Neoadjuvant chemotherapy has become the standard of care for breast cancer patients with large tumors in order to render them operable for mastectomy or, in some cases, for lumpectomy and radiation therapy. Building on this theme, several large hormonal therapies are extensively investigated in the neoadjuvant setting, together with biologic correlates for response and resistance. As a further extension, neoadjuvant therapies with biologic agents are now too, being investigated for biologic evidence of efficacy before large-scale clinical trials of thousands of patients are embarked on. The neoadjuvant setting is especially attractive for these studies for several reasons including early assessment of response to therapy, biopsiable access to the primary tumor, and considerable reduced sample sizes compared to those required in the adjuvant setting. In addition, clinical response to neoadjuvant chemotherapy is a validated surrogate marker for improved survival. It may be used to test the overall efficacy of neoadjuvant treatment regimens and mirrors the effect of therapy on micrometastases setting. In a recent study, good clinical response to neoadjuvant chemotherapy was the only independent variable, by multivariate analysis, associated with decreased risk of death.
GW572016 is a new and promising dual tyrosine kinase inhibitor against HER1/2. Hundreds of patients were treated in phase I and II studies world-wide and results indicate that this reversible, oral small molecule is generally well-tolerated. Studies of neoadjuvant Trastuzumab indicate that HER2 interference leads to significant tumor regression even after 3 weeks of monotherapy. We aim to extend these findings with a novel agent, GW572016 that may be more effective, especially from its in vitro data, and to discover the true response rate to inhibiting HER1/2 signal transduction in breast cancer patients.

开始日期2023-07-31

申办/合作机构

The University of New Mexico

NCT05400902 / Recruiting临床2期IIT

Hepatic Arterial Infusion Chemotherapy Combined With Sintilimab and Bevacizumab in the Treatment of Unresectable Intrahepatic Cholangiocarcinoma: A Prospective, Single-Center, Phase II Study

Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma accounts for 10%-15%. Surgical resection is the only curative method for ICC, but most patients are diagnosed at an advanced stage, and only 15% of patients can undergo surgical resection. In locally advanced ICC patients without distant metastases, although the tumor was initially assessed as unresectable, these patients may have the opportunity for surgical resection after reducing the size tumor lesion and increasing the remnant liver volume through conversion therapy. The current standard first-line treatment for unresectable ICC is gemcitabine combined with cisplatin, with a median overall survival of only 11.7 months and an ORR of 26.1%. In view of the poor effect of the standard chemotherapy regimen, the NCCN guidelines recommend that patients could participate in clinical study. Hepatic arterial infusion chemotherapy can increase the local blood drug concentration and improve the tumor regression rate. By reducing the dose of systemic chemotherapy drugs concentration, the incidence of adverse reactions can be reduced. Hepatic arterial infusion chemotherapy may be a better choice for locally advanced intrahepatic cholangiocarcinoma. PD-1 immunotherapy combined with targeted therapy is expected to improve the prognosis of patients with intrahepatic cholangiocarcinoma. This study investigates the safety and efficacy of hepatic arterial infusion chemotherapy combined with sintilimab and bevacizumabin the treatment of unresectable ICC.

开始日期2023-05-31

申办/合作机构

中山大学

NCT05290116 / Recruiting临床2期IIT

Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Apatinib in the Treatment of Unresectable Intrahepatic Cholangiocarcinoma: A Prospective, Single-Center, Phase II Study

Primary liver cancer is the sixth most common cancer worldwide, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, of which intrahepatic cholangiocarcinoma accounts for 10%-15%. Surgical resection is the only curative method for ICC, but most patients are diagnosed at an advanced stage, and only 15% of patients can undergo surgical resection. In locally advanced ICC patients without distant metastases, although the tumor was initially assessed as unresectable, these patients may have the opportunity for surgical resection after reducing the size tumor lesion and increasing the remnant liver volume through conversion therapy. The current standard first-line treatment for unresectable ICC is gemcitabine combined with cisplatin, with a median overall survival of only 11.7 months and an ORR of 26.1%. In view of the poor effect of the standard chemotherapy regimen, the NCCN guidelines recommend that patients could participate in clinical study. Hepatic arterial infusion chemotherapy can increase the local blood drug concentration and improve the tumor regression rate. By reducing the dose of systemic chemotherapy drugs concentration, the incidence of adverse reactions can be reduced. Hepatic arterial infusion chemotherapy may be a better choice for locally advanced intrahepatic cholangiocarcinoma. PD-1 immunotherapy combined with targeted therapy is expected to improve the prognosis of patients with intrahepatic cholangiocarcinoma. This study investigates the safety and efficacy of hepatic arterial infusion chemotherapy combined with tislelizumab and apatinib in the treatment of unresectable ICC.

开始日期2022-07-21

申办/合作机构

中山大学

100 项与二甲苯磺酸拉帕替尼相关的临床结果

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100 项与二甲苯磺酸拉帕替尼相关的转化医学

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100 项与二甲苯磺酸拉帕替尼相关的专利（医药）

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2,978

项与二甲苯磺酸拉帕替尼相关的文献（医药）

2025-01-01·Anti-Cancer Agents in Medicinal Chemistry

Lapatinib: A Potential Therapeutic Agent for Colon Cancer Targeting Ferroptosis

Article

作者: Sun, Yue ; Lang, Xiujuan ; Wang, Dan ; Yuan, Chen ; Fu, Songbo

Background::

Colon cancer poses a significant threat to the lives of several patients, impacting their quality of life, thus necessitating its urgent treatment. Lapatinib, a new generation of targeted anti-tumor drugs for clinical application, has yet to be studied for its molecular mechanisms in treating colon cancer.

Objectives::

This study aimed to uncover the underlying molecular mechanisms through which lapatinib exerts its therapeutic effects in colon cancer treatment.

Methods::

We accessed pertinent data on patients with colon cancer from the Cancer Genome Atlas (TCGA) database and performed bioinformatics analysis to derive valuable insights. The cell counting kit-8 (CCK8) assay was employed to assess whether lapatinib has a potential inhibitory effect on the growth and proliferation of HT- 29 cells. Additionally, we employed western blot and real-time quantitative polymerase chain reaction methods to investigate whether lapatinib regulates the expression of the ferroptosis-associated protein GPX4 in HT-29 cells. Furthermore, we utilized specific assay kits to measure the levels of reactive oxygen species (ROS) and malondialdehyde in HT-29 cells treated with lapatinib, aiming to elucidate the precise pattern of cell damage induced by this compound.

