A Phase 2, Open-Label, Randomized, Global Study of Two Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

开始日期2025-01-20

申办/合作机构

AbbVie, Inc.

NCT06093503

/ Withdrawn临床3期

Phase 3, Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Combined With Osimertinib vs Platinum-Based Chemotherapy in Subjects With c-Met Overexpressing (OE) EGFR Mutant, Locally Advanced/Metastatic Non-Squamous NSCLC After a First Progression on Prior Third Generation EGFR TKi Treatment

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how telisotuzumab vedotin in combination with osimertinib affects the disease state compared to standard of care in adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the epidermal growth factor receptor (EGFR) gene and that overexpresses the c-Met protein. Change in disease activity will be assessed.
Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC that overexpresses the c-Met protein. Participants are randomly placed in one of the two groups to receive telisotuzumab vedotin and osimertinib or standard of care chemotherapy. Approximately 250 adult participants with locally advanced/metastatic non-squamous NSCLC that has a mutation in the EGFR gene and that overexpresses the c-Met protein will be enrolled in the study in approximately 180 sites worldwide.
Participants will receive intravenous telisotuzumab vedotin every 2 weeks in combination with oral osimertinib tablets daily or standard of care chemotherapy (carboplatin/pemetrexed or cisplatin/pemetrexed as prescribed by the physician). Overall duration of the study is estimated to be approximately 47 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

开始日期2024-05-31

申办/合作机构

AbbVie, Inc.

CTR20221935

/ Recruiting临床3期

一项比较Telisotuzumab Vedotin（ABBV-399）和多西他赛治疗既往接受过治疗的c-Met过表达、EGFR野生型、局部晚期/转移性非鳞状非小细胞肺癌受试者的3期开放、随机、对照、全球研究

主要目的是确定与多西他赛治疗相比，telisotuzumab vedotin是否能够改善以下人群的无疾病进展生存期（PFS）和/或总生存期（OS）： - c-Met高度过表达、EGFR野生型、非鳞状NSCLC受试者和 - 所有c-Met过表达、EGFR野生型、非鳞状NSCLC受试者次要目的是确定： -客观缓解率（ORR）； -缓解持续时间（DoR）； -根据研究者评估的无疾病进展生存期（PFS）； -通过EORTC-QLQ-C30的总体健康状况/生存质量领域测量的第12周时生存质量相对于基线的变化； -通过EORTC QLQ-核心30（EORTC QLQ-C30）的身体功能领域测量的第12周时身体功能相对于基线的变化； -安全性和耐受性。

开始日期2023-04-21

申办/合作机构

BSP Pharmaceuticals SpA

[+2]

100 项与 Telisotuzumab vedotin 相关的临床结果

登录后查看更多信息

100 项与 Telisotuzumab vedotin 相关的转化医学

登录后查看更多信息

100 项与 Telisotuzumab vedotin 相关的专利（医药）

登录后查看更多信息

582

项与 Telisotuzumab vedotin 相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

作者: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

2025-04-01·BIOORGANIC & MEDICINAL CHEMISTRY

Fine-tuning phenoxy silyl scaffolds for the development of glutathione-responsive prodrugs and antibody–drug conjugates

Article

作者: Qi, Cheng ; Jiang, Yuecheng ; Yu, Xianqiang ; Chen, Hongli ; Wei, Ding ; Wang, Huihui ; Huangfu, Shangwei ; Jiang, Biao

Silyl ether is particularly attractive for application in drug development for its easy preparation, non-toxicity and remarkable biocompatibility. Earlier studies relied on the use of intracellular acidic conditions to induce the cleavage of alkoxy silyl ethers. However, acidic conditions are not suitable to trigger the release of phenoxy silyl ethers, since they are more stable under acidic conditions compared with neutral conditions. We explored the vulnerability of the phenoxy silyl ether towards biological nucleophilic reagents and found that glutathione (GSH) could effectively and selectively induce the cleavage of phenoxy silyl ether. We also demonstrated that the rate of cleavage was controllable by adjusting the substituents on the phenyl ring. Phenoxy silyl ether-based prodrugs and antibody-drug conjugates (ADCs) were designed and synthesized, which could be effectively activated in cells with high GSH levels and there was an obvious therapeutic window between cells with different GSH levels.

