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更新于：2025-06-10

Lenvatinib mesylate

甲磺酸仑伐替尼

更新于：2025-06-10

概要

基本信息

药物类型

小分子化药

别名

lenvatinib、lenvatinib mesilate、Lenvatinib mesilate (JAN)

+ [18]

靶点

FGFR1 x FGFR2 x FGFR3 x FGFR4 x PDGFRα x RET x VEGFR1 x VEGFR2 x VEGFR3 x c-Kit

作用方式

拮抗剂、抑制剂

作用机制

FGFR1拮抗剂(成纤维细胞生长因子受体-1拮抗剂)、FGFR2拮抗剂(成纤维细胞生长因子受体-2拮抗剂)、FGFR3拮抗剂(成纤维细胞生长因子受体-3拮抗剂)

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [12]

在研适应症

晚期子宫内膜癌复发性子宫内膜癌胸腺肿瘤+ [98]

非在研适应症

晚期乳腺癌晚期胃癌晚期非小细胞肺癌+ [27]

原研机构

Eisai Co., Ltd.

在研机构

Eisai, Inc.

Merck Sharp & Dohme Corp.

Eisai Co., Ltd.

+ [7]

非在研机构

Bristol Myers Squibb Co.

Merck & Co., Inc.

江苏康宁杰瑞生物制药有限公司

权益机构

Biotoscana Investments SA

Merck & Co., Inc.

Novartis AG

+ [3]

最高研发阶段批准上市

首次获批日期

美国 (2015-02-13),

甲状腺癌

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、附条件批准 (中国)、孤儿药 (日本)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、特殊审批 (中国)、优先审评 (中国)

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结构/序列

分子式C22H23ClN4O7S

InChIKeyHWLFIUUAYLEFCT-UHFFFAOYSA-N

CAS号857890-39-2

关联

607

项与甲磺酸仑伐替尼相关的临床试验

NCT06669572

/ Not yet recruiting临床2期IIT

A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and/or Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.

The purpose of this study is to gather information on the safety and effectiveness of lenvatinib combined with pembrolizumab in anal/rectal cancer that has spread to other parts of the body and will not respond to standard care.

开始日期2026-01-13

申办/合作机构

The University of Chicago

NCT05077215

/ Not yet recruiting临床3期

A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab Vs. Lenvatinib Plus Pembrolizumab in Patients with Advanced Endometrial Cancer

This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol).
Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors:
* Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer)
* ECOG score at baseline (0 vs 1)
* Geographic region (Asia vs ROW)

开始日期2025-12-01

申办/合作机构

Evergreen Therapeutics, Inc

NCT07011849

/ Not yet recruiting临床2期

A Multi-center, Open-label Phase II Study of Lenvatinib Plus Pembrolizumab (LEAP) in Renal Cell Carcinoma Patients With Brain Metastasis Previously Treated With Immune Checkpoint Blockade

This is a multi-center, open-label phase II study evaluating the efficacy and safety of pembrolizumab in combination with lenvatinib in patients with renal cell carcinoma (RCC) and brain metastasis who were previously treated with immune checkpoint blockade.

开始日期2025-11-01

申办/合作机构

Merck Sharp & Dohme LLC

100 项与甲磺酸仑伐替尼相关的临床结果

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100 项与甲磺酸仑伐替尼相关的转化医学

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100 项与甲磺酸仑伐替尼相关的专利（医药）

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3,700

项与甲磺酸仑伐替尼相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Immune infiltration landscape and potential drug-targeted implications for hepatocellular carcinoma with ‘progression/hyper-progression’ recurrence

Article

作者: Qi, Lu-Nan ; Peng, Yu-Chong ; Su, Yue-Xiang ; Xu, Jing-Xuan ; Chen, Yuan-Yuan ; Chen, Zu-Shun ; Huang, Yi-Yue

BACKGROUND AND AIMS:

Hepatocellular carcinoma (HCC) recurrence was previously characterized into four types, and patients with progression/hyper-progression recurrence (type III-IV) have an extremely poor prognosis. However, the immune background of resectable HCC, particularly in patients who experience recurrence, remains underexplored. Therefore, this study aimed to describe the immune landscape of resectable HCC, especially postoperative type III-IV recurrent HCC, and explore potential immune-targeted anti-relapse strategies for treated populations.

METHODS:

The differences in gene expression in patients with recurrent HCC (type I-II (solitary or multi-intrahepatic oligo recurrence) vs. type III-IV) were investigated using bulk sequencing. Multiple immune infiltration methods (single-sample gene set enrichment analysis (GSEA), Microenvironment Cell Populations-counter and ESTIMATE) were used, and patients were divided into four groups to identify four distinct immune subtypes: immune-enrichment/matrix-poor (IE1), immune-enrichment/matrix-rich (IE2), immune intermediate/matrix-rich (ITM) and immune desert/matrix-poor (ID). Co-expression and protein interaction analyses were used to identify characteristic genes in ITM closely associated with type III-IV recurrence, which was matched with drug targets for Huaier granules (HG) and lenvatinib. Virtual docking was used to identify potential therapeutic targets, and the results were verified using single-nuclei RNA sequencing and histological analysis.

RESULTS:

ITM was closely related to type III-IV recurrence and exhibited immunotherapy potential. The potential efficacy of inhibiting CCNA2, VEGFA, CXCL8, PLK2, TIMP1, ITGB2, ALDOA, ANXA5 and CSK in ITM reversal was determined. Molecular docking demonstrated that the proteins of these genes could bind to HG or lenvatinib. The immunohistochemical findings demonstrated differential VEGFA (p < .01) and PLK2 (p < .001) expression in ITM type and ID in type III-IV recurrent HCC.

CONCLUSIONS:

Three primary immunotypes of resectable HCC (IE2, ITM and ID) were identified, and HG and lenvatinib could potentially overcome immune checkpoint blockade (ICB) resistance in ITM patients with HCC, particularly those classified as type III-IV.

2025-12-31·Human Vaccines & Immunotherapeutics

Immunotherapy-induced microsatellite instability status shift in recurrent perihilar cholangiocarcinoma: A case report

Article

作者: Deng, Tan ; Liu, Hongbing ; Yu, Hailing

Immunotherapy revolutionized the treatment of biliary tract tumors and tumors with high microsatellite instability (MSI-H). This paper reports a 52-year-old woman with recurrent perihilar cholangiocarcinoma. The tumor was initially microsatellite stable (MSS) and proficient mismatch repair (pMMR) but shifted to MSI-H and deficient mismatch repair (dMMR) after combined immunotherapy. Following laparoscopic radical resection for jaundice, stage IV recurrence was diagnosed. Genetic testing revealed the MSS status. Subsequent treatment with camrelizumab and lenvatinib led to a partial response. Ovarian metastases, removed due to abdominal symptoms, exhibited dMMR and MSI-H. The mismatch in MSI status between the primary tumor and metastases suggests tumor heterogeneity and the influence of spatial or temporal factors. This shift can have important clinical significance since MSI-H is associated with significant responses to immune checkpoint inhibitors. MSI-H should be systematically tested in tumors and metastases to personalize treatments. MSI heterogeneity is not only rare but potentially has implications for treatment personalization and prognosis in patients with cholangiocarcinoma. This case highlights the dynamic changes in tumor characteristics during immunotherapy.

