This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III/IV ovarian cancer (OC).

开始日期2026-09-01

申办/合作机构

Georgetown University

[+1]

NCT07371897

/ Not yet recruiting临床3期IIT

A Randomized, Open-label, Multi-center Phase III Clinical Study of Toripalimab Combined With Cisplatin and Docetaxel Versus Toripalimab Alone as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

This study compares two short pre-surgery treatments for locally advanced head and neck squamous cell cancer to see which one keeps the cancer from coming back longer.
Eligible patients (18-70 years, newly diagnosed, operable) will be randomly assigned to receive either toripalimab (immunotherapy) alone or toripalimab plus two cycles of chemotherapy (docetaxel and cisplatin). After the two cycles, all patients will have standard surgery followed by radiation (or chemo-radiation).
We will track tumor response, side effects, and quality of life. Possible benefits: tumor shrinkage and lower chance of recurrence; possible risks: low blood counts, rash, tiredness, or other drug-related side effects.
Taking part is voluntary and you can leave the study at any time.

开始日期2026-06-30

申办/合作机构

中山大学

NCT07362186

/ Not yet recruiting临床3期

A Phase III, Open-Label, Multicenter, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of LM-108 in Combination With Toripalimab Versus Paclitaxel Injection as Second-Line Therapy for CCR8-Positive Locally Advanced or Metastatic Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

This is a phase III， Multicenter, Randomized study， evaluating the efficacy and Safety of LM-108(an Anti-CCR8 mAb) in combination With Toripalimab Versus Paclitaxel Injection in subjects with CCR8-Positive locally advanced or metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma.

开始日期2026-04-03

申办/合作机构

礼新医药科技（上海）有限公司

100 项与特瑞普利单抗相关的临床结果

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100 项与特瑞普利单抗相关的转化医学

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100 项与特瑞普利单抗相关的专利（医药）

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600

项与特瑞普利单抗相关的文献（医药）

2026-03-05·NEW ENGLAND JOURNAL OF MEDICINE

Neoadjuvant GOLP in Resectable High-Risk Intrahepatic Cholangiocarcinoma

Article

作者: Shi, Guo-Ming ; Lu, Jia-Cheng ; Ding, Zhen-Bin ; Huang, Xiao-Yong ; Fan, Jia ; Peng, Yuan-Fei ; Ji, Yuan ; Sun, Hui-Chuan ; Huang, Cheng ; Liang, Fei ; Hu, Zhi-Qiang ; Li, Xiao-Wu ; Yang, Wei ; Zou, Jian-Jun ; Wang, Kui ; Shi, Ying-Hong ; Yu, Zheng-Ping ; Zhou, Jian ; Sun, Jian ; Gao, Qiang ; Zhang, Jia-Lin ; He, Yi-Feng ; Huang, Xiao-Wu ; Shen, Ying-Hao ; Zhai, Wen-Long ; Ye, Qing-Hai ; Liang, Xiao ; Wang, Xiao-Ying ; Qiu, Shuang-Jian ; Dong, Rui ; Liu, Wei-Ren ; Yang, Xin-Rong ; Xu, Yang ; Liu, Fu-Bao

BACKGROUND:

No neoadjuvant treatment has been considered to be standard therapy for patients with resectable intrahepatic cholangiocarcinoma with high-risk factors for recurrence. The GOLP regimen (gemcitabine-oxaliplatin, lenvatinib, and an anti-programmed death 1 antibody) has shown promising efficacy with a manageable safety profile in advanced intrahepatic cholangiocarcinoma and biliary tract cancer.

METHODS:

In a phase 2-3 trial, we randomly assigned, in a 1:1 ratio, patients with resectable high-risk intrahepatic cholangiocarcinoma to the neoadjuvant group (intravenous gemcitabine-oxaliplatin plus toripalimab every 3 weeks for three cycles and oral lenvatinib once daily for 9 weeks, followed by curative resection) or the control group (curative resection and no neoadjuvant treatment). All patients received adjuvant capecitabine for eight cycles after surgery. The primary end point was event-free survival. Secondary end points included overall survival and safety.

RESULTS:

A total of 178 patients underwent randomization (88 patients to the neoadjuvant group and 90 to the control group). At the interim analysis at a median follow-up of 16.9 months, the median event-free survival was significantly longer in the neoadjuvant group (18.0 months; 95% confidence interval [CI], 13.8 to 27.6) than in the control group (8.7 months; 95% CI, 7.2 to 12.4) (P<0.001). Overall survival at 24 months was 79% (95% CI, 70 to 90) in the neoadjuvant group and 61% (95% CI, 50 to 75) in the control group (hazard ratio for death, 0.43; 95% CI, 0.23 to 0.79; P = 0.005, which did not meet the significance criterion [two-sided alpha, 0.0019]). Across all treatment phases, adverse events occurred in 97% of the patients in the neoadjuvant group and in 70% of those in the control group. During the neoadjuvant phase, adverse events of grade 3 or higher occurred in 28% of the patients, and treatment-related adverse events of grade 3 or higher in 26%. No treatment-related adverse event led to death.

CONCLUSIONS:

Neoadjuvant GOLP led to significantly longer event-free survival than control therapy, with mainly low-grade adverse events, among patients with resectable high-risk intrahepatic cholangiocarcinoma. (Funded by the Clinical Research Plan of Shanghai Hospital Development Center and others; ZSAB-neoGOLP ClinicalTrials.gov number, NCT04669496.).

2026-03-01·MedComm

Efficacy and Safety of DNV3 (a Lymphocyte‐activation Gene 3–blocking Antibody) Combined With Toripalimab and Chemotherapy in Advanced Melanoma: An Open‐label, Single‐arm Clinical Trial

Article

作者: Zhang, Huishan ; Chen, Yu ; Lu, Yuping ; Chen, Ping ; Chen, Ling ; Xiao, Zuoxiang ; Lin, Jing ; Wang, Dingyi ; Yan, Wei ; Chen, Lizhu

ABSTRACT:

Despite the remarkable therapeutic advances achieved with immune checkpoint inhibitors in advanced melanoma, treatment options remain limited for patients with refractory subtypes. This study evaluated a novel combination of DNV3 (anti‐LAG‐3), toripalimab (anti‐PD‐1), and chemotherapy (nab‐paclitaxel/cisplatin) in 27 Asian patients with unresectable or metastatic melanoma (77.8% [21/27] previously treated with anti‐PD‐[L]1 and 22.2% [6/27] treatment‐naïve mucosal melanoma; subtypes: 13 mucosal, 6 acral, 5 cutaneous, and 3 of unknown primary origin). The regimen achieved an overall response rate (ORR) of 44.4%, which was further elevated to 54.5% in the subgroup of 11 patients with hepatic metastases. Notably, it also demonstrated substantial efficacy in anti‐PD‐(L)1‐resistant cases, with a 42.9% ORR and a median progression‐free survival (PFS) of 7.36 months. Among treatment‐naïve mucosal melanoma, the ORR reached 50%. At data cutoff, median overall survival remained unreached in all cohorts. Grade ≥3 treatment‐related adverse events initially occurred in 55.6% of participants; subsequent dose modification of nab‐paclitaxel (from 260 mg/m 2 to 200 mg/m 2 ) improved tolerability, reducing the incidence of grade ≥3 events to 22.2%. Immune‐related toxicities (grade 3–4, 22.2%) were clinically manageable. Therefore, the combination of LAG‐3/PD‐1 blockade and chemotherapy demonstrated promising efficacy, notably in treatment‐naïve mucosal melanoma with liver metastases. (Chinese Clinical Trial Registry number, ChiCTR2400079543)

2026-02-01·CANCER

Antibody–drug conjugate combinations take center stage in recent urothelial cancer advancements

作者: Lawrence, Leah

This news section offers Cancer readers timely information on events, public policy analysis, and topical issues. In this issue, overall survival nearly doubled in patients assigned to disitamab vedotin plus toripalimab in comparison with those assigned to chemotherapy. In addition, nine‐year data show a sustained benefit of nivolumab in patients with high‐risk resected melanoma, and zanzalintinib plus atezolizumab is the first immunotherapy regimen to benefit patients with metastatic colorectal cancer.

