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公告及新闻稿, 肿瘤学 / 免疫学 | 2026-05-22

和黄医药将于美国临床肿瘤学会 (ASCO) 2026年年会公布数据

中国香港、上海和美国新西州:2026522日,星期五: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的数项研究的最新及更新后的数据将于2026年5月29日至6月2日在美国芝加哥召开的美国临床肿瘤学会(ASCO)年会上公布。

 

赛沃替尼(savolitinib)用于治疗伴有MET扩增的胃癌或胃食道连接部腺癌患者的中国关键性II期注册研究结果将于快速口头摘要环节公布。该研究已达到主要终点,即根据RECIST 1.1标准经独立审查委员会(“IRC”)评估的客观缓解率(“ORR”)。至数据截止日2025年10月8日,IRC评估的ORR为32.3%(95%CI:21.2%,45.1%),超过了预设的疗效阈值。次要终点包括IRC评估的疾病控制率(DCR)为63.1%,中位到达疾病缓解的时间(TTR)为1.4个月,中位缓解持续时间(DoR)为9.7个月(95%CI:3.7,18.5),以及中位无进展生存期(PFS)为4.0个月(95%CI:2.6,5.0)。这些数据支持了向中国国家药品监督管理局提交新药上市申请,该申请已于2025年12月获受理并纳入优先审评

 

此外,呋喹替尼(fruquintinib)的FRESCO、FRESCO-2、FRUSICA-1和FRUSICA-2研究的进一步分析结果,以及由研究者发起的呋喹替尼和索凡替尼(surufatinib)在多项潜在肿瘤适应症中的临床试验结果亦将于大会公布。

 

报告详情包括已公布的摘要链接如下:

摘要标题 告人/ 主要作者

公司申的研究

沃替尼用于伴有MET增的胃癌或胃食道接部腺癌患者的II关键性研究
A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas
彭智,中国北京 4011
快速口头摘要 | Rapid Oral Abstract: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
2026年6月1日 (星期一)
北美中部夏令时间下午1:15
呋喹替尼治疗转移性癌患者的小和深度: FRESCOFRESCO-2研究
Tumor shrinkage and depth of response with fruquintinib in patients with metastatic colorectal cancer: Results from FRESCO and FRESCO-2
Elena Elez,西班牙巴塞罗那 3555
海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal
呋喹替尼联合信迪利比阿昔替尼或依莫司在经治的晚期肾细胞癌患者中基于基线IMDC风险分和PD-L1表达情况估的: FRUSICA-2研究的亚分析
Efficacy of fruquintinib plus sintilimab versus axitinib or everolimus by scores of IMDC risk factors and PD-L1 expression at baseline in previously treated advanced renal cell carcinoma: A subgroup analysis of FRUSICA-2 study
杨恺惟,中国北京 4531
海报展示 | Poster Session: Genitourinary Cancer – Kidney and Bladder
呋喹替尼联合信迪利比阿昔替尼或依莫司在晚期肾细胞癌中的: 基于基线肿荷的FRUSICA-2研究事后分析
Efficacy with fruquintinib plus sintilimab versus axitinib or everolimus in advanced renal cell carcinoma: A post-hoc analysis from FRUSICA-2 trial by baseline tumor burden
瞿元元,中国上海 4533
海报展示 | Poster Session: Genitourinary Cancer – Kidney and Bladder
经治的pMMR宫内膜癌患者中掌跖红肿综合征、甲腺功能减退与局的相: FRUSICA-1研究的亚分析
Association of Palmar-plantar erythrodysesthesia syndrome (PPES), hypothyroidism and clinical outcome in previously treated endometrial cancer (EMC) with pMMR status: A subgroup analysis of FRUSICA-1
韩啸天,中国上海 e17612
线上发表 | Publication Only: Gynecologic Cancer

研究者发起的研究

呋喹替尼联合化和贝伐抗联合化用于二线疗转移性癌的效和安全性: 前瞻性、多中心、随机照研究
Efficacy and safety of fruquintinib combined with chemotherapy versus bevacizumab combined with chemotherapy as second-line treatment for metastatic colorectal cancer: A prospective, multicenter, randomized controlled trial
许剑民,中国上海 LBA3563
海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal
CONCEPT研究 (西妥昔抗联合呋喹替尼±免疫): 线pMMR RAS/ BRAF野生型不可切除的移性癌的多中心、随机、标签II期研究
CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer
刘月,中国杭州 TPS3680
海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal
呋喹替尼联合替雷利珠曲氟尿苷/替吡嘧啶联合贝伐珠抗用于治无活动性肝移的MSS移性癌患者的: IKF-080/QUINTIS研究
Fruquintinib in combination with tislelizumab vs trifluridine/tipiracil and bevacizumab in MSS mCRC without active liver metastases: The IKF‑080/QUINTIS trial
Joseph Tintelnot,德国汉堡 TPS3684
海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal
项评估呋喹替尼联合信迪利抗和西达本胺用于治疗难治性MSS移性癌的II期研究: 初步效和安全性
A phase 2 study of fruquintinib combined with sintilimab and chidamide in refractory MSS metastatic colorectal cancer: Preliminary efficacy and safety
王畅,中国长春 2631
海报展示 | Poster Session: Developmental Therapeutics – Immunotherapy
呋喹替尼联合FOLFIRImFOLFOX6方案用于二线RAS突变移性癌患者: II期、多中心、标签研究
Fruquintinib plus FOLFIRI or mFOLFOX6 as second-line therapy for patients with RAS-mutant metastatic colorectal cancer (mCRC): A phase II, multicenter, open-label study
许贇,中国上海 3528
海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal
呋喹替尼联合卡培他滨比卡培他滨药作为转移性癌一线持治的一II期随机研究
A randomized phase II trial of fruquintinib plus capecitabine versus capecitabine alone as maintenance therapy following first-line chemotherapy in metastatic colorectal cancer (mCRC)
李文桦,中国上海 3534
海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal
呋喹替尼联合卡度尼利抗用于治伴有肺移的治性MSS/pMMR癌的一II试验
A phase II trial of fruquintinib combined with cadonilimab in refractory MSS/pMMR colorectal cancer with pulmonary metastases
郭梦舟,中国上海 3552
海报展示 | Poster Session: Gastrointestinal Cancer – Colorectal and Anal
免疫化联合或不联合呋喹替尼用于一线晚期胃癌/胃食道接部腺癌的基于生物志物的: MGC-FLORA研究的初步果和亚分析
Biomarker-driven assessment of immunochemotherapy with or without fruquintinib as first-line treatment for advanced gastric/GEJ adenocarcinoma: Initial clinical results and subgroup analysis from the MGC-FLORA study
朱晓东,中国上海 4063
海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
优替德隆联合呋喹替尼治疗铂耐药复发性卵巢癌的II试验 (FRUTD研究)
Phase II study of utidelone plus fruquintinib for the treatment of platinum-resistant recurrent ovarian cancer (FRUTD trial)
温灏,中国上海 5579
海报展示 | Poster Session: Gynecologic Cancer
呋喹替尼和贝伐珠抗联合卡培他滨交替作为转移性癌一线后的持治: 多中心、标签II期研究
Fruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, phase II study
廖旺军,中国广州 e15539
线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal
间歇用呋喹替尼联合曲氟尿苷/替吡嘧啶治疗难治性移性: 项单中心、II期研究
Intermittent fruquintinib plus trifluridine/tipiracil in refractory metastatic colorectal cancer (mCRC): A single-center, single-arm phase II study
何义富/牛佳郁,中国合肥 e15560
线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal
伊立替康脂体联合呋喹替尼作为转移性癌三线或后线I期研究
Phase I study of liposomal irinotecan plus fruquintinib as third- or later-line therapy for metastatic colorectal cancer
黎倩,中国南宁 e15571
线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal
西达本胺联合斯抗和瑞戈非尼或呋喹替尼用于三线晚期 (C‑operate/SCOG‑C001研究): 项单臂、探索性、多中心II试验
Chidamide combined with serplulimab and regorafenib or fruquintinib as third-line therapy for advanced colorectal cancer (C-ooperate/SCOG-C001): A single-arm, exploratory, multicenter, phase 2 trial
李伟,中国苏州 e15583
线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal
呋喹替尼在美国治性移性癌的真实世界
Real-world use of fruquintinib in refractory metastatic colorectal cancer in the United States
Vasu Bansal,美国堪萨斯城 e15713
线上发表 | Publication Only: Gastrointestinal Cancer – Colorectal and Anal
呋喹替尼联合信迪利抗和CAPEOX用于一线晚期胃癌/胃食道接部腺癌: 项单臂、标签、多中心Ib/II试验 (FUNCTION研究)
Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma: A single-arm, open-label, multicenter phase Ib/II study (FUNCTION)
陈贝贝,中国郑州 e16033
线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
呋喹替尼联合卡瑞利珠抗、紫杉醇脂体和奈达用于一线晚期食管鳞状细胞癌: 项单II期研究的最新
Fruquintinib in combination with camrelizumab, paclitaxel liposome, and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from a single-arm, phase II study
顾艳宏,中国南京 e16070
线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
索凡替尼联合吉西他滨、顺铂和免疫查点抑制用于治不可切除的局部晚期或移性肝胆管癌的最新
Updated results of surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma
石学涛/钟敬涛,中国济南 4136
海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
索凡替尼联合KN046和化用于一线晚期胰腺管腺癌: Ib/II期研究的最新果和生物志物分析
Surufatinib plus KN046 and chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma: Updated results and biomarker analysis from a phase 1b/2 trial
王文权,中国上海 4198
海报展示 | Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
索凡替尼联合特瑞普利抗用于治复发性卵巢透明胞癌: 前瞻性中心II试验的最新
Surufatinib combined with toripalimab for the treatment of recurrent ovarian clear cell carcinoma: Update of a prospective single center, single‑arm phase II clinical trial
杨慧娟,中国上海 5586
海报展示 | Poster Session: Gynecologic Cancer
索凡替尼治晚期或移性化疗难治性胸腺上皮: 项单臂、中心II期研究
Surufatinib for advanced or metastatic chemotherapy-refractory thymic epithelial tumor: A single-arm, single-center, phase II study
徐蓓,中国上海 8119
海报展示 | Poster Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
索凡替尼联合抗PD-1/PD-L1抗体用于二线药用于三线晚期肝胞癌:项单臂、标签、多中心II期研究
Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II study
周福祥,中国武汉 e16172
线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
索凡替尼联合免疫查点抑制和化用于治胆管癌患者的效和安全性: 真实世界研究
Efficacy and safety of surufatinib combined with immune checkpoint inhibitors plus chemotherapy in patients with biliary tract cancers: A real-world study
范莎莎,中国长沙 e16222
线上发表 | Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
奥希替尼联合沃替尼用于治MET基因拷贝的奥希替尼耐药性非小胞肺癌: 多中心、标签II期研究
Osimertinib plus savolitinib in osimertinib-resistant non-small-cell lung cancer with low level gene copy number MET: A multi-center, open-label, and phase 2 study
韩翔,中国青岛 e20079
线上发表 | Publication Only: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

