Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)

This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.

开始日期2024-12-01

申办/合作机构

中山大学

NCT06684600 / Recruiting临床2期IIT

A Single-arm, Phase II Clinical Trial of Dalpiciclib Combined with Pyrotinib As Second-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

The purpose of this study is to observe and evaluate the efficacy and safety of dalpiciclib combined with pyrotinib as second-line therapy in patients with advanced esophageal squamous cell carcinoma.

开始日期2024-11-01

申办/合作机构

北京大学

ChiCTR2400090883 / Suspended临床4期IIT

The efficacy and safety of Trastuzumab combined with pyrotinib in neoadjuvant treatment for HER2-positive eraly breast cancer: A real-world study

开始日期2024-10-20

申办/合作机构-

100 项与马来酸吡咯替尼相关的临床结果

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100 项与马来酸吡咯替尼相关的转化医学

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100 项与马来酸吡咯替尼相关的专利（医药）

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297

项与马来酸吡咯替尼相关的文献（医药）

2025-01-01·Current cancer drug targets

Twenty-four-month Progression-free Survival in HER2-amplified Advanced Gastric Cancer with Brain Metastases after Trastuzumab Deruxtecan Treatment: A Case Report and Literature Review

作者: Xu, Min ; Zhang, Haibo

Background::

Trastuzumab deruxtecan (T-DXd) has shown promising outcomes as a second or subsequent-line treatment for human epidermal growth factor-2 (HER2)-positive advanced gastric or gastroesophageal junction cancer.

Case Presentation::

We reported a 49-year-old male patient with stage IV HER2-amplified gastric cancer. Despite extensive pretreatments, including first-line trastuzumab plus FOLFOX, second-- line trastuzumab plus FOLFOX, followed by traditional Chinese medicine, third-line nivolumab plus trastuzumab, fourth-line pyrotinib plus paclitaxel and five hepatic arterial chemoembolization procedures, and fifth-line pembrolizumab plus nab-paclitaxel and thoracic radiotherapy, the patient experienced disease progression. In April 2021, T-DXd was initiated as the sixth-line therapy in combination with radiotherapy for brain metastases. After one treatment cycle, the patient achieved a partial response. T-DXd was discontinued in August 2022 due to recurrent anemia attributed to cardiac stenosis-related bleeding.

Conclusion::

The condition of the patient remained stable until May 2023, indicating a progression- free survival of over 24 months. This case suggests that T-DXd may offer long-term clinical benefits in patients with HER2-amplified advanced gastric cancer with brain metastases.

2025-01-01·Translational Oncology

An exploration of the optimal combination chemotherapy regimen based on neoadjuvant therapy containing pyrotinib for HER2-positive breast cancer: A multicenter real-world study

Article

作者: Tang, Shuhong ; Wang, Shan ; Wang, Xiaolan ; Liu, Bin ; Yao, Fan ; Zhu, Guolian ; Jin, Feng ; Zhang, Dianlong ; Wang, Jia ; Jin, Zining ; Li, Zhaohui ; Zhao, Yi ; Wen, Jian

BACKGROUND:

The combination of pyrotinib (Py) with cytotoxic agents proved to be effective in early human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC). However, the optimal chemotherapy regimen is unknown. This study attempts to explore it from real-world research data.

METHODS:

Information was collected from patients with early-stage HER2-positive BC from 23 centers across the country. They were categorized into the anthracycline group (A group) and non-anthracycline group (non-A group). Patients in the non-A group were further categorized into the platinum group and non-platinum group and the short-cycle (≤4 cycles) taxane group and long-cycle (>4 cycles) taxane group. Total pathological complete response (tpCR, ypT0/is ypN0) and breast pathological complete response (bpCR, ypT0/is) rates were assessed.

RESULTS:

A total of 107 patients were enrolled. Postoperative pathology indicated a tpCR rate of 36.8 %, a bpCR rate of 42.1 % in the A group, the non-A group had a tpCR rate of 47.8 %, and a bpCR rate of 53.6 %, with P-values of 0.273 and 0.254, respectively. In the long-cycle taxane group, the tpCR and bpCR rates were 60.8 % and 66.7 %, respectively. In the short-cycle taxane group, the tpCR and bpCR rates were 11.1 % and 16.7 %, respectively (both P<0.001). The platinum group had higher tpCR rate (62.9 % vs. 32.4 %, respectively; P = 0.011) and bpCR rate (65.7 % vs. 41.2 %, respectively; P = 0.041).