Results::

GPX4 exhibited high expression levels in tissues from patients with colon cancer and was significantly associated with patient prognosis and diagnosis. Lapatinib inhibited the growth and proliferation of the colon cancer cell line HT-29. Additionally, lapatinib suppressed the expression of GPX4 in HT-29 cells, while the ferroptosis inhibitor ferrostatin-1 (Fer-1) partially restored its expression. Lapatinib induced an increase in intracellular ROS levels and malondialdehyde content in HT-29 cells, with Fer-1 partially restoring these levels.

Conclusion::

Our findings demonstrated that lapatinib could effectively suppress the mRNA and protein expression of GPX4 in colon cancer cells, which elevates intracellular levels of ROS and malondialdehyde, ultimately inducing ferroptosis in these cells. This mechanism underscores the potential of lapatinib as a therapeutic strategy for targeting tumors.

2025-01-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

LC-HRMS-based global metabolomics profiling unravels the distinct metabolic signature of lapatinib-resistant and trastuzumab-resistant HER2+ breast cancer cells

Article

作者: Windarsih, Anjar ; Fatimah, Nurul ; Putri, Dyaningtyas Dewi Pamungkas ; Hermawan, Adam

The effectiveness of lapatinib (LAP) and trastuzumab (TRZ), the first-line therapies for HER2⁺ breast cancer, has been limited owing to the development of acquired resistance in patients with HER2⁺. This study aimed to investigate the alterations in metabolic signatures in LAP-resistant HCC1954 and TRZ-resistant HCC1954 and pathways in human HER2⁺ breast cancer cells using liquid chromatography-high-resolution mass spectrometry (LC-HRMS) and enrichment analysis. The HCC1954 parental cells were sequentially treated 13 rounds with LAP or TRZ to develop resistant cells and then tested for their cytotoxicity using the MTT assay. Metabolites were prepared from HCC1954 parental (MBXWT), HCC1954-LAP (MBXLAP), and HCC1954-TRZ (MBXTRZ) cells prior to LC-HRMS, chemometric, enrichment, and joint pathway analyses. LAP- and TRZ-resistant cells were successfully developed from HCC1954, and 29 and 17 differentially expressed metabolites (DEMs) were identified between MBXWT-MBXLAP and MBXWT-MBXTRZ, respectively. The analysis of DEMs between MBXWT and MBXLAP revealed significant enrichment in D-amino acid metabolism, while MBXWT and MBXTRZ identified valine, leucine, isoleucine biosynthesis, ascorbate, and aldarate metabolism. Joint pathway enrichment analysis of LAP-resistant DEMs and differentially expressed genes (DEGs) showed enrichment in glutathione metabolism, while that of TRZ-resistance and DEGs showed enrichment in carbohydrate metabolism, namely pentose and glucuronate interconversions, starch and sucrose metabolism, and galactose metabolism. The findings from this study indicate considerable metabolic changes in LAP- and TRZ-resistant HCC1954 cells, which are crucial for understanding the resistance mechanisms and developing strategies to overcome these problems.

2024-12-01·APOPTOSIS

5-Aminolevulinic acid-mediated photodynamic therapy in combination with kinase inhibitor lapatinib enhances glioblastoma cell death

Article

作者: Chandratre, Sharayu ; Merenich, Daniel ; Myers, Kenneth ; Chen, Bin

Abstract:

5-Aminolevulinic acid (ALA) is an intraoperative imaging agent approved for protoporphyrin IX (PpIX) fluorescence-guided resection of glioblastoma (GBM). It is currently under clinical evaluation for photodynamic therapy (PDT) after the completion of GBM surgery. We previously showed that lapatinib, a clinical kinase inhibitor of epidermal growth factor receptor 1 & 2 (EGFR and HER2), enhanced PpIX fluorescence in a panel of GBM cell lines by blocking ABCG2 (ATP-binding cassette super-family G member 2)-mediated PpIX efflux, which suggests its potential for improving ALA for GBM surgery and PDT. Here we show that lapatinib enhanced PDT-induced cytotoxicity by promoting GBM cell death with the induction of apoptosis followed by necrosis. While the induction of tumor cell apoptosis was massive and rapid in the H4 cell line with no detectable Bcl-2 and a low level of Bcl-xL, it was delayed and much less in extent in A172, U-87 and U-118 cell lines with higher levels of pro-survival Bcl-2 family proteins. Lapatinib treatment alone neither reduced GBM cell viability nor had any significant effect on EGFR downstream signaling. Its enhancement of ALA–PDT was largely due to the increase of intracellular PpIX particularly in the mitochondria, resulting in the activation of mitochondria-mediated apoptosis in H4 cells. Our present study demonstrates that lapatinib inhibits ABCG2-mediated PpIX efflux and sensitizes GBM cells to ALA–PDT by inducing tumor cell death.

