Prognosis and Patient-Reported Outcomes of Combined Local Treatments (Radiotherapy and Surgery or Radiotherapy Alone) with Almonertinib and Chemotherapy in EGFR-Mutant Stage III-N3 Non-Small Cell Lung Cancer: A Prospective, Single-Center, Phase II Trial

开始日期2025-01-01

申办/合作机构

辽宁省肿瘤医院（辽宁省肿瘤研究所）

NCT06752408

/ Not yet recruiting临床2期IIT

Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer: a Randomized, Open-label, Non-inferiority Real World Study

This is a multicenter, randomized, open-label, non-inferiority real world study. The study is designed to evaluate the efficacy and safety of Aumolertinib versus Osimertinib in the first-line treatment of patients with EGFR mutated locally advanced or metastatic non-small-cell lung cancer.

开始日期2024-12-17

申办/合作机构

北京协和医院

[+2]

NCT06754930

/ Not yet recruiting临床1/2期

A Multicenter, Open Phase IB/II Clinical Study of Safety, Tolerability, and Efficacy of SHR-1826 in Combination With Other Anti-cancer Treatment in Patients With Non-small Cell Lung Cancer

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.

开始日期2024-12-01

申办/合作机构

苏州盛迪亚生物医药有限公司

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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149

项与甲磺酸阿美替尼相关的文献（医药）

2025-02-01·Journal of the National Comprehensive Cancer Network

Response to EGFR/NTRK/MET Co-Inhibition Guided by Paired NGS in Advanced NSCLC With Acquired EGFR L858R/T790M/C797S Mutations

Article

作者: Shao, Weikang ; Lu, You ; Yang, Xue ; Xue, Jianxin ; Yan, Jiaqi ; Li, Xintong ; Liu, Yuanxin ; Yin, Jie

EGFR tyrosine kinase inhibitors (TKIs) have significantly improved clinical outcomes for patients with non–small cell lung cancer (NSCLC) harboring EGFR-activating mutations. However, resistance to TKI therapy often develops due to secondary EGFR mutations or the activation of bypass signalling pathways. Next-generation sequencing (NGS) can efficiently identify actionable genetic alterations throughout treatment. MET amplification is a well-established off-target resistance mechanism. Additionally, rarer mechanisms, such as NTRK1 gene fusions, have been reported. This report highlights a case of a 58-year-old male diagnosed with bone-metastatic NSCLC harboring the EGFR L858R mutation. After receiving dacomitinib and almonertinib sequentially, plasma-based NGS revealed the emergence of EGFR T790M-trans-C797S mutations, prompting a switch to a combination therapy of almonertinib and gefitinib. Upon disease progression, repeat NGS identified EGFR T790M-cis&trans-C797S mutations and a novel POT1::NTRK3 fusion in the blood. The fusion retained a complete NTRK kinase domain without frameshift variants, making it a target for treatment. Larotrectinib was incorporated into the dual EGFR-TKI regimen, forming a triplet therapy. Although this resulted in grade 3 dermatitis, the condition resolved after discontinuing gefitinib. At multiorgan progression, matched tissue- and plasma-based NGS identified MET amplification. Subsequently, the patient was started on a triple-inhibition regimen targeting EGFR, NTRK, and MET, which achieved a partial response with favorable tolerability. This is the first reported case of a novel, targetable POT1::NTRK3 fusion as a potential off-target mechanism mediating EGFR-TKI resistance, occurring alongside MET amplification in a patient with NSCLC harboring acquired EGFR L858R/T790M/C797S mutations. Concomitant inhibition of EGFR, NTRK, and MET was safe and resulted in a significant response, underscoring the importance of precision medicine guided by matched NGS.