2,952

项与特瑞普利单抗相关的新闻（医药）

2026-03-16

·药研苑

罗氏维泊妥珠单抗新增两项弥漫大B细胞淋巴瘤适应症

药品营销避坑”试读：药品导入期管理视频课（试听）药品生命周期管理（案例）药品立项需要注意什么（案例） 2026年3月13日，罗氏宣布注射用维泊妥珠单抗（优罗华®Polivy®），获得中国国家药品监督管理局（NMPA）正式宣布批准联合利妥昔单抗、吉西他滨和奥沙利铂（Pola-R-GemOx）方案，适用于不适合接受造血干细胞移植的复发或难治性弥漫大B细胞淋巴瘤（DLBCL）成人患者；以及联合苯达莫司汀和利妥昔单抗（Pola-BR）方案用于不适合接受造血干细胞移植的复发或难治性弥漫大B细胞淋巴瘤（DLBCL）成人患者。此次Pola-R-GemOx方案获批基于3期临床试验POLARGO的研究结果。该研究共纳入270名DLBCL患者，入组患者按1:1比例随机授维泊妥珠单抗（1.8 mg/kg）联合R-GemOx方案（利妥昔单抗375mg/m²；吉西他滨1000mg/m²；奥沙利铂100mg/m²）或单独接受R-GemOx方案，每21天一个治疗周期，≤8个治疗周期。截至2024年11月29日Pola-R-GemOx方案组和R-GemOx方案组中位总生存期分别为19.5个月和12.5个月，Pola-R-GemOx方案组与R-GemOx方案组相比降低40%的死亡风险（HR 0.60, 95% CI] 0.43–0.83; p = 0.0017）。在安全性方面，Pola-R-GemOx方案组和R-GemOx方案组3–4级不良事件（AE）发生率相似，分别为57.0%和58.4%，Pola-R-GemOx方案组血小板减少和感染的发生率相对较高，两组分别为34.4%和26.4%，以及14.1%和8.0%。Pola-R-GemOx方案组周围神经病变的发生率高于R-GemOx方案组，两组分别为57.0%和28.8%。周围神经病变多为1级，两级分别为37.5%和23.2%。Pola-R-GemOx方案组5名患者发生3级周围神经病变。由于治疗相关不良事件导致中止治疗的比例，Pola-R-GemOx方案组高于R-GemOx方案组，两组分别为23.4%和8.0%。5级不良事件的发生率，Pola-R-GemOx方案组高于R-GemOx方案组，两组分别为11.7%和4.0%，主要为新型冠状病毒感染（J. Sancho., 2025）。中国3期桥接临床试验（NCT04236141）研究共纳入42名DLBCL患者。入组患者按2:1比例随机接受Pola+BR方案或安慰剂+BR方案。截至2021年7月12日，Pola-BR方案组和安慰剂+BR方案组的完全缓解率分别为25.0%和14.3%，无进展生存期分别为4.6个月和2.0个月（HR 0.50; 95% CI: 0.24-1.05）, 中位总生存期分别为10.6个月 6.5 个月，Pola-BR方案组和安慰剂+BR方案组3–4级不良事件（AE）发生率相似，分别为74.1%和78.6%。该研究的研究结果与维泊妥珠单抗3期临床试验GO29365的研究结果相似（Yuqin Song., 2024）。维泊妥珠单抗（Polatuzumab Vedotin）为靶向CD79b的抗体偶联药物（ADC），其有效载荷为微管抑制剂MMAE。 CD79b在B细胞上表达，是B细胞受体（BCR）的重要组成部分，是B细胞受体的信号转导分子。除上述适应症外，维泊妥珠单抗已在国内获批，联合利妥昔单抗、环磷酰胺、多柔比星和泼尼松（Pola-R-CHP）方案，用于治疗既往未经治疗的弥漫大B细胞淋巴瘤（DLBCL）成人患者。推荐指数：★★ 推荐原因：目前维泊妥珠单抗在国内市场增长良好，本次获批新适应症，有助于进一步巩固维泊妥珠单抗的市场地位。相关阅读：恒瑞医药海曲泊帕获批一线治疗重型再生障碍性贫血恒瑞医药申请舒地胰岛素诺利糖肽注射液上市哈尔滨三联药业申请非典型抗精神药物阿塞那平舌下片上市 IgA肾病3期临床期中分析Povetacicept降低52%尿蛋白君实生物特瑞普利单抗注射液（皮下注射）上市申请获得受理 ‌活动性银屑病关节炎3期临床，比奇珠单抗击败利生奇珠单抗歌礼长效储库型小分子GLP-1 ASC30二期试验16周减重7.5% 荃信生物抗IL-17A鲁塞奇塔单抗新药上市申请获受理 2025年1-3季度口崩片市场哪个强？ 2025年1-3季度口溶膜制剂哪家强？免疫检查点抑制剂，谁将成为下一个王者？质子泵相关抑酸类药物市场即将回暖改剂型，口服液体制剂“金矿”还是“陷阱” 相关内容只作为药物研发的参信息。不构成任何与用药咨询有关的建议。如需发稿，您可通过在药研苑公众号下以发送信息的方式将官网或官方公众号的稿件链接和标题发送给我们。我们将择优确定是否发布。