CONCLUSION:

As for a neoadjuvant therapy regimen with Py, an anthracycline-free regimen is feasible. Besides, platinum-containing, long-cycle taxane regimens appear to achieve superior efficacy under anthracycline-removed conditions.

2024-11-01·EBioMedicine

Pyrotinib and trastuzumab combination treatment synergistically overcomes HER2 dependency in HER2-positive breast cancer: insights from the PHILA trial

Article

作者: Ge, Hewei ; Xu, Binghe ; Zeng, Cheng ; Qian, Haili ; Li, Lixi ; Liu, Shuning ; Wang, Yuanyi ; Lan, Bo ; Yang, Tao ; Ma, Fei

BACKGROUND:

The PHILA study suggests that pyrotinib, trastuzumab, and docetaxel significantly improved progression-free survival (PFS) compared with placebo, trastuzumab, and docetaxel in patients with untreated HER2-positive metastatic breast cancer. In this study, we aimed to investigate the synergistic mechanisms of pyrotinib plus trastuzumab and provide further insights for the PHILA trial.

METHODS:

The in vitro activity of combination treatments was assessed through cell biological and biochemical experiments. The in vivo efficacy was evaluated in cell-derived xenografts, a TUBO tumour model, and one clinical case. Next-generation sequencing was performed on circulating tumour DNA (ctDNA) from patients in the PHILA trial.

FINDINGS:

The combination of pyrotinib and trastuzumab more effectively inhibited cell growth than pyrotinib or trastuzumab alone in models of HER2-dependent breast cancer. It potentiated membrane HER2 ubiquitination and downregulation, which resulted in a comprehensive blockade of the HER2 signalling pathway. The pyrotinib-altered membrane HER2 levels had no significant effect on trastuzumab-mediated antibody-dependent cell-mediated cytotoxicity (ADCC). We further validated the synergistic mechanisms in TUBO tumours and one clinical case, rather than models of HCC1954 cells harbouring the PIK3CA H1047R mutation. Similarly, in our centre cohort of the PHILA study, patients with genetic alterations in the HER2 signalling cascade had significantly shorter median PFS than individuals with the wild-type pathway.

INTERPRETATION:

Our findings underscore the robust synergy between pyrotinib and trastuzumab in overcoming HER2 dependency and provide a rationale for pyrotinib, trastuzumab, and docetaxel as one of the optimal choices for patients with untreated HER2-positive metastatic breast cancer, who are dependent on the HER2 signalling cascade.

FUNDING:

This work was supported by the National Key Research and Development Program of China (2021YFF1201300), the National Natural Science Foundation of China (82172875), the CAMS Innovation Fund for Medical Sciences (CIFMS) (2022-I2M-2-001), and the Joint Innovative Fund of Beijing Natural Science Foundation and Changping District (L234004).