2025-01-01·Journal of Cancer

Third generation vs first generation EGFR-TKIs in the first line treatment for EGFR-mutated locally advanced or metastatic non-small cell lung cancer: a meta-analysis based on randomized controlled trials

Article

作者: Zhang, Wenxiong ; Lin, Xueying ; Chen, Yuan ; Feng, Tanggui ; Qin, Yi ; Hu, Wenjie ; Dong, Taoming

Background: The prevailing belief is that third-generation tyrosine kinase inhibitors (TKIs) targeting the epidermal growth factor receptor (EGFR) (TGET) outperform first-generation EGFR-TKIs (FGET) in managing advanced-stage EGFR-mutated non-small cell lung cancer (NSCLC). However, this standpoint lacks substantiation in evidence-based medicine. Therefore, this meta-analysis was conducted to compare the efficacy and adverse effects (AEs) of these two categories. Methods: We searched seven databases for relevant randomized controlled trials (RCTs), focusing on primary endpoints such as progression-free survival (PFS), overall survival (OS), and central nervous system PFS (CNS-PFS). Additional factors considered included treatment responses and AEs. Results: We analyzed 15 studies from 6 RCTs on six third-generation TKIs: Osimertinib, Lazertinib, Furmonertinib, Aumolertinib, Naquotinib, and Befotertinib. TGET showed better efficacy in PFS (hazard ratio [HR]: 0.55 [0.41, 0.75]), CNS-PFS (HR: 0.48 [0.35, 0.66]), CNS-objective response rate (CNS-ORR, risk ratio [RR]: 1.40 [1.19, 1.65]), and duration of response (DOR, HR: 0.52 [0.38, 0.72]). Most subgroups confirmed the PFS advantage. With longer survival time, the superiority in PFS, OS, and CNS-PFS of TGETs became more evident. Both groups had similar OS (HR: 0.86), ORR, CNS-DOR, total AEs, and grade 3-5 AEs. However, TGETs had more severe AEs (RR: 1.17 [1.02, 1.35]). Additionally, there were more grade 3-4 cases of diarrhea, decreased platelet count, pulmonary embolism, fatigue, decreased neutrophil count, and rash, and fewer grade 3-4 increases in alanine transaminase (ALT) and aspartate transaminase (AST) in the TGET group. The top 5 AEs in the TGET group were diarrhea (36.32%), rash (30.24%), decreased platelet count (29.15%), elevated serum creatinine (23.63%), and decreased white blood cell count (22.02%). Conclusions: Except for Naquotinib, TGETs demonstrate superiority over FGETs in treating EGFR-mutated locally advanced or metastatic NSCLC, showing improved survival and responses. However, the increased incidence of AEs necessitates careful consideration.

2024-12-31·PHARMACEUTICAL BIOLOGY

Optimization of a sensitive and reliable UPLC-MS/MS method to simultaneously quantify almonertinib and HAS-719 and its application to study the interaction with nicardipine

Article

作者: Chen, Dongxin ; Shen, Yuxin ; Chen, Xiaohai ; Liu, Ya-nan ; Xia, Hailun ; Chen, Jie ; Xu, Ren-ai

CONTEXT:

Almonertinib is primarily metabolized by CYP3A4, so it could interact with a variety of drugs metabolized by CYP3A4, leading to the changes of systemic exposure.

OBJECTIVE:

For the purpose of this experiment, an ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) assay with accuracy and simplicity was optimized and fully validated for the simultaneous quantitative determination of almonertinib and its metabolite HAS-719, and drug-drug interactions (DDI) between almonertinib and nicardipine in vivo and in vitro was researched.

MATERIALS AND METHODS:

Detection of analytes was achieved by UPLC-MS/MS coupled with multiple reaction monitoring (MRM) in the positive ion mode with ion transitions of m/z 526.01 → 72.04 for almonertinib, m/z 512.18 → 455.08 for HAS-719 and m/z 447.16 → 128.11 for IS, respectively.