172

项与二甲苯磺酸拉帕替尼相关的新闻（医药）

2024-11-13

·药渡Daily

康宁杰瑞开始底部反转

康宁杰瑞过去多个项目的失败，让整个市场都见识到了创新药研发残酷的一面。在2024年以前，中国的Biotech甚少传出研发失败的声音，主要原因在于此前整个研发领域充斥着各种me-too。而如今，低垂的果实已经被采摘完毕，创新药研发开始进入深水区。而康宁杰瑞的数次失败也说明了这些项目是真正的First-in-class项目，没办法耍小聪明，前路尽是未知。往往在这种时刻，更能体现一家具有真正创新精神Biotech的韧性。在资本市场逐渐火热的氛围下，康宁杰瑞已经悄悄地从低谷爬起，短时间内实现了市值翻倍。 1 倚仗ADC 从底部浮出水面喘上一口气，康宁杰瑞要感谢石药集团。在国庆前一天，康宁杰瑞发布公告称，与石药集团子公司津曼特生物订立了一项许可协议。根据许可协议的条款，津曼特生物将获得在大中华区开发、销售、许诺销售及商业化JSKN003（一种靶向HER2双表位ADC）的独家许可及再权限，并成为该地区的唯一上市许可持有人。康宁杰瑞有权收取最高合共30.8亿元的预付款及里程碑付款，其中包括收取4亿元的预付款，与开发里程碑付款3亿元，以及产品销售净额两位数百分比的特许权使用费。这不是康宁杰瑞与津曼特生物的首次合作，此前的2021年，双方就KN026的权益达成过合作。来源：公告 JSKN003是一款靶向HER2双表位ADC，通过糖基定点偶联将拓扑异构酶I抑制剂连接至抗体KN026（重组人源化抗HER2双特异性抗体）的N糖基化位点处。点击反应偶联物较马来酰亚胺－迈克尔反应的偶联物具有更好的血清稳定性。双表位HER2靶向性使JSKN003具有更强的内吞诱导及旁观者杀伤效应，使其在HER2表达肿瘤中具有较强的抗肿瘤活性。目前正在澳大利亚进行JSKN003的I期临床试验，并在中国开展I/II期和III期临床试验。研究结果显示JSKN003在既往经多线治疗的晚期/转移性实体瘤患者中耐受性、安全性良好，显示出令人鼓舞的初步抗肿瘤活性。于2024年6月在ASCO年会上展示的数据显示，JSKN003在2.1mg/kg至8.4mg/kg的剂量范围耐受性良好，且在既往接受过深度治疗的患者中显示出令人鼓舞的抗肿瘤活性。以JSKN003为基础的复方制剂JSKN033的临床数据也在近期于2024年SITC年会上发布。 JSKN033是一款康宁杰瑞自主研发的全球首个皮下注射ADC复方制剂，由JSKN003和KN035组成。一项开放、多中心及首次人体的I/II期临床试验JSKN033-101数据表明，安全性方面，最常见的TRAEs是注射部位反应，均为1级，且通常在无需任何治疗、或仅接受抗组胺药物后的2周内自行缓解，未观察到DLT，不同剂量组之间的安全性无显著差异；有效性方面，10例疗效可评估患者中，3例患者出现PR，5例患者SD，DCR达80%，在4.5mg/kg剂量下即对患者表现出抗肿瘤活性。在以往的方案中，以复方制剂这种形式进行的药物联用较为少见，JSKN033具有探索性意义。更进一步细究之下，JSKN033是以KN026（HER2双抗）为基础的ADC，此等环环相扣的产品设计可以说在国内Biotech中绝无仅有。 2 环环相扣 KN026是目前康宁杰瑞最具战略意义的在研产品。这是一款HER2双抗，可以同时结合两种不同的HER2表位。在中国及美国的I期及II期临床试验中，KN026对于经多线治疗的HER2表达癌症患者，显示出良好的初步疗效及安全性。目前，KN026正在中国进行数项临床试验，正在开展KN026联合多西他赛（白蛋白结合型）一线治疗HER2阳性BC（乳腺癌）及KN026联合化疗二线及以上治疗HER2阳性GC/GEJ（胃癌/胃食管结合部癌）的III期临床试验。KN026联合化疗用于一线标准治疗（曲妥珠单抗联合化疗）失败的HER2阳性GC（包括GEJ）患者已获国家药监局CDE授予突破性疗法认定。 HER2作为肿瘤领域热门靶点，已有多个不同类型的药物相继上市。罗氏的曲妥珠单抗是全球第一个获批上市的HER2靶向药物；GSK/诺华的拉帕替尼是全球第一个获批上市的HER2小分子靶向抑制剂药物；罗氏的恩美曲妥珠单抗（T-DM1）是全球第一个获批上市的HER2靶向ADC药物。这些产品都已经非常成熟，经过了时间的严格考验。曲妥珠单抗已不必赘述，目前光在国内获批的生物类似药就有复宏汉霖的汉曲优、齐鲁制药的安曲妥、安科生物的安赛汀等多款；恩美曲妥珠单抗在全球首次获批上市到现在的二十年多中，从二线到一线，从辅助治疗到新辅助，从联合内分泌治疗到联合小分子药物，其在乳腺癌领域的探索实现全面开花，并展现出多维的临床应用潜力。值得注意的是，靶向HER2的ADC药物当下的主角已不再是恩美曲妥珠单抗，而是来自阿斯利康和第一三共联合开发的DS-8201（Enhertu）。国内也已经有获批上市的HER2 ADC，即来自荣昌生物的维迪西妥单抗。根据药渡数据不完全统计，目前全球范围内涉及HER2靶点的药物已超600款，其中，ADC超130款，其次为单抗和小分子化药各超100款、双抗超40款等。康宁杰瑞的这一套HER2靶点的连环设计的竞争压力可想而知。康宁杰瑞主要研发管线来源：2024年半年报除了KN026，康宁杰瑞此前的王牌KN046虽然遭遇了些许挫折，但依然是其管线中最具商业化前景的双抗。今年2月和3月KN046的一线三阴性乳腺癌和一线非小细胞肺癌（NSCLC）的II期临床试验结果分别在《Nature Communications》及《Cell Reports Medicine》上发表；2024年9月，完成了KN046治疗晚期sq NSCLC的III期临床试验的最终OS分析，试验结果具有统计学差异的OS获益。此外，对于PFS的最终分析显示KN046联合含铂化疗组显著获益。在过去的两年里，ADC大放异彩，但进入2024年，双抗的光芒似乎正在逐渐绽放，国内Biotech的双抗出海频率开始加快。 3 双抗赛道即将爆发双特异性抗体，简称双抗，是指拥有两个不同的抗原结合位点，能同时靶向两个抗原或同一抗原两个不同表位的人工抗体。双抗靶向两种抗原或抗原表位，可以同时阻断或激活其介导的生物学功能，或使表达两种抗原的细胞相互接近，从而增强两者间的相互作用，并以不同的作用机制介导多种特定的生物学效应。目前普遍认为双抗的药效学或生物学作用机制主要包括空间重排和背负式运输，在研的大部分双抗药物采用空间重排（桥联细胞、桥联受体、桥联因子）的方式起效。双抗作用机制分类及其代表案例来源：东吴证券研报因其具有潜在的优效和安全性优势，国内外企业纷纷布局双抗领域，成为仅次于ADC的热点领域。根据药渡数据，截至2024年10月，全球双抗药物共获批上市17款（其中首款商业化药物Catumaxomab已退市），进入临床阶段超460款。主要适应症集中在肿瘤领域，自免领域相关临床也在逐步推进。随着双抗药物逐步上市，双抗市场规模也来到了新的高度，于2023年上市的12款双抗药物的全年销售额达到了83亿美元。今年以来，国内Biotech的双抗（多抗）出海开始走上快车道，诞生了多项价值巨大的交易。 7月，康诺亚与Belenos合作，授权两款双抗产品，将获得1500万美元首付款和近期里程碑付款，最高1.7亿美元里程碑款，及分层特许权使用费，并持有Belenos约30.01%的股权；8月，嘉和生物宣布采用NewCo模式将其GB261（CD3×CD20）授权给TRC2004，获得数千万美元首付款、4.43亿美元里程碑付款及分层特许权使用费，并持有TRC2004一定股权；9月，岸迈生物宣布与Vignette Bio就开发BCMA×CD3双特异性抗体EMB-06达成了战略合作，岸迈生物以现金和Vignette股权的形式收取总计6000万美元的首付款对价，并将有权收取最多5.75亿美元的里程碑付款；10月，葛兰素史克（GSK）宣布和恩沐生物达成合作，将以3亿美元的首付款从恩沐生物拿下CMG1A46（CD3/CD19/CD20三抗），后者将有资格获得总计5.5亿美元的开发和商业化里程碑付款。据不完全数据统计，全球目前有超过上千款双抗在研药物，其中近400款已进入临床阶段，这其中，将近一半的管线来自中国企业，康方生物、百利天恒、宜明昂科、康宁杰瑞、科望医药、普米斯、友芝友生物等都是个中翘楚。 4 结语作为国内最早涉足双抗研发的Biotech，康宁杰瑞追求创新的精神令人敬佩，不论是挑战“癌王”胰腺癌，还是双抗ADC的探索，都极具勇气。从在研产品的布局上看，连环扣式的研发布局风险性极高，但好在瞄准的是成熟靶点。因此，一旦连环扣中有一项突破，有望将带来连带效应，实现全线在研的前景重塑。后续发展如何，药渡还将持续关注。参考资料康宁杰瑞官网、公告、年报等东吴证券、国盛证券、中信建投研报等《一年“闪崩”三次，康宁杰瑞的“癌王”适应症还是失败了》，华尔街见闻，2024-05-29 《国产ADC“硬刚”罗氏T-DM1！复星、科伦会否复制DS-8201完胜？》，医药经济报，2023-06-20 《天堂和地狱！上市、在研和失败的Her2 ADC们》，胖猫的生命医学札记，2024-06-26

