A Single-Arm, Open-Lable Study of Adjuvant Aumolertinib for Completely Resected Stage IB-IIIA Non-Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations.

Aumolertinib (almonertinib; HS-10296) is a novel third-generation EGFR-TKI showing activity against EGFR-sensitizing mutations and EGFR T790M mutation. The third-generation EGFR-TKI osimertinib has been approved in the adjuvant setting. This study is to studying 3-year aumolertinib as adjuvant therapy to see how well it works in treating patients with resected stage IB-IIIA NSCLC harboring sensitizing EGFR mutations.

开始日期2024-04-01

申办/合作机构

中山大学

NCT06300424 / Recruiting临床2期IIT

Neoadjuvant Almonertinib Followed by Adebrelimab-based Chemo-immunotherapy in II-IIIB EGFR-mutant Non-small Cell Lung Cancer, a Single Arm, Phase II Study

Phase II, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon investigators' decisions.

开始日期2024-04-01

申办/合作机构

广东省人民医院

NCT06185400 / Not yet recruiting临床2期IIT

Disitamab Vedotin（RC48）Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.

开始日期2024-02-01

申办/合作机构

中国医学科学院肿瘤医院

100 项与甲磺酸阿美替尼相关的临床结果

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100 项与甲磺酸阿美替尼相关的转化医学

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100 项与甲磺酸阿美替尼相关的专利（医药）

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项与甲磺酸阿美替尼相关的文献（医药）

2024-01-12·Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases

[Clinical analysis of lung adenocarcinoma with epidermal growth factor receptor mutation transformed into sarcoma].

Review

作者: Shen, D ; Du, M Z ; Zhu, Q Q ; Huang, J A ; Wu, W T ; Guo, L C

Objective: To analyze the clinical data of a case of lung adenocarcinoma with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) resistance transforming into sarcoma, and to conduct a literature review to improve the understanding of the resistance mechanism. Histological transformation is a unique form of acquired resistance of EGFR-TKIs in non-small cell lung cancer (NSCLC). Thereinto, the transformation of small cell carcinoma is more common, and the transformation of sarcoma is rarely reported. Methods: Clinicopathological data on the treatment process, pathological features, and clinical outcome of the patient with EGFR-TKIs-resistance lung adenocarcinoma transforming into sarcoma were collected. The literature was reviewed to analyze the pathogenetic mechanism for sarcomatoid carcinoma or sarcoma transformation after drug resistance of adenocarcinoma, as well as the clinical characteristics of the patients and the corresponding therapeutic schemes. Results: We reported a patient with lung adenocarcinoma who developed EGFR-T790M mutation after first-line treatment with icotinib and sarcoma transformation after second-line treatment with almonertinib. Chemotherapy, radioactive particle implantation, antiangiogenic therapy and immunotherapy were followed, but the results were unsatisfactory. There was no report of EGFR-TKIs-resistant lung adenocarcinoma transforming into sarcoma. Among the 14 reports of adenocarcinoma transforming into sarcomatoid carcinoma, 8 cases had EGFR mutation, 3 cases had ALK mutation, 2 cases had ROS1 mutation, and 1 case had no asscoiated sensitive mutation. The median survival of 14 patients with adenocarcinoma transforming to sarcomatoid carcinoma was only 3 months. Conclusions: Sarcoma transformation can be one of the forms of drug resistance in patients with lung adenocarcinoma with EGFR-TKIs. The prognosis of patients with adenocarcinoma after transformation into sarcoma is poor.

2023-10-31·Zhonghua yi xue za zhi

[China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023)].

Article

The incidence and mortality of lung cancer rank first among malignant tumors in China. Among them, non-small cell lung cancer (NSCLC) is the most important pathological type, accounting for 80%-85% of lung cancer patients, including adenocarcinoma, squamous cell carcinoma and other pathological subtypes. In recent years, with the discovery of epidermal growth factor receptor (EGFR) gene and the successful development of tyrosine kinase inhibitors (TKIs), the treatment efficacy of stage Ⅳ NSCLC patients with EGFR gene sensitive mutation has been greatly improved. As of August 23, 2023, the first generation EGFR-TKIs, gefitinib, icotinib, and erlotinib; the second generation EGFR-TKIs, afatinib and dacomitinib; and the third generation EGFR-TKIs, osimertinib, almonertinib, furmonertinib and befotertinib were all approved for marketing by China National Medical Products Administration (NMPA). In addition, multiple domestic third-generation EGFR-TKIs are undergoing clinical trials, such as rezivertinib (BPI-7711), limertinib (ASK120067), and oritinib (SH-1028). Meanwhile, mobocertinib and sunvozertinib, which targets EGFR 20ins mutations, were also approved by NMPA. With the increasing variety of EGFR-TKIs approved for marketing subsequently, it brings confusion to clinicians when choosing specific medications, and there is an urgent need to develop relevant treatment guidelines. Hence, the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care and the Chinese Association for Clinical Oncologists convened experts to integrate the research results of various EGFR-TKIs, and proposed the "China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023)", to provide reference for better clinical practice.

2023-10-01·International journal of radiation oncology, biology, physics

Stereotactic Radiotherapy (SRT) in Combination with Aumolertinib to Treat Intracranial Oligometastatic Non-Small Cell Lung Cancer (NSCLC): An Update of a Phase II, Prospective Study.

Article

作者: Wang, B ; Fan, M ; Chen, J

PURPOSE/OBJECTIVE(S):

Stereotactic radiotherapy (SRT) is highly effective and less toxic for limited intracranial metastases. Aumolertinib is a tolerable third-generation epidermal growth factor receptor tyrosine kinase inhibitor that has CNS efficacy in patients with EGFR-mutant NSCLC. We aim to investigate the efficacy and safety of aumolertinib followed by SRT in patients with intracranial oligometastatic NSCLC.

MATERIALS/METHODS:

Intracranial oligometastatic Patients with EGFR sensitive mutations (EGFR-TKIs naive) were enrolled and received aumolertinib 110mg daily until intracranial disease progression. Then SRT (32-40 Gy total, 8 Gy/f) was given to intracranial oligo-progression disease if possible. The primary endpoint was intracranial objective response rate (iORR). Secondary endpoints included intracranial progression-free survival (iPFS), intracranial duration of response (iDOR)according to RECIST 1.1, cerebral radiation necrosis rate (CRNR) and overall survival (OS). Safety was evaluated according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). This trial is registered with ClinicalTrials.gov, NCT04519983.

RESULTS:

To February 10, 2023, a total of 38 patients were enrolled and 35 patients were assessable followed for 3 months to 18 months. All patients received 110mg aumolertinib daily and received at least one independent imaging evaluation by a radiologist. After oral administration of aumolertinib, the best response of 94% patients in intracranial and extracranial lesions was partial response (PR). Two patients had stable intracranial disease. At data cut-off, one patient developed intracranial primary lesion progression at 12 months after oral administration of aumolertinib but stable in extracranial lesions. SRT treatment was given to this patient. No grade ≥3 adverse events occurred after continued oral administration of aumolertinib. The most common adverse reactions were rash and abnormal liver enzymes, 1 patient had grade 2 CK elevation.

CONCLUSION:

This report showed pronounced intracranial objective response benefit in patients with intracranial oligometastatic disease followed by SRT after intracranial oligo-progression and no new safety signals. Aumolertinib has promising efficacy and good tolerability in intracranial oligometastatic EGFR mutated NSCLC. [Keywords] Non-small cell lung cancer; epidermal growth factor receptor tyrosine kinase inhibitor; Aumolertinib; Stereotactic radiotherapy.

