博士表示：“玛仕度肽是全球GCG/GLP-1双受体激动剂中第一个即将获批的分子，其注册研究GLORY-1在《新英格兰医学杂志》的发表为中国内分泌代谢领域新药临床研究实现了零的突破，也为中国超重或肥胖受试者的的临床治疗提供了高质量的循证医学证据，未来必将改写指南与临床诊疗实践。这一学术成果同时证明了我国研究者卓越的临床研究水平和中国创新制药企业扎实的创新研发能力。玛仕度肽即将在中国获批上市，我们期待玛仕度肽为中国超重或肥胖人群带来更多和更优的治疗选择，为生活更添美好。作为创新药企业，信达生物积极响应国家号召，与有关各方携手同行，以前沿医学成果助力全民科学减重、推进健康中国建设。”关于肥胖/超重- 滑动查看更多介绍 -肥胖是一项成因复杂的慢性代谢性疾病，是导致糖尿病、脂肪肝、心脑血管疾病、肾病、关节疾病、呼吸睡眠障碍和癌症等一系列疾病的重要病因或危险因素。随着经济发展和生活方式的改变，中国肥胖症的患病人数已跃居世界首位iii。在较为严重的肥胖患者中，心血管疾病、糖尿病和某些肿瘤的发生率及死亡率明显上升。2019年超重和肥胖导致的死亡在慢性非传染性疾病相关死亡中占比11.1%，相比1990年的5.7%显著增加iv。超重/肥胖已成为一个严重的健康问题，生活方式干预是超重/肥胖者的基础且重要手段，但是仍有相当一部分患者由于种种原因不能达到期望的减重目标，需用药物辅助治疗。传统减肥药减重效果有限，且存在安全性问题，对疗效更好且安全的减肥疗法的临床需求尚未得到满足。关于玛仕度肽（IBI362）- 滑动查看更多介绍 -玛仕度肽是信达生物与礼来制药共同推进的一款胰高血糖素（GCG）/胰高血糖素样肽-1（GLP-1）双受体激动剂。作为一种哺乳动物胃泌酸调节素（OXM）类似物，玛仕度肽除了通过激动GLP-1受体促进胰岛素分泌、降低血糖和减轻体重外，还可通过激动GCGR增加能量消耗增强减重疗效，同时改善肝脏脂肪代谢。玛仕度肽已在多项临床研究中展现出优秀的减重和降糖疗效，以及降低腰围、血脂、血压、血尿酸、肝酶及肝脏脂肪含量，以及改善胰岛素敏感性，带来多重代谢获益。玛仕度肽当前共开展了六项III期临床研究，包括：在中国超重或肥胖受试者中开展的III期临床研究（GLORY-1）；在中国中重度肥胖受试者中开展的III期临床研究（GLORY-2）；在中国超重或肥胖合并MAFLD受试者中开展的III期临床研究（GLORY-3）;在初治的中国2型糖尿病患者中开展的III期临床研究（DREAMS-1）；在口服药物治疗血糖控制不佳的中国2型糖尿病受试者中开展的对比玛仕度肽和度拉糖肽的III期临床研究（DREAMS-2）；在中国2型糖尿病合并肥胖的受试者中开展的对比玛仕度肽和司美格鲁肽的III期临床研究（DREAMS-3）。其中，GLORY-1、DREAMS-1和DREAMS-2研究均已达成终点，其他研究还在进行中。此外，玛仕度肽的多项新临床研究计划启动，其中包括治疗青少年肥胖和阻塞性睡眠呼吸暂停（OSA）的两项III期临床研究，以及治疗代谢相关脂肪性肝炎（MASH）、射血分数保留心力衰竭（HFpEF）等新临床研究。关于信达生物- 滑动查看更多介绍 -“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有15个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®），雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®），伊基奥仑赛注射液（福可苏®），托莱西单抗注射液（信必乐®），氟泽雷塞片（达伯特®），匹妥布替尼片(捷帕力®)，己二酸他雷替尼胶囊（达伯乐®），利厄替尼片（奥壹新®）和替妥尤单抗N01注射液（信必敏®）。目前，同时还有3个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有15个新药品种已进入临床研究。公司已与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及20余万普通患者，药物捐赠总价值36亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。详情请访问公司网站：www.innoventbio.com或公司领英账号：Innovent Biologics。声明：1.信达不推荐任何未获批的药品/适应症使用。2.雷莫西尤单抗注射液（希冉择®），塞普替尼胶囊（睿妥®）和匹妥布替尼片（捷帕力®）由礼来公司研发。参考文献：i. JI L, et al. 1856-LB: Efficacy and Safety of Mazdutide in Chinese Participants with Overweight or Obesity (GLORY-1)[J]. Diabetes, 2024, 73(Supplement_1).ii.Mazdutide reduces body weight in adults with overweight or obesity: a multiple-dose study.2024 EASD Abstract # 734.iii.Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373-92.iv.Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool. http://ghdx.healthdata.org/gbd-resultstool (accessed Jan 10, 2021).前瞻性声明本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

临床3期申请上市

2025-05-23

·和黄医药官微

和黄医药将于美国临床肿瘤学会(ASCO)2025年年会公布数据

中国香港、上海和美国新泽西州：2025年5月23日，星期四：和黄医药(中国)有限公司 (简称 "和黄医药" 或 "HUTCHMED") (纳斯达克/伦敦证交所: HCM; 香港交易所: 13) 今日宣布和黄医药自主研发的化合物赛沃替尼、HMPL-306 (ranosidenib)、呋喹替尼和索凡替尼的数项研究的最新及更新后的数据将于2025年5月30日至6月3日在美国芝加哥召开的2025年美国临床肿瘤学会(ASCO) 年会上公布。SACHI中国III期研究的结果将以最新突破性口头报告的形式公布，该研究旨在评估赛沃替尼联合奥希替尼用于一线表皮生长因子受体 ("EGFR") 抑制剂治疗后疾病进展的EGFR突变阳性伴MET扩增的局部晚期或转移性非小细胞肺癌患者。 SACHI 在预设的中期分析中已达到预设的主要终点无进展生存期 ("PFS")。SACHI研究的数据支持了该口服疗法的新药上市申请，该申请已于中国获受理并纳入优先审评。赛沃替尼联合奥希替尼用于治疗既往接受奥希替尼治疗后疾病进展、伴有MET过表达和/或扩增的EGFR突变的非小细胞肺癌患者的SAVANNAH II期研究中高MET过表达和/或扩增亚组的进一步数据，以及根据脑转移状态分层的分析结果亦于大会公布。与赛沃替尼加安慰剂相比，赛沃替尼和奥希替尼的联合疗法显示出更佳的疗效。此联合疗法显示出良好的中枢神经系统活性，延缓中枢神经系统进展并减少新的中枢神经系统病灶。HMPL-306的I期临床试验剂量递增阶段的结果将于大会公布。HMPL-306是一种新型、高选择性的小分子口服异柠檬酸脱氢酶 ("IDH")1和IDH2酶双重抑制剂，正于伴有IDH突变的局部晚期或转移性实体瘤患者中开展研究。结果显示，该药物耐受性良好，在患者中显示出靶点抑制和持久的缓解。研究观察到疗效信号，且在低级别胶质瘤的疗效评估组 (N=14)中尤其显著，客观缓解率 ("ORR")为7.1%，疾病控制率 ("DCR")为100%。FRUSICA-1 开放标签、单臂、关键性II期临床试验的亚组分析结果亦将公布，该研究旨在评估呋喹替尼联合信迪利单抗用于治疗经治的晚期错配修复完整 (pMMR) 子宫内膜癌患者的疗效和安全性。浆液性癌患者 (N=27) 中观察到具有临床意义的疗效结果，与整体研究人群 (N=98) 中观察到的缓解情况相似。独立审查委员会 ("IRC") 评估的ORR为37.0%，DCR为88.9%。在缓解是否会受到既往新辅助/辅助化疗 ("NACT/ACT") 影响的分析中表明，无论患者既往是否曾接受 NACT/ACT治疗，均显示出持久且具有临床意义的缓解。接受过和未接受NACT/ACT治疗的患者的结果相若，IRC 评估的ORR分别为34.0%和31.4%，DCR分别为85.1%和82.4%。两项来自呋喹替尼在中国2798名结直肠癌患者中开展的IV期研究的亚组分析结果将会公布。在评估呋喹替尼单药疗法和联合疗法安全性的亚组分析中，呋喹替尼在两组中均显示出可控的安全性。3级以上治疗期间不良事件 (TEAE) 在呋喹替尼单药治疗组中发生率为23.94%，与其他抗癌药物联合疗法组则为26.06%。两组中最常见的治疗相关不良事件 (TRAE) 均为掌跖红肿感觉异常 (PPES) 和高血压。联合疗法组的治疗持续时间更长，这可能表明患者的治疗结果有所改善。在按年龄分组的亚组分析中，评估了呋喹替尼在较年轻患者 (年龄<50岁) 和高龄患者 (年龄≥75岁) 中的安全性。两个年龄组中的安全性相似，较年轻患者接受了更为密集的治疗。呋喹替尼联合疗法的治疗持续时间在两个年龄组中也均优于单药疗法，这可能表明带来更高的生存获益。报告详情包括已公布的摘要链接如下：公司申办的研究标题：赛沃替尼联合奥希替尼对比化疗用于治疗EGFR TKI治疗后疾病进展的EGFR突变伴MET扩增的晚期非小细胞肺癌：SACHI III期随机研究的结果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主要作者：陆舜，上海交通大学医学院附属胸科医院上海肺癌中心，中国上海会议环节：口头报告 | Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic摘要编号：LBA8505时间：2025年6月1日 (星期日) 北美中部夏令时上午9:48标题：赛沃替尼联合奥希替尼对比赛沃替尼联合安慰剂的SAVANNAH II期研究中随机亚组的疗效和中枢神经系统结果Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) 主要作者：Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 会议环节：快速口头报告 | Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic摘要编号：8513时间：2025年6月2日 (星期一) 北美中部夏令时上午8:06标题：IDH1/IDH2突变抑制剂HMPL-306用于治疗晚期IDH突变的实体瘤 (包括神经胶质瘤) 西方患者的I期研究Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma主要作者：Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX会议环节：快速口头报告 | Rapid Oral Session: Central Nervous System Tumors摘要编号：2013时间：2025年5月31日 (星期六) 北美中部夏令时下午3:06标题：FRUSICA-1研究中浆液性癌的亚组分析: 呋喹替尼联合信迪利单抗用于治疗晚期pMMR子宫内膜癌患者Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status主要作者：吴小华，复旦大学附属肿瘤医院，中国上海会议环节：海报展示 | Poster Session: Gynecologic Cancer摘要编号：5596 标题：既往新辅助/辅助化疗 (NACT/ACT) 对呋喹替尼联合信迪利单抗在晚期pMMR子宫内膜癌患者中治疗结果的影响: FRUSICA-1研究的亚组分析The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1主要作者：王静，湖南省肿瘤医院，中国长沙会议环节：海报展示 | Poster Session: Gynecologic Cancer摘要编号：5611标题：真实世界临床实践中呋喹替尼治疗年轻和高龄结直肠癌中国患者的安全性: 呋喹替尼IV期研究的年龄亚组分析Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study主要作者：王奕，宁波市第二医院，中国宁波会议环节：线上发表| Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15512标题：真实世界临床实践中呋喹替尼单药疗法和联合疗法治疗中国结直肠癌患者的安全性: IV期研究的亚组分析Safety of fruquintinib monotherapy and combination therapy in Chinese patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study主要作者：王志强，中山大学肿瘤防治中心，中国广州会议环节：线上发表| Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15515标题：血管生成抑制剂和化疗用于晚期胃腺癌或胃食管结合部腺癌患者的适当治疗顺序: FRUTIGA III期研究的探索性分析The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study主要作者：李进，同济大学附属东方医院，中国上海会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16011标题：FRUTIGA研究中呋喹替尼联合紫杉醇对比紫杉醇用于治疗胃食管结合部腺癌的疗效和安全性亚组分析: 一项二线治疗胃/胃食管结合部腺癌的随机III期临床试验Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/ gastroesophageal junction 主要作者：刘天舒，复旦大学附属中山医院，中国上海会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16012研究者发起的研究标题：呋喹替尼联合卡瑞利珠单抗和紫杉醇脂质体和奈达铂用于一线治疗晚期食道鳞状细胞癌: 一项单臂II期研究Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study 主要作者：顾艳宏，江苏省人民医院 (南京医科大学第一附属医院)，中国南京会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4042标题：呋喹替尼联合PD-1抑制剂及化疗用于一线治疗HER2阴性的晚期胃癌或胃食管结合部腺癌(FDZL-FIX)的更新结果: 一项单臂、开放标签II期研究Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study主要作者：王辰辰，复旦大学附属肿瘤医院，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4046标题：呋喹替尼联合曲妥珠单抗及XELOX方案用于一线治疗晚期HER2阳性的转移性胃腺癌或胃食管结合部腺癌的开放标签、单臂、单中心Ib/II期临床试验Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma主要作者：吕慧芳，河南省肿瘤医院 (郑州大学附属肿瘤医院)，中国郑州会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：TPS4203标题：转移性结直肠癌治疗的多队列真实世界研究: 整体疗效分析以及既往是否使用贝伐珠单抗的亚组分析A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not 主要作者：吕汪霞，浙江省肿瘤医院，中国杭州会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15530标题：呋喹替尼联合伊立替康和卡培他滨用于二线治疗晚期结直肠癌的真实世界观察性研究Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer主要作者：徐玲，中国医科大学附属第一医院，中国沈阳会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15539 标题：呋喹替尼联合FOLFIRI方案用于二线治疗RAS突变的转移性结直肠癌的初步结果: 一项前瞻性单中心II期研究 Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study主要作者：贾茹，解放军总医院第五医学中心，中国北京会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15541标题：评估呋喹替尼对比瑞戈非尼和曲氟尿苷/替吡嘧啶用于治疗晚期转移性结直肠癌的疗效: 匹配调整间接比较Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/ tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison主要作者：秦叔逵，中国药科大学附属南京天印山医院，中国南京会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Colorectal and Anal摘要编号：e15550标题：呋喹替尼联合信迪利单抗和SOX方案作为初始不可切除的胃/胃食管结合部腺癌的转化治疗: 单臂II期临床试验的更新疗效和手术结果Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial主要作者：马飞，河南省肿瘤医院 (郑州大学附属肿瘤医院)，中国郑州会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16016标题：一项评估呋喹替尼联合恩沃利单抗用于治疗晚期或不可切除的局部晚期骨肉瘤和软组织肉瘤患者的疗效和安全性的II期研究A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma主要作者：周陈亮，上海交通大学附属第六人民医院，中国上海会议环节：线上发表 | Publication Only: Sarcoma摘要编号：e23506标题：索凡替尼联合紫杉醇用于二线治疗晚期胃癌的疗效和安全性: II期研究的最终结果Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial主要作者：肖秀英，上海交通大学医学院附属仁济医院，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4028标题：索凡替尼联合KN046和化疗用于一线治疗晚期胰腺的疗效和安全性:一项单臂Ib/II期研究Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial主要作者：王文权，复旦大学附属中山医院，中国上海会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4157标题：索凡替尼、卡瑞利珠单抗、白蛋白结合型紫杉醇和替吉奥用于一线治疗局部晚期或转移性胰腺导管腺癌患者: 一项Ib/II期随机研究First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study主要作者：贾茹/戴广海，解放军总医院第五医学中心，中国北京会议环节：海报展示 | Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：4161标题：一项探索帕米帕利联合索凡替尼作为新辅助疗法用于治疗晚期不可切除卵巢癌的前瞻性、单臂、II期临床研究 (PASSION)A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) 主要作者：夏百荣，中国科学技术大学附属第一医院，中国合肥会议环节：海报展示 | Poster Session: Gynecologic Cancer摘要编号：5589标题：索凡替尼单药疗法用于三线治疗晚期肝细胞癌的疗效及安全性: 一项单臂、开放标签、多中心II期研究The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study 主要作者：周福祥，武汉大学中南医院，中国武汉会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16209标题：索凡替尼联合吉西他滨与顺铂和免疫检查点抑制剂用于治疗不可切除的局部晚期或转移性胆管细胞癌Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma主要作者：钟敬涛/石学涛，山东第一医科大学附属肿瘤医院，中国济南会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16222标题：索凡替尼联合信迪利单抗和IBI310用于治疗高级别晚期神经内分泌肿瘤患者的多中心、单臂II期研究的最新结果Updated results from a multicenter, single-arm Phase ll study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN)主要作者：陆明/沈琳，北京大学肿瘤医院，中国北京会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16342标题：索凡替尼联合吉西他滨和白蛋白结合型紫杉醇作为可切除和临界可切除胰腺癌新辅助治疗的前瞻性、单臂II期研究A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer主要作者：高松/郝继辉，天津医科大学肿瘤医院，中国天津会议环节：线上发表 | Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary摘要编号：e16442前瞻性陈述本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款中定义的前瞻性陈述。这些前瞻性陈述反映了和黄医药目前对未来事件的预期，包括对赛沃替尼、HMPL-306、呋喹替尼、和索凡替尼的治疗潜力的预期，赛沃替尼、HMPL-306、呋喹替尼和索凡替尼的进一步临床研究计划，对赛沃替尼、HMPL-306、呋喹替尼和索凡替尼的研究是否能达到其主要或次要终点的预期，以及对此类研究完成时间和结果发布的预期。此类风险和不确定性包括下列假设：入组率、满足研究入选和排除标准的受试者的时间和可用性；临床方案或监管要求变更；非预期不良事件或安全性问题；赛沃替尼、HMPL-306、呋喹替尼和索凡替尼 (包括作为联合疗法) 达到研究的主要或次要终点的疗效；获得不同司法管辖区的监管批准及获得监管批准后获得上市许可；赛沃替尼、HMPL-306、呋喹替尼和索凡替尼用于目标适应症的潜在市场，以及资金充足性等。此外，由于部分研究可能依赖于与其他药物联合使用，因此此类风险和不确定性包括有关这些治疗药物的安全性、疗效、供应和监管批准的假设。当前和潜在投资者请勿过度依赖这些前瞻性陈述，这些陈述仅在截至本新闻稿发布当日有效。有关这些风险和其他风险的进一步讨论，请查阅和黄医药向美国证券交易委员会、香港联合交易所有限公司以及AIM提交的文件。无论是否出现新讯息、未来事件或情况或其他因素，和黄医药均不承担更新或修订本新闻稿所含讯息的义务。医疗信息本新闻稿所提到的产品可能并未在所有国家上市，或可能以不同的商标进行销售，或用于不同的病症，或采用不同的剂量，或拥有不同的效力。本文中所包含的任何信息都不应被看作是任何处方药的申请、推广或广告，包括那些正在研发的药物。和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）是一家处于商业化阶段的创新型生物医药公司，致力于发现、全球开发和商业化治疗癌症和免疫性疾病的靶向药物和免疫疗法。自成立以来，和黄医药致力于将自主发现的候选药物带向全球患者，首三个药物现已在中国上市，其中首个药物亦于美国、欧洲和日本等全球各地获批。欲了解更多详情，请访问：www.hutch-med.com/sc。

ASCO会议临床结果优先审批临床2期临床3期

2025-05-23

·EINPresswire

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new data from several studies of compounds discovered by HUTCHMED including savolitinib, ranosidenib, fruquintinib and surufatinib, will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place on May 30 – June 3, 2025 in Chicago, USA. Results from the SACHI China Phase III study of savolitinib in combination with osimertinib in patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation-positive non-small cell lung cancer (“NSCLC”) with MET amplification after disease progression on EGFR inhibitor therapy will be presented at a late breaking oral presentation. SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. SACHI data supports the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China. Further data with additional analysis stratified by brain metastasis status from a high MET overexpression and/or amplification treatment subset of the SAVANNAH Phase II study of the savolitinib and osimertinib combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression after progressing on osimertinib were reported. The savolitinib and osimertinib combination demonstrated better efficacy outcomes compared to savolitinib plus placebo. The combination showed promising central nervous system (“CNS”) activity, with reduced CNS progression and fewer new CNS lesions. Results will be presented from the dose-escalation stage of the Phase I study of ranosidenib (HMPL-306), a novel, small-molecule, highly selective oral dual-inhibitor of both Isocitrate dehydrogenase (“IDH”) 1 and IDH2 enzymes, being studied in patients with locally advanced or metastatic solid tumors with IDH mutations. Results show that the compound was well tolerated, showing target inhibition and durable responses in patients. Efficacy signals were observed especially in the efficacy evaluated group of lower-grade glioma patients (N=14), with an objective response rate (“ORR”) of 7.1% and a disease control rate (“DCR”) of 100%. Results will also be presented from the sub-group analyses of the FRUSICA-1 open-label, single-arm, pivotal Phase II study to evaluate the efficacy and safety of fruquintinib plus sintilimab in previously treated advanced endometrial cancer (EMC) patients with pMMR (proficient mismatch repair) status. Efficacy findings for patients with serous carcinoma (N=27) were clinically meaningful and characterized by responses similar to those observed in full trial population (N=98), with an Independent Review Committee (“IRC”)-assessed ORR of 37.0% and a DCR of 88.9%. The analysis of whether the response was affected by prior neoadjuvant/adjuvant chemotherapy (“NACT/ACT”) showed durable and clinically meaningful responses regardless of whether the patient had received NACT/ACT. Results were comparable for patients with and without prior NACT/ACT, with an IRC-assessed ORR of 34.0% versus 31.4% and DCR of 85.1% versus 82.4%, respectively. Results from two subgroup analyses of a Phase IV study of fruquintinib involving 2,798 colorectal cancer patients in China will be presented. In the subgroup analysis evaluating the safety of fruquintinib as monotherapy and in combination therapy, fruquintinib demonstrated a manageable safety profile in both groups. Treatment-emergent adverse events (TEAE) of Grade 3 or above occurred in 23.94% in the fruquintinib monotherapy group and 26.06% in the combination therapy group with other anti-cancer treatments. The most common treatment related adverse events (TRAE) of any grade in both groups were palmar-plantar erythrodysesthesia (PPES) and hypertension. The combination therapy group exhibited a longer treatment duration, potentially indicating improved patient outcomes. In the subgroup analysis by age, the safety of fruquintinib was assessed in younger (age <50) and late-elderly (age ≥75) patients. The safety profile was comparable across both age groups, with younger patients receiving more intensive treatment. Combination therapy with fruquintinib also showed a longer duration than monotherapy in both age subgroups, which may suggest improved survival potential. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead author Presentation details SPONSORED STUDIES Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET -amplification ( MET amp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China LBA8505 Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Sunday, June 1, 2025 9:48 AM CDT Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO) Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD 8513 Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic Monday, June 2, 2025 8:06 AM CDT Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in western patients (pts) with advanced mIDH solid tumor, including glioma Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center, Houston, TX 2013 Rapid Oral Session: Central Nervous System Tumors Saturday, May 31, 2025 3:06 PM CDT Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with pMMR status Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China 5596 Poster Session: Gynecologic Cancer The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC) Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1 Jing Wang, Hunan Cancer Hospital, Changsha, China 5611 Poster Session: Gynecologic Cancer Safety of fruquintinib in young and late-elderly Chinese patients with colorectal cancer in real-world clinical practice: Age subgroup analysis of a fruquintinib Phase IV study Yi Wang, Ningbo No.2 Hospital, Ningbo, China e15512 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Safety of fruquintinib monotherapy and combination therapy in Chinese Patients with colorectal cancer in real-world clinical practice: A subgroup analysis from Phase IV study Zhiqiang Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China e15515 Publication Only: Gastrointestinal Cancer - Colorectal and Anal The appropriate therapeutic sequence with angiogenesis inhibitor and chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study Jin Li, Shanghai East Hospital, Tongji University, Shanghai, China e16011 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel versus paclitaxel in gastroesophageal junction adenocarcinoma patients from FRUTIGA: A randomized Phase III clinical trial in second-line treatment of gastric/gastroesophageal junction Tianshu Liu, Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China e16012 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary INVESTIGATOR-INITIATED STUDIES Fruquintinib in combination with camrelizumab and paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): a single-arm, Phase II study Yanhong Gu, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China 4042 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy in the first-line treatment of HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label Phase II study Chenchen Wang, Fudan University Shanghai Cancer Center, Shanghai, China 4046 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Open-label, single-arm, single-center Phase Ib/II clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma Huifang Lv, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China TPS4203 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A multi-cohort real-world study of treatment for metastatic colorectal cancer (mCRC): Overall efficacy analysis and subgroup analysis of previous bevacizumab use or not Wangxia Lv, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China e15530 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Real-world Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal Cancer Ling Xu, the First Hospital of China Medical University, Shenyang, China e15539 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study Ru Jia, Fifth Medical Center, Chinese PLA General Hospital, Beijing, China e15541 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison Shukui Qin, Gastrointestinal Cancer Center of Nanjing Tianyinshan Hospital, China Pharmaceutical University, Nanjing, China e15550 Publication Only: Gastrointestinal Cancer - Colorectal and Anal Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial Fei Ma, Henan Cancer Hospital, Zhengzhou, China e16016 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma Chenliang Zhou, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China e23506 Publication Only: Sarcoma Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase II trial Xiuying Xiao, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China 4028 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial Wenquan Wang, Zhongshan Hospital, Fudan University, Shanghai, China 4157 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study Ru Jia/ Guanghai Dai, the Fifth Medical Center of the PLA General Hospital, Beijing, China 4161 Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadiuvant therapy for advanced, unresectable ovarian cancer (PASSION) Bairong Xia, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China 5589 Poster Session: Gynecologic Cancer The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study Fuxiang Zhou, Zhongnan Hospital of Wuhan University, Wuhan, China e16209 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Jingtao Zhang/ Xuetao Shi, Cancer Hospital of Shandong First Medical University, Jinan, China e16222 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary Updated results from a multicenter, single-arm Phase II study of surufatinib plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine neoplasm (HG-NEN) Ming Lu/ Lin Shen, Peking University Cancer Hospital, Beijing, China e16342 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary A prospective, single-arm, Phase II study of surufatinib in combination with gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and borderline resectable pancreatic cancer Song Gao/ Jihui Hao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China e16442 Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of savolitinib, ranosidenib, fruquintinib and surufatinib, the further clinical development for savolitinib, ranosidenib, fruquintinib and surufatinib, its expectations as to whether any studies on savolitinib, ranosidenib, fruquintinib and surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, ranosidenib, fruquintinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib, ranosidenib, fruquintinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床结果临床2期ASCO会议临床3期临床1期

100 项与信迪利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	信迪利单抗	L01XC	DB15765

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期子宫内膜癌	中国	信达生物制药（苏州）有限公司	2024-12-01
典型霍奇金淋巴瘤	中国澳门	信达生物制药（苏州）有限公司	2024-02-22
非小细胞肺癌	中国澳门	信达生物制药（苏州）有限公司	2024-02-22
EGFR阳性非鳞状非小细胞肺癌	中国	信达生物制药（苏州）有限公司	2023-05-06
胃食管交界处腺癌	中国	信达生物制药（苏州）有限公司	2022-06-23