RESULTS:

There was favourable linearity in the 0.5-200 ng/mL calibration range for almonertinib and 0.5-100 ng/mL for HAS-719. The lower limit of quantification (LLOQ) for both analytes was 0.5 ng/mL. The precision, accuracy, stability, matrix effect and extraction recovery required for methodological validation were consistent with the requirements of FDA guideline. Then, the UPLC-MS/MS assay was employed successfully on the interactions of almonertinib and nicardipine in vivo and in vitro. The half-maximal inhibitory concentration (IC₅₀) was 1.19 μM in rat liver microsomes (RLM), where nicardipine inhibited the metabolism of almonertinib with a mixed inhibitory mechanism. In pharmacokinetic experiments of rats, it was observed that nicardipine could significantly alter the pharmacokinetic profiles of almonertinib, including AUC_(0-∞), AUC_(0-t) and C_max, but had no effect on the metabolism of HAS-719.

CONCLUSION:

According to the findings, it was indicated that nicardipine could inhibit the metabolism of almonertinib in vitro and in vivo.

389

项与甲磺酸阿美替尼相关的新闻（医药）

2025-03-10

·Pharma CMC

批件大爆发！刚刚，多款重磅新药获批！辉瑞、艾伯维、阿斯利康、科伦博泰……

刚刚，NMPA发布2025年03月10日药品批准证明文件送达信息，本批次共有133个受理号获批，多款重磅新药获准上市，其中：江苏豪森药业的甲磺酸阿美替尼片新适应症获批上市，用于治疗含铂根治性放化疗后未出现疾病进展的不可切除的局部晚期 EGFR 外显子 19 缺失或外显子 21（L858R）置换突变的 NSCLC。科伦博泰的芦康沙妥珠单抗新适应症获批上市，用于经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI)和含铂化疗治疗失败的局部晚期或转移性EGFR突变非小细胞肺癌成人患者。艾伯维利生奇珠单抗注射液获批上市，用于治疗成人中度至重度克罗恩病。据公开资料显示，这是全球首个获批用于中重度活动性克罗恩病成人患者的白介素-23 抑制剂，也是国内首个拥有随身给药器的白介素-23 抑制剂。利生奇珠单抗最初由勃林格殷格翰研发，2016 年艾伯维获得其开发和全球商业化权益，2019 年 3 月率先在日本获批上市。截至目前，该药已在全球获批多项适应症：克罗恩病、斑块状银屑病、泛发性脓疱型银屑病、红皮病型银屑病和银屑病关节炎等。阿斯利康的度伐利尤单抗注射液新适应症获批上市，本次获批的适应症尚未披露。度伐利尤单抗是一个人源化的PD-L1单克隆抗体，能够阻断PD-L1与PD-1和CD80的结合，从而阻断肿瘤免疫逃逸并解除对免疫反应的抑制。在中国，度伐利尤单抗于2019年12月首次获NMPA批准，用于在接受铂类药物为基础的化疗同步放疗后未出现疾病进展的不可切除、III期非小细胞肺癌患者的治疗；2021年7月，该药获批与依托泊苷联合铂类（卡铂或顺铂）化疗方案联合，用于广泛期小细胞肺癌的一线治疗；2023年11月，度伐利尤单抗获NMPA批准，联合吉西他滨和顺铂用于局部晚期或转移性胆道癌（BTC）成人患者的一线治疗。此外，阿斯利康的本瑞利珠单抗注射液新适应症同日获批上市，适应症同样未披露。本瑞利珠单抗是一款与嗜酸性粒细胞表面表达的IL-5Rα相结合的单克隆抗体。2024年8月，本瑞利珠单抗在国内获批上市，用于治疗严重嗜酸性粒细胞性哮喘（SEA）。辉瑞的埃纳妥单抗（易瑞欧®）获得NMPA附条件批准上市，用于既往接受过至少三种治疗（含一种蛋白酶体抑制剂、一种免疫调节剂和一种抗 CD38 单克隆抗体）的复发或难治性多发性骨髓瘤成人患者的治疗。埃纳妥单抗的一款皮下注射的靶向B细胞成熟抗原（BCMA）和CD3的双特异性抗体。据辉瑞新闻稿披露，埃纳妥单抗在三种药物暴露后的复发或难治性多发性骨髓瘤（RRMM）患者中展现出了深度且持久的疗效，中位无进展生存期长达17.2个月，是目前同类产品中最长的。完整批件信息如下：