2025-02-19·BIOCONJUGATE CHEMISTRY

A Unique Prodrug Targeting the Prostate-Specific Membrane Antigen for the Delivery of Monomethyl Auristatin E

Article

作者: Bomba, Hunter N. ; Langton-Webster, Beatrice ; Fulton, Melody D. ; Berkman, Clifford E. ; Savoy, Emily A.

Monomethyl auristatin E (MMAE) is a promising treatment option for patients diagnosed with prostate cancer (PCa); however, toxicities prevent MMAE from being administered as free drug. No MMAE-based treatment is currently marketed for PCa. Herein, we describe a small-molecule-drug conjugate, CTT2274, for the selective delivery of MMAE. CTT2274 is composed of a prostate-specific membrane antigen (PSMA)-binding scaffold, a biphenyl motif, a pH-sensitive phosphoramidate linker, and MMAE payload. We demonstrate that CTT2274 shows selective binding to PSMA, which is overexpressed on PCa cells, and induces tumor cell death in vitro. In a patient-derived xenograft tumor model of PCa in mice, we show that weekly intravenous dosing of CTT2274 at 3.6 mg/kg for six weeks is superior to treatment with free MMAE at equivalent doses. Mice treated with CTT2274 experienced prolonged tumor suppression and significantly greater overall survival than mice treated with PBS. Additionally, the safety of CTT2274 compared to an equivalent dose of MMAE was assessed in healthy, non-tumor-bearing mice. Our results demonstrate that CTT2274 therapy is as efficacious as MMAE, results in superior overall survival, and has a more favorable safety profile. Together, these data indicate that CTT2274 is a candidate for clinical translation for the treatment of PCa.