 

关于和黄医药

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或关注我们的领英专页。

 

前瞻性

本新稿包含1995年《美国私人诉讼改革法案》“安全港”条款中定义的前瞻性述。些前瞻性述反映了和黄医药目前事件的期,包括呋喹替尼、沃替尼和索凡替尼的治潜力的期,呋喹替尼、沃替尼和索凡替尼的一步床研究划,呋喹替尼、沃替尼和索凡替尼的研究是否能达到其主要或次要点的期,以及此类研究完成间和果发布的期。此类风险和不确定性包括下列假设:入率、足研究入和排除准的受者的间和可用性;床方案或管要求变更;期不良事件或安全性问题呋喹替尼、沃替尼和索凡替尼(包括作联合法)达到研究的主要或次要点的效;得不同司法管辖区管批准及管批准后得上市可;呋喹替尼、沃替尼和索凡替尼用于目症的潜在市,以及金充足性等。此外,由于部分研究可能依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药物的安全性、效、供管批准的假设。前和潜在投度依赖这些前瞻性述,在截至本新稿发布日有效。关这些风险和其他风险的一步讨论和黄医药向美国券交易委会、香港联合交易所有限公司以及AIM提交的文件。无是否出息、未事件或情况或其他因素,和黄医药均不承担更新或修本新稿所含息的义务。

 

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。