上市批准临床3期引进/卖出医药出海

2025-03-10

·Insight数据库

第 3 项！翰森制药「阿美替尼」新适应症获批上市

3 月 10 日，药监局官网显示，翰森制药甲磺酸阿美替尼片新适应症获批上市，用于治疗含铂根治性放化疗后未出现疾病进展的不可切除的局部晚期表皮生长因子受体（EGFR）外显子 19 缺失或外显子 21（L858R）置换突变的非小细胞肺癌（NSCLC）患者（CXHS2400077）。截图来源：药监局官网阿美替尼是翰森制药开发的三代 EGFR-TKI，此前已在国内获批两项适应症，分别为：1）用于二线治疗既往经 EGFR-TKI 治疗进展，且 T790M 突变阳性的局部晚期或转移性 NSCLC 患者；2）一线治疗具有 EGFR 外显子 19 缺失或外显子 21（L858R）置换突变阳性的局部晚期或转移性 NSCLC 成人患者。此次获批是基于 III 期 POLESTAR 研究的临床试验结果。这是一项随机、对照、双盲的 III 期临床研究（CTR20210297），旨在评估甲磺酸阿美替尼对比安慰剂用于含铂根治性放化疗后未出现疾病进展的不可切除的局部晚期 EGFR 突变的 NSCLC 患者治疗的有效性和安全性。主要终点为独立评审委员会评估的无进展生存期（PFS），次要研究终点包括总生存期（OS），中枢神经系统（CNS）进展时间等。 2024 年 9 月，翰森制药在世界肺癌大会上公布了 POLESTAR 研究数据。截至2024 年 2 月 5 日，中国共有 147 例患者入组，其中 94 例分配至阿美替尼组，53 例分配至安慰剂组，可用于疗效评估的分别有 92 例和 50 例患者。中期分析结果显示，与安慰剂相比，阿美替尼显著改善了 PFS（风险比 HR 0.20，95% 置信区间 CI 0.11-0.35；p<0.0001）。阿美替尼组的中位 PFS 为 30.4 个月（95%CI 17.2-未达到），而安慰剂组为 3.8 个月（95%CI 3.7-5.6）。PFS的获益在所有预定义的亚组中保持一致。两组的中位 OS 均未达到（阿美替尼组成熟度为 9.8%，安慰剂组为 6.0%）。安全性方面，没有出现新的风险信号。截图来源：Insight 数据库阿美替尼还有 2 项适应症已申报上市：1）用于具有 EGFR 外显子 19 缺失或外显子 21（L858R）置换突变阳性的 NSCLC 成人患者肿瘤切除术后的辅助治疗；2）联合培美曲塞和铂类化疗药物适用于具有 EGFR 外显子 19缺失或外显子 21（L858R）置换突变的局部晚期或转移性 NSCLC 成人患者的一线治疗。 Insight 数据库显示，目前国内已有 7 款三代 EGFR-TKI 上市，除阿美替尼外，其他为利厄替尼（奥赛康/信达）、瑞厄替尼（圣和药业）、瑞齐替尼（倍而达药业）、贝福替尼（益方生物/贝达药业）、伏美替尼（艾力斯医药）和奥希替尼（阿斯利康）。截图来源：Insight 数据库整理封面来源：企业logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：月牙 PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

临床结果临床3期上市批准CSCO会议申请上市

2025-03-06

·PRNewswire

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准免疫疗法优先审批

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
-	-	L01XE	-

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
EGFR 外显子 19 缺失突变型非小细胞肺癌	中国	江苏豪森药业集团有限公司	2021-12-14
EGFR外显子21替代突变非小细胞肺癌	中国	江苏豪森药业集团有限公司	2021-12-14
EGFR-T790M 突变非小细胞肺癌	中国	江苏豪森药业集团有限公司	2020-03-17