抗体药物偶联物引进/卖出ASCO会议临床1期临床结果

2024-11-06

·ioncology

SABCS 2024盛幕将启，中国之声唱响全球！

点击蓝字，关注我们编者按：第47届圣安东尼奥乳腺癌研讨会（SABCS）将于当地时间2024年12月10日至13日在美国得克萨斯州圣安东尼奥举行。日前，官网已公布摘要题目，肿瘤瞭望特将General Session、Poster Spotlight Sessions和Year in Review等环节中国专家报告内容进行汇总，以飨读者。 General Session 1 时间：12月11日9:15 – 11:30 am 地点：Hall 1 GS1-03: Pyrotinib or placebo in combination with trastuzumab and docetaxel for untreated HER2-positive metastatic breast cancer (mBC): prespecified final analysis of progression-free survival (PFS) of the phase 3 PHILA trial. 吡咯替尼或安慰剂联合曲妥珠单抗和多西他赛用于未接受过治疗的HER2阳性转移性乳腺癌（mBC）：III期PHILA试验预设的无进展生存期（PFS）最终分析讲者：徐兵河（中国医学科学院肿瘤医院） GS1-04: HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Open-label, Phase 2 Trial. 靶向HER2的抗体-药物偶联物SHR-A1811用于HER2阳性早期乳腺癌的新辅助治疗：一项前瞻性、随机、开放标签的2期试验讲者：李俊杰（复旦大学附属肿瘤医院） General Session 3 时间：12月13日9:00 – 11:45 am 地点：Hall 1 GS3-06: Neoadjuvant camrelizumab plus chemotherapy (chemo) for early or locally advanced triple-negative breast cancer (TNBC): a randomized, double-blind, phase 3 trial. 卡瑞利珠单抗联合化疗（chemo）新辅助治疗早期或局部晚期三阴性乳腺癌（TNBC）：一项随机、双盲、3期试验讲者：邵志敏（复旦大学附属肿瘤医院） Concurrent Poster Spotlight Sessions 1, 3-5, 7 ▌Session 1: New Insights into Immune Biomarkers（免疫生物标志物的新见解）时间：12月11日7:00 – 8:30 am 地点：Room 221ABC 主持人：David Rimm, Yale University PS1-03: Prediction of Prognosis and Efficacy of Neoadjuvant Therapy in HER2-Positive Breast Cancer Patients Based on Tertiary Lymphoid Structures. 基于三级淋巴结构预测HER2阳性乳腺癌患者的预后和新辅助治疗的疗效讲者：张克兢（中南大学湘雅医院） ▌Session 3: Highlights on Novel Therapeutics（新型治疗亮点）时间：12月11日7:00 – 8:30 am 地点：Stars at Night 1-2 主持人：Sara Tolaney, Dana-Farber Cancer Institute PS3-01: Tislelizumab plus sitravatinib and nab-paclitaxel in patients with untreated locally recurrent or metastatic triple negative breast cancer (TNBC): updated efficacy and safety results. 替雷利珠单抗+sitravatinib+白蛋白结合型紫杉醇治疗未经治疗的局部复发或转移性三阴性乳腺癌（TNBC）：最新的疗效和安全性结果讲者：Xiyu Liu（复旦大学附属肿瘤医院） PS3-02: Induction of Cisplatin/abraxane/pembrolizumab followed by pembrolizumab ± Olaparib Maintenance in triple-negative Metastatic breast cancer patients (COMPLEMENT) – A Randomized, Open-label, Phase II Study. COMPLEMENT：一项随机、开放标签的II期研究，在转移性三阴性乳腺癌患者中，采用顺铂/白蛋白结核型紫杉醇/帕博利珠单抗诱导治疗，后续以帕博利珠单抗±奥拉帕利进行维持治疗讲者：胡夕春（复旦大学附属肿瘤医院） PS3-05: Evaluation of the safety and efficacy of ivonescimab in combination with chemotherapy as first-line (1L) treatment for triple-negative breast cancer (TNBC). 评估ivonescimab联合化疗作为三阴性乳腺癌（TNBC）一线（1L）治疗的安全性和有效性讲者：欧阳取长（湖南省肿瘤医院） PS3-08: Interim Overall Survival of Patients with Locally Advanced or Metastatic Triple-Negative Breast Cancer treated wtih First Line PM8002/BNT327 in Combination with Nab-Paclitaxel in Phase Ib/II Study. Ib/II期研究中，PM8002/BNT327联合白蛋白结合型紫杉醇一线治疗局部晚期或转移性三阴性乳腺癌患者的中期总生存讲者：吴炅（复旦大学附属肿瘤医院） ▌Session 4: Prediction of Chemotherapy Response（化疗疗效预测）时间：12月11日7:00 – 8:30 am 地点：Stars at Night 3-4 主持人：Sherene Loi, Peter Macallum Cancer Centre PS4-08: The tumor heterogeneous overexpressed CD155 promotes treatment resistance in HER2-positive breast cancer through immune microenvironment modulation. 肿瘤异质性CD155过表达通过调节免疫微环境促进HER2阳性乳腺癌的治疗抵抗讲者：Yi Zhang（复旦大学附属肿瘤医院） Concurrent Poster Spotlight Sessions 2, 6, 8, 9 and 15 ▌Session 2: Personalizing CDK 4/6 inhibitor therapy for patients with Metastatic Breast Cancer: Survival, QOL and biomarkers（转移性乳腺癌患者的个体化CDK 4/6抑制剂治疗：生存期、生活质量和生物标志物）时间：12月12日7:00 – 8:30 am 地点：Hemisfair Ballroom 1-2 主持人：Lisa Carey, Lineberger Comprehensive Cancer Center University of North Carolina PS2-01: Dalpiciclib versus placebo in combination with letrozole or anastrozole as first-line treatment for women with HR+/HER2- advanced breast cancer: prespecified final analysis of progression-free survival of the phase 3 DAWNA-2 trial. 3期DAWNA-2研究预设的无进展生存最终分析：达尔西利vs安慰剂联合来曲唑或阿那曲唑作为HR+/HER2-晚期乳腺癌女性患者一线治疗讲者：徐兵河（中国医学科学院肿瘤医院） PS2-02：Tibremciclib (BPI-16350) plus fulvestrant versus placebo plus fulvestrant for patients with HR+/HER2- advanced breast cancer after progressing on endocrine therapy: Updated analysis of the phase III study. 在内分泌治疗进展后的HR+/HER2-晚期乳腺癌患者，Tibremciclib（BPI-16350）联合氟维司群对比安慰剂联合氟维司群的疗效：III期研究的更新分析讲者：胡夕春（复旦大学附属肿瘤医院） PS2-06：First-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in clinically aggressive HR+/HER2- advanced breast cancer (ABC): a subgroup analysis of RIGHT Choice by intrinsic subtype & gene & signature expression. 