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Pharmacokinetic exposure and treatment outcomes of lenvatinib in patients with renal cell carcinoma and differentiated thyroid carcinoma

Article

作者: Steeghs, Neeltje ; Giraud, Eline L ; van Erp, Nielka P ; Walraven, Janneke E W ; de Boer, Jan Paul ; Huitema, Alwin D R ; Zielhuis, Sybrand W J ; Hassan, Esbar ; Meertens, Marinda ; van Thienen, Johannes V ; Desar, Ingrid M E ; Snels, Tiemen T ; Wilgenhof, Sofie

PURPOSE:

After initial approval of lenvatinib for radioiodine-refractory differentiated thyroid cancer (DTC), it has also shown promising outcomes in among others metastatic renal cell carcinoma (mRCC). Given that trial populations typically do not represent routine clinical care populations, questions arise about how applicable trial outcomes are in clinical practice. This study aims to compare the pharmacokinetics (PK), toxicity patterns, and survival data of lenvatinib in a real-world cohort with DTC and mRCC to those observed in pivotal clinical trials.

MATERIALS AND METHODS:

Patients were included when diagnosed with DTC or mRCC, had received current or prior treatment with lenvatinib, and had at least one available lenvatinib plasma concentration measurement. A descriptive comparison was made between the baseline characteristics, PK data, toxicity and survival data in this real-world cohort and those described in the phase III trials.

RESULTS:

Overall, 29 patients with mRCC and 35 patients with DTC were included. For mRCC, median time to treatment discontinuation (mTTD) was shorter than observed in the phase III trial (7.5 versus 11.0 months) with fewer dose-limiting toxicities, likely because 66% of the patients started with a reduced dose. mRCC patients were more pretreated and had a worse performance status than trial participants. This was resembled in overall lower PK exposure in mRCC patients. For DTC, mTTD was longer in our cohort (17.1 versus 13.8 months), with similar toxicity patterns and PK exposure as in the phase III trial.

CONCLUSIONS:

Our data suggests that patient characteristics and outcomes in routine clinical care deviate from clinical trials and show the need for alternative treatment strategies to manage tolerability to lenvatinib.