102

项与 Telisotuzumab vedotin 相关的新闻（医药）

2025-03-29

·医药速览

橙帆医药（VelaVigo）ADC管线

橙帆医药（VelaVigo）成立于2021年10月，聚焦大分子相关的新技术，包括双抗/多抗，ADC和新分子类型。已经建立十余个首创/最佳（FIC/BIC）多特异性抗体和ADC分子的广泛研发管线，聚焦于肿瘤学和自身免疫疾病等领域。2024年11月18日橙帆医药将获得高达5000万美元的首付款及近期里程碑付款。此外，在达成开发、监管审批及销售的关键里程碑后，公司有望再获得高达7.5亿美元的后续里程碑付款，并根据 Avenzo区域的销售情况获取分级特许权使用费。橙帆医药（VelaVigo）ADC管线就两条，就卖出去一条，转化率还是很高的。VBC101-F11VBC101-F11是一种双特异性抗EGFR/cMet ADC，毒素与抗体的比例（DAR）为4。2024 AACR上面公布了部分临床前研发数据。 EGFR和cMet是两种在实体瘤中经常共同高表达的经典生长因子受体，而在正常组织中仅以中等水平表达。除了它们的共同表达模式外，它们在途径中的异常或过度表达与肿瘤发生有关。值得注意的是，MET途径的激活，无论是通过增加cMet表达还是其配体，通常与对EGFR酪氨酸激酶抑制剂（TKI）的耐药性相关。因此，EGFR和cMet之间的相互作用，以及它们在肿瘤与正常组织中的差异表达，为针对这两个受体的双特异性方法提供了理论依据，以增强肿瘤特异性。 VBC101-F11具有低亲和力的EGFR臂和高亲和力的cMet臂。结合低亲和力的EGFR臂增强了结合亲和力和内化，与仅针对cMet的ABBV-399相比，IC50提高了5倍，从而实现了卓越的细胞毒性。这种微妙的EGFR臂设计确保了在正常组织中减少与EGFR相关的非靶向毒性。 cMet臂的双特异性设计进一步强调了战略合理性，通过展示在结合、内化和功能性阻断方面的协同效应，与针对单一表位的单特异性亲本抗体相比，EC50提高了10倍。这确保了VBC101-F11在肿瘤细胞中的最大疗效。VBC101-F11的创新纳米抗体格式使我们的分子与众不同。在小鼠模型中的活体成像数据显示，VBC101-F11（90kD）在1小时至90小时以上实现了优于150kD的mAb ABBV399和双特异性抗体AZD9592的肿瘤穿透和积累。VBC101-F11在压力测试中表现出卓越的分子可开发性，特别是在人和非人灵长类动物（NHP）血浆中，抗体组分和整个ADC分子都显示出显著的稳定性，使VBC101-F11成为未来化学、制造和控制（CMC）开发的可行候选物。整体来看，该ADC是为了验证他们做的纳米双抗做成ADC的可行性，他们用VBC101-F11偶联MMAE弹头的ADC跟相同弹头的ABBV-399体内药效有一定优势（TGI为60%，而MMAE偶联ADC ABBV-399为17%）；用VBC101-F11偶联TOP1i弹头的ADC跟同类型弹头的AZD9592的体内活性相当。VBC-103 VBC103是一款靶向Trop2/Nectin4的双特异性抗体偶联药物，目前处于临床前阶段,是该靶点的第一个ADC,拟用于治疗膀胱尿路上皮癌 (UC)、三阴性乳腺癌 (TNBC) 等。VBC101-F11和VBC103抗体均采用VHH-Fc融合蛋白设计，分子量小，可以提高肿瘤组织的渗透和聚集，VBC103 Ab（90kD）分子量小于一般抗体（150kD）。TROP2 Arm中等Affinity，Nectin-4 Arm中等Affinity高Avidity，利用双抗的协同效应来提高结合、內吞和毒性，同时降低Nectin-4和TROP2靶点介导的正常组织的副作用；Paylaod采用TOPO1i，具有强旁观者效应。宽治疗窗口（TW），在猕猴中进行的初步毒性研究表明，VBC103的重复剂量（18和36 mpk）显示出良好的耐受性，这相当于IgG1 ADC的30和60 mpk。这些发现可能建立了一个大于10的治疗窗口（HNSTD/MED）。橙帆的两个ADC: cMET/EGFR靶向VBC101-F11和TROP2/Nectin-4靶向VBC103均采用VHH-Fc融合蛋白形式的双抗，cMET/EGFR目前在研管线众多，VBC101-F11很难脱颖而出，TROP2/Nectin-4靶向的VBC103目前只有一个，有望成为FIC，所以Avenzo Therapeutics眼疾手快收入囊中。 cMET/EGFR双抗ADC研管线众多推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。有问题可发邮件至yong_wang@pku.edu.cn获取更多信息。©2021 医药速览保留所有权利往期链接“小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记PROTAC技术| 抗体药物| 抗体药物偶联-ADC核酸疫苗 | CAR技术| 化学生物学温馨提示医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群加作者微信（yiyaoxueshu666）或者扫描公众号二维码添加作者，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。简单操作即可星标⭐️医药速览，第一时间收到我们的推送①点击标题下方“医药速览” ②至右上角“...” ③点击“设为星标

抗体药物偶联物引进/卖出AACR会议临床结果

2025-03-12

·Antibody Research

新锐ADC公司：安领科EGFR/cMET双抗ADC获批临床

中国国家药监局药品审评中心（CDE）官网最新公示，安领科生物申报的1类新药注射用ALK202获批临床，拟用于既往标准治疗失败或无标准治疗（包括无法接受标准治疗）的成人局部晚期或转移性实体瘤。根据官网公开信息，ALK202为安领科旗下第二款临床获批的ADC，为EGFR/cMET双抗ADC。根据clinicaltