Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical Trial

Exploring the efficacy of PD-1 inhibitor combination therapy strategies for adjuvant therapy in a population that has not achieved major pathological regression after neoadjuvant immunotherapy for non-small cell lung cancer: a multicenter, phase II clinical study

开始日期2024-09-30

申办/合作机构

上海市肺科医院

NCT06580574 / Recruiting临床2期IIT

Sintilimab With Selective Combination of Sintilimab, IBI310 and Lenvatinib Used for Organ Preservation in Non-metastatic Gastric or Colon Cancers With Mismatch Repair Deficiency or High Microsatellite Instability

This study intends to explore the role of PD1/PDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR/MSI-H gastric or colon cancers with mismatch repair deficiency or high microsatellite instability

开始日期2024-08-13

申办/合作机构

北京大学

NCT05890742 / Recruiting临床3期

A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer

开始日期2023-05-25

申办/合作机构

信达生物制药（苏州）有限公司

100 项与重组全人源抗细胞毒T淋巴细胞相关抗原4 (CTLA-4)单克隆抗体 (信达生物) 相关的临床结果

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100 项与重组全人源抗细胞毒T淋巴细胞相关抗原4 (CTLA-4)单克隆抗体 (信达生物) 相关的转化医学

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100 项与重组全人源抗细胞毒T淋巴细胞相关抗原4 (CTLA-4)单克隆抗体 (信达生物) 相关的专利（医药）

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项与重组全人源抗细胞毒T淋巴细胞相关抗原4 (CTLA-4)单克隆抗体 (信达生物) 相关的文献（医药）

2024-07-01·The Innovation

IBI310 (anti-CTLA-4 antibody) monotherapy or in combination with sintilimab in advanced melanoma or urothelial carcinoma

Article

作者: Yang, Yue ; Shen, Yuping ; Li, Juan ; Wei, Xiaoting ; Si, Lu ; Guo, Jun ; Tang, Bixia ; Chi, Zhihong ; Zheng, Shirui ; Zhou, Li ; Mao, Lili ; Guo, Qun ; Li, Siming ; Lian, Bin ; Cui, Chuanliang ; Yan, Xieqiao ; Wang, Xuan

IBI310 is a recombinant fully human IgG1 antibody against cytotoxic T lymphocyte antigen 4. This study was conducted to evaluate IBI310 monotherapy or combination therapy with sintilimab in the patients with advanced melanoma or urothelial carcinoma (UC). Patients in phase 1a received IBI310 at 0.3/1/2/3 mg/kg intravenously (IV) every 3 weeks (Q3W) following the accelerated titration and 3 + 3 escalation design. Patients in phase 1b received IBI310 (1/2/3 mg/kg IV, Q3W) plus sintilimab (200 mg IV, Q3W) for four cycles, followed by sintilimab maintenance therapy. The phase 1b expansion of IBI310 plus sintilimab was performed in patients with advanced melanoma or UC. Overall, 53 patients were enrolled, including 10 patients with melanoma in phase 1a, 34 with melanoma, and 9 with UC in phase 1b. Overall, 94.3% of patients (50/53) experienced at least one treatment-related adverse event (TRAE) with most being grade 1-2; 26.4% of patients (14/53) experienced grade 3 or higher TRAEs. In phase 1a, the disease control rate (DCR) was 50.0% (95% confidence interval [CI], 18.7%-81.3%). In phase 1b, the objective response rate (ORR) and DCR were 17.6% (95% CI, 6.8%-34.5%) and 44.1% (95% CI, 27.2%-62.1%), respectively, for melanoma, and were 22.2% (95% CI, 2.8%-60.0%) and 66.7% (95% CI, 29.9%-92.5%), respectively, for UC. IBI310 monotherapy or combination therapy with sintilimab was well tolerated with favorable antitumor activity across patients with advanced melanoma and UC.

2024-02-01·Cancer medicine

A phase Ib study evaluating the safety and efficacy of IBI310 plus sintilimab in patients with advanced non‐small‐cell lung cancer who have progressed after anti‐PD‐1/L1 therapy

Article

作者: Yao, Jun ; Zhao, Jun ; Long, Jianlin ; Chen, Ye ; Cui, Jiuwei ; Meng, Rui ; Liu, Ziling ; Zhao, Yuguang ; Li, Li ; Zang, Aimin ; Guo, Qun ; Mao, Yong ; Chen, Xiao ; Luo, Yang ; Wu, Di

Abstract:

Background:

The development of immune checkpoint inhibitors has made a significant breakthrough in the treatment of non‐small‐cell lung cancer (NSCLC). However, there remains a huge unmet clinical need for patients with acquired resistance after initial treatment response.

Methods:

This study evaluated the combination of IBI310 (an anti‐cytotoxic T lymphocyte‐associated antigen‐4 [CTLA‐4] antibody) and sintilimab (an anti‐programmed death 1 [PD‐1]) antibody) in NSCLC patients who have previously been treated with anti‐PD‐1/ligand (L)1 and acquired resistance. The patients were randomly assigned to receive either a lower dose of IBI310 (1 mg/kg Q3W, cohort A) or a higher dose of IBI310 (3 mg/kg Q3W, cohort B) in combination with sintilimab (200 mg Q3W). The primary endpoints of the study were objective response rate (ORR) assessed by RECISTv1.1 and safety, while secondary endpoints included disease control rate (DCR), progression‐free survival (PFS), and overall survival (OS).

Results:

As of November 2, 2023, the study had enrolled 30 patients, with 15 patients in each cohort. The ORR was 13.3% (2/15, 95% confidence interval [CI], 1.7–40.5) in cohort B. DCR were 46.7% (95% CI, 21.3–73.4) and 66.7% (95% CI, 38.4–88.2) in cohorts A and B, respectively. In cohorts A and B of this trial, the median follow‐up times were 4.2 and 5.6 months, respectively. Median PFS was 1.45 (95% CI, 1.35–2.73) versus 2.73 (95% CI, 1.41–4.90) months for cohort A versus B; the median OS was 7.03 (95% CI, 3.09–not calculable [NC]) months in cohort A and 8.90 (95% CI, 5.13–NC) months in cohort B. Of the 30 patients, 86.7% in both cohorts experienced treatment‐related adverse events (TRAEs) with Grade ≥3 TRAEs occurring in 40% and 53.3% of patients in cohorts A and B, respectively.

Conclusion:

IBI310 3 mg/kg Q3W plus sintilimab was effective in a small number of previously treated anti‐PD‐1/L1‐resistant NSCLC patients.

2022-01-01·Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva4区 · 医学

Metastatic lesion of choroidal melanoma located in the head of pancreas

4区 · 医学

ArticleOA

作者: Castro Rodríguez, Javier ; Perdices López, Emilia Victoria ; Osuna Soto, Julio

Metastases in pancreas are uncommon, ranging from 2 to 5 % of pancreatic malignancies. Choroidal melanoma is rare, and less than 1% spread to the pancreas. It can cause obstructive jaundice if it affects the pancreatic head region. Advanced disease is associated with poor prognosis, however immunotherapy with PD-1 inhibitors (nivolumab or pembrolizumab), alone or in combination with anti-CTLA-4 antibodies (ipilimumab), has shown an increase in survival.

项与重组全人源抗细胞毒T淋巴细胞相关抗原4 (CTLA-4)单克隆抗体 (信达生物) 相关的新闻（医药）

2024-11-25

·PRNewswire

Innovent to Present Clinical Data of Multiple Novel Molecules at ESMO Asia 2024

SAN FRANCISCO and SUZHOU, China, Nov. 24, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that nearly 10 accepted clinical data of its novel oncology molecules, including an oral presentation of updated Phase 1 result of its novel TOPO1i CLDN18.2 ADC (IBI343) in previously-treated pancreatic cancer, will be released at the European Society of Medical Oncology Asia (ESMO Asia) Congress 2024 from Dec 06-08, 2024, in Singapore. Details on the abstracts are listed below: Mini Oral Abstract Title: Anti-claudin18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients with advanced pancreatic ductal adenocarcinoma (PDAC): updated results from a Phase 1 study Abstract No: 132MO Session Type and Title: Mini Oral session: Gastrointestinal tumors Presentation Time: 2024-12-07, 09:50-09:55 Presenter: Jian Zhang, Fudan University Shanghai Cancer Center, CN Abstract Title: mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody in Locally Advanced MSS CRC (BASKETⅡ): A Prospective, Single-Arm, Open-Label, Phase 2 Study Abstract No: 74MO Session Type and Title: Mini Oral session: Gastrointestinal tumors Presentation Time: 2024-12-07, 10:20-10:25 Presenter: Jun Huang, The Sixth Affiliated Hospital, Sun Yat-sen University, CN Posters Abstract Title: Anlotinib plus Sintilimab as First-line Treatment for Patients with Advanced Colorectal Cancer (APICAL-CRC): an Open-Label, Single-arm, Phase 2 study Abstract No: 75P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Zhan Wang, Shanghai Changzheng Hospital, The Second Affiliated Hospital of Naval Medical University, CN Abstract Title: A single-arm, multicenter, Phase 2 study of hepatic arterial infusion chemotherapy (HAIC) combined with donafenib and sintilimab as first-line treatment for unresectable intrahepatic cholangiocarcinoma (CHANCE 2203) Abstract No: 137P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Gaojun Teng, Zhongda Hospital, Southeast University, CN Abstract Title: FOLFOX-HAIC combined with sintilimab and bevacizumab for advanced hepatocellular carcinoma: a single-arm, Phase 2 study Abstract No: 207P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Bin Liang/ Zizhuo Wang, Union Hospital Tongji Medical College Huazhong University of Science and Technology, CN Abstract Title: Updated results from Phase 2 study of HAIC plus sintilimab and bevacizumab biosimilar in patients with advanced hepatocellular carcinoma (HCC) Abstract No: 214P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Haibin Zhang, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital of Naval Medical University, CN Abstract Title: Anlotinib Combined with Sintilimab Versus Chemotherapy Combined with Immunotherapy in Perioperative NSCLC: A Phase 2 Study Abstract No: 599P Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Tianqing Chu, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, CN Trial in Progress abstracts (TiP) Abstract Title: A randomized, controlled, multicenter Phase 3 study of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) as neoadjuvant treatment for resectable microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colon cancer: Trial in Progress Abstract No.: 119TiP Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Ruihua Xu, Sun Yat-sen University Cancer Center, CN Abstract Title: Efficacy and Safety of Combination Therapy of Sintilimab and Chemotherapy with Cryoablation in the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Abstract No.: 722TiP Session Type and Title: Poster Display session Presentation Time: 2024-12-07, 17:50-18:45 Presenter: Zhiqiang Gao, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, CN Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are very pleased to present and share a robust set of clinical data at EAMO Asia 2024. Notably, we are highlighting the breakthrough potential for our TOPO1i CLDN18.2 ADC (IBI343) in pancreatic cancer, a global difficult-to-treat cancer. Consistent with the preliminary signal observed in small patient size, the data in dose expansion stage demonstrated encouraging efficacy and good safety, which reinforced our confidence in advancing its development. Given unique design of Fc-silent antibody, combined with stable linker and potent extecan payload, IBI343 pioneered in the exploration of CLDN18.2 ADC agents for PDAC treatment. As one of the few biopharmaceutical companies with both advanced technology platforms and a robust pipeline in "IO+ADC" areas, Innovent remains dedicated to transforming cancer treatment by delivering innovative, effective, and safe therapeutic options for doctors and patients." 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 11 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 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. 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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company 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 materialise or turn out to be incorrect. 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

临床2期临床1期临床结果抗体药物偶联物免疫疗法

2024-11-25

·信达生物

信达生物将在ESMO Asia 2024年会上公布IBI343（CLDN18.2 ADC）等多项创新管线更新临床数据

2024年11月25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，将在2024年欧洲肿瘤内科学会亚洲年会（ESMO Asia）上公布近10项临床数据，含2项口头报告，其中包括IBI343（创新TOPO1i CLDN18.2 ADC）治疗胰腺癌的I期更新数据。ESMO Asia年会将于当地时间2024年12月6日-8日在新加坡举办。详细摘要信息如下：口头报告摘要标题：抗Claudin18.2 (CLDN18.2) ADC药物IBI343治疗晚期胰腺导管腺癌 (PDAC): I期研究数据更新摘要编号: 132MO 展示形式：Mini Oral 展示时间：2024年12月7日, 09:50-09:55 讲者：张剑教授，复旦大学附属肿瘤医院摘要标题：mFOLFOX6+贝伐珠单抗+信迪利单抗 (PD-1抗体) 治疗局部晚期MSS型结直肠癌：一项前瞻性、单臂、开放标签II期研究（BASKET II）摘要编号：74MO 展示形式：Mini Oral 展示时间：2024年12月7日, 10:20-10:25 讲者：黄俊教授，中山大学附属第六医院壁报展示摘要标题：信迪利单抗联合安罗替尼一线治疗晚期肠癌 (APICAL-CRC)：一项开放标签、单臂、II期研究摘要编号: 75P 展示形式：壁报展示时间：2024年12月7日, 17:50-18:45 讲者：王湛教授，上海长征医院摘要标题：肝动脉灌注化疗（HAIC）联合信迪利单抗和多纳非尼作为不可切除肝内胆管癌一线治疗的一项单臂、多中心、II期研究（CHANCE 2203）摘要编号：137P 展示形式：壁报展示时间：2024年12月7日, 17:50-18:45 讲者：滕皋军教授，东南大学附属中大医院摘要标题：FOLFOX-HAIC联合信迪利单抗及贝伐珠单抗治疗晚期肝细胞癌：一项单臂II期研究摘要编号：207P 展示形式：壁报展示时间：2024年12月7日, 17:50-18:45 讲者：梁斌/王子卓教授，华中科技大学同济医学院附属协和医院摘要标题：肝动脉灌注化疗（HAIC）联合信迪利单抗和贝伐珠单抗用于晚期肝细胞癌患者治疗的II期研究的更新结果摘要编号：214P 展示形式：壁报展示时间：2024年12月7日, 17:50-18:45 讲者：张海斌教授，上海东方肝胆外科医院中文标题: 信迪利单抗联合安罗替尼vs. 免疫联合化疗治疗围手术期NSCLC：II期临床研究摘要编号：599P 展示形式：壁报展示时间：2024年12月7日, 17:50-18:45 讲者：储天晴教授，上海交通大学附属胸科医院方案发表（TiP）摘要标题：IBI310（抗CTLA-4抗体）联合信迪利单抗作为可切除的MSI-H/dMMR结肠癌新辅助治疗的一项随机、对照、多中心的3期研究：正在进行中摘要编号：119TiP 展示形式：壁报展示时间：2024年12月7日, 17:50-18:45 讲者：徐瑞华教授，中山大学肿瘤防治中心摘要标题: 信迪利单抗联合化疗及冷冻消融一线治疗晚期非鳞状非小细胞肺癌的疗效和安全性摘要编号：722TiP 展示形式：壁报展示时间：2024年12月7日, 17:50-18:45 讲者：高志强教授，上海交通大学附属胸科医院信达生物制药集团高级副总裁周辉博士表示：“很高兴在本次ESMO Asia大会上持续更新我们多个突破性临床数据，尤其在全球难治癌种胰腺癌上，信达生物创新TOPO1i CLDN18.2 ADC IBI343，在早期少量人群初步疗效信号的基础上，扩大入组后依然看到了令人鼓舞的疗效信号和良好的安全性。IBI343以其独特的抗体端Fc沉默设计、稳定的linker、强活性extecan的payload，成为目前在PDAC治疗方面进度最为领先的CLDN18.2 ADC分子。作为少数拥有“IO+ADC”技术平台和充沛管线储备的生物制药企业，信达生物将在癌症治疗领域持续取得突破，致力于为医生和患者提供更创新、有效和安全的治疗手段及方案。” 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11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®）和氟泽雷塞片（达伯特®）。目前，同时还有5个品种在NMPA审评中，3个新药分子进入III期或关键性临床研究，另外还有17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17余万普通患者，药物捐赠总价值34亿元人民币。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.信达生物不推荐未获批的药品/适应症的使用。 2.雷莫西尤单抗注射液（希冉择®）和塞普替尼胶囊（睿妥®）由礼来公司研发。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，目的均是要指明其属前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述乃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，有些乃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。