临床3期临床结果临床成功上市批准

2026-03-16

·和泽医药

【药闻周选】医药行业重点资讯速览（03.09-03.15）

政策监管动态 1. 国家药监局：严格药品安全监管，支持创新药和医疗器械高质量发展 3月13日，国家药监局召开党组（扩大）会议。会议指出，政府工作报告对严格药品安全监管、推动创新药和医疗器械高质量发展等作出重要部署。药品监管部门要紧紧锚定推动“十五五”时期健康中国建设取得决定性进展的战略目标，严格药品安全监管，支持创新药和医疗器械高质量发展。 2. 国家药监局国家卫生健康委国家医保局发布《关于做好后续品种实施医疗器械唯一标识工作的公告》《公告》提到，2027年6月1日起生产的全部第二类医疗器械（包括体外诊断试剂）和全部第一类体外诊断试剂应当具有医疗器械唯一标识。行业新品动态 1. 君实生物皮下注射抗PD-1单抗12项癌症适应症申报上市 3月9日，君实生物自主研发的抗PD-1单抗皮下制剂特瑞普利单抗注射液（皮下注射）用于肿瘤治疗的12项适应症上市申请于近日获得国药监局受理。本次上市申请中的12项适应症为特瑞普利单抗注射液目前在中国内地已获批的全部适应症，有望覆盖非小细胞肺癌、鼻咽癌、食管癌、肾癌、肝癌等多种肿瘤治疗。 2. 和誉医药FGFR2/3抑制剂获FDA授予罕见儿科疾病资格 3月11日，和誉医药自主研发的高选择性小分子FGFR2/3抑制剂ABSK061治疗软骨发育不全适应症获得FDA授予的罕见儿科疾病资格认定。ABSK061是和誉医药自主研发的高活性、高选择性小分子FGFR2/3抑制剂，通过降低对FGFR1的抑制以及保持对FGFR2/3的高活性，该产品作为第二代FGFR抑制剂有望在临床上取得更好的安全窗及疗效。 3. 金赛药业治疗胰腺癌1类新药获FDA孤儿药资格 3月11日，金赛药业自主研发的GenSci128片已获得FDA授予的孤儿药资格，用于胰腺癌的治疗。在肿瘤领域，金赛药业正形成多元化的管线矩阵：除GenSci128外，EGFR/HER2的双靶点ADC药物GenSci139、针对FRα的双表位ADC药物GenSci140以及新型突变选择性PI3Kα抑制剂GenSci145等均已进入临床阶段。 4. 华东医药ADC新药三项适应症获FDA孤儿药资格 3月11日，华东医药全资子公司中美华东自主研发的抗体偶联药物（ADC）创新药注射用HDM2017的胆道癌、胃癌和胰腺癌三项适应症获得FDA孤儿药资格。注射用HDM2017是由中美华东研发的1类生物生物新药，是一款靶向钙黏蛋白17（Cadherin17，LI-cadherin）的新型ADC。 5. 康哲药业肾性贫血新药获批 3月13日，康哲药业宣布：其肾性贫血新药德昔度司他片已获国家药监局批准上市。该药适用于非透析的成人慢性肾脏病（CKD）患者的贫血治疗。此前，该药已在印度获批上市。 6. 全球首款侵入式脑机接口三类医疗器械在华获批上市 3 月 13 日，国家药监局正式批准博睿康医疗的植入式脑机接口手部运动功能代偿系统上市，这是全球首个获得三类医疗器械注册证的侵入式脑机接口医疗产品，填补了高端脑机接口医疗器械的市场空白，为肢体运动功能障碍患者提供了新的治疗方案。市场与资本动态 1. 浙江医药出资 1.57 亿元参投生物医药专项基金 3 月 9 日，浙江医药发布公告，作为有限合伙人出资 1.57 亿元参与投资厦门华犇启航股权投资合伙企业，该基金总规模 3.20 亿元，60% 以上资金将聚焦生物医药战略新兴产业，本次投资旨在深化公司在生物医药领域的产业布局与资本联动。 2.合碳智能获5000万融资：加速“物理AI科学家”落地，在百济神州实验室开启“实战演练” 合碳智能成立于2022年，核心产品Talos采用通用双臂移动机器人作为硬件载体，通过自研传感器与专有的VLA（视觉-语言-行动）架构，使机器人具备在专业实验中的自主操作技能和实时推理能力。与传统自动化设备“专机专用”的刚性模式不同，Talos是目标驱动的通用机器人，无需改造现有实验室，即可直接操作已有仪器，并具备实时适应与错误恢复能力。 3. 亦立医药完成新一轮近亿元人民币融资，加速推进新靶点项目研发与临床转化亦立医药成立于2024年，是一家专注于开发创新型放射性药物及高科技应用的生物医药企业，现已完成3亿元人民币融资。公司秉承“创新驱动，精准医疗”的核心理念，致力于针对多种肿瘤和神经科学领域疾病开发精准的放射性诊疗一体化方案。通过整合分子靶向技术与放射性核素技术，研发高效、安全的诊断性和治疗性放射性药物，为全球患者提供更精准的诊断和更有效的治疗方案，助力人类实现更健康、更长久的生命旅程。 4. 博创生物完成 Pre-A+轮融资以胶原可控组装技术赋能医疗新发展博创生物深耕植入类创新生物医用材料领域，以原创核心技术构筑企业发展护城河，其核心竞争力源自中科院院士刘昌胜教授、国家杰青屈雪教授领衔团队研发的高纯度胶原蛋白生产及可控电化学组装加工（EDP）技术。这一拥有自主知识产权的创新技术，通过电场实现对高纯度胶原蛋白等分子定向排列的精准调控，为高端植入类医疗器械的功能化创新设计奠定底层技术基础。 5. 礼来2亿美元投资口服减肥药生产 3月11日，礼来和康龙化成就礼来最受瞩目的口服GLP-1减肥药Orforglipron达成生产合作协议。根据协议，礼来将向康龙化成投资2亿美元支持其技术能力建设，未来视发展情况会逐步扩大规模。根据已披露信息，礼来向康龙化成投资的主要是针对Orforglipron的制剂生产，双方合作项目的年产能峰值将达到数十亿片的规模。 END