387

项与马来酸吡咯替尼相关的新闻（医药）

2024-11-15

·生物世界

Cell子刊：宋尔卫院士团队发布乳腺癌新辅助治疗临床试验结果——效果良好、毒性可控

编辑丨王多鱼排版丨水成文约55%的早期乳腺癌（EBC）表现出低水平的人表皮生长因子受体2（HER2），其定义为免疫组织化学（IHC） 2+且荧光原位杂交（FISH）阴性或IHC 1+。HER2低表达的早期乳腺癌具有生物学异质性，高达90%为激素受体（HR）阳性，属于luminal型。通过化疗和内分泌治疗，luminal/HER2低表达的早期乳腺患者的预后得到了显著改善。然而，尽管取得了这些进展，5年内的死亡率仍约为15%，并且在有高危临床或基因组特征的患者中，死亡率进一步加剧。与HER2阳性早期乳腺癌患者相比，luminal/HER2水平早期乳腺癌患者并未从传统的抗HER2药中获得额外获益。此外，虽然抗HER2抗体-药物偶联物（ADC）——trastuzumab deruxtecan（T-DXd）在HER2低表达的晚期乳腺癌中显示出令人惊叹的疗效，但将其应用于luminal/HER2低表达的早期乳腺癌的新辅助治疗时，肿瘤反应性有限，导致残余癌症负担（RCB）0/I率仅为12.1%。因此，有必要进一步探索更有效的治疗luminal/HER2低表达的早期乳腺癌的方法。近日，中山大学孙逸仙纪念医院宋尔卫院士、龚畅教授等在 Cell 子刊 Cell Reports Medicine 上发表了题为：Preclinical study and phase 2 trial of neoadjuvant pyrotinib combined with chemotherapy in luminal/HER2-low breast cancer: PILHLE-001 study 的研究论文。这项在luminal/HER2低表达（IHC 2+/FISH-）的早期乳腺癌患者中进行的2期临床试验结果显示，泛HER酪氨酸激酶抑制剂吡咯替尼（Pyrotinib）联合化疗的新辅助治疗，表现出良好的抗肿瘤活性和可控的副作用，值得进一步探索。吡咯替尼（Pyrotinib）是一种靶向HER1、HER2和HER4的不可逆泛HER酪氨酸激酶抑制剂（TKI），在HER2阳性的早期和晚期乳腺癌患者中显示出良疗效。然而，其在HER2低水平早期乳腺癌中的疗效仍不确定。之前有研究显示，抗HER2酪氨酸激酶抑制剂（TKI）的抗体依赖性细胞毒性（ADCC）抗肿瘤作用可能不依赖于乳腺癌细胞HER2表达和膜定位。除ADCC外，酪氨酸激酶抑制剂（TKI）可消除HER2与STING结合所介导的免疫抑制作用。这提示了抗HER2 TKI可能通过其他途径发挥抗HER2作用，而非阻断HER2信号通路。因此，研究团队开展了一项临床前研究和2期临床试验，以探索关于吡咯替尼（Pyrotinib）联合化疗治疗luminal/HER2低表达（IHC 2+/FISH-）的早期乳腺癌患者疗效和安全性的初步证据，同时探索潜在的生物标志物。临床前实验表明，在luminal/HER2低表达乳腺癌模型中，吡咯替尼（Pyrotinib）联合化疗具有协同抗肿瘤作用。在48例luminal/HER2低表达高危早期乳腺癌女性患者中，接受吡咯替尼（Pyrotinib）联合化疗（表柔比星-环磷酰胺联合多西他赛）新辅助治疗。最终26例患者（54.2%）达到主要终点（残余癌症负担评分为0/I）。21例患者（43.8%）发生了与治疗相关的≥3级不良事件，最常见的是腹泻（10例）。总的来说，在luminal/HER2低表达高危早期乳腺癌女性患者中，吡咯替尼（Pyrotinib）联合化疗的新辅助治疗具有令人鼓舞的疗效和可控的副作用，因此，该治疗方案值得进一步验证。论文链接： https://www-cell-com.libproxy1.nus.edu.sg/cell-reports-medicine/fulltext/S2666-3791(24)00554-8 设置星标，不错过精彩推文开放转载欢迎转发到朋友圈和微信群微信加群为促进前沿研究的传播和交流，我们组建了多个专业交流群，长按下方二维码，即可添加小编微信进群，由于申请人数较多，添加微信时请备注：学校/专业/姓名，如果是PI/教授，还请注明。点在看，传递你的品味