临床2期临床1期抗体药物偶联物临床结果

2024-11-24

·信达生物

信达生物将在ESMO Asia 2024年会上公布IBI343（CLDN18.2 ADC）等多项创新管线更新临床数据

2024年11月25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，将在2024年欧洲肿瘤内科学会亚洲年会（ESMO Asia）上公布近10项临床数据，含2项口头报告，其中包括IBI343（创新TOPO1i CLDN18.2 ADC）治疗胰腺癌的I期更新数据。ESMO Asia年会将于当地时间2024年12月6日-8日在新加坡举办。详细摘要信息如下：口头报告摘要标题：抗Claudin18.2 (CLDN18.2) ADC药物IBI343治疗晚期胰腺导管腺癌 (PDAC): I期研究数据更新摘要编号: 132MO 展示形式： Mini Oral 展示时间： 2024年12月7日, 09:50-09:55 讲者：张剑教授，复旦大学附属肿瘤医院摘要标题： mFOLFOX6+贝伐珠单抗+信迪利单抗 (PD-1抗体) 治疗局部晚期MSS型结直肠癌：一项前瞻性、单臂、开放标签II期研究（BASKET II）摘要编号： 74MO 展示形式： Mini Oral 展示时间： 2024年12月7日, 10:20-10:25 讲者：黄俊教授，中山大学附属第六医院壁报展示摘要标题：信迪利单抗联合安罗替尼一线治疗晚期肠癌 (APICAL-CRC)：一项开放标签、单臂、II期研究摘要编号: 75P 展示形式：壁报展示时间： 2024年12月7日, 17:50-18:45 讲者：王湛教授，上海长征医院摘要标题：肝动脉灌注化疗（HAIC）联合信迪利单抗和多纳非尼作为不可切除肝内胆管癌一线治疗的一项单臂、多中心、II期研究（CHANCE 2203）摘要编号： 137P 展示形式：壁报展示时间： 2024年12月7日, 17:50-18:45 讲者：滕皋军教授，东南大学附属中大医院摘要标题： FOLFOX-HAIC联合信迪利单抗及贝伐珠单抗治疗晚期肝细胞癌：一项单臂II期研究摘要编号： 207P 展示形式：壁报展示时间： 2024年12月7日, 17:50-18:45 讲者：梁斌/王子卓教授，华中科技大学同济医学院附属协和医院摘要标题：肝动脉灌注化疗（HAIC）联合信迪利单抗和贝伐珠单抗用于晚期肝细胞癌患者治疗的II期研究的更新结果摘要编号： 214P 展示形式：壁报展示时间： 2024年12月7日, 17:50-18:45 讲者：张海斌教授，上海东方肝胆外科医院中文标题: 信迪利单抗联合安罗替尼vs. 免疫联合化疗治疗围手术期NSCLC：II期临床研究摘要编号： 599P 展示形式：壁报展示时间： 2024年12月7日, 17:50-18:45 讲者：储天晴教授，上海交通大学附属胸科医院方案发表（TiP）摘要标题： IBI310（抗CTLA-4抗体）联合信迪利单抗作为可切除的MSI-H/dMMR结肠癌新辅助治疗的一项随机、对照、多中心的3期研究：正在进行中摘要编号： 119TiP 展示形式：壁报展示时间： 2024年12月7日, 17:50-18:45 讲者：徐瑞华教授，中山大学肿瘤防治中心摘要标题: 信迪利单抗联合化疗及冷冻消融一线治疗晚期非鳞状非小细胞肺癌的疗效和安全性摘要编号： 722TiP 展示形式：壁报展示时间： 2024年12月7日, 17:50-18:45 讲者：高志强教授，上海交通大学附属胸科医院信达生物制药集团高级副总裁周辉博士表示：“很高兴在本次ESMO Asia大会上持续更新我们多个突破性临床数据，尤其在全球难治癌种胰腺癌上，信达生物创新TOPO1i CLDN18.2 ADC IBI343，在早期少量人群初步疗效信号的基础上，扩大入组后依然看到了令人鼓舞的疗效信号和良好的安全性。