2026-03-16

·上海和誉生物医药科技有限公司

和誉医药依帕戈替尼联合靶免疗法一线治疗晚期肝细胞癌完成II期临床首例患者给药

2026年3月16日，上海和誉生物医药科技有限公司（以下简称“和誉医药”，港交所代码：02256）今日宣布，其自主研发的高选择性口服小分子FGFR4抑制剂依帕戈替尼（Irpagratinib/ABSK-011）联合标准疗法（特瑞普利单抗+贝伐珠单抗生物类似物），已在针对晚期或不可切除肝细胞癌一线治疗的II期临床研究中完成首例患者给药。原发性肝癌是全球第三大肿瘤相关死亡原因，其中HCC约占75%-85%。目前，免疫检查点抑制剂联合抗血管生成治疗的“靶免联合”方案已成为晚期HCC的一线标准疗法，但临床实践发现，不同分子分型的患者获益存在差异。回顾性研究显示，与FGF19低表达患者相比，FGF19过表达HCC患者接受一线靶免联合治疗后，中位无进展生存期（mPFS）显著缩短（6.1个月 vs 11.4个月），客观缓解率（ORR）呈下降趋势（33.3% vs 45.2%）1。研究认为，这一差异可能与FGFR4/FGF19信号通路异常激活相关。该通路的持续激活可上调PD-L1表达，促进肿瘤免疫逃逸及肿瘤转移，从而削弱免疫联合治疗的疗效2,3。因此，在标准靶免方案基础上进一步联合FGFR4抑制剂，有望从机制层面增强抗肿瘤效应，为该类患者带来额外临床获益。然而，尽管多达30%的HCC患者存在FGF19过表达，目前却尚无针对该靶点的获批产品，使得这一人群在现有标准治疗体系下仍存在未满足的治疗需求。依帕戈替尼是和誉医药自主研发的一款高选择性、口服小分子FGFR4抑制剂。在2025年欧洲肿瘤内科学会胃肠道肿瘤大会（ESMO GI）上，和誉公布了依帕戈替尼联合阿替利珠单抗治疗HCC的II期研究数据。结果显示，对于初治及既往接受过免疫检查点抑制剂（ICI）治疗的FGF19过表达患者，观察到超过50%的ORR及超过7个月的mPFS，且整体安全性可控，未出现新的安全性信号1。该研究数据充分展示了依帕戈替尼与免疫治疗的潜在协同增效作用，为后续联合一线标准疗法的临床研究奠定了坚实基础。基于上述积极研究成果，和誉医药正式启动了依帕戈替尼联合特瑞普利单抗及贝伐珠单抗生物类似物的临床研究，旨在系统评估该三联方案用于FGF19过表达的晚期或不可切除HCC患者一线治疗的安全性、耐受性及初步疗效。除该研究外，全球范围内也有其他研究者在积极探索依帕戈替尼联合更多标准疗法的新策略。未来，随着更多高质量临床研究的深入推进和数据积累，依帕戈替尼有望为FGF19过表达HCC患者带来新的生存希望，助力HCC诊疗迈向更加精准化、个体化的新阶段。参考文献 1. Cheng, Q., et al. (2025). 149MO Irpagratinib (ABSK-011) plus atezolizumab in first-line (1L) and immune checkpoint inhibitors (ICIs) treated advanced hepatocellular carcinoma (HCC) with FGF19 overexpression (+): Updated results of the phase II ABSK-011-201 study. Annals of Oncology. 2. Guo C, et al. FGF19/FGFR4 signaling contributes to hepatocellular carcinoma survival and immune escape by regulating IGF2BP1-mediated expression of PD-L1. Biomed Pharmacother. 2024 Jan;170:115955. 3. Xie M, et al. FGF19/FGFR4-mediated elevation of ETV4 facilitates hepatocellular carcinoma metastasis by upregulating PD-L1 and CCL2. J Hepatol. 2023 Jul;79(1):109-125. 关于依帕戈替尼（Irpagratinib/ABSK-011）依帕戈替尼（ABSK-011）是一种高选择性小分子FGFR4抑制剂，被开发用于治疗FGF19过表达的晚期肝细胞癌（aHCC）。研究表明，全球约30%的HCC患者存在FGF19过表达。开发针对该信号通路的靶向疗法代表了治疗HCC的一种新颖的创新方法。当前，全球尚无FGFR4抑制剂获批上市，根据弗若斯特沙利文的分析，依帕戈替尼凭借其在竞争格局中的领先地位，有望成为首个治疗FGF19过表达HCC患者的突破性药物。除单药之外，和誉医药同时在探索联合抗PD-L1抗体阿替利珠单抗（由F. Hoffmann-La Roche Ltd.及罗氏（中国）投资有限公司制造）的II期试验。在2025年ESMO-GI大会上，和誉医药发布了联合用药治疗aHCC患者的最新临床试验数据，其中，依帕戈替尼联用阿替利珠单抗队列在初治及既往接受过ICI治疗的FGF19过表达HCC患者中，客观缓解率（ORR）均超过50%，中位无进展生存期（mPFS）超过7个月。 Abbisko Therapeutics' Irpagratinib Combined with Targeted-Immunotherapy Completes First Patient Dosing in Phase II Trial for First-Line Treatment of Advanced HCC 16 March 2026, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256) today announced that the first patient has been dosed in a Phase II study evaluating its independently developed, highly selective, oral small-molecule FGFR4 inhibitor irpagratinib (ABSK-011), in combination with standard of care (toripalimab plus bevacizumab biosimilar) as first-line treatment for patients with advanced or unresectable hepatocellular carcinoma (HCC). Primary liver cancer ranks as the third leading cause of cancer-related mortality worldwide, with HCC accounting for approximately 75%–85% of cases. Currently, immune checkpoint inhibitors (ICIs) combined with anti-angiogenic therapy have become the standard first-line treatment for advanced HCC. However, clinical practice has shown that treatment outcomes vary among patients with different molecular subtypes. Retrospective analyses have demonstrated that, compared with patients with low FGF19 expression, those with FGF19 overexpression experienced a significantly shorter median progression-free survival (mPFS) when receiving first-line targeted immunotherapy combinations (6.1 vs. 11.4 months) 1. A downward trend in objective response rate (ORR) was also observed (33.3% vs. 45.2%) 1. This difference may be associated with aberrant activation of the FGFR4/FGF19 signaling pathway. Persistent activation of this pathway can upregulate PD-L1 expression in tumor cells, thereby promoting immune evasion and metastasis, and potentially attenuating the efficacy of immunotherapy-based combinations 2,3. Therefore, adding an FGFR4 inhibitor to the existing immunotherapy-anti-angiogenic combination regimen may enhance antitumor activity through a complementary mechanism and potentially deliver additional clinical benefit to these patients. However, despite