一线（1L）瑞波西利（RIB）+内分泌治疗（ET）vs联合化疗（combo CT）治疗临床侵袭性HR+/HER2-晚期乳腺癌（ABC）：基于内在亚型、基因及特征表达的RIGHT Choice研究亚组分析讲者：卢彦伸（中国台湾大学医学院附属医院） PS2-10: Integrating ctDNA and Tumor Fraction Features for Deciphering Molecular Response and Resistance Mechanism to Endocrine Therapy and CDK4/6 Inhibition in Advanced HR-positive Metastatic Breast Cancer. 整合ctDNA和肿瘤组分特征以解析晚期激素受体阳性转移性乳腺癌对内分泌治疗和CDK4/6抑制剂的分子应答及耐药机制讲者：Hao Liao（北京大学肿瘤医院） ▌Session 8: Novel HER2 Therapeutics（新型HER2治疗）时间：12月12日7:00 – 8:30 am 地点：Stars at Night 1-2 主持人：Ian Krop, Yale School of Medicine PS8-01: ZN-1041, a potential best-in-class BBB Penetrable HER2 Inhibitor, has high antitumor activity in patients with Breast Cancer with CNS Metastases. ZN-1041是一种具有潜力的同类最佳血脑屏障（BBB）可穿透性HER2抑制剂，在中枢神经系统（CNS）转移乳腺癌患者中展现出高抗肿瘤活性讲者：马飞（中国医学科学院肿瘤医院） PS8-02: A Phase 1 study Evaluating the Safety, Efficacy and Pharmacokinetics of TL938 in HER2-Positive Patients with Advance Solid Tumors. 一项评价TL938治疗HER2阳性晚期实体瘤患者的安全性、疗效和药代动力学的1期研究讲者：石远凯（中国医学科学院肿瘤医院） PS8-05: ACE-Breast-08: a phase I study of ARX788, a novel anti-HER2 antibodydrug conjugate, in patients with TKI pretreated HER2 positive advanced breast cancer. ACE-Breast-08：一项I期研究，评估新型抗HER2抗体-药物偶联物ARX788在TKI预治疗的HER2阳性晚期乳腺癌患者中的疗效讲者：王晓稼（浙江省肿瘤医院） PS8-06: A randomized, open-label phase III study comparing disitamab vedotin (an anti-HER2 monoclonal antibody-MMAE conjugate) with lapatinib plus capecitabine in patients with HER2-positive, advanced breast cancer with liver metastasis. 一项随机、开放标签的III期研究，在伴肝转移的HER2阳性晚期乳腺癌患者中比较维迪西妥单抗（一种抗HER2单克隆抗体-MMAE偶联物）联合拉帕替尼联合卡培他滨的治疗疗效讲者：王佳玉（中国医学科学院肿瘤医院） PS8-07：Efficacy and Safety of GQ1005, a Promising HER2-ADC, in Patients with Metastatic HER2-Positive Breast Cancer. GQ1005（一种很有前景的HER2-ADC）治疗转移性HER2阳性乳腺癌患者的疗效和安全性讲者：王碧芸（复旦大学附属肿瘤医院） PS8-08: Efficacy and safety of SHR-A1811, an anti-HER2 antibody-drug conjugate (ADC), in 391 heavily pretreated multiple solid tumors with HER2-expression or mutations: a global, multi-center, first-in-human, phase 1 study. SHR-A1811是一种抗HER2抗体-药物偶联物（ADC），在391例既往接受过大量治疗且有HER2表达或突变的多种实体瘤中，SHR-A1811的疗效和安全性：一项全球性、多中心、首次人体1期研究讲者：姚和瑞（中山大学孙逸仙纪念医院） Concurrent Poster Spotlight Sessions 10-14 ▌Session 11: Imaging to Guide Breast Cancer Treatment – Molecular Imaging and AI（影像学指导乳腺癌治疗——分子影像学和人工智能）时间：12月13日7:00 – 8:30 am 地点：Hemisfair Ballroom 1-2 主持人：David Mankoff, Perelman School of Medicine University of Pennsylvania PS11-08: MRI improves multi-modal AI system for breast cancer diagnosis and prognosis. MRI提高了多模态AI系统对乳腺癌的诊断和预后判断讲者：Yanqi Xu（中国药科大学） ▌Session 12: Immunobiology Impact on Therapeutic Efficacy（免疫生物学对治疗效果的影响）时间：12月13日7:00 – 8:30 am 地点：Room 221ABC 主持人：Lajos Pusztai, Yale School of Medicine, New Haven, Connecticut PS12-04: HDACi combined with anthracycline elicits interactions between MHC-II+ triple-negative breast cancer and CD69+CD4+Trm orchestrating synergistic immunotherapy. HDACi联合蒽环类药物引发MHC-II+三阴性乳腺癌与CD69+CD4+Trm协同免疫治疗之间的相互作用讲者：Zehao Wang（复旦大学附属肿瘤医院） ▌Session 14: Brain Metastasis（脑转移）时间：12月13日7:00–8:30 am 地点：Stars at Night 3-4 主持人：William Gradishar, Northwestern University Feinberg School of Medicine, Chicago, Illinois PS14-02: A Prospective Phase II Trial of Hypofractionated Stereotactic Radiotherapy (FSRT) for Patients with 1-10 Brain Metastases from Breast Cancer. 一项前瞻性II期试验，1～10个乳腺癌脑转移患者采用大分割立体定向放疗（FSRT）讲者：Jin Meng（上海交通大学附属第六人民医院） PS14-03: Updated analyses from a Phase I study of the brain-penetrant oral SERD- SIM0270 in patients with ER-positive,HER2-negative advanced breast cancer. 脑渗透性口服SERD- SIM0270治疗ER阳性/HER2阴性晚期乳腺癌患者的I期研究的最新分析讲者：张清媛（哈尔滨医科大学附属肿瘤医院） PS14-04: SIM0270, a brain-penetrant oral SERD, in combination with everolimus in patients with ER+/HER2- advanced breast cancer: the phase Ib study. SIM0270，一种脑渗透性口服SERD，联合依维莫司在ER+/HER2-晚期乳腺癌患者中的Ⅰb期研究讲者：张剑（复旦大学附属肿瘤医院） Year in Review 时间：12月13日3:00 – 5:00 pm 地点：Stars at Night 1-2 主持人：Moderators: Carlos Arteaga, UT Southwestern Medical Center, Dallas, Texas; and Virginia Kaklamani, UT Health Mays Cancer Center, San Antonio, Texas Early Breast Cancer Updates 早期乳腺癌最新进展讲者：Janice Tsang（中国香港大学）（来源：《肿瘤瞭望》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2期临床结果临床3期