临床结果抗体药物偶联物临床2期ASCO会议

2024-11-14

·米内网

第十批集采4个抗肿瘤药亮了！670亿市场大洗牌，38亿大品种承压，齐鲁、科伦发力

精彩内容第十批集采拟纳入4个抗肿瘤药，38亿大品种在列。米内网数据显示，2024H1中国公立医疗机构终端化药抗肿瘤药销售额同比增长3.42%，阿斯利康、恒瑞医药、正大制药领跑市场。品牌TOP20中，4大超10亿品种领跑，国产1类新药暴涨112%。4个拟集采抗肿瘤药，齐鲁制药均已过评，科伦、重庆药友、豪森等各有2个品种过评。超670亿化药抗肿瘤药市场，蛋白激酶抑制剂领跑受集采等政策影响，近年来化药抗肿瘤药市场承压。米内网数据显示，化药抗肿瘤药2023年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额超过677亿元，同比下滑4.98%；2024年上半年销售额超过360亿元，同比增长3.42%。中国公立医疗机构终端化药抗肿瘤药销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局从治疗类别上看，化药抗肿瘤药涉及8个治疗大类，其中蛋白激酶抑制剂（替尼类药物）是销售主力，占据的市场份额均达45.91%，植物生物碱和其它天然药、抗代谢药占比分别为12.35%、11.54%。令人瞩目的是，近十年来国内蛋白激酶抑制剂市场持续上升，从2013年的超过37亿元增长至2023年的接近300亿元。化药抗肿瘤药一级集团销售额排名中，阿斯利康位列第一，销售额超过30亿元；恒瑞医药位列第二，销售额超过27亿元；正大制药位列第三，销售额超过25亿元；位列第四的豪森药业销售额大涨25.17%；位列第九、第十的贝达药业、赛诺菲销售额分别增长13.42%、13.77%。 2024H1中国公立医疗机构终端化药抗肿瘤药销售额TOP10一级集团来源：米内网中国公立医疗机构药品终端竞争格局 4大超10亿品种领跑，明星药暴涨111.87% 化药抗肿瘤药销售额TOP20品牌中，阿斯利康的甲磺酸奥希替尼片位列第一，销售额超过22亿元；正大天晴的盐酸安罗替尼胶囊位列第二，销售额超过16亿元；豪森药业的甲磺酸阿美替尼片、石药欧意的盐酸多柔比星脂质体注射液分别位列第三、第四，销售额均超过10亿元。 2024H1中国公立医疗机构终端化药抗肿瘤药销售额TOP20品牌来源：米内网中国公立医疗机构药品终端竞争格局 12个品牌销售额实现正增长，其中5个品牌销售额增逾10%，艾力斯的甲磺酸伏美替尼片暴涨111.87%、豪森药业的甲磺酸阿美替尼片大涨44.04%、百济神州的泽布替尼胶囊大涨21.88%、赛诺菲的注射用奥沙利铂增长13.78%、再鼎医药的甲苯磺酸尼拉帕利胶囊增长11.47%。从企业层面上看，恒瑞医药有3个品种马来酸吡咯替尼片、注射用紫杉醇(白蛋白结合型)、甲磺酸阿帕替尼片上榜；阿斯利康有2个品种甲磺酸奥希替尼片、奥拉帕利片上榜；石药欧意有2个品种盐酸多柔比星脂质体注射液、注射用紫杉醇(白蛋白结合型)上榜。 20个品牌中，国产1类新药逐渐崭露头角，上榜品牌多达8个，进口原研药有5个，早期集采的原研药多数跌出榜单。紫杉醇白蛋白为第二批集采品种、卡培他滨片为第三批集采品种，上榜企业均为本土企业，注射用奥沙利铂为第五批集采品种，赛诺菲持续领跑市场。盐酸多柔比星脂质体注射液、瑞戈非尼片为第十批拟集采品种，市场格局将迎变化。 38亿大品种在列！4个品种备战第十批集采已落地执行的八批化药集采中，化药抗肿瘤药分别有3个、2个、2个、3个、6个、6个、0个、0个药品被纳入，合计22个品种。其中12个为注射剂，10个为口服常释剂型，包括吉非替尼、伊马替尼、培美曲塞、替吉奥、紫杉醇白蛋白等重磅品种。抗肿瘤药国家集采品种 11月1日，国家组织药品联合采购办公室发布通知，开展第十批国家组织药品集中采购相关药品信息填报工作，62个品种（263个品规）被纳入填报范围。化药抗肿瘤药有4个品种氟尿嘧啶注射剂、盐酸多柔比星脂质体注射液、哌柏西利胶囊、瑞戈非尼片在列。第十批拟集采抗肿瘤药竞争格局 4个通用名药品2023年在中国公立医疗机构终端的销售额合计接近60亿元。其中，盐酸多柔比星脂质体注射液销售额超过38亿元，氟尿嘧啶注射剂、瑞戈非尼片销售额均超过9亿元。氟尿嘧啶注射剂、哌柏西利胶囊过评企业均已有14家，竞争较为激烈；瑞戈非尼片在TOP20品牌排名第20，过评企业已有9家，原研厂家拜耳在过往的国采中仅中标了第二批集采的阿卡波糖片、盐酸莫西沙星片，本次集采拜耳是否会竞标值得关注。盐酸多柔比星脂质体注射液是一款重磅广谱抗肿瘤药，也是国家集采开展以来首个入选的脂质体。该品种2023年院内市场销售额超过38亿元，过评企业共有8家，包括复旦张江、石药欧意、齐鲁制药、常州金远药业、印度瑞迪博士实验室等，其中齐鲁制药该产品于今年5月获批上市，预计公司将积极竞标迅速抢占市场。从过评企业上看，本次集采的4个抗肿瘤药齐鲁制药均已过评，科伦药业、重庆药友、豪森药业、上海创诺制药、青峰医药、正大制药等企业均有2个品种过评。资料来源：米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