IBI343以其独特的抗体端Fc沉默设计，稳定的linker，强活性extecan的payload，成为目前在PDAC治疗方面进度最为领先的CLDN18.2 ADC分子。作为少数拥有“IO+ADC”技术平台和充沛管线储备的生物制药企业，信达生物将在癌症治疗领域持续取得突破，致力于为医生和患者提供更创新、有效和安全的治疗手段及方案。” 关于信达生物 “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11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®）和氟泽雷塞片（达伯特®）。目前，同时还有5个品种在NMPA审评中，3个新药分子进入III期或关键性临床研究，另外还有17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17余万普通患者，药物捐赠总价值34亿元人民币。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www.linkedin.com/company/innovent-biologics/。声明：1.信达生物不推荐未获批的药品/适应症的使用。 2.雷莫西尤单抗注射液（希冉择®）和塞普替尼胶囊（睿妥®）由礼来公司研发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，目的均是要指明其属前瞻性表述。本公司并无义务不断地更新这些预测性陈述。这些前瞻性表述乃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，有些乃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。如需了解更多信息，敬请联系: 媒体：邮件： pr@innoventbio.com 电话：+86 512-69566088 投资者：邮件： ir@innoventbio.com 电话：+86 512-69566088

临床2期临床1期抗体药物偶联物临床结果

100 项与重组全人源抗细胞毒T淋巴细胞相关抗原4 (CTLA-4)单克隆抗体 (信达生物) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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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	临床3期	中国	信达生物制药（苏州）有限公司	2023-05-25
晚期肝细胞癌	临床3期	中国	信达生物制药（苏州）有限公司	2021-02-07
肢端雀斑恶性黑色素瘤	临床3期	中国	信达生物制药（苏州）有限公司	2020-04-17
黑色素瘤	临床3期	中国	苏州信达生物科技有限公司	2020-04-17
晚期胆道癌	临床2期	中国	信达生物制药（苏州）有限公司	2023-03-10
鼻咽癌	临床2期	中国	苏州信达生物科技有限公司	2021-07-07
晚期宫颈癌	临床2期	中国	信达生物制药（苏州）有限公司	2020-11-23
错配修复缺陷或微卫星高度不稳定性结直肠癌	临床2期	中国	信达生物制药	2020-08-07
晚期胃食管交界处腺癌	临床2期	中国	信达生物制药（苏州）有限公司	2019-12-13
爱泼斯坦-巴尔病毒相关胃癌	临床2期	中国	信达生物制药（苏州）有限公司	2019-12-13