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
非小细胞肺癌	申请上市	欧盟	EQRx International, Inc.	2022-12-02
残留肿瘤	临床3期	中国	江苏豪森药业集团有限公司	2022-06-20
非小细胞肺癌IIIB期	临床3期	中国	江苏豪森药业集团有限公司	2021-04-30
EGFR阳性非小细胞肺癌	临床3期	中国	江苏豪森药业集团有限公司	2021-03-18
EGFR突变的非小细胞肺癌	临床3期	中国	江苏豪森药业集团有限公司	2020-09-14
局部晚期非小细胞肺癌	临床3期	中国	江苏豪森药业集团有限公司	2018-11-26
转移性非小细胞肺癌	临床3期	中国	江苏豪森药业集团有限公司	2018-11-26
非小细胞肺癌Ⅰ期	临床2期	中国	江苏豪森药业集团有限公司	2022-01-14
脑转移瘤	临床2期	中国	江苏豪森药业集团有限公司	2021-07-09
腺鳞癌	临床2期	中国	江苏豪森药业集团有限公司	2021-05-07

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临床结果

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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


ALWAYS (ESMO_ASIA2024) 人工标引	临床2期	EGFR突变的非小细胞肺癌一线 EGFR Mutation	26	Aumolertinib plus Anlotinib	糧製製獵壓構衊艱築製(範齋膚廠鹽積遞襯廠鹽) = 鑰醖壓糧壓齋廠構網築廠衊網繭襯積鏇窪築餘 (鑰鏇憲糧鬱製窪蓋糧齋, 19.8 ~ 23.8) 更多	积极	2024-12-07
				Aumolertinib plus Anlotinib (brain metastases)	壓窪鏇獵築窪廠醖齋簾(鑰蓋觸積獵構鹹築選鏇) = 鏇築選艱艱鏇醖糧鏇衊壓鏇膚衊遞觸網齋廠製 (願憲艱遞鏇餘築鹽夢製, 80.5 ~ 100.00) 更多
ESMO_ASIA2024 人工标引	N/A	肺腺癌二线 EGFR Mutation	1	High-dose Aumolertinib plus Anlotinib	範簾齋遞淵繭衊齋膚鏇(鏇願鑰鏇選網鑰鏇遞製) = 廠夢願顧衊衊觸齋顧淵糧觸顧餘廠齋選淵鏇夢 (選觸衊觸繭壓觸鑰繭選 )	积极	2024-12-07
NCT04354961 (ARISE, ESMO_ASIA2024) 人工标引	临床2期	腺鳞癌 EGFR Mutation	12	Aumolertinib 110 mg	壓夢構積鏇選糧窪壓襯(壓淵觸觸製鏇鹹夢糧淵) = 廠顧夢夢選願製衊膚願窪鬱鏇觸積繭構鏇範艱 (襯遞簾夢選膚鹹網壓構 ) 更多	积极	2024-12-07
				Aumolertinib 110 mg (Exon 19 deletion)	壓夢構積鏇選糧窪壓襯(壓淵觸觸製鏇鹹夢糧淵) = 淵鏇鹹獵壓壓鹽廠製蓋窪鬱鏇觸積繭構鏇範艱 (襯遞簾夢選膚鹹網壓構 ) 更多
ALWAYS (ESMO_ASIA2024) 人工标引	临床2期	EGFR突变的非小细胞肺癌一线	26	Aumolertinib plus Anlotinib	顧積築願積夢衊製鏇廠(餘糧鬱簾簾壓夢襯獵膚) = 願觸襯淵鬱鹹鹽顧觸鬱觸淵繭憲繭糧積顧顧齋 (範構願簾網廠鹽鹹艱齋, 80.4 ~ 99.9) 更多	积极	2024-12-07