1,039

项与甲磺酸仑伐替尼相关的新闻（医药）

2025-06-07

·药明康德

客观缓解率达100%的抗体疗法；100%降解目标蛋白的潜在“first-in-class”口服降解剂…… | 一周盘点

本期看点1. 靶向Clever-1的单克隆抗体bexmarilimab与标准治疗（SoC）联用治疗初治高危骨髓增生异常综合征（HR-MDS）患者的早期临床试验结果亮眼，客观缓解率（ORR）达100%。2. 口服靶向抗癌化合物ibrilatazar联合化疗治疗III/IV期鳞状非小细胞肺癌（SQ-NSCLC）患者的1/2a期临床试验结果积极，与历史对照相比，联合治疗组的中位总生存期（OS）接近翻倍（22.5个月对比11.3个月）。3. Kymera Therapeutics公司的口服STAT6降解剂KT-621在一项1期研究的所有≥50 mg的多剂量递增（MAD）组中表现积极，患者血液与皮肤中的目标蛋白均达成完全降解。Bexmarilimab：公布1期联合治疗试验数据Faron Pharmaceuticals公司宣布，其靶向Clever-1的单克隆抗体bexmarilimab的一项1期研究结果已发表在《柳叶刀-血液学》（Lancet Haematology）杂志上。该研究旨在评估bexmarilimab联合SoC治疗高危骨髓增生异常综合征和复发/难治性（r/r）急性髓系白血病（AML）患者的安全性和有效性。Bexmarilimab是Faron公司全资拥有的研究性免疫疗法，旨在通过靶向髓系细胞功能和激活免疫系统，克服对现有疗法的耐药性并优化临床疗效。Bexmarilimab能与巨噬细胞上的免疫抑制受体Clever-1结合，该受体有助于肿瘤生长和转移（即帮助癌症躲避免疫系统）。通过靶向巨噬细胞上的Clever-1受体，bexmarilimab可改变肿瘤微环境，将巨噬细胞从免疫抑制（M2）状态重编程为免疫刺激（M1）状态，上调干扰素的产生，启动免疫系统攻击肿瘤，使癌细胞对标准治疗敏感。此次公布的结果显示，bexmarilimab联合阿扎胞苷在初治和低甲基化药物（HMA）治疗失败的HR-MDS患者中的ORR分别为100%和89%。HMA治疗失败的MDS患者的估计中位OS为13.4个月，r/r AML患者为8.1个月。两名HMA治疗失败的MDS患者在治疗后接受了造血干细胞移植（HSCT）。此外，治疗后患者的骨髓免疫生物标志物较基线水平提升了近3倍。在67%的HMA治疗失败的MDS患者中观察到HLA-DR分子增加，进一步支持bexmarilimab的作用机制。安全性方面，bexmarilimab联合治疗的耐受性良好，未观察到剂量限制性毒性。大多数治疗伴发不良事件（TEAE）为轻度至中度，仅6%与bexmarilimab相关。Ibrilatazar（ABTL0812）：公布1/2a期联合治疗试验数据AbilityPharma公司宣布，其评估ibrilatazar（ABTL0812）联合化疗（紫杉醇/卡铂）治疗III/IV期鳞状非小细胞肺癌患者的1/2a期临床试验ENDOLUNG的数据已发表在Lung Cancer杂志上。Ibrilatazar是一种潜在“first-in-class”、差异化的口服靶向抗癌化合物，通过诱导内质网应激和抑制PI3K/Akt/mTOR通路来引发自噬。在临床试验中，ibrilatazar对子宫内膜癌和肺癌患者显示出临床益处。此外，它在包括肺癌、子宫内膜癌、胰腺癌、神经母细胞瘤和胶质母细胞瘤等癌症类型的动物模型中展示了强有力的临床前概念验证。此次公布的结果显示，与历史对照相比，ibrilatazar联合化疗在所有疗效终点均显示出改善，包括：ibrilatazar联合治疗组的总缓解率为52%，历史对照为31.7%；ibrilatazar联合治疗组的中位无进展生存期（PFS）为6.2个月，历史对照为4.2个月；ibrilatazar联合治疗组的中位OS为22.5个月，历史对照为11.3个月。安全性方面，ibrilatazar联合化疗表现出良好的安全性。在紫杉醇/卡铂基础上加入ibrilatazar的安全性与历史对照中紫杉醇/卡铂单独使用时的安全性一致，并未带来除紫杉醇/卡铂本身已知不良事件之外的显著新增安全性风险。KT-621：公布1期临床试验数据Kymera Therapeutics公司公布其潜在“first-in-class”口服STAT6降解剂KT-621在1期健康受试者研究中的积极结果。数据显示，KT-621在每日一次口服给药下，于所有高于1.5 mg剂量水平中实现了超过90%的平均血液STAT6降解；在所有≥50 mg的MAD组中，更在血液与皮肤中均达成完全降解。此外，KT-621对Th2炎症相关生物标志物TARC和Eotaxin-3的中位降低幅度分别高达37%与63%，表现优于或相当于现有获批药物。KT-621在本项试验中展现出优异的安全性，未观察到严重不良事件或与治疗相关的不良事件，整体耐受性与安慰剂无明显差异。Kymera公司指出，KT-621的临床表现已显著优于其预设的产品特征目标，进一步验证了其“生物制品口服化”开发策略的可行性。当前，KT-621正在中重度特应性皮炎（AD）患者中开展1b期BroADen试验，预计将在2025年第四季度公布数据，并计划分别于2025年第四季度与2026年第一季度启动针对AD与哮喘的两项2b期临床研究。ISB 2001：公布1期临床试验的新数据Ichnos Glenmark Innovation公司公布了其三特异性抗体ISB 2001用于治疗复发/难治性多发性骨髓瘤（RRMM）的1期研究的新数据。ISB 2001同时靶向多发性骨髓瘤（MM）细胞上的BCMA和CD38，以及T细胞上的CD3，旨在增加对MM细胞的特异性结合，同时最大限度地减少脱靶效应。此次公布的结果显示，在经过大量治疗的患者群体中，7个活性剂量（≥50 μg/kg）组患者的持续总缓解率为79%，完全缓解/严格完全缓解（CR/sCR）率为30%。所有接受治疗的患者的总缓解率为74%，包括2例接受较低剂量治疗的患者。安全性方面，ISB 2001具有良好的安全性，大多数患者在数据截止时仍在接受治疗。EBC-129：公布1期临床试验的新数据新加坡实验药物研发中心（EDDC）公布了其在研抗体偶联药物（ADC）EBC-129的一项1期临床试验的新数据。EBC-129靶向CEACAM5和CEACAM6上保守的肿瘤特异性N256糖基化位点，这两种蛋白在肿瘤发生和转移中起关键作用。该ADC的毒性有效载荷是微管蛋白抑制剂MMAE，该药物已在其他上市的ADC中被广泛测试并获批用于临床，且已显示出与PD-1抑制剂之间的协同作用。此次公布的结果显示，EBC-129在21名此前接受过大量治疗的胰腺导管腺癌（PDAC）患者中显示出积极的总缓解率和延长的无进展生存期，包括那些之前接受过SoC（通常含有紫杉烷类药物）的患者。在接受1.8 mg/kg和2.2 mg/kg剂量治疗的患者中，总缓解率分别为25%和20%，疾病控制率（DCR）达87.5%和63.6%，中位PFS分别为19周和12周。EBC-129在迄今为止接受治疗的58例患者中显示出可控的安全性，观察到的主要治疗相关不良事件（TRAE）为无并发症的中性粒细胞减少和输液相关反应。IMC-002：公布1期联合治疗试验的中期数据ImmuneOncia Therapeutics公司公布了其下一代CD47靶向抗体IMC-002与lenvatinib联用治疗晚期肝细胞癌（HCC）患者的1b期临床试验的中期结果。IMC-002是一款全人源化IgG4单克隆抗体，通过阻断CD47-SIRPα相互作用，促进巨噬细胞对肿瘤细胞的吞噬作用。该抗体疗法可以在保证高疗效的同时最大限度地减少与红细胞的结合并避免血液学毒性。此次公布的结果显示，IMC-002表现出良好的安全性特征，未报告中性粒细胞减少或血小板减少，96%的不良事件为1/2级。在疗效可评估的10名患者中，有3名达到部分缓解（PR），DCR达80%，中位PFS为8.3个月。两名患者的治疗时间已超过一年，提示该疗法可能带来持久的临床获益。参考资料（可上下滑动查看）[1] ImmuneOncia Announces Interim Results from Phase 1b Clinical Trial of Next-Generation CD47 Antibody 'IMC-002' at ASCO 2025. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/immuneoncia-announces-interim-results-from-phase-1b-clinical-trial-of-next-generation-cd47-antibody-imc-002-at-asco-2025-302470514.html[2] Pasithea Therapeutics Presents Updated Interim Data from Ongoing Phase 1 Study of PAS-004 at the ASCO Annual Meeting 2025. Retrieved June 5, 2025, from https://ir.pasithea.com/news-events/press-releases/detail/122/pasithea-therapeutics-presents-updated-interim-data-from[3] Allogene Therapeutics Provides Updated Phase 1 Data Highlighting Durable Responses with ALLO-316 in Heavily Pretreated Advanced Renal Cell Carcinoma at ASCO. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/01/3091475/0/en/Allogene-Therapeutics-Provides-Updated-Phase-1-Data-Highlighting-Durable-Responses-with-ALLO-316-in-Heavily-Pretreated-Advanced-Renal-Cell-Carcinoma-at-ASCO.html[4] MYTX-011, a cMET-targeting antibody-drug conjugate (ADC), in patients with previously treated, advanced NSCLC: Updated dose escalation results in the phase 1 KisMET-01 study. Retrieved June 5, 2025, from https://ascopubs-org.libproxy1.nus.edu.sg/doi/10.1200/JCO.2025.43.16_suppl.8613[5] NervGen Pharma Reports Positive Topline Data from the Chronic Cohort of its Phase 1b/2a Clinical Trial Evaluating NVG-291 in Spinal Cord Injury. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091725/0/en/NervGen-Pharma-Reports-Positive-Topline-Data-from-the-Chronic-Cohort-of-its-Phase-1b-2a-Clinical-Trial-Evaluating-NVG-291-in-Spinal-Cord-Injury.html[6] Kymera Therapeutics Announces Positive First-in-Human Results from Phase 1 Healthy Volunteer Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091701/0/en/Kymera-Therapeutics-Announces-Positive-First-in-Human-Results-from-Phase-1-Healthy-Volunteer-Clinical-Trial-of-KT-621-a-First-in-Class-Oral-STAT6-Degrader.html[7] Erasca Announces IND Clearance for Potential First-in-Class and Best-in-Class Pan-KRAS Inhibitor ERAS-4001. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091800/0/en/Erasca-Announces-IND-Clearance-for-Potential-First-in-Class-and-Best-in-Class-Pan-KRAS-Inhibitor-ERAS-4001.html[8] Diakonos Oncology Presents Promising Phase I Results of Dubodencel (DOC1021) for the Treatment of Glioblastoma at the ASCO 2025 Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/diakonos-oncology-presents-promising-phase-i-results-of-dubodencel-doc1021-for-the-treatment-of-glioblastoma-at-the-asco-2025-annual-meeting-302469896.html[9] GV20 Therapeutics Presents Updated Phase 1 Monotherapy Data on GV20-0251 at the ASCO Annual Meeting 2025. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/gv20-therapeutics-presents-updated-phase-1-monotherapy-data-on-gv20-0251-at-the-asco-annual-meeting-2025-302463359.html[10] Mersana Therapeutics Reports Additional Positive Interim Phase 1 Clinical Data for Emi-Le in Oral Presentation at 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091831/0/en/Mersana-Therapeutics-Reports-Additional-Positive-Interim-Phase-1-Clinical-Data-for-Emi-Le-in-Oral-Presentation-at-2025-ASCO-Annual-Meeting.html[11] Merck Announces MK-1084, an Investigational KRAS G12C Inhibitor, Shows Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations. Retrieved May 30, 2025 from https://www-merck-com.libproxy1.nus.edu.sg/news/merck-announces-mk-1084-an-investigational-kras-g12c-inhibitor-shows-antitumor-activity-in-phase-1-trial-of-patients-with-advanced-colorectal-cancer-and-non-small-cell-lung-cancer-whose-tumors-harbo/[12] IN8bio Presents Positive Phase 1 Data of INB-200 in Newly Diagnosed GBM Demonstrating Prolonged Progression-Free Survival. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091745/0/en/IN8bio-Presents-Positive-Phase-1-Data-of-INB-200-in-Newly-Diagnosed-GBM-Demonstrating-Prolonged-Progression-Free-Survival.html[13] OnCusp Therapeutics Announces Encouraging Initial Phase 1a Results from Ongoing First-in-Human Study Evaluating its CDH6-Directed Antibody-Drug Conjugate, CUSP06, in Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/oncusp-therapeutics-announces-encouraging-initial-phase-1a-results-from-ongoing-first-in-human-study-evaluating-its-cdh6-directed-antibody-drug-conjugate-cusp06-in-platinum-refractoryresistant-ovarian-cancer-and-other-advanced--302470621.html[14] Perspective Therapeutics Highlights Updated Interim Data from its Ongoing Phase 1/2a Clinical Trial of [212Pb]VMT-α-NET at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/05/30/3091346/0/en/Perspective-Therapeutics-Highlights-Updated-Interim-Data-from-its-Ongoing-Phase-1-2a-Clinical-Trial-of-212Pb-VMT-%CE%B1-NET-at-the-2025-ASCO-Annual-Meeting.html[15] AbCellera Receives Authorization from Health Canada to Initiate a Phase 1 Clinical Trial of ABCL575. Retrieved June 5, 2025, from https://investors.abcellera.com/news/news-releases/2025/AbCellera-Receives-Authorization-from-Health-Canada-to-Initiate-a-Phase-1-Clinical-Trial-of-ABCL575/default.aspx[16] Faron announces publication of full Phase I BEXMAB study data in Lancet Haematology. Retrieved June 5, 2025, from https://faron.com/releases-and-publications/faron-announces-publication-of-full-phase-i-bexmab-study-data-in-lancet-haematology/[17] Enterome presents positive Phase 1/2 MSS/pMMR metastatic colorectal cancer data in patients treated with EO4010 OncoMimics™ immunotherapy plus nivolumab at ASCO 2025. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/05/30/3090836/0/en/Enterome-presents-positive-Phase-1-2-MSS-pMMR-metastatic-colorectal-cancer-data-in-patients-treated-with-EO4010-OncoMimics-immunotherapy-plus-nivolumab-at-ASCO-2025.html[18] Experimental Drug Development Centre Announces the Presentation of Updated Data from the Phase 1 Study of Antibody-Drug Conjugate EBC-129 at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO). Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/experimental-drug-development-centre-announces-the-presentation-of-updated-data-from-the-phase-1-study-of-antibody-drug-conjugate-ebc-129-at-the-2025-annual-meeting-of-the-american-society-of-clinical-oncology-asco-302467763.html[19] Full Dose-Escalation Data Show Continued High Response Rates and Favorable Safety Profile of ISB 2001, a First-in-Class BCMA × CD38 × CD3 Trispecific Antibody, for the Treatment of Relapsed/Refractory Multiple Myeloma. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3091923/0/en/Full-Dose-Escalation-Data-Show-Continued-High-Response-Rates-and-Favorable-Safety-Profile-of-ISB-2001-a-First-in-Class-BCMA-CD38-CD3-Trispecific-Antibody-for-the-Treatment-of-Relap.html[20] Cardiff Oncology Announces Positive Data from Investigator-Initiated Trial of Onvansertib in Combination with Paclitaxel in Metastatic Triple-Negative Breast Cancer Presented at ASCO 2025. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/02/3092323/0/en/Cardiff-Oncology-Announces-Positive-Data-from-Investigator-Initiated-Trial-of-Onvansertib-in-Combination-with-Paclitaxel-in-Metastatic-Triple-Negative-Breast-Cancer-Presented-at-AS.html[21] Lilly presents first clinical data for its investigational, next-generation FRα targeting ADC in platinum-resistant ovarian cancer at the 2025 ASCO Annual Meeting. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/lilly-presents-first-clinical-data-for-its-investigational-next-generation-fr-targeting-adc-in-platinum-resistant-ovarian-cancer-at-the-2025-asco-annual-meeting-302470018.html[22] Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-ALK7 for the Treatment of Obesity. Retrieved June 5, 2025, from https://ir.arrowheadpharma.com/news-releases/news-release-details/arrowhead-pharmaceuticals-initiates-phase-12a-study-aro-alk7[23] Obsidian Therapeutics Announces Positive Clinical Data from OBX-115 in Patients with Advanced Melanoma in Ongoing Multicenter Study at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Retrieved June 5, 2025, from https://obsidiantx.com/news-releases/obsidian-therapeutics-announces-positive-clinical-data-from-obx-115-in-patients-with-advanced-melanoma-in-ongoing-multicenter-study-at-the-2025-american-society-of-clinical-oncology-asco-annual-meet/[24] Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer. Retrieved June 5, 2025, from https://www.prnewswire.com/news-releases/johnson--johnson-unveils-first-in-human-results-for-pasritamig-showing-early-anti-tumor-activity-in-prostate-cancer-302470142.html[25] Initial Data from the ARC-20 Study of Casdatifan Plus Cabozantinib Showed Nearly Half of Patients with Metastatic Kidney Cancer Had a Confirmed Response. Retrieved June 5, 2025, from https://www.businesswire.com/news/home/20250601016939/en/Initial-Data-from-the-ARC-20-Study-of-Casdatifan-Plus-Cabozantinib-Showed-Nearly-Half-of-Patients-with-Metastatic-Kidney-Cancer-Had-a-Confirmed-Response[26] 에이비엘, 'B7-H4x4-1BB' 삼중 1b/2상 "국내 IND 승인". Retrieved June 5, 2025, from https://www.biospectator.com/news/view/25313[27] Sionna Therapeutics Announces Positive Phase 1 Data for NBD1 Stabilizers SION-719 and SION-451 and Advances Both Programs in Clinical Development for Cystic Fibrosis. Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/04/3093440/0/en/Sionna-Therapeutics-Announces-Positive-Phase-1-Data-for-NBD1-Stabilizers-SION-719-and-SION-451-and-Advances-Both-Programs-in-Clinical-Development-for-Cystic-Fibrosis.html[28] Moleculin Reports Positive Topline Efficacy Results from U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB-107). Retrieved June 5, 2025, from https://www.globenewswire.com/news-release/2025/06/04/3093575/0/en/Moleculin-Reports-Positive-Topline-Efficacy-Results-from-U-S-Phase-1B-2-Clinical-Trial-Evaluating-Annamycin-for-the-Treatment-of-Soft-Tissue-Sarcoma-Lung-Metastases-MB-107.html[29] REGENXBIO REPORTS NEW POSITIVE FUNCTIONAL DATA FROM PHASE I/II AFFINITY DUCHENNE® TRIAL OF RGX-202. Retrieved June 5, 2025 from https://ir.regenxbio.com/news-releases/news-release-details/regenxbio-reports-new-positive-functional-data-phase-iii[30] AbilityPharma’s IBRILATAZAR (ABTL0812) doubles overall survival in patients with squamous non-small cell lung cancer. Retrieved June 5, 2025 from https://abilitypharma.com/en/main-menu/media-center-2/press-release/abilitypharma%E2%80%99s-ibrilatazar-(abtl0812)-doubles-overall-survival-in-patients-with-squamous-non-small-cell-lung-cancer免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新2