2024-10-29

·摩熵医药

胃癌HER2靶向治疗：曲妥珠单抗与ADC药物崛起，罗氏、复宏汉霖争霸！

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。胃癌是全球范围内常见的恶性肿瘤之一，其高发病率与死亡率持续构成严峻的健康挑战。近年来，得益于医学研究的持续深化与技术创新的飞速发展，胃癌的诊疗策略正经历着深刻的变革，同时，相关药物市场的竞争格局也日益复杂化。本文依托摩熵咨询最新发布的《市场研究专题报告——胃癌药物》中的部分精华内容，聚焦于HER2治疗靶点，深入地探讨胃癌治疗领域的最新诊疗指南进展，分析当前市场的竞争格局，旨在为临床医生提供前沿的治疗方案参考，助力患者获取最有效的治疗信息，也为制药企业及相关行业参与者提供宝贵的市场洞察与策略指导。 01 HER2靶点治疗进展与市场分析 1. 曲妥珠单抗为基础的治疗方案仍是一线治疗标准选择 HER2是表皮生长因子受体家族重要成员，作为酪氨酸激酶受体，在调节细胞增值、分化和生存等众多过程中发挥重要作用。在胃癌中，HER2阳性率约为12%-18%。曲妥珠单抗作为基础的治疗方案，长期以来一直是HER2阳性晚期胃癌一线治疗的标准选择。然而，随着新型ADC药物如德曲妥珠单抗（T-DXd/DS-8201）的崛起，这一领域正经历着深刻变革。三线治疗中既往ADC只有维迪西妥单抗，在《CSCO胃癌诊疗指南（2024版）》中，德曲妥珠单抗由于临床研究中对HER2阳性（IHC3+或IHC2+/ISH+）患者的疗效表现被纳入指南，作为III级推荐（2A类证据）。针对HER2阳性（IHC 3+或IHC2+）的转移性胃癌患者的三线及以上治疗，国内自主研发的维迪西妥单抗（RC48）仍然稳居I级推荐（2A类证据）。摩熵咨询（原药融咨询）深度报告目前，在HER2阳性晚期胃癌三线治疗中国际上以德曲妥珠单抗为代表，国内以维迪西妥单抗为代表，但随着德曲妥珠单抗可及性提高，其他药物的份额可能被蚕食。 2. 曲妥珠单抗原研市场逐渐被生物类似药蚕食 2010年，ToGA研究首次证明了曲妥珠单抗联合化疗可以显著延长HER2阳性转移性胃癌患者的生存期，开启了胃癌抗HER2靶向治疗时代。但在随后10年里，针对HER2靶点的药物帕妥珠单抗、拉帕替尼、奈拉替尼等多种药物在HER2阳性的胃癌患者中均未达到研究终点，这也造就了曲妥珠单抗的霸主地位。曲妥珠单抗（Trastuzumab）原研是罗氏的赫赛汀，最早于1998年9月获得美国FDA 批准上市，2002年9月在我国批准进口。曲妥珠单抗是全球第一个针对HER2致癌位点的药物，也是第一个上市的抗癌靶向药，它的上市开启了肿瘤靶向治疗的先河。据悉，曲妥珠单抗原研产品全球销售峰值超过70亿瑞士法郎，近年来受生物类似药冲击，其销售额持续下挫。在国内，2017年曲妥珠单抗被纳入医保以后，国内市场便进入了快速放量期，曲妥珠单抗的销售呈现井喷式增长。摩熵医药数据库显示，2022年全国医院终端市场曲妥珠单抗销售额达到68亿元，2023年进一步放量，销售额超过78亿元。曲妥珠单抗医院终端市场年度销售趋势截图来源：摩熵医药全国医院销售（全终端）数据库然而随着专利到期，2020年以来曲妥珠单抗生物类似药在我国相继上市，原研企业罗氏的市场份额已经下降至近60%，未来市场份额可能会被进一步蚕食。摩熵咨询（原药融咨询）深度报告 2020年8月，复宏汉霖自主研发生产的首个国产曲妥珠单抗类似药（商品名：汉曲优）在中国和欧盟同步上市，后其60mg的规格也于2021年8月获批。2023年2月，博锐生物全资子公司博之锐的注射用曲妥珠单抗（商品名：安瑞泽）获批上市，成为国产第2家。 2023年7月和2023年10月，正大天晴和安科生物的曲妥珠单抗产品也相继获批上市。2024年7月，齐鲁制药的注射用曲妥珠单抗生物类似药（商品名：安曲妥）已获得国家药监局批准上市。 3. 曲妥珠单抗各级医院市场分析据摩熵医药药物流向数据显示，2023年在哈尔滨市，罗氏原研的曲妥珠单抗药物总销售额达到4408.25万元，而复宏汉霖生产的国产曲妥珠单抗类似药总销售额为3856.91万元。在这一年中，罗氏在各季度的销售额均高于复宏汉霖。摩熵咨询（原药融咨询）深度报告在哈尔滨市，罗氏及复宏汉霖的曲妥珠单抗2023年销售市场主要集中在三级医院，其中复宏汉霖2023年未涉及一级及其它级别医院市场。摩熵咨询（原药融咨询）深度报告罗氏的曲妥珠单抗2023年销售额TOP3医院（哈尔滨市为例）分别为哈尔滨医科大学附属第三医院、哈尔滨医科大学附属第二医院、北大荒集团总医院。摩熵咨询（原药融咨询）深度报告复宏汉霖的曲妥珠单抗2023年销售额TOP3医院（哈尔滨市为例）分别为哈尔滨医科大学附属第三医院、北大荒集团总医院、宾县人民医院。摩熵咨询（原药融咨询）深度报告摩熵医药药物流向数据，是与全国各省市多家药品流通配送商合作，脱敏合规统计的药物在全国范围内的流向数据，数据详细且全面，落地到具体医院，可覆盖全国三级医院3000+，二级医院10000+，一级和未定级医院75000+，为企业提供全面的市场洞察，助力其优化市场策略、供应链管理和政策响应。 4. ADC引领HER2阳性晚期胃癌精准治疗近年来ADC药物在HER2阳性胃癌治疗领域蓬勃发展，打破了曲妥珠单抗独木难支的困境。多款创新ADC药物，诸如维迪西妥单抗、德曲妥珠单抗、anvatabart opadotin以及trastuzumab deruxtecan等，针对HER2阳性胃癌展现出了显著的治疗潜力与探索热情。推动了HER2阳性胃癌治疗向更加精准化、个体化的方向迈进，为患者带来了更多希望与选择。维迪西妥单抗作为首款中国自主研发的HER2 ADC类药物，也是我国首个获得FDA、NMPA突破性疗法双重认定的ADC。2021年6月，维迪西妥单抗通过NMPA优先审评审批程序，附条件批准用于至少接受过2种系统化疗的HER2过表达局部晚期或转移性胃癌，包括胃食管结合部腺癌患者的治疗。当年12月，又获批用于尿路上皮癌治疗。维迪西妥单抗在肿瘤抗HER2治疗中展现了广阔的应用前景，自上市以来销售额增长迅速，由2021年0.25亿增长至2023年5.95亿，年复合增长率达386%。德曲妥珠单抗是第一三共和阿斯利康旗下重磅ADC药物。自 2019 年首次获批以来，已在美国、日本、欧盟、中国多个国家和地区获批上市，适应症领域涵盖 HER2 阳性乳腺癌、HER2 阳性胃癌、HER2 低表达乳腺癌、HER2 突变非小细胞肺癌、HER2 阳性实体瘤。目前，其转移性胃癌适应症在国内处于申请上市阶段。摩熵咨询（原药融咨询）深度报告此外，强生的anvatabart opadotin和恒瑞医药的trastuzumab deruxtecan，其胃癌适应症的中国研发进度均处于III期临床；石药集团的trastuzumab-MMAE、美雅珂生物的trastuzumab vedotin、复星医药的trastuzumab-drug、百奥泰生物的BAT-8010、百力司康生物/卫材的BB-1701等，其胃癌适应症的中国研发进度处于II期临床阶段。结语胃癌诊疗指南的不断更新与市场竞争格局的深刻变化，共同推动着胃癌治疗领域的持续进步。未来，随着更多创新药物的研发与上市，以及精准医疗理念的深入实践，胃癌患者的治疗将更加精准化、个体化，生存率和生活质量也将得到显著提升。市场研究专题报告：胃癌药物下期内容预告目录一、2024年胃癌诊疗指南及市场竞争格局分析：PD-(L)1、VEGFR2治疗靶点二、2024年胃癌市场趋势分析：CLDN18.2靶点药物研发加速，信达、康方、恒瑞...竞相布局近期将持续更新，敬请期待 END 本文为原创文章，转载请留言获取授权联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击阅读原文，了解更多品牌升级详情！