核酸药物医药出海上市批准

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

100 项与马来酸吡咯替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB14993

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 HER2 阳性乳腺癌	中国	江苏恒瑞医药股份有限公司	2023-04-17

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低表达乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2024-01-17
HR阳性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2024-01-17
HR阳性/HER2低表达乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2024-01-17
浸润性乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2024-01-17
不能切除的乳腺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2022-08-04
非鳞状非小细胞肺癌	临床3期	美国	江苏恒瑞医药股份有限公司	2020-09-11
非鳞状非小细胞肺癌	临床3期	中国	江苏恒瑞医药股份有限公司	2020-09-11
非鳞状非小细胞肺癌	临床3期	澳大利亚	江苏恒瑞医药股份有限公司	2020-09-11
非鳞状非小细胞肺癌	临床3期	比利时	江苏恒瑞医药股份有限公司	2020-09-11
非鳞状非小细胞肺癌	临床3期	法国	江苏恒瑞医药股份有限公司	2020-09-11

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临床结果

适应症

分期

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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


Pubmed \| Neoplasia 人工标引	N/A	HER2阳性转移性乳腺癌	137	Pyrotinib	構憲範齋願獵製餘遞範(醖憲網艱鏇廠願選廠網) = 觸襯糧製獵繭製遞憲遞簾鹹觸顧遞選醖願繭觸 (衊襯蓋蓋遞蓋淵艱鏇鑰 ) 更多	积极	2024-10-01
				Pyrotinib (brain radiotherapy (BRT))	齋餘鏇簾衊鏇衊窪鑰夢(選醖鑰夢鹹艱夢願壓鏇) = 鹹齋觸膚選繭積鹽網醖鑰獵築網鑰鹹鹽夢範壓 (簾鹽膚襯選膚蓋鹹積獵, 7.815 ~ 20.925)
NCT03691051 (PERMEATE, Pubmed \| EClinicalMedicine) 人工标引	临床2期	HER2阳性乳腺癌 HER2 Positive	78	Pyrotinib plus capecitabine (cohort A + radiotherapy-naïve brain metastases)	膚獵簾廠製製網鏇鬱範(鹹獵構選憲廠糧築淵鹹) = 顧網範網範壓蓋淵鹽鬱衊願製齋積觸顧願醖鬱 (餘膚鹽顧蓋衊網齋遞構, 24.4 ~ not reached) 更多	积极	2024-10-01
				Pyrotinib plus capecitabine (progressive disease after radiotherapy + cohort B)	膚獵簾廠製製網鏇鬱範(鹹獵構選憲廠糧築淵鹹) = 壓顧範遞網製醖壓遞襯衊願製齋積觸顧願醖鬱 (餘膚鹽顧蓋衊網齋遞構, 12.6 ~ 33.3) 更多