305

项与甲磺酸阿美替尼相关的新闻（医药）

2024-04-28

·药智网

利润暴涨769%，创新药第一股悄然转型

近日，贝达药业发布2023年年报，相比于2022年的净利润下跌，今年给出的答卷令人眼前一亮：2023年实现营业收入24.56亿元，同比增长3.35%；实现扣非归母净利润2.63亿元，同比增长768.65%。创新药第一股贝达药业，正在悄然转型。01第一个小分子创新药，走过十年2011年，国内医药市场还处于仿制药时代，人们讨论的是进口靶向药的昂贵与难以负担，并对中国创新药的未来充满迷茫。当年6月，贝达药业的核心单品盐酸埃克替尼横空出世，它是中国第一个小分子靶向抗癌药，它对中国创新药发展的影响之大，足以被写进中国创新药编年史。盐酸埃克替尼是表皮生长因子受体酪氨酸激酶抑制剂，简称EGFR-TKI。机理上，表皮生长因子受体(EGFR)在正常细胞和肿瘤细胞均有表达，在细胞的生长分化过程中起重要的作用。非小细胞肺癌细胞中的EGFR突变(外显子19缺失和外显子21L858R突变)可促进肿瘤细胞生长，抑制细胞凋亡，增加血管生成因子的产生，以及促进肿瘤转移。而EGFR-TKI可抑制EGFR受体酪氨酸的自体磷酸化，从而进一步抑制下游信号传导，阻止EGFR依赖的细胞增殖。第一个EGFR-TKI是阿斯利康的吉非替尼，于2002年在日本获批上市，后来的第一代EGFR-TKI有2004年FDA批准的厄洛替尼，2007年FDA批准的拉帕替尼等。而贝达药业的埃克替尼，同属于第一代靶向药，被誉为国产易瑞沙（吉非替尼）。在2011年埃克替尼成果发布会上，时任卫生部部长、中国科学院院士陈竺表示，埃克替尼的成功研发堪比“民生领域的两弹一星”。贝达药业一路高歌猛进的扩张史，就是埃克替尼开疆拓土的创新药当代史。埃克替尼从2011年开始销售，2011年、2012年、2013年、2014年及2015年的销售额分别为0.6亿元、3.1亿元、4.7亿元、7.0亿元和9.1亿元，在国内治疗肺癌的小分子靶向抗癌药物的市场占有率分别约为4.89%、20.49%、22.25%、25.03%及28.16%。到2016年，该药的销售额首次突破10亿元，这一年，贝达药业敲钟上市。2021年年报显示，2021年是埃克替尼上市的第10年，其累计销售已超百亿。即便是后来面临着集采和仿制药的双重压力，埃克替尼仍然在2021年卖出了21亿元的销售额，位列国产化学创新药排行榜第四名。02新获批单品不断放量，助力利润增长随着埃克替尼面临集采和仿制药的双重压力，贝达药业以后续重磅管线，逐渐释放。其第二个获批的药物，是2020年获批的恩沙替尼。恩沙替尼在市场上需要面临的竞争，比当初埃克替尼刚上市时要激烈很多。与恩沙替尼同类进口产品阿来替尼，2021年在国内的销售额曾达到18.7亿元，占市场比近60%。尽管竞争激烈，但恩沙替尼销售放量的情况也算中规中矩，2021年，恩沙替尼前三季度的销售额为1.5亿元，而2022年达到了5.4亿元。恩沙替尼的总市场规模目前大约为40-50亿元。作为国产第一款同类产品，对标进口产品，其销售天花板有望突破10亿元。而在EGFR-TKI上，贝达药业也完成了迭代，开发了三代药物贝福替尼。2023年，贝福替尼二线、一线适应症已于2023年5月、10月先后获批。目前，国内三代主要的市场被三大药物占领：奥希替尼，阿美替尼和伏美替尼。奥西替尼作为首个上市的三代EGFR-TKI一直保持较大的市场份额，2022年占有国内67%市场份额，阿美替尼约占18%国内市场份额，伏美替尼约占3%国内市场份额。但是，随着2023年伏美替尼进入医保后销量快速提升，2023年上半年约占9%国内市场份额，而2023年上半年奥西替尼的市场份额被国内两家EGFR-TKI挤占而有所下降。而且有多款药物正处于NDA阶段，市场竞争可谓激烈。不过可以肯定的是，三代EGFR-TKI凭借良好的临床效果，在样本医院中的销售额迅速增长，目前已成为EGFR-TKI的主流药物。公开资料对贝福替尼销售天花板的预期为20亿元。03悄然转型，未来布局几何？贝达药业转型的第一个想象力是眼药。2022年2月，贝达子公司Equinox曾与EyePoint签署了《独占许可协议》，独家授权EyePoint在中国区域外以局部给药方式开发伏罗尼布；后者在其递送技术基础上开发了EYP-1901。2022年5月，贝达药业与制药公司EyePoint签署《扩大许可协议》。根据《扩大许可协议》，贝达药业取得在中国（包括香港、澳门和台湾）区域开发和商业化EYP-1901的独家权利，EyePoint保留EYP-1901在全球其他地区的眼科权利。EYP-1901是将伏罗尼布和Durasert技术（Durasert技术是一种已批准上市的玻璃体内给药系统，它将另一种药物注射进入玻璃体内后缓释，有效期可长达3年）相结合，形成了一种新的治疗方案，可在门诊办公室注射，实现至少6个月的药物释放。该技术可以使药物以一种可控和可耐受的方式持续地在眼部释放，延长注射治疗周期，提高患者治疗依从性，减轻医疗负担，并最终改善患者临床效果。2023年底，EYP-1901治疗湿性年龄相关性黄斑变性的2期DAVIO 2试验取得积极的顶线结果。研究达到了其主要终点，即与aflibercept对照组相比，两种剂量的EYP-1901均显示出最佳矫正视力的统计学非劣效性变化，且具有良好的安全性，没有出现与药物相关的眼部或全身严重不良事件。同在2023年12月，EYP-1901玻璃体内植入剂药品临床试验申请已获得国家药监局受理。目前，黄斑变性市场可谓火热。根据弗若斯特沙利文报告，2020 年，中国湿性老年性黄斑变性患者数量达376.27万例，超过同期美国186.65万例的两倍，预计到2025年将增长至432万例，CAGR为 2.8%，到2030年增长至487.09万例，CAGR为2.4%。人群需求的增长带动市场规模持续放量。据相关数据，我国等级医院眼科用药销售额2022年达107.7亿元，2023Q1达27.9亿元，其中眼底血管病变治疗药市场份额最高，2022年销售额达28.47亿元，2023Q1达7.05亿元。而玻璃体内注射内抗VEGF药物仍然是目前眼底血管性疾病最主要的治疗手段，相比起来，Durasert技术的缓释特点，可以让其给药周期大大延长，安全性极大得到提升，可以把这看作是黄斑变性治疗的一次技术迭代。贝达药业转型的第二个想象力，为创新药出海。今年3月，贝达药业董事长丁列明提出：中国企业要抓住创新机会，出海是一个很大的板块。不论是与跨国企业合作“借船出海”，还是自己到海外做临床研究、开发全球市场，都有很大的机会。3月12日，贝达药业宣布，恩沙替尼的上市申请获得FDA受理，其有望成为首个由中国企业主导在全球上市的肺癌靶向创新药。据推测，该药在美国的销售峰值将远高于中国，如果在中国销售峰值是在20亿元出头，那么在美国这个数字将达到38.22亿元。结语：贝达药业辉煌过，也阶段性失败过，但无论是裁员的降本增效，还是利润上的同比猛涨，无不昭示其渴望回归原本地位的决心。虽然市场竞争激烈，但贝达药业值得期待。参考来源：贝达药业招股书、贝达药业官网、弗若斯特沙利文数据声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 金银花转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是昨天最受欢迎的文章哦