FGF19 overexpression occurring in up to 30% of HCC patients, there are currently no approved therapies targeting this pathway, leaving this population with unmet medical needs under the existing SOC treatment paradigm. Irpagratinib is a highly selective, orally administered small-molecule FGFR4 inhibitor independently developed by Abbisko Therapeutics that precisely targets the FGFR4/FGF19 signaling pathway. At the 2025 European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI), Abbisko presented Phase II study results of irpagratinib in combination with atezolizumab for the treatment of HCC. In both treatment-naïve patients and those previously treated with ICIs whose tumors exhibited FGF19 overexpression, the combination achieved an ORR exceeding 50% and mPFS of more than 7 months, with a manageable safety profile with no new safety signals observed 1. These findings highlight the potential synergistic activity of irpagratinib with immunotherapy and provide a strong foundation for further studies combining irpagratinib with first-line standard therapy. Based on these encouraging findings, Abbisko Therapeutics has initiated the clinical study evaluating irpagratinib in combination with toripalimab and bevacizumab biosimilar, aiming to systematically assess the safety, tolerability, and preliminary efficacy of this triplet regimen as a first-line treatment for patients with FGF19-overexpressing advanced or unresectable HCC. In addition to this study, researchers worldwide are actively exploring new strategies combining irpagratinib with additional SOC therapies. As more high-quality clinical studies progress and additional data accumulate, irpagratinib has the potential to offer new hope for patients with FGF19-overexpressing HCC and help advance the management of HCC toward more precise and personalized treatment. References 1. Cheng, Q., et al. (2025). 149MO Irpagratinib (ABSK-011) plus atezolizumab in first-line (1L) and immune checkpoint inhibitors (ICIs) treated advanced hepatocellular carcinoma (HCC) with FGF19 overexpression (+): Updated results of the phase II ABSK-011-201 study. Annals of Oncology. 2. Guo C, et al. FGF19/FGFR4 signaling contributes to hepatocellular carcinoma survival and immune escape by regulating IGF2BP1-mediated expression of PD-L1. Biomed Pharmacother. 2024 Jan;170:115955. 3. Xie M, et al. FGF19/FGFR4-mediated elevation of ETV4 facilitates hepatocellular carcinoma metastasis by upregulating PD-L1 and CCL2. J Hepatol. 2023 Jul;79(1):109-125. About Irpagratinib (ABSK-011) Irpagratinib is a highly-selective FGFR4 small molecule inhibitor designed to target overexpression of the FGF19 signaling pathway. Several epidemiological studies indicate that approximately 30% of HCC patients worldwide exhibit FGF19 overexpression. Development of targeted therapies against FGFR4 represent an innovative and novel approach to the treatment of HCC. To date, no FGFR4 inhibitor has been granted regulatory approval globally. According to Frost & Sullivan, irpagratinib is expected to become the first breakthrough treatment for the treatment of HCC patients with FGF19 overexpression. In addition to monotherapy, Abbisko Therapeutics is exploring irpagratinib in combination with atezolizumab, an anti-PD-L1 antibody manufactured by F. Hoffmann-La Roche and Roche (China), in a Phase II study. At the the 2025 ESMO GI Congress, Abbisko presented clinical data showing that the combination of irpagratinib and atezolizumab achieved an objective response rate (ORR) exceeding 50% and a median progression-free survival (mPFS) of more than 7 months in FGF19-overexpressing HCC patients previously treated with immune checkpoint inhibitors. About Abbisko Therapeutics Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK), is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology. Please visit www.abbisko.com for more information. 关于和誉和誉医药（香港联交所代码：02256）成立于2016年，是一家立足中国，着眼全球的创新药研发公司。公司的创始人和管理团队拥有多年顶尖跨国药企的研发和管理经验，并参与了多个临床及上市新药的研发。和誉医药专注于肿瘤新药研发，以小分子肿瘤精准治疗和小分子肿瘤免疫治疗药物为核心，着眼病患及医药市场的需求，秉承国际新药开发的理念和标准，致力于开发新颖及高潜力药物靶点的潜在first-in-class或best-in-class创新药物，用于改善中国及全球病人的生活质量。自成立以来，和誉医药已经建立了丰富的创新产品管线，涵盖肿瘤精准治疗领域以及肿瘤免疫治疗领域。更多信息，欢迎访问 www.abbisko.com。