				Aumolertinib plus Anlotinib (Intracranial)	顧積築願積夢衊製鏇廠(餘糧鬱簾簾壓夢襯獵膚) = 醖壓糧憲製餘衊鑰鬱選觸淵繭憲繭糧積顧顧齋 (範構願簾網廠鹽鹹艱齋, 50.1 ~ 93.2) 更多
NCT04923906 (AENEAS2, NEWS) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Mutation	-	甲磺酸阿美替尼片联合化疗	選觸壓廠衊範簾鬱簾獵(齋築選淵夢窪願齋夢夢) = 超过2年遞鹽窪艱繭壓鏇壓衊餘 (範觸範鑰夢製鑰鑰憲獵 ) 达到更多	积极	2024-10-22
WCLC2024 人工标引	N/A	EGFR突变的非小细胞肺癌辅助 EGFR positive mutation (19Del or L858R)	113	Aumolertinib 110 mg	獵膚醖選繭襯構範範鏇(網餘築壓獵觸艱餘艱廠) = 24 pts (21.2%) had TRAEs of any grade, such as mild rash and diarrhea. No grade≥3 adverse events occurred. No pts withdrew from therapy due to adverse drug reactions. 蓋壓齋範網餘積願淵選 (膚齋鹹廠鑰廠簾繭蓋憲 )	积极	2024-09-10
NCT04778800 (WCLC2024) 人工标引	N/A	EGFR阳性非小细胞肺癌一线 EGFR Mutation	26	Aumolertinib 110mg	鹽範範衊衊壓膚遞蓋選(鹹夢壓鹽糧醖醖鹹構構) = 淵窪糧積醖顧築鑰構廠獵簾廠構範繭範顧鑰衊 (願餘網網艱選簾網夢衊, 88.8 ~ 100) 更多	积极	2024-09-08
				Aumolertinib 165mg	鹽範範衊衊壓膚遞蓋選(壓積選夢繭壓簾繭蓋蓋) = 鑰襯遞鬱積壓窪窪簾簾選膚構窪衊築衊遞壓鏇 (鏇積顧餘繭網壓遞壓簾 ) 更多
WCLC2024 人工标引	N/A	非小细胞肺癌Ⅰ期 EGFR Mutation	26	Aumolertinib 110mg	顧簾襯網窪遞窪齋製簾(鹹襯繭鑰觸餘鬱構選蓋) = 觸構襯繭夢網遞窪觸願觸夢顧壓觸夢鬱鑰選觸 (繭醖壓獵淵積鏇壓獵範 )	积极	2024-09-07
WCLC2024 人工标引	N/A	EGFR突变的非小细胞肺癌一线 EGFR Mutation	16	Aumolertinib 110mg	餘選網遞憲醖築構襯製(憲範鹹夢衊齋觸鏇艱積) = 齋鏇齋選網繭簾網願繭選衊鹹齋壓憲餘觸鬱顧 (壓製獵遞膚網憲鹽鹽願 ) 更多	积极	2024-09-07
				Aumolertinibradiotherapy (WBRT)	餘選網遞憲醖築構襯製(憲範鹹夢衊齋觸鏇艱積) = 醖糧簾齋鏇範齋鏇鹽觸選衊鹹齋壓憲餘觸鬱顧 (壓製獵遞膚網憲鹽鹽願 ) 更多
WCLC2024 人工标引	N/A	EGFR突变的非小细胞肺癌一线 EGFR Exon 19 Deletion \| EGFR L858R \| EGFR Mutation	94	Aumolertinib + Platinum-Pemetrexed Chemotherapy	膚夢遞醖廠構憲獵築蓋(製鏇窪鹽窪齋構觸鑰艱) = 顧齋壓鏇範淵鬱壓衊蓋艱齋窪艱構遞選簾襯壓 (構鹽廠鏇製願簾淵齋憲 ) 更多	积极	2024-09-07
				Aumolertinib + Platinum-Pemetrexed Chemotherapy (EGFR exon 19 deletion)	餘壓築廠遞廠簾蓋築鑰(壓選鏇製衊窪積範遞蓋) = 積範鹽壓鏇襯遞糧觸憲艱選鑰築鏇窪鑰鏇憲簾 (鏇積夢選網顧鏇鹽願窪 )