抗体药物偶联物上市批准CSCO会议临床1期临床结果

100 项与二甲苯磺酸拉帕替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	二甲苯磺酸拉帕替尼	L01XE07	DB01259

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
转移性乳腺癌	美国	Novartis Pharmaceuticals Corp.	2010-01-29
HER2阳性乳腺癌	瑞士	Novartis AG	2007-05-23
乳腺癌	美国	Novartis Pharmaceuticals Corp.	2007-03-13

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
ER阳性/HER2阳性乳腺癌	临床3期	日本	葛兰素史克（中国）投资有限公司	2011-05-05
ER阳性/HER2阳性乳腺癌	临床3期	日本	Glaxo Group Ltd.	2011-05-05
ER阳性/HER2阳性乳腺癌	临床3期	阿根廷	葛兰素史克（中国）投资有限公司	2011-05-05
ER阳性/HER2阳性乳腺癌	临床3期	阿根廷	Glaxo Group Ltd.	2011-05-05
ER阳性/HER2阳性乳腺癌	临床3期	比利时	葛兰素史克（中国）投资有限公司	2011-05-05
ER阳性/HER2阳性乳腺癌	临床3期	比利时	Glaxo Group Ltd.	2011-05-05
ER阳性/HER2阳性乳腺癌	临床3期	法国	葛兰素史克（中国）投资有限公司	2011-05-05
ER阳性/HER2阳性乳腺癌	临床3期	法国	Glaxo Group Ltd.	2011-05-05
ER阳性/HER2阳性乳腺癌	临床3期	希腊	Glaxo Group Ltd.	2011-05-05
ER阳性/HER2阳性乳腺癌	临床3期	希腊	葛兰素史克（中国）投资有限公司	2011-05-05

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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