胃癌	中国	信达生物制药（苏州）有限公司	2022-06-23
食管鳞状细胞癌	中国	信达生物制药（苏州）有限公司	2022-06-16
肝细胞癌	中国	信达生物制药（苏州）有限公司	2021-06-28
非鳞状非小细胞肺癌	中国	信达生物制药（苏州）有限公司	2021-02-03
霍奇金淋巴瘤	中国	信达生物制药（苏州）有限公司	2018-12-24

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
错配修复缺陷或微高卫星不稳定性结肠癌	申请上市	中国	信达生物制药（苏州）有限公司	2025-02-22
EGFR-T790M 突变非小细胞肺癌	申请上市	中国	信达生物制药（苏州）有限公司	2022-01-30
食管癌	申请上市	中国	信达生物制药（苏州）有限公司	2021-09-22
不能切除的大肠癌	临床3期	中国	深圳微芯生物科技股份有限公司	2024-11-27
非小细胞肺癌IIIB期	临床3期	中国	信达生物制药（苏州）有限公司	2024-03-15
可切除非小细胞肺癌	临床3期	中国	信达生物制药（苏州）有限公司	2024-03-15
局部晚期食管鳞状细胞癌	临床3期	中国	信达生物制药（苏州）有限公司	2022-11-01
晚期肾细胞癌	临床3期	中国	和黄医药（中国）有限公司	2022-10-27
肝癌	临床3期	中国	信达生物制药（苏州）有限公司	2022-01-30
进展期胃腺癌	临床3期	中国	信达生物制药（苏州）有限公司	2021-03-10

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed 人工标引	N/A	晚期胆道癌	221	Durvalumab	淵淵窪範壓遞觸積糧鹽(醖鹽顧遞壓願顧獵醖餘) = 窪衊鑰簾膚淵繭選齋蓋廠遞觸蓋廠鹹觸顧鹹觸 (顧製獵壓糧鹽襯構憲襯 ) 更多	积极	2025-03-31
				Sintilimab	淵淵窪範壓遞觸積糧鹽(醖鹽顧遞壓願顧獵醖餘) = 觸鹽繭膚窪憲蓋憲齋齋廠遞觸蓋廠鹹觸顧鹹觸 (顧製獵壓糧鹽襯構憲襯 ) 更多
NCT05522231 (FRUSICA-2, GlobeNewswire) 人工标引	临床2/3期	晚期肾细胞癌二线	-	fruquintinib + sintilimab	鑰廠壓壓艱製壓夢積願(壓鬱鑰製鏇鹽鹽醖簾艱) = met its primary endpoint of progression free survival. 憲網鑰壓淵餘簾廠餘願 (遞襯獵淵鬱壓範簾範襯 ) 达到更多	积极	2025-03-18
NCT04745130 (Pubmed) 人工标引	临床2期	微卫星稳定型结直肠癌	-	Regorafenib plus Sintilimab	顧鹽鏇鹹鏇觸範鏇鏇淵(廠鏇齋鬱鹹齋鑰廠鹽醖) = 獵鏇鏇夢觸醖艱願網糧網淵遞淵壓築構壓築艱 (鏇製範衊網鑰壓獵鑰蓋, 10.5 ~ 17.7) 更多	积极	2025-02-10
				Regorafenib plus Sintilimab (RAS/RAF wild-type)	顧鹽鏇鹹鏇觸範鏇鏇淵(廠鏇齋鬱鹹齋鑰廠鹽醖) = 觸鬱餘憲獵淵構觸範範網淵遞淵壓築構壓築艱 (鏇製範衊網鑰壓獵鑰蓋, 10.0 ~ 36.6)
NCT04722718 (NeoSAC, Signal Transduct Target Ther) 人工标引	临床2期	三阴性乳腺癌新辅助 HER2 Negative \| PR Negative \| ER Negative	34	Apatinib + sintilimab + nab-paclitaxel + carboplatin	膚壓製範憲鹽積構餘衊(夢鑰憲齋遞顧繭簾蓋襯) = 願廠選獵壓壓糧範鬱製廠繭襯餘顧繭鑰襯鏇艱 (窪餘遞獵顧製膚廠壓衊, 53.0 ~ 85.3) 更多	积极	2025-02-07
NCT05244798 (SCIENCE, ASCO_GI2025) 人工标引	临床3期	食管鳞状细胞癌新辅助	146	Sintilimab combined with nCT (nab-paclitaxel plus carboplatin) for two cycles	築願觸選鹽淵醖衊積淵(齋糧鬱餘鹽鬱憲廠膚蓋) = 齋遞艱夢醖齋窪壓餘夢選網壓衊艱襯鏇築憲憲 (蓋廠憲簾觸壓襯糧積網 ) 达到更多	积极	2025-01-27
				Sintilimab combined with concurrent nCRT (nab-paclitaxel plus carboplatin chemotherapy and radiotherapy using IMRT/IGRT totaling 41.4 Gy)	築願觸選鹽淵醖衊積淵(齋糧鬱餘鹽鬱憲廠膚蓋) = 壓餘範簾鹽遞鑰築窪鹽選網壓衊艱襯鏇築憲憲 (蓋廠憲簾觸壓襯糧積網 ) 达到更多
NCT05024968 (ASCO_GI2025) 人工标引	临床2期	原发部位不明恶性肿瘤	10	Sintilimab 200 mg IV every 3 weeks	鏇選觸構蓋鏇餘鑰鑰鏇(襯衊壓艱壓選壓鹽製觸) = 鬱簾壓窪願醖遞遞鹹淵鬱壓製築蓋繭簾鹽艱觸 (齋廠顧願製齋鏇獵鏇齋, 12.2 ~ 73.8) 更多	积极	2025-01-23
ESMO_ASIA2024 人工标引	临床2期	非小细胞肺癌新辅助	30	Anlotinib + Sintilimab	衊廠獵鏇範壓顧築艱製(獵鏇襯衊壓鏇廠獵獵鏇) = 鹹襯艱淵鏇壓襯遞醖壓遞範願餘築齋淵鹹鏇憲 (網願觸積廠壓製積衊積 ) 更多	积极	2024-12-07
				Chemotherapy + Immunotherapy	衊廠獵鏇範壓顧築艱製(獵鏇襯衊壓鏇廠獵獵鏇) = 餘壓膚鏇簾壓衊壓壓廠遞範願餘築齋淵鹹鏇憲 (網願觸積廠壓製積衊積 ) 更多
NCT04271813 (ESMO_ASIA2024) 人工标引	临床2期	结直肠癌一线	29	Sintilimab plus Anlotinib	繭鹽選蓋窪鹹構衊網鏇(築餘鹹鹽網鏇淵齋遞顧) = 獵鏇壓鹹憲繭夢夢網艱鏇獵積窪網衊鑰衊範製 (艱衊窪觸憲積壓廠夢製, 28.3–65.7) 更多	积极	2024-12-07
NCT05017103 (CTgov)	临床2期	恶性纤维组织细胞瘤	6	sintilimab	餘構窪襯糧壓襯襯齋觸 = 築觸鑰齋糧淵獵膚顧繭鹽蓋壓遞簾鏇膚餘鏇製 (築選顧獵蓋遞窪衊獵製, 餘構簾築鹽鏇鹽憲膚築 ~ 蓋簾簾簾願網簾壓襯獵) 更多	-	2024-11-12
NCT05400070 (TD-NeoFOUR, Pubmed) 人工标引	临床2期	可切除非小细胞肺癌新辅助	45	Sintilimab+Anlotinib+Chemotherapy (ITT)	鑰夢觸淵範蓋鑰鹹醖鏇(願膚餘廠鏇餘觸糧範廠) = 憲窪衊糧憲齋襯簾範壓遞衊齋選鹽鑰獵鬱製獵 (鏇壓壓鬱網鬱鏇構窪襯 ) 更多	积极	2024-10-28
				Sintilimab+Anlotinib+Chemotherapy (per-protocol set)	鑰夢觸淵範蓋鑰鹹醖鏇(願膚餘廠鏇餘觸糧範廠) = 糧鑰構廠醖願鬱觸蓋襯遞衊齋選鹽鑰獵鬱製獵 (鏇壓壓鬱網鬱鏇構窪襯 ) 更多