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临床结果

适应症

分期

评价

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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


NCT05890742 (PRNewswire) 人工标引	临床1期	错配修复缺陷或微卫星高度不稳定性结直肠癌 Deficient DNA Mismatch Repair (dMMR) \| MSI-High	101	IBI310 + sintilimab	鏇壓選選觸積蓋夢願憲(鹽積糧願衊蓋齋壓鬱鏇) = 鹽廠獵艱鹽願襯壓鬱鹹願製鹽範壓構衊壓簾築 (鏇壓廠餘網觸遞鹽醖網 ) 更多	积极	2024-06-02
				sintilimab	鏇壓選選觸積蓋夢願憲(鹽積糧願衊蓋齋壓鬱鏇) = 餘淵壓選糧艱壓餘齋鬱願製鹽範壓構衊壓簾築 (鏇壓廠餘網觸遞鹽醖網 ) 更多
NCT05890742 (ASCO2024) 人工标引	临床1期	错配修复缺陷或微卫星高度不稳定性结直肠癌一线 \| 新辅助 microsatellite instability-high \| mismatch repair-deficient	101	IBI310 1 sintilimabsintilimab 200 mg Q3W	蓋餘鹹齋艱簾遞憲蓋網(膚壓鏇衊餘範鹽獵繭糧) = 繭願範鹹顧窪糧窪遞醖構齋膚願夢鑰廠衊衊選 (觸蓋鑰獵觸製繭鹽製鹹, 66.3 ~ 90.0) 更多	积极	2024-05-24
				Sintilimab 200 mg Q3W	蓋餘鹹齋艱簾遞憲蓋網(膚壓鏇衊餘範鹽獵繭糧) = 選餘憲繭顧膚簾憲觸遞構齋膚願夢鑰廠衊衊選 (觸蓋鑰獵觸製繭鹽製鹹, 32.5 ~ 63.3) 更多
NCT04202601 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	爱泼斯坦-巴尔病毒相关胃癌一线 \| 二线 EBV Positive	49	Sintilimab 3mg/kg plus IBI310 1mg/kg	鹽醖鹹構艱憲鏇鬱選鹹(遞構鹹淵獵選觸膚簾鏇) = 簾廠選鬱範鏇艱淵廠餘築壓獵顧襯獵簾醖觸選 (願獵觸蓋簾窪獵壓鹹醖 ) 更多	积极	2023-10-23
				Sintilimab 3mg/kg plus IBI310 1mg/kg (treatment-naïve)	遞繭鬱獵鏇艱夢網鑰願(鏇鑰鑰醖觸廠遞製積積) = 蓋選築鏇糧鬱積鏇齋衊衊夢餘鏇鏇壓襯鬱窪遞 (憲顧餘齋醖鏇醖簾憲選, 40.6 ~ 79.8) 更多
NCT04401813 (ASCO_GI2022) 人工标引	临床1期	晚期肝细胞癌	29	sintilimab+IBI310	鬱遞醖鬱艱襯襯餘製醖(憲顧淵餘願獵願範築壓) = 觸壓廠壓鏇網顧觸廠構窪鏇膚醖夢鑰構夢繭膚 (膚鬱簾窪蓋餘窪衊鬱製 ) 更多	积极	2022-01-19
NCT03545971 (ESMO 12021 \| ESMO 22021) 人工标引	临床1期	局部晚期黑色素瘤	44	IBI310	糧簾築範鏇襯遞觸艱壓(廠鏇築築窪鹹餘簾鑰齋) = part A: only one treatment-related AE (TRAE) of grade 3 (gamma glutamyltransferase increased); part B: ≥grade 3 TRAE occurred in 20.6% of 34 pts 積憲願簾選觸獵膚夢憲 (醖膚積襯築壓艱艱齋淵 ) 更多	积极	2021-09-16
				IBI310+sintilimab