财报上市批准高管变更医药出海

2024-04-27

·精准药物

国产三代EGFR抑制剂「甲磺酸伏美替尼」2023年销售额20亿元，24年有望超30亿元！

2024年4月25日，上海艾力斯医药发布2023年年度报告和2024年一季报，2023年全年艾力斯营收20.18亿元，净利润6.44亿元，2024年第一季度营收7.43亿元，净利润3.06亿元。艾力斯公司核心产品为小分子靶向抗肿瘤新药甲磺酸伏美替尼片，2023年11月，获得了RET抑制剂普拉替尼胶囊在中国大陆地区的独家商业化推广权。2023年和2024年第一季度营收均主要来自伏美替尼。可以预见的是，甲磺酸伏美替尼片2024年销售有望突破30亿元，成为名副其实的国产抗肿瘤重磅产品。甲磺酸伏美替尼是上海艾力斯医药科技有限公司自主研发的 1 类新药，为新型的第三代不可逆、选择性的 EGFR-TKI 靶向药。伏美替尼设计之初便针对脑转移进行了特别设计，其创新性引入的三氟乙氧基吡啶分子结构修饰赋予其独特的药理和生理活性，包括“双活性、双入脑、高选择和代谢佳”。图片来自（药论编辑）甲磺酸伏美替尼于2021年3月3日获国家药品监督管理局（NMPA）批准上市，用于既往经表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的治疗。甲磺酸伏美替尼继奥希替尼（阿斯利康）、阿美替尼（江苏豪森）之后正式成为国内第三个获批的三代EGFR-TKI。一线治疗适应症于2022年6月获批上市。一线治疗适应症与二线治疗适应症均被纳入国家医保目录。为充分挖掘伏美替尼品种的临床优势，扩大伏美替尼的临床适用范围，艾力斯积极开展针对伏美替尼各项适应症的临床试验，其中辅助治疗适应症（针对接受根治性切除伴或不伴辅助化疗后的表皮生长因子受体（EGFR）突变阳性II-IIIA期非小细胞肺癌患者的治疗）目前处于III期临床试验阶段。另外伏美替尼20外显子插入突变二线治疗适应症（即用于经检测确认存在EGFR 20外显子插入突变阳性，含铂化疗期间或化疗后出现疾病进展的局部晚期或转移性NSCLC成人患者的治疗）的II期注册临床研究目前正在进行中；20外显子插入突变一线治疗适应症（即用于一线治疗EGFR 20外显子插入突变的局部晚期或转移性非小细胞肺癌患者的治疗）的III期注册临床研究目前正在进行中；具有EGFR PACC突变或EGFR L861Q突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗III期注册临床研究已获得药物临床试验批准通知书；具有EGFR或HER2突变晚期NSCLC患者的Ib期临床试验目前正在进行中；伏美替尼与FAK小分子抑制剂IN10018联合用药治疗晚期NSCLC目前处于Ib/II期临床阶段；伏美替尼与RC108抗体偶联药物联合用药治疗晚期NSCLC的Ib/II期临床试验目前正在进行中。EGFR-TKI的临床应用为EGFR突变晚期非小细胞肺癌（NSCLC）患者带来了良好的生存获益，先后有第一、二、三代EGFR-TKI获批上市。第一代EGFR-TKI：第一代EGFR-TKI针对的是EGFR激酶区结构中“L858R”或“exon19 del”突变，结构中具有典型的苯胺喹唑啉骨架，代表上市药物有吉非替尼、厄洛替尼和埃克替尼。第二代EGFR-TKI：研究人员基于第一代EGFR-TKI苯胺喹唑啉骨架开发了EGFR酪氨酸激酶共价抑制剂。该激酶在配体结合位点附近含有半胱氨酸残基（C797），通过迈克尔受体（如丙烯酰胺）取代喹唑啉环，可以捕获半胱氨酸残基。第二代EGFR-TKI临床效果和抗耐药性较第一代有一定提升，代表上市药物有阿法替尼和达克替尼。第三代EGFR-TKI：第一、二代EGFR-TKI使用不久出现耐药，超过半数的耐药原因是肿瘤细胞EGFR激酶结构域的又一新型突变，这个突变就是现在认识比较清晰的790位苏氨酸（Thr，简称T）点突变为甲硫氨酸（Met,简称M），一般称之为“T790M”。三代EGFR-TKI对“L858R”合并“T790M”、“exon19 del”合并“T790M”的EGFR突变肿瘤细胞均表现出明显抑制活性，同时具备一定选择性（不明显抑制野生型），代表（曾）上市药物有奥希替尼、阿美替尼、伏美替尼、olmutinib、Lazertinib（韩国上市）和贝福替尼。三代EGFR奥希替尼与激酶结合模式结合（来源：参考2）事实上，为了解决耐药问题而生的奥希替尼等第三代EGFR-TKI，也不可避免地会出现了耐药现象。EGFR-TKI耐药机制分为EGFR相关与EGFR非相关两种，其中EGFR相关的耐药约占30%~45%，C797S突变占比20％左右，三级 C797S (Cys 797 → Ser 797 ) 突变会破坏Cys797和丙烯酰胺弹头之间的共价形成。奥希替尼与EGFR/T790M和EGFR/C797S结合作用的示意图(来源：文献3)尽管具有反式EGFR（T790M/C797S）突变的患者(其中T790M和C797S突变位于不同的等位基因上)可以通过第一代和第三代EGFR-TKI组合来有效地治疗，但是占到85％的顺式- EGFR（T790M/C797S）突变（突变位于相同等位基因）介导的耐药性仍然是未满足的临床需求。许多努力致力于开发新药来克服含有 C797S 的 EGFR 三重突变（L858R/T790M/C797S 或 Del19/T790M/C797S），目前这一领域已经取得了令人瞩目的进展，在此不做赘述。参考：1.上海艾力斯2023年年报，2024年一季报.2. https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d3.Lu X, Yu L, Zhang Z, et al. Targeting EGFRL858R/T790M and EGFRL858R/T790M/C797S resistance mutations in NSCLC: Current developments in medicinal chemistry[J]. Medicinal research reviews, 2018, 38(5): 1550-1581.声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

财报临床3期上市批准申请上市

2024-04-25

·BiG生物创新社

ASCO 2024丨这些中国临床专家，将分享最新重磅研究

2024年美国临床肿瘤学会(ASCO)年会将于5月31日到6月4日在芝加哥举办，是世界上规模最大、学术水平最高、最具权威性的临床肿瘤学会议，会议汇集了全球肿瘤学医生和专业人士、患者倡导者、工业界代表和主要媒体，共同探讨当前国际最前沿的研究发现和临床试验成果。ASCO成立于1964年,是世界上最大、最具影响力的肿瘤专业学术组织,致力于癌症的预防、治疗及改善对患者的护理。ASCO在全球150多个国家和地区拥有超过45,000名成员。4月24日晚，ASCO官网公布了本次大会的研究标题，几十余名中国专家将在世界舞台上展示其研究成果，报告涵盖了多个瘤种的最新治疗策略和技术，展示了中国在全球癌症研究中的重要地位和贡献。世易编辑团队精心整理了中国专家们的研究报告，供您参考。全体大会报告Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study. Abstract: LBA4 · Suresh S. Ramalingam教授，美国埃默里大学Winship癌症研究所· 陆舜教授，上海交通大学附属胸科医院口头报告Lung Cancer—Non-Small Cell MetastaticSacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. Abstract: 8502 · 方文峰教授，中山大学肿瘤防治中心 Ivonescimab combined with chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor treatment (HARMONi-A): A randomized, double-blind, multi-center, phase 3 trial. Abstract: 8508 · 张力教授，中山大学肿瘤防治中心 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Adjuvant icotinib of 12 months or 6 months versus observation following adjuvant chemotherapy for resected EGFR-mutated stage II–IIIA non-small-cell lung cancer (ICTAN, GASTO1002): A randomized phase 3 trial. Abstract: 8004 ·王思愚教授，中山大学肿瘤防治中心 A phase II randomized trial evaluating consolidative nivolumab in locally advanced non-small cell lung cancer post neoadjuvant chemotherapy plus nivolumab and concurrent chemoradiotherapy (GASTO-1091). Abstract: 8008 · 刘慧教授，中山大学肿瘤防治中心 Taiwan national lung cancer early detection program for heavy smokers and non-smokers with family history of lung cancer. Abstract: 8009 · Pan-Chyr Yang, MD, PhD，台湾大学医学院 Gastrointestinal Cancer—Colorectal and Anal Neoadjuvant treatment of IBI310 (anti-CTLA-4 antibody) plus sintilimab (anti-PD-1 antibody) in patients with microsatellite instability-high/mismatch repair-deficient colorectal cancer: Results from a randomized, open-labeled, phase Ib study. Abstract: 3505 · 徐瑞华教授，中山大学肿瘤防治中心 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Phase I study of CN201, a novel CD3xCD19 IgG4 bispecific antibody, in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Abstract: 6505 · 王迎教授，中国医学科学院血液病医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia CLAMP: A phase II prospective study of camrelizumab combined with pegaspargase, etoposide, and high-dose methotrexate in patients with natural killer (NK)/T-cell lymphoma. Abstract: 7002 · 刘涛教授，华中科技大学同济医学院附属协和医院 Tucidinostat plus R-CHOP in previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2: An interim analysis from the phase III DEB study. Abstract: LBA7003 · 赵维莅教授，上海交通大学医学院附属瑞金医院 Hematologic Malignancies—Plasma Cell DyscrasiaPhase 3 study results of isatuximab, bortezomib, lenalidomide, and dexamethasone (Isa-VRd) versus VRd for transplant-ineligible patients with newly diagnosed multiple myeloma (IMROZ). Abstract: 7500 ·Thierry Facon, MD，University of Lille, CHU Lille·刘卓刚教授，中国医科大学附属盛京医院Central Nervous System Tumors Efficacy and safety of the vebreltinib in patients with previously treated, secondary glioblastoma/IDH mutant glioblastoma with PTPRZ1-METFUsion GENe (FUGEN): A randomised, multicentre, open-label, phase II/III trial. Abstract: 2003 · Zhaoshi Bao, MD, PhD，首都医科大学附属北京天坛医院 High-dose almonertinib in treatment-naïve EGFR-mutated NSCLC with CNS metastases: Efficacy and biomarker analysis. Abstract: 2007 · 范云教授，浙江省肿瘤医院 SarcomaUpdated efficacy results of olverembatinib (HQP1351) in patients with tyrosine kinase inhibitor (TKI)-resistant succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST) and paraganglioma. Abstract: 11502 · 邱海波教授，中山大学肿瘤防治中心 Sintilimab, doxorubicin and ifosfamide (AI) as first-line treatment in patients with advanced undifferentiated pleomorphic sarcoma (UPS), synovial sarcoma (SS), myxoid liposarcoma (MLPS) and de-differentiated liposarcoma (DDLPS): A single-arm phase 2 trial. Abstract: 11505 · 罗志国教授，复旦大学附属肿瘤医院 ARTEMIS-002: Phase 2 study of HS-20093 in patients with relapsed or refractory osteosarcoma. Abstract: 11507 · 谢璐教授，北京大学人民医院 Head and Neck Cancer Adjuvant PD-1 blockade with camrelizumab in high-risk locoregionally advanced nasopharyngeal carcinoma (DIPPER): A multicenter, open-label, phase 3, randomized controlled trial. Abstract: LBA6000 · 刘需教授，中山大学肿瘤防治中心 Tislelizumab versus placebo combined with induction chemotherapy followed by concurrent chemoradiotherapy and adjuvant tislelizumab or placebo for locoregionally advanced nasopharyngeal carcinoma: Interim analysis of a multicenter, randomized, placebo-controlled, double-blind, phase 3 trial. Abstract: 6001 · 陈秋燕教授，中山大学肿瘤防治中心 Endostar combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone for locoregionally advanced nasopharyngeal carcinoma (LA-NPC): A phase III, prospective, randomised-controlled, multicenter clinical trial. Abstract: 6002 · 康敏教授，广西医科大学第一附属医院 Developmental Therapeutics—ImmunotherapyClaudin18.2-targeted chimeric antigen receptor T cell-therapy for patients with gastrointestinal cancers: Final results of CT041-CG4006 phase 1 trial. Abstract: 2501 · 齐长松教授，北京大学肿瘤医院 A potential best-in-class BCMA-CD19 bispecific CART with advanced safety by self-inhibiting IFNG signaling during CRS. Abstract: 2502 · Lei Xue Efficacy and safety of LM-108, an anti-CCR8 monoclonal antibody, in combination with an anti-PD-1 antibody in patients with gastric cancer: Results from phase 1/2 studies. Abstract: 2504 · Chang Liu, MD，北京大学肿瘤医院Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Phase I/II first-in-human study to evaluate the safety and efficacy of tissue factor-ADC MRG004A in patients with solid tumors.Abstract: 3002· Wungki Park, MD, MS，美国纪念斯隆凯瑟琳癌症中心· 张剑教授，复旦大学附属肿瘤医院Updated safety and efficacy data of combined KRAS G12C inhibitor (glecirasib, JAB-21822) and SHP2 inhibitor (JAB-3312) in patients with KRAS p.G12C mutated solid tumors. Abstract: 3008 · 赵军教授，北京大学肿瘤医院快速口头摘要报告 Lung Cancer—Non-Small Cell Metastatic A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon 20 insertion mutations: Primary analysis of WU-KONG1 study. Abstract: 8513 · James Chih-Hsin Yang 教授，台大肿瘤中心 Efficacy and safety of taletrectinib in patients with advanced or metastatic ROS1+ non–small cell lung cancer: The phase 2 TRUST-I study. Abstract: 8520 · 李玮教授，同济大学附属上海市肺科医院 Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Overall survival of adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer. Abstract: 8014 · 陈大卫教授，山东省肿瘤医院 Breast Cancer—Metastatic ACE-Breast-02: A pivotal phase II/III trial of ARX788, a novel anti-HER2 antibody-drug conjugate (ADC), versus lapatinib plus capecitabine for HER2+ advanced breast cancer (ABC). Abstract: 1020 · 胡夕春教授，复旦大学附属肿瘤医院 Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of cadonilimab in combination with pulocimab and paclitaxel as second-line therapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer who failed immunochemotherapy: A multicenter, double-blind, randomized trial. Abstract: 4012 · 张小田教授，北京大学肿瘤医院 Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC). Abstract: 4019 · 章琦教授，浙江大学医学院附属第一医院肝胆胰外科 Gastrointestinal Cancer—Colorectal and Anal Total neoadjuvant treatment with long-course radiotherapy versus concurrent chemoradiotherapy in local advanced rectal cancer with high risk factors (TNTCRT): A multicenter, randomized, open-label, phase 3 trial. Abstract: LBA3511 · Xin Wang, MD，四川大学华西医院 Phase I trial of hypoxia-responsive CEA CAR-T cell therapy in patients with heavily pretreated solid tumor via intraperitoneal or intravenous transfusion. Abstract: 3514 · Hangyu Zhang，浙江大学医学院第一附属医院 Three-year disease-free survival after transanal vs. laparoscopic total mesorectal excision for rectal cancer (TaLaR): A randomized clinical trial. Abstract: 3516 · 康亮教授，中山大学附属第六医院 Genitourinary Cancer—Kidney and Bladder Camrelizumab plus apatinib for previously treated advanced adrenocortical carcinoma: A single-arm, open-label, phase 2 trial. Abstract: 4511 · Zhigong Wei，四川大学华西医院 Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant Latest results of a phase 2 study of IMM01 combined with azacitidine (AZA) as the first-line treatment in adults with higher risk myelodysplastic syndromes (MDS). Abstract: 6510 · Wei Yang，中国医科大学附属盛京医院 Safety and efficacy of CD7-CAR-T cell in patients with relapsed/refractory T-lymphoblastic leukemia/lymphoma: Phase I dose-escalation/dose-expansion study. Abstract: 6515 · Lijuan Hu, MD, 北京大学人民医院 Hematologic Malignancies—Plasma Cell Dyscrasia OriCAR-017, a novel GPRC5D-targeting CAR-T, in patients with relapsed/refractory multiple myeloma: Long term follow-up results of phase 1 study (POLARIS). Abstract: 7511 · Shan Fu，浙江大学医学院附属第一医院 Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia Timdarpacept (IMM01) in