临床结果免疫疗法临床2期临床1期

2025-06-07

·药学进展

行业动态 | 信达生物IBI363（PD-1/IL-2α-bias双特异性抗体融合蛋白）获国家药监局纳入突破性治疗药物品种

“点击蓝字关注我们再获BTD：信达生物IBI363（PD-1/IL-2α-bias双特异性抗体融合蛋白）获国家药品监督管理局纳入突破性治疗药物品种，治疗免疫耐药鳞状非小细胞肺癌PPS 2025年6月5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、眼科等重大疾病领域创新药物的生物制药公司，宣布其全球首创PD-1/IL-2α-bias双特异性抗体融合蛋白IBI363已被中国国家药品监督管理局（NMPA）药品审评中心（CDE）纳入突破性治疗药物（BTD）品种名单，拟定适应症为经含铂化疗及抗PD - 1/PD - L1免疫治疗失败的局部晚期或转移性鳞状非小细胞肺癌。截至目前，IBI363在鳞状非小细胞肺癌和黑色素瘤的两项适应症已经分别获得中国CDE的BTD认证和美国FDA快速通道资格（FTD）认定，此次BTD标志着IBI363在解决免疫耐药及冷肿瘤治疗难题中再前进一步。IBI363在既往接受过免疫治疗的鳞状非小细胞肺癌受试者的临床I期研究最新数据在2025年ASCO大会上以口头形式报告。在免疫治疗耐药的鳞状非小细胞肺癌和野生型肺腺癌中，都观察到了可控的安全性、令人鼓舞的疗效和长期生存获益，有望为免疫耐药患者提供新的治疗希望。在今年ASCO会议上，IBI363口头报告了在免疫耐药非小细胞肺癌、结直肠癌、黑色素瘤三项免疫耐药及冷肿瘤中的突破性临床研究结果，并获得广泛关注。信达生物制药集团高级副总裁周辉博士表示：“IBI363引领着下一代免疫治疗的进化方向——通过‘PD-1靶向+IL-2激活扩增肿瘤特异性T细胞’的免疫检查点阻断+细胞因子激动双重作用，重塑肿瘤免疫微环境。IBI363在近期接连获得多项FTD和BTD，标志着监管机构认可其针对未满足需求的临床价值。我们正在加速推进IBI363的多瘤种的全球开发，其中头对头帕博利珠单抗的首个注册临床研究在粘膜及肢端型黑色素瘤已启动，公司还将与监管沟通IBI363在肺癌和结直肠癌的注册临床研究方案，以创新疗法开启肿瘤免疫治疗新篇章。”突破性治疗药物资格认定是为了加快开发针对严重疾病、且已在初步临床试验中显示疗效或安全性方面显著优于现有治疗手段的新药而设计的。获得突破性治疗药物认定能够使该药在研发过程中与CDE密切交流、获得指导，从而加快新药上市，更早解决中国病患未满足的临床需求。关于鳞状非小细胞肺癌肺癌是全球及中国发病率和死亡率最高的恶性肿瘤1，是危害公共健康的重大问题。尽管免疫治疗已经彻底改变了非小细胞肺癌的治疗格局，但对于免疫治疗失败且无驱动基因突变的非小细胞肺癌患者，目前仍缺乏有效的治疗手段。标准治疗方案多西他赛疗效有限，ORR不到20%，PFS不到4个月，OS不到12个月2-7。近年来，虽然免疫联合治疗、抗体偶联药物（Antibody-drug conjugates，ADCs）等新型治疗方案的探索带来了新的希望，但多项针对含铂化疗及免疫治疗失败的非小细胞肺癌人群的大型III期临床研究均未获得令人满意的结果，其中多数研究未达到主要终点2-6。TROPION-Lung01研究虽然在NSCLC中达到PFS主要终点（未达到OS主要终点），但在鳞状非小细胞肺癌中，试验组的PFS/OS/ORR均未见提升7。因此，在免疫治疗失败的鳞状非小细胞肺癌中，存在巨大且迫切的未满足的临床需求。关于IBI363（PD-1/IL-2α-bias双特异性融合蛋白） IBI363是由信达生物自主研发的全球首创PD-1/IL-2α-bias双特异性融合蛋白，同时具有阻断PD-1/PD-L1通路和激活IL-2通路两项功能。IBI363的IL-2臂经过了设计改造，保留了其对IL-2 Rα的亲和力，但削弱了对IL-2Rβ和IL-2Rγ的结合能力，以此降低毒性；而PD-1结合臂可以同时实现对PD-1的阻断和IL-2的选择性递送。由于新激活的肿瘤特异性T细胞同时表达PD-1和IL-2α，这一差异性策略可以更精确和有效地实现对该T细胞亚群的靶向和激活。IBI363不仅在多种荷瘤药理学模型中展现出了良好抗肿瘤活性，在PD-1耐药和转移模型中也表现出了突出的抑瘤效力。在今年ASCO会议上，IBI363口头报告了在免疫耐药非小细胞肺癌、结直肠癌、黑色素瘤三项免疫耐药及冷肿瘤中的突破性临床研究结果，并获得广泛关注。从临床迫切需求出发，信达生物正在中国、美国、澳大利亚开展临床研究探索IBI363在针对各种恶性肿瘤的有效性和安全性。IBI363已开出首个关键注册临床研究，用于治疗未经免疫治疗的粘膜型和肢端型黑色素瘤。IBI363已获美国FDA两项快速通道资格认定，分别用于治疗晚期鳞状非小细胞肺癌和黑色素瘤。IBI363也获得中国NMPA纳入两项突破性疗法认证，治疗晚期黑色素瘤和鳞状非小细胞肺癌。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®）和利厄替尼片（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。信达生物已与礼来、罗氏、赛诺菲、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。详情请访问信达生物网站：www.innoventbio.com或信达生物领英账号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®）塞普替尼胶囊（睿妥®）和匹妥布替尼片（捷帕力®）由礼来公司研发前瞻性声明此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，凡与公司有关的，目的均是要指明其属前瞻性表述。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此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。信达生物、此公司董事及雇员代理概不承担 (a) 更正或更新此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。参考文献：[1] Globocan 2022 (version 1.1) - 08.02.2024[2] Paz-Ares LG, Juan-Vidal O, Mountzios GS, et al. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. Aug 20 2024;42(24):2860-2872. doi:10.1200/JCO.24.00733[3] Neal J, Pavlakis N, Kim SW, et al. CONTACT-01: A Randomized Phase III Trial of Atezolizumab + Cabozantinib Versus Docetaxel for Metastatic Non-Small Cell Lung Cancer After a Checkpoint Inhibitor and Chemotherapy. J Clin Oncol. Jul 10 2024;42(20):2393-2403. doi:10.1200/JCO.23.02166[4] SAFFRON-301: Tislelizumab plus sitravatinib in advanced/metastatic NSCLC progressing on/after chemotherapy and anti–PD-(L)1. WCLC 2024.[5] 65O - Phase 3 LEAP-008 study of lenvatinib plus pembrolizumab versus docetaxel for metastatic non-small cell lung cancer (NSCLC) that progressed on a PD-(L)1 inhibitor and platinum-containing chemotherapy. ESMO IO 2023.[6] Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial. Lung Cancer . 2024 Mar:189:107451. doi: 10.1016/j.lungcan.2023.107451. Epub 2024 Jan 16.[7] Ahn MJ, Tanaka K, Paz-Ares L, et al. Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study. J Clin Oncol. Sep 9 2024:JCO2401544. doi:10.1200/JCO-24-01544文章来源：信达生物美编排版：何裕爽文章审核：杨美帆何裕爽罗琪【免责声明】以上内容来源于互联网，不代表本平台立场或观点；如有侵犯作者著作权，请及时与我们联系（Tel：025-83271227，或直接在微信平台留言），我们将及时更正或删除。《药学进展》杂志由教育部主管、中国药科大学主办，中国科技核心期刊（中国科技论文统计源期刊）。刊物以反映药学科研领域的新方法、新成果、新进展、新趋势为宗旨，以综述、评述、行业发展报告为特色，以药学学科进展、技术进展、新药研发各环节技术信息为重点，是一本专注于医药科技前沿与产业动态的专业媒体。《药学进展》注重内容策划、加强组稿约稿、深度挖掘、分析药学信息资源、在药学学科进展、科研思路方法、靶点机制探讨、新药研发报告、临床用药分析、国际医药前沿等方面初具特色；特别是医药信息内容以科学前沿与国家战略需求相合，更加突出前瞻性、权威性、时效性、新颖性、系统性、实战性。根据最新统计数据，刊物篇均下载率连续三年蝉联我国医药期刊榜首，复合影响因子1.216，具有较高的影响力。《药学进展》编委会由国家重大专项化学药总师陈凯先院士担任主编，编委由新药研发技术链政府监管部门、高校科研院所、制药企业、临床医院、CRO、金融资本及知识产权相关机构近两百位极具影响力的专家组成。联系《药学进展》↓↓↓编辑部官网：pps.cpu.edu.cn；邮箱：yxjz@163.com；电话：025-83271227。欢迎投稿、订阅！往期推荐聚焦“兴药为民·2023生物医药创新融合发展大会”“兴药为民·2023生物医药创新融合发展大会”盛大启幕！院士专家齐聚杭城，绘就生物医药前沿赛道新蓝图“兴药强刊”青年学者论坛暨《药学进展》第二届青年编委会议成功召开“兴药为民·2023生物医药创新融合发展大会”路演专场圆满收官！校企合作新旅程已启航我知道你在看哟