免疫疗法临床2期临床结果

100 项与特瑞普利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	DB15043

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
转移性黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
不可切除的黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
晚期肝细胞癌	中国	上海君实生物医药科技股份有限公司	2025-03-18
转移性食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	欧盟	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	冰岛	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	挪威	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
三阴性乳腺癌	中国	上海君实生物医药科技股份有限公司	2024-06-18

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
HER2阳性尿路上皮癌	申请上市	中国	上海君实生物医药科技股份有限公司	2025-08-09
肿瘤	申请上市	加拿大	Apotex, Inc.	2024-12-01
复发性鼻咽癌	申请上市	欧盟	Tmc Pharma (Eu Ltd.	2022-11-14
复发性非鳞状非小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2024-04-03
难治性经典霍奇金淋巴瘤	临床3期	中国	上海君实生物医药科技股份有限公司	2023-12-28
局限期小细胞肺癌	临床3期	美国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	比利时	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	法国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	德国	上海君实生物医药科技股份有限公司	2023-11-15

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临床结果

适应症

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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


NCT05979740 (DECIDING-I, ASCO_GU2026)	临床1期	非肌层浸润性膀胱肿瘤 HER2-positive	6	Disitamab vedotinToripalimabedotin + Disitamab vedotinToripalimab (HER2-positive + Muscle Invasive Bladder Cancer + Radiotherapy)	憲簾齋繭觸繭願遞觸蓋(構鏇獵顧艱獵醖鬱窪範) = 艱蓋積壓壓獵齋繭襯壓淵遞鑰襯鏇夢簾膚壓網 (壓壓窪積醖淵網壓顧製 )	积极	2026-02-26
NCT05297552 (RC48-C017, ASCO_GU2026)	临床2期	HER2阳性肌层浸润性膀胱癌新辅助 HER2-expressing	47	Disitamab vedotin + Toripalimab	壓鏇鹽餘顧築獵積淵積(鏇窪鏇繭簾餘願築壓蓋) = 繭積膚衊夢獵積壓積膚蓋鬱鹹糧夢顧繭積築窪 (簾蓋艱繭醖醖壓顧繭膚, 77.8 ~ 96.5) 更多	积极	2026-02-26
NCT04250948 (NEOSUMMIT-01, ASCO_GI2026)	临床2期	胃食管交界处癌	108	Toripalimab plus SOX/XELOX chemotherapy	淵願繭廠觸鏇憲淵蓋壓(艱廠鹹齋製蓋夢鏇顧顧) = 膚顧鹽艱艱願糧繭繭蓋襯繭淵壓築廠糧蓋糧範 (網夢顧選選簾膚遞壓繭, 63.6 ~ 87.7) 更多	积极	2026-01-08