combination with tislelizumab in prior anti-PD-1 failed classical Hodgkin lymphoma: An open label, multicenter, phase II study (IMM01-04) evaluating safety as well as preliminary anti-tumor activity. Abstract: 7017 · Zhenjiu Wang, MD Gynecologic Cancer Efficacy and safety of sintilimab plus paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer: A phase II trial. Abstract: 5512 ·刘继红教授，中山大学肿瘤防治中心 Nimotuzumab plus concurrent chemoradiotherapy for locally advanced cervical squamous cell carcinoma: The randomized, phase 3 CC3 study. Abstract: 5514 ·王俊杰教授，北京大学第三人民医院 A phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer (SCORES). Abstract: LBA5516 · 袁光文教授，中国医学科学院肿瘤医院 Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): A final overall survival analysis of a multicenter, open-label, randomized, phase 3 trial. Abstract: 5520 · 臧荣余教授，复旦大学附属中山医院 Head and Neck Cancer Preliminary results of phase I/II study to evaluate safety and efficacy of combination pucotenlimab with epidermal growth factor receptor-ADC (EGFR-ADC) MRG003 in patients with EGFR positive solid tumors. Abstract: 6013 · 阮丹云教授，中山大学肿瘤防治中心 Covalent FAPI PET enables accurate management of medullary thyroid carcinoma: a prospective single-arm comparative clinical trial. Abstract: LBA6018 · Ziren Kong, MD, 中国医学科学院北京协和医学院 Sarcoma A phase II study of anlotinib and an anti-PDL1 antibody in patients with alveolar soft part sarcoma: Results of expansion cohorts. Abstract: 11515 · 刘佳勇教授，北京大学肿瘤医院 Phase 1 study of NB003, a broad-spectrum KIT/PDGFRα inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST). Abstract: 11518 · 李健教授，北京大学肿瘤医院 Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Results of a phase 1/2 study of MHB088C: A novel B7H3 antibody-drug conjugate (ADC) incorporating a potent DNA topoisomerase I inhibitor in recurrent or metastatic solid tumors. Abstract: 3012 · 沈琳教授，北京大学肿瘤医院 9MW2821, a nectin-4 antibody-drug conjugate (ADC), in patients with advanced solid tumor: Results from a phase 1/2a study. Abstract: 3013 · 张剑教授，复旦大学附属肿瘤医院 Developmental Therapeutics—Immunotherapy Phase I study of GUCY2C CAR-T therapy IM96 in patients with metastatic colorectal cancer. Abstract: 2518 · 齐长松教授，北京大学肿瘤医院 Safety and preliminary efficacy results of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with solid tumors and gastric or gastro-esophageal tumors: A phase 1 dose escalation and expansion study. Abstract: 2519 · 郑莉教授，四川大学华西医院 Symptom Science and Palliative Care Effect of nurse-led multi-disciplinary treatment on patients with head and neck tumors: A randomized controlled trial. Abstract: 12013 · Jingjing Wang, MD，四川大学华西医院肿瘤中心临床科学研讨会A phase 1/2 study of the TORC1/2 inhibitor onatasertib combined with toripalimab in patients with advanced solid tumors: Cervical cancer cohort. Abstract: 5509 · Hui Xie，德琪医药有限公司临床研发部 KRYSTAL-12: Phase 3 study of adagrasib versus docetaxel in patients with previously treated advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. Abstract: LBA8509 · Tony S. K. Mok 教授，香港大学 Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. Abstract: 104 · 樊英教授，中国医学科学院肿瘤医院 Efficacy of disitamab vedotin (RC48) plus tislelizumab and S-1 as first-line therapy for HER2-overexpressing advanced stomach or gastroesophageal junction adenocarcinoma: A multicenter, single-arm, phase II trial (RCTS). Abstract: 4009 · 刘联教授，山东大学齐鲁医院 A novel and uniquely designed bispecific antibody (LBL-024) against PD-L1 and 4-1BB in patients with advanced malignant tumors and neuroendocrine carcinoma: A report of safety and robust efficacy of LBL-024 monotherapy in phase I/II, first-in-human, open-label, multicenter, dose escalation/expansion study. Abstract: 4010 · 张盼盼医生，北京大学肿瘤医院 Safety and efficacy of IBI389, an anti-CLDN18.2/CD3 bispecific antibody, in patients with advanced pancreatic ductal adenocarcinoma: Preliminary results from a phase 1 study. Abstract: 4011 · 郝继辉教授，天津医科大学肿瘤医院 Neoadjuvant sintilimab and platinum-doublet chemotherapy followed by transoral robotic surgery for HPV-associated resectable oropharyngeal cancer: Single-arm, phase II trial. Abstract: 6011 · 宋明教授，中山大学肿瘤防治中心 BiG 十周年预告本次BiG十周年庆典，将首次分为国内和国际篇章，以原创科学和临床需求为出发点，讨论创新技术平台和创新疗法（PROTACT/分子胶、双抗/ADC、siRNA/ASO、CGT、AI制药）的重大进展和发展前景，十年一药曙光现，大浪淘沙始见金！▼报名参会会议门票：审核制(免费)；含主论坛+分论坛，不含餐；优先biotech/Pharma、临床、院校科学家共建Biomedical创新生态圈！如何加入BiG会员？