突破性疗法ASCO会议临床1期临床结果免疫疗法

2025-06-05

·ioncology

ASCO中国之声丨陆荫英教授：三联四药方案为ICC患者预后提升带来希望

编者按：胆道恶性肿瘤（BTC）包括肝内胆管癌（ICC)，肝外胆管癌（ECC）和胆囊癌（GBC），是一组具有高度侵袭性和异质性的肿瘤，约占消化系统恶性肿瘤的3%。多数BTC患者确诊时即为晚期，治疗选择有限、生存预后不佳。因此，尽管发病率不高，但其仍是危害公众健康的重要公共卫生负担1。在本月召开的2025年美国临床肿瘤学会（ASCO）年会中，解放军总医院第五医学中心肝病医学部主任陆荫英教授团队报道的一项真实世界回顾性研究2显示，帕博利珠单抗联合仑伐替尼和GEMOX化疗为晚期ICC患者带来了可观的疾病缓解与生存改善。研究简介研究方法纳入患者标准：接受帕博利珠单抗联合仑伐替尼和GEMOX方案治疗的不可切除的晚期ICC患者，所有纳入患者均经病理学确诊。用药方案：患者接受标准剂量的帕博利珠单抗联合GEMOX治疗，仑伐替尼剂量则为4 mg。研究终点：主要疗效终点为总生存期（OS）；次要疗效终点包括无进展生存期（PFS）、客观缓解率（ORR）和疾病控制率（DCR），这些指标均根据mRECIST标准评估。不良事件（AE）根据CTCAE v5.0进行记录。研究结果2021年10月至2024年9月，共入组71例符合条件的患者，其中40例患者接受该联合方案作为一线全身治疗。截至2025年1月数据，中位随访时间为8.8个月。总人群疗效：中位OS为17.3个月[95%置信区间（CI）10.3-24.3个月]，中位PFS为7.1个月（95%CI：4.7-9.5个月）。ORR和DCR分别为38.0%和78.9%。根治性肝切除术后复发的晚期患者OS短于未接受过肝切除术的晚期患者（11.8个月 vs. 21.3个月，P=0.024）。6例患者在治疗后达到转化切除标准并接受了肝切除术。一线治疗人群疗效：ORR（55.0%）和DCR（87.5%）相对更高。中位PFS为8.47个月（95%CI：6.4-10.5个月），OS尚未达到，3、6、9个月的OS率分别为94.8%、87.8%和83.2%。安全性：几乎所有患者均出现AE，其中24例（33.8%）患者在联合治疗开始后6个月内出现3/4级AE。表1. 所有患者和一线治疗患者疗效研究结论帕博利珠单抗联合仑伐替尼和GEMOX方案有望成为晚期ICC的一线治疗方案，且安全性和有效性普遍可接受。然而，仍需进一步开展更大样本量的前瞻性研究来证实这些发现。研究者说近年来，在传统化疗的基础上，免疫治疗的加入已一定程度改善了BTC患者预后。KEYNOTE-966和TOPAZ-1两大Ⅲ期研究的成功，使免疫联合化疗正式成为当前指南推荐的晚期BTC一线治疗优选方案。然而，从现有数据和临床经验来看，BTC患者的长期生存仍面临着巨大的挑战。考虑到不同BTC亚型在解剖学、流行病学和分子特征等维度的差异，针对不同亚型和不同人群探索更适宜的联合治疗方案，是当前BTC治疗优化的重要方向。数据显示，ICC的发病率在2000年至2018年间翻倍（从2000年的每10万人0.6例增至2018年的每10万人1.3例），整体预后不佳3,4。相较于GBC和ECC，ICC在肿瘤来源、免疫微环境和预后等方面均存在一定差异。因此，针对ICC患者开展治疗方案的探索具有重要意义。如我们所知，既往已有研究报道了ICC群体中免疫加化疗基础上进一步联合靶向治疗的价值5。本研究则首次探索了帕博利珠单抗在ICC三联四药治疗中的应用。除了免疫检查点抑制剂选择的不同，我们结合临床经验对联合应用的仑伐替尼也进行了减量，以期达成疗效和安全性的平衡。团队先前开展的一项前瞻性研究纳入了33名接受PD-1、仑伐替尼和GEMOX一线治疗的晚期胆管癌患者，17名接受标准剂量仑伐替尼，16名接受减量仑伐替尼。结果显示，标准剂量组经RECIST v1.1评估的ORR和DCR分别为35.2%和82.3%，减量组分别为62.5%和87.5%，减量组患者的治疗相关不良事件和严重不良事件较标准剂量组更少，提示联合方案中仑伐替尼减量的可行性6。本研究中，优化调整后的方案在实现可观疗效的同时，安全性也相对可控。值得注意的是，三联四药方案用于一线治疗时，ORR较免疫联合化疗方案明显提升，提示转化治疗的潜力。本次真实世界回顾性分析中亦有6例患者在接受治疗后已达到转化切除标准并接受了手术切除。因此，在潜在可切除BTC患者中进行以转化为目的的三联四药探索，或是未来进一步发挥现有治疗药物价值的重要方向。参考文献：（上下滑动查看更多）1.Zhou J, Tan G, Zhang L, et al. Epidemiology of biliary tract cancer in China: A narrative review. Chin J Cancer Res. 2024;36(5):474-488. 2.Hongli Yu et al. Efficacy and safety in advanced intrahepatic cholangiocarcinoma using pembrolizumab combined with lenvatinib and GEMOX: A retrospective analysis of real-world evidence.. JCO 43, e16191-e16191(2025).3.Xing, H., et al., Incidence Trend and Competing Risk Analysis of Patients With Intrahepatic Cholangiocarcinoma: A Population-Based Study. Frontiers in Medicine, 2022. 9.4.Li, Q., et al., Burden of liver cancer: From epidemiology to prevention. Chinese Journal of Cancer Research, 2022. 34(3): p. 554-566.5.Shi GM, Huang XY, Wu D, et al. Toripalimab combined with lenvatinib and GEMOX is a promising regimen as first-line treatment for advanced intrahepatic cholangiocarcinoma: a single-center, single-arm, phase 2 study.?Signal Transduct Target Ther. 2023;8(1):106. 6.PP1007. 2025 APASL 专家简介陆荫英教授解放军总医院第五医学中心/肝病医学部主任主任医师博导北京大学医学部；深圳大学特聘教授清华大学合成与系统生物学中心特聘研究员中国老年学及老年医学学会/转化医学分会执行主委亚太肝病诊疗技术联盟/肝癌学术委员会主委中国研究型医院协会/分子诊断专委会副主委欧美同学会/医师协会青委会秘书长“一带一路”肝胆肿瘤及传染病国际大会执行主席国际灾害医学应急救援大会（IPRED）主席团成员科技部重点研发项目评审专家国家自然科学基金面上项目评审专家《肝癌电子杂志》副主编Cancer biology & medicine编委享受“军队优秀专业人才岗位津贴”北京市“百佳青年医生”第一/通讯发表SCI论著70余篇，包括Lancet Infectious Diseases、Gut、Hepatology、Diabetes Care、Nature Communication、Signal Transduct Target Ther、Protein cell等，累计IF＞400；主编专著3部，牵头发布行业专家共识6部。（来源：《国际肝病》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果ASCO会议临床3期免疫疗法引进/卖出

100 项与甲磺酸仑伐替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09920	甲磺酸仑伐替尼	L01XE	DB09078

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	欧盟	Eisai GmbH	2023-07-25
晚期子宫内膜癌	冰岛	Eisai GmbH	2023-07-25
晚期子宫内膜癌	列支敦士登	Eisai GmbH	2023-07-25
晚期子宫内膜癌	挪威	Eisai GmbH	2023-07-25
复发性子宫内膜癌	欧盟	Eisai GmbH	2023-07-25
复发性子宫内膜癌	冰岛	Eisai GmbH	2023-07-25
复发性子宫内膜癌	列支敦士登	Eisai GmbH	2023-07-25
复发性子宫内膜癌	挪威	Eisai GmbH	2023-07-25
胸腺肿瘤	日本	Eisai Co., Ltd.	2021-03-23
晚期肾细胞癌	欧盟	Eisai GmbH	2016-08-25
晚期肾细胞癌	冰岛	Eisai GmbH	2016-08-25
晚期肾细胞癌	列支敦士登	Eisai GmbH	2016-08-25
晚期肾细胞癌	挪威	Eisai GmbH	2016-08-25
子宫内膜癌	澳大利亚	Eisai Co., Ltd.	2016-01-28
肾细胞癌	澳大利亚	Eisai Co., Ltd.	2016-01-28
晚期肝细胞癌	欧盟	Eisai GmbH	2015-05-28
晚期肝细胞癌	冰岛	Eisai GmbH	2015-05-28
晚期肝细胞癌	列支敦士登	Eisai GmbH	2015-05-28
晚期肝细胞癌	挪威	Eisai GmbH	2015-05-28
分化型甲状腺癌	欧盟	Eisai GmbH	2015-05-28

未上市

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适应症	最高研发状态	国家/地区	公司	日期
晚期非小细胞肺癌	临床3期	中国	江苏康宁杰瑞生物制药有限公司	2021-10-28
转移性食管癌	临床3期	美国	Eisai, Inc.	2021-07-28
转移性食管癌	临床3期	美国	Merck Sharp & Dohme Corp.	2021-07-28
转移性食管癌	临床3期	中国	Eisai, Inc.	2021-07-28
转移性食管癌	临床3期	中国	Merck Sharp & Dohme Corp.	2021-07-28
转移性食管癌	临床3期	日本	Eisai, Inc.	2021-07-28
转移性食管癌	临床3期	日本	Merck Sharp & Dohme Corp.	2021-07-28
转移性食管癌	临床3期	阿根廷	Eisai, Inc.	2021-07-28
转移性食管癌	临床3期	阿根廷	Merck Sharp & Dohme Corp.	2021-07-28
转移性食管癌	临床3期	加拿大	Merck Sharp & Dohme Corp.	2021-07-28