ESMO_GI2024 人工标引	N/A	HER2阳性胆道肿瘤二线 HER2 Positive	21	Trastuzumab plus lapatinib	壓簾夢獵網憲選觸鹽構(構壓鑰壓壓鬱範觸鏇範) = 艱衊獵夢夢顧鏇選簾鹹觸蓋鬱鬱鏇鏇築鏇鹹淵 (獵膚築襯簾膚齋範築艱, 28.6 ~ 57.1) 更多	积极	2024-06-27
NCT01619111 (DETECT III, Pubmed) 人工标引	临床3期	HER2 阴性乳腺癌 \| 循环肿瘤细胞 HER2 Negative \| HER2 Positive	101	Standard therapy + Lapatinib	壓蓋憲艱醖齋積衊製憲(獵鏇夢衊願齋憲夢衊網) = 觸餘積積範窪鹽鹹夢遞鹽鹹夢製鏇憲艱積範蓋 (齋遞選遞積齋鬱遞醖鏇 ) 更多	积极	2024-01-04
				Standard therapy	壓蓋憲艱醖齋積衊製憲(獵鏇夢衊願齋憲夢衊網) = 夢憲衊築獵鹽願繭壓願鹽鹹夢製鏇憲艱積範蓋 (齋遞選遞積齋鬱遞醖鏇 ) 更多
ESMO2023 人工标引	N/A	HER2阳性转移性乳腺癌 HER2 positive	53	lapatinib or pyrotinib	膚顧醖鑰鬱衊遞壓鬱廠(遞廠獵鹹糧積願鑰淵獵) = 簾顧鹽淵顧醖窪構窪鹽廠獵鑰獵鏇壓積衊壓獵 (獵窪製襯窪憲鹽製製鏇, 7.9 ~ 15.9) 更多	积极	2023-10-21
				lapatinib or pyrotinib (brain metastasis)	膚顧醖鑰鬱衊遞壓鬱廠(遞廠獵鹹糧積願鑰淵獵) = 構襯築築夢廠鬱範夢鑰廠獵鑰獵鏇壓積衊壓獵 (獵窪製襯窪憲鹽製製鏇, 7.5 ~ 13.5) 更多
NCT01306045 (CTgov)	临床2期	家族性胸腺瘤 \| 小细胞肺癌 \| 晚期非小细胞肺癌 ... 更多	647	Selumetinib (AZD6244)+Erlotinib+Lapatinib+MK-2206+Sunitinib (Non-Small Cell Lung Cancer (NSCLC))	憲鹽餘壓遞簾遞繭鹹鹽(構餘願衊願網窪觸積夢) = 壓鏇遞製積鹹淵蓋鏇艱願構廠簾築憲糧遞艱選 (顧艱簾艱膚製積壓壓鬱, 願夢鑰製蓋醖觸艱積壓 ~ 憲遞製製夢鑰餘齋壓簾) 更多	-	2023-04-11
				Selumetinib (AZD6244)+Erlotinib+Lapatinib+MK-2206+Sunitinib (Small Cell Lung Cancer (SCLC))	憲鹽餘壓遞簾遞繭鹹鹽(構餘願衊願網窪觸積夢) = 廠鹹餘鹹築壓夢顧齋鹽願構廠簾築憲糧遞艱選 (顧艱簾艱膚製積壓壓鬱, 簾簾蓋淵糧範襯醖齋壓 ~ 願繭襯獵選網齋積蓋廠) 更多
ESMO_ASIA2022	N/A	HER2阳性转移性乳腺癌	47	Low dose or metronomic lapatinib (500mg daily with meal)	觸糧鑰顧餘選窪淵製糧(壓窪顧淵淵築憲鏇鹹顧) = 齋繭糧膚廠獵窪製衊構簾製選簾簾遞醖簾鬱膚 (築顧獵壓鏇醖構簾選築 ) 更多	-	2022-12-03
Pubmed 人工标引	N/A	HER2阳性胃癌三线 HER2-Positive	59	Lapatinib Ditosylate Hydrate	窪衊構壓鬱顧選鬱餘餘(醖積鏇醖鑰網顧繭簾壓) = 衊範簾顧顧夢夢壓鹹齋夢衊廠淵餘餘獵衊蓋觸 (壓蓋襯鑰簾遞醖願鹽夢 ) 更多	积极	2022-10-01
ASCO2022	N/A	HER2阳性转移性乳腺癌	102	Lapatinib and capecitabine combination	鏇遞鏇壓夢窪構鹽網窪(繭鬱醖積網蓋夢鬱糧鹽) = 簾簾鹽醖鹽願醖獵製願憲餘範膚衊衊膚襯製鏇 (蓋淵顧憲窪簾窪願糧製, 5.1 ~ 10.8)	-	2022-06-02
Pubmed 人工标引	临床2期	胸腺上皮肿瘤	25	Lapatinib Ditosylate Hydrate	齋餘顧獵鑰鹹鬱襯遞齋(淵餘糧願鬱衊壓選夢壓) = 壓壓鬱鹽襯遞願鹽襯網製獵壓衊積製網獵製糧 (蓋蓋願窪鏇構艱夢衊膚, 21 ~ 61) 更多	积极	2022-05-10
NCT00470704 (TBCRC003 \| TBCRC 003, CTgov)	临床2期	HER2阳性乳腺癌	87	Herceptin+Lapatinib (Cohort 1)	築繭夢窪壓繭願顧衊構(鬱膚鏇鹹製衊醖糧遞鏇) = 齋製顧壓襯衊蓋夢構製膚選餘醖鬱憲醖構膚憲 (鑰簾淵觸簾夢壓簾醖獵, 鹽醖顧餘蓋願獵選積鑰 ~ 鑰夢觸鏇艱遞壓襯鹹觸) 更多	-	2022-03-15
				Herceptin+Lapatinib (Cohort 2)	築繭夢窪壓繭願顧衊構(鬱膚鏇鹹製衊醖糧遞鏇) = 衊觸鏇鹹醖膚選衊遞醖膚選餘醖鬱憲醖構膚憲 (鑰簾淵觸簾夢壓簾醖獵, 鏇糧遞鹹構築憲獵憲顧 ~ 構壓憲積憲觸築構艱鬱) 更多
NCT01711658 (TRYHARD, CTgov)	临床2期	局部晚期头颈部鳞状细胞癌	142	placebo+cisplatin (IMRT + Cisplatin + Placebo)	網襯顧顧願襯艱齋遞簾(鬱觸網積夢憲製憲簾觸) = 齋齋蓋壓範膚築餘餘網衊網鹹淵鏇觸獵積醖壓 (範積觸艱淵構鹽遞製願, 選鏇鹽窪鑰築鬱鹽願襯 ~ 糧衊鏇鏇繭鬱顧構鏇餘) 更多	-	2021-11-29
				IMRT+Lapatinib+cisplatin (IMRT + Cisplatin + Lapatinib)	網襯顧顧願襯艱齋遞簾(鬱觸網積夢憲製憲簾觸) = 網衊網淵繭繭鑰築築醖衊網鹹淵鏇觸獵積醖壓 (範積觸艱淵構鹽遞製願, 鏇構淵獵選艱糧顧淵簾 ~ 簾鹹鹹膚鹽鑰鹹築餘積) 更多