ASCO会议临床结果

100 项与甲磺酸阿美替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

适应症	最高研发状态	国家/地区	公司
非小细胞肺癌	申请上市	欧盟更多	EQRx International, Inc. 更多
转移性非小细胞肺癌	临床3期	中国更多	江苏豪森药业集团有限公司更多
EGFR突变的非小细胞肺癌	临床3期	中国更多	江苏豪森药业集团有限公司更多
非小细胞肺癌Ⅰ期	临床2期	中国更多	江苏豪森药业集团有限公司更多
肝病	临床1期	美国更多	EQRx International, Inc. 更多

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESMO_ELCC2024 人工标引	N/A	EGFR突变的非小细胞肺癌辅助 EGFR Mutation	136	Aumolertinib (EGFRm)	顧願鹽壓顧鬱蓋齋觸襯(壓夢鹽積膚構衊顧鬱簾) = 膚繭遞觸鹽餘襯艱鬱襯膚觸淵積糧鹹觸鑰襯膚 (憲積鹽選鹹簾膚糧夢蓋 ) 更多	积极	2024-03-22
				Aumolertinib (EGFRm)	壓壓壓範鹹餘選構築鑰(網鏇襯製膚襯襯鏇範鏇) = 築齋淵餘願構選觸繭襯窪壓顧獵糧壓築憲願餘 (觸繭廠選觸範鏇餘壓簾 )
ESMO_ELCC2024 人工标引	N/A	非小细胞肺癌辅助 EGFR Mutation	290	Aumolertinib 110 mg	廠繭膚選餘觸願鬱鬱範(齋蓋網願繭齋鑰簾網願) = 糧衊鏇繭醖選膚製膚範簾鹽壓膚艱衊壓鹹餘鏇 (蓋齋鬱繭獵鬱醖糧糧糧 ) 更多	积极	2024-03-20
ChiCTR2000040590 (ADVANCE, ESMO_ELCC2024) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Mutation	40	aumolertinib+Radiotherapy	鬱鏇積憲簾鬱憲鏇糧襯(鏇窪醖夢壓簾醖衊膚鏇) = 衊製簾獵鹹窪製淵壓遞餘衊齋鹽鹹壓網廠衊簾 (壓鬱鹽選襯觸窪齋選衊 ) 更多	积极	2024-03-20
				Radiotherapy+Cisplatin+Pemetrexed	鬱鏇積憲簾鬱憲鏇糧襯(鏇窪醖夢壓簾醖衊膚鏇) = 網鑰網膚鑰蓋遞願鏇廠餘衊齋鹽鹹壓網廠衊簾 (壓鬱鹽選襯觸窪齋選衊 ) 更多
ADAURA (ESMO_ASIA2023)	N/A	EGFR突变的非小细胞肺癌辅助 TP53	91	Aumolertinib 110 mg	鹽壓顧憲範範築衊觸鏇(淵獵範簾齋選糧夢醖範) = No grade≥3 adverse events occurred. The common adverse events were mild rash and diarrhea. No pts withdrew from therapy due to adverse drug reactions. 觸網窪齋廠遞鹹構鏇糧 (繭鏇壓蓋積艱蓋醖築蓋 )	-	2023-12-02
AENEAS study (ESMO_ASIA2023)	临床3期	EGFR突变的非小细胞肺癌二线 EGFR+	88	Aumolertinib	顧夢鬱廠選夢網鏇顧鬱(齋鹹簾壓齋淵願遞鏇簾) = 顧構願獵範廠築築淵網繭鹹餘淵製築遞顧製鑰 (艱積廠築選鹽憲鹹築齋 )	-	2023-12-02
NCT03849768 (AENEAS, ESMO2023) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Mutation	-	Aumolertinib	壓淵蓋鑰鬱窪積膚簾範(獵簾製夢襯淵範襯選構) = 醖淵範選衊繭簾鹹構壓獵築夢壓製齋願鹹鏇衊 (獵憲觸鑰廠築顧願夢餘 )	积极	2023-10-23
				Gefitinib	壓淵蓋鑰鬱窪積膚簾範(獵簾製夢襯淵範襯選構) = 鏇艱網簾鑰壓襯憲繭鑰獵築夢壓製齋願鹹鏇衊 (獵憲觸鑰廠築顧願夢餘 )
ChiCTR2100047453 (ESMO 12023 \| ESMO 22023) 人工标引	临床3期	EGFR突变的非小细胞肺癌一线 EGFR L858R \| EGFR Exon 19 Deletion	98	Aumolertinib+apatinib	廠製糧簾遞蓋艱鏇簾選(糧膚鬱蓋遞簾築壓願衊) = PFS has beneficial trend in AUM + APA arm 範壓願鏇願淵齋製齋齋 (鹽鑰簾鹹窪淵醖鑰獵築 ) 更多	积极	2023-10-20
				Aumolertinib
WCLC2023 人工标引	临床1/2期	EGFR突变的非小细胞肺癌一线 EGFR Mutation	24	Aumolertinib+Icotinib	積衊鏇繭構齋獵鹹廠遞(鹽廠簾衊積膚遞糧憲構) = aumolertinib 110 mg po qd plus icotinib 125mg po tid 鏇鬱範鏇鹹鑰範積積醖 (構遞築積顧願簾膚鬱淵 ) 更多	积极	2023-09-11
WCLC2023 人工标引	临床2期	肺癌脑转移一线 EGFR-positive	39	Aumolertinib+Anlotinib	願鹹壓憲獵築構範繭夢(壓遞鹹齋窪鹹遞選憲衊) = 膚製獵繭壓簾膚醖艱製醖鏇顧壓積憲願窪膚網 (艱憲衊窪窪範積糧壓遞, 91.0 ~ 100) 更多	积极	2023-09-10
				Aumolertinib+Anlotinib (patients with multiple brain metastases)	艱艱壓鬱窪壓餘鏇鬱構(鑰顧糧築顧鹹積簾鑰積) = 構餘襯鹹選壓窪鹹齋繭鑰窪窪廠壓壓齋築範鑰 (遞鏇繭餘獵顧衊夢齋夢, 58.90 ~ 90.41)
ALWAYS (WCLC2023) 人工标引	临床2期	EGFR突变的非小细胞肺癌一线 EGFR Mutation	26	Aumolertinib+Anlotinib	構醖艱積觸艱廠觸襯鏇(衊積齋餘鹹製憲餘願夢) = There were no grade ≥3 adverse events occurred during combined treatment, and the most common adverse reactions were rash, pruritus and diarrhea. 築蓋齋膚築襯醖糧選選 (齋餘糧獵顧壓鹽製鏇築 )	积极	2023-09-09
				Aumolertinib+Anlotinib (patients with brain metastases)