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临床结果

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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


NCT03838796 (Pubmed \| Hepatobiliary Pancreat Dis Int)	N/A	肝细胞癌辅助	297	Lenvatinib + TACE	醖簾憲夢淵選築衊淵鏇(齋窪夢衊夢廠鬱範築鹹) = 艱糧觸憲淵築齋積觸範廠鏇襯鑰膚膚鑰淵艱製 (壓膚鹽構襯衊廠淵廠襯 ) 更多	积极	2025-06-01
				lenvatinib (TACE)	醖簾憲夢淵選築衊淵鏇(齋窪夢衊夢廠鬱範築鹹) = 觸製築糧蓋蓋鏇顧繭製廠鏇襯鑰膚膚鑰淵艱製 (壓膚鹽構襯衊廠淵廠襯 ) 更多
NCT04662710 (LEAP-015, ASCO2025)	临床3期	转移性胃食管腺癌一线 HER-2 negative \| PD-L1 CPS ≥1	880	Pembrolizumab plus Lenvatinib and Chemotherapy	襯獵蓋窪齋窪窪觸廠獵(淵鑰廠齋膚鹽範鹽網遞) = 網憲構廠糧憲鹽艱廠積製餘顧壓鬱遞憲醖淵憲 (齋壓積簾顧鏇膚遞積窪 ) 更多	积极	2025-05-30
				Chemotherapy alone	襯獵蓋窪齋窪窪觸廠獵(淵鑰廠齋膚鹽範鹽網遞) = 鬱鬱鏇製構鬱齋構繭選製餘顧壓鬱遞憲醖淵憲 (齋壓積簾顧鏇膚遞積窪 ) 更多
SELECT (ASCO2025)	临床3期	甲状腺癌一线 TP53	77	Lenvatinib 10 mg	網鹽鹽艱襯淵窪糧鹽構(齋選簾築遞淵製淵壓窪) = 廠衊蓋夢夢願淵築積築齋遞鹹選鹽襯齋窪選築 (鏇製鹹築鹹選網衊醖構 ) 更多	积极	2025-05-30
				Lenvatinib 14 mg	網鹽鹽艱襯淵窪糧鹽構(齋選簾築遞淵製淵壓窪) = 鏇衊鹽範夢範簾製糧鹽齋遞鹹選鹽襯齋窪選築 (鏇製鹹築鹹選網衊醖構 ) 更多
NCT04209660 (phase II study of lenvatinib plus pembrolizumab in patients with recurrent/metastatic salivary gland cancers, ASCO2025)	临床2期	唾液腺癌复发	27	Lenvatinib 20 mg	鹽選艱網獵襯選範範蓋(膚顧鑰膚餘築衊鹽鏇觸) = 憲窪齋鏇積襯鬱願獵醖窪網鏇齋鏇鏇鬱夢膚壓 (積蓋獵襯鑰蓋廠遞獵襯 ) 更多	积极	2025-05-30
NCT05585580 (STILL, ASCO2025)	临床2期	胃食管交界处腺癌二线 PD-L1 combined positive score (CPS)	47	Serplulimab + Lenvatinib + Paclitaxel	鏇鹹鬱蓋顧蓋鏇壓壓蓋(憲鬱膚選齋艱觸鹽餘廠) = 夢淵壓範築積構糧衊觸網淵範窪顧顧醖艱窪鑰 (積鬱鏇齋衊壓簾願繭積, 35.1% ~ 67.1) 更多	积极	2025-05-30
NCT03950609 (phase II study of lenvatinib plus everolimus in advanced extra-pancreatic neuroendocrine tumors (epNETs), ASCO2025)	临床2期	胰腺外神经内分泌肿瘤	32	Lenvatinib 18 mg + Everolimus 5 mg	醖製願膚廠築築製廠獵(構齋繭壓襯獵築鑰簾遞) = 繭繭鑰淵簾鏇顧艱蓋積膚壓獵願範淵憲鹽觸壓 (鹽選願壓衊淵廠遞壓鑰 ) 更多	积极	2025-05-30
				Everolimus alone	醖製願膚廠築築製廠獵(構齋繭壓襯獵築鑰簾遞) = 鑰憲鬱獵襯願鬱壓製蓋膚壓獵願範淵憲鹽觸壓 (鹽選願壓衊淵廠遞壓鑰 ) 更多
ASCO2025	N/A	晚期肝细胞癌 ICGR15	-	Lenvatinib group	艱積壓鏇遞衊築鑰壓壓(齋糧鏇齋網艱築鏇積願) = One case of intra-tumor bleeding in G3, which was stopped with TAE and could be managed with a reduced dose of lenvatinib 構願繭衊艱獵糧網鏇蓋 (膚憲築壓願繭築鬱壓窪 ) 更多	积极	2025-05-30
ChiCTR2000040863 (ASCO2025)	N/A	门静脉血栓形成辅助	74	TACE + Lenvatinib	鹽廠顧窪衊觸獵範積網(憲窪顧鹹艱獵鬱製鹽製) = 選夢齋顧壓醖構廠鹹膚簾窪鬱獵築製範繭窪遞 (鬱窪顧築範範鏇糧積餘, 20.5 ~ NA)	积极	2025-05-30
				TACE alone	鹽廠顧窪衊觸獵範積網(憲窪顧鹹艱獵鬱製鹽製) = 齋築鏇艱築積餘獵範繭簾窪鬱獵築製範繭窪遞 (鬱窪顧築範範鏇糧積餘, 10.2 ~ NA)
NCT04869137 (phase II study of neoadjuvant lenvatinib plus pembrolizumab in Merkel cell carcinoma, ASCO2025)	临床2期	梅克尔细胞癌新辅助 \| 辅助	26	Lenvatinib 20mg	範窪繭膚選顧築壓選蓋(艱鑰餘艱壓醖淵壓願製) = 鑰積膚簾構壓壓壓糧齋鑰觸範糧鏇簾艱遞餘網 (獵遞膚網網鏇襯糧鬱糧 )	积极	2025-05-30
ASCO2025	N/A	晚期肝细胞癌二线	388	Lenvatinib	蓋窪構顧構獵遞蓋鑰膚(簾鏇淵網鏇顧蓋醖糧願) = 醖顧獵襯鹽夢鹽鹽壓觸網憲鏇衊蓋繭鹹願製繭 (窪鬱獵願願觸鏇製夢簾, 7.39 ~ 17.22) 更多	积极	2025-05-30