NCT03923179 (ESMO2024) 人工标引	临床2期	HER2阳性转移性乳腺癌 HER2 Positive	22	Pyrotinib combined with metronomic oral etoposide (VP-16)	簾範顧製鑰夢廠衊窪鏇(遞糧願選鹽鏇遞範衊廠) = 餘淵積糧繭網壓築鏇齋範壓衊鹽顧鏇積觸齋鏇 (積糧積簾鹹選築膚獵願, 7.6 ~ 10.4) 更多	积极	2024-09-16
ChiCTR1900021684 (PATHER2, ESMO2024)	临床2期	非小细胞肺癌 TP53 \| DNMT3A \| ARID1B ... 更多	27	Pyrotinib plus apatinib	醖窪鏇憲遞窪願糧製淵(鑰餘鬱構糧蓋鹽廠壓憲) = 築壓糧餘艱願選網淵憲鑰憲範鹽繭鹹餘膚簾選 (鏇餘構餘醖糧襯遞網鏇 )	积极	2024-09-15
ChiCTR2100052156 (ESMO2024) 人工标引	临床2期	非小细胞肺癌一线 ERBB2 Mutation (Activating) \| ERBB2 Amplification	21	pyrotinib and apatinib	顧壓積淵鹹繭積襯築積(憲鏇衊壓鏇醖壓鏇網繭) = 醖願網構觸餘憲鹹夢憲構艱顧襯窪積構築衊繭 (鹹餘願鹽簾齋觸鏇構淵 ) 更多	积极	2024-09-14
ChiCTR2000041217 (ASCO2024) 人工标引	临床4期	HER2阳性转移性乳腺癌三线 HER2 Positive	101	Pyrotinib + taxanes or vinorelbine	餘願廠糧膚築選構夢積(範衊觸網糧艱鹽醖艱醖) = 淵衊鏇鏇範壓繭範觸顧窪鏇鏇鏇構鹹餘糧糧鬱 (艱構糧繭範壓鑰築醖壓, 8.8 ~ 15.7)	积极	2024-05-24
				Pyrotinib + taxanes	餘願廠糧膚築選構夢積(範衊觸網糧艱鹽醖艱醖) = 構繭鏇憲膚繭積餘窪衊窪鏇鏇鏇構鹹餘糧糧鬱 (艱構糧繭範壓鑰築醖壓, 9.2 ~ 18.6) 更多
NCT06234137 (NeoPICD study, ASCO2024)	N/A	晚期 HER2 阳性乳腺癌辅助 HER2-positive	143	Inetetamab	壓積鹹繭壓齋餘夢鹹願(範淵餘淵糧齋鏇願廠廠) = 膚繭網廠廠構蓋築製選糧鹹蓋衊遞壓淵糧顧蓋 (衊餘顧襯齋窪襯築構鬱, 0.515 ~ 0.791)	积极	2024-05-24
ASCO2024	N/A	HER2阳性乳腺癌 HER2-positive	52	Pyrotinib-based therapy + SRS	製鹽鏇鹹窪鹽遞淵觸鑰(艱窪憲餘鏇觸積範襯遞) = 餘範憲範鹽製觸淵鑰憲網蓋觸積鹹網範鹹製鹹 (襯願鏇淵齋簾餘獵衊築, 17.5 ~ 27.6) 更多	积极	2024-05-24
ChiCTR1900022293 (1900022293, ASCO2024)	临床2期	HER2阳性乳腺癌新辅助 PIK3CA mutations	50	pyrotinib	簾淵醖選築鏇網築鹹觸(襯淵齋襯範壓積夢觸艱) = 製鹹夢鬱觸鏇壓鹽壓鏇鹽觸簾繭夢醖簾齋壓範 (鹽衊鬱鹹遞積壓築繭蓋, 83.2% ~ 99.8) 更多	不佳	2024-05-24
				pyrotinib	簾淵醖選築鏇網築鹹觸(襯淵齋襯範壓積夢觸艱) = 鹽醖繭構範觸網淵願憲鹽觸簾繭夢醖簾齋壓範 (鹽衊鬱鹹遞積壓築繭蓋 ) 更多
NCT03847818 (NeoPaTHer, ASCO2024)	N/A	HER2阳性乳腺癌新辅助 TMB \| RTK-RAS mutation	129	Trastuzumab + chemotherapy	艱齋積獵艱築膚製艱築(蓋鬱醖範遞壓鑰齋淵壓) = 範積鏇觸獵壓積憲艱鹽鹹範範鑰選窪醖鏇餘壓 (鬱衊獵築淵窪鹽積築獵, 20.6% ~ 43.0)	积极	2024-05-24
				Trastuzumab + chemotherapy + pyrotinib	艱齋積獵艱築膚製艱築(蓋鬱醖範遞壓鑰齋淵壓) = 鏇顧製構繭襯顧鹹廠鹹鹹範範鑰選窪醖鏇餘壓 (鬱衊獵築淵窪鹽積築獵, 17.6% ~ 44.5)