				SOX/XELOX chemotherapy	淵願繭廠觸鏇憲淵蓋壓(艱廠鹹齋製蓋夢鏇顧顧) = 遞鏇膚蓋鑰遞鏇衊鬱夢襯繭淵壓築廠糧蓋糧範 (網夢顧選選簾膚遞壓繭, 43.3 ~ 73.0) 更多
NCT03430297 (Pubmed \| JAMA Oncol)	临床3期	肢端雀斑恶性黑色素瘤一线	256	Toripalimab 240 mg	獵糧襯膚餘壓鹽衊齋顧(遞觸廠鬱齋顧積鏇齋餘) = 鹹遞蓋鏇壓範遞鑰夢醖簾壓顧願糧衊鹽願觸蓋 (顧廠艱廠壓網築衊繭選, 6.2 ~ 17.8) 更多	积极	2026-01-02
				Dacarbazine 1000 mg/m2	獵糧襯膚餘壓鹽衊齋顧(遞觸廠鬱齋顧積鏇齋餘) = 願醖願願齋鑰遞選選鹽簾壓顧願糧衊鹽願觸蓋 (顧廠艱廠壓網築衊繭選, 4.4 ~ 14.9) 更多
NCT03581786 (JUPITER-02, ESMO_ASIA2025)	临床3期	鼻咽癌一线	289	Toripalimab 240 mg + Gemcitabine-Cisplatin (GP)	築蓋遞廠憲網顧醖觸壓(鑰餘遞築顧繭膚選範簾) = 觸鑰糧製餘夢願網築艱衊壓壓鏇鹹觸鬱鏇鏇窪 (膚簾獵願築顧醖鏇網艱 )	积极	2025-12-06
				Placebo + Gemcitabine-Cisplatin (GP)	築蓋遞廠憲網顧醖觸壓(鑰餘遞築顧繭膚選範簾) = 鹽憲淵窪網鏇夢餘鬱製衊壓壓鏇鹹觸鬱鏇鏇窪 (膚簾獵願築顧醖鏇網艱 )
NCT03829969 (JUPITER-06, ESMO_ASIA2025)	临床3期	转移性食管鳞状细胞癌一线 PD-L1 expression \| tumor mutation burden (TMB) \| copy number alteration-corrected TMB (ccTMB)	514	Toripalimab plus chemotherapy	鬱簾製襯遞糧簾簾鹹構(繭簾蓋蓋膚醖觸鑰網膚) = 範鑰窪網簾窪觸繭網獵憲製顧醖壓鹽衊願艱願 (糧築簾蓋壓艱觸繭鹽網 ) 更多	积极	2025-12-06
				Placebo plus chemotherapy	鬱簾製襯遞糧簾簾鹹構(繭簾蓋蓋膚醖觸鑰網膚) = 願衊鹹艱淵窪齋遞衊鏇憲製顧醖壓鹽衊願艱願 (糧築簾蓋壓艱觸繭鹽網 ) 更多
ASH2025	N/A	肿瘤 PD-1 \| PD-L1 \| CTLA-4	84,885	Atezolizumab	簾艱餘糧築積壓繭艱構(壓淵壓顧鬱廠構鬱醖蓋) = 繭艱壓夢顧淵膚繭廠鏇鬱鏇網鏇願夢襯製艱鑰 (蓋憲鏇鑰鏇簾觸鑰顧選 ) 更多	积极	2025-12-06
				toripalimab	簾艱餘糧築積壓繭艱構(壓淵壓顧鬱廠構鬱醖蓋) = 窪窪襯鬱鏇衊觸鏇襯構鬱鏇網鏇願夢襯製艱鑰 (蓋憲鏇鑰鏇簾觸鑰顧選 ) 更多
ESMO_ASIA2025	N/A	MSI-H 癌症 microsatellite instability-high (MSI-H)	83	Immune Checkpoint Inhibitor	鬱繭網鏇構範範顧窪淵(壓艱網廠網鏇壓鹹觸壓) = 選淵鏇鹽艱齋繭網艱壓壓遞壓廠壓廠淵築獵繭 (淵衊簾觸窪鏇衊網築糧 ) 更多	积极	2025-12-05
NCT04606303 (RENAISSANCE, Pubmed \| BMC Med) 人工标引	临床2期	可切除非小细胞肺癌新辅助	100	Toripalimab + chemotherapy (pts that underwent surgery)	夢壓壓鹽窪選築壓衊鏇(夢齋淵遞廠憲觸積膚鬱) = 壓獵鑰壓願鬱廠艱醖廠艱鹽簾淵顧窪築膚餘獵 (鏇醖築糧築糧積選窪築 ) 更多	积极	2025-11-05
NCT06975293 (STC15-24202, SITC2025)	临床1/2期	晚期恶性实体瘤	18	STC-15 + Toripalimab	遞廠選鹹鏇製鬱艱遞積(築網淵襯衊顧簾鹽積齋) = 衊構構鏇願網醖築獵鬱齋膚顧壓簾範製艱範艱 (廠蓋齋壓簾窪觸簾鏇醖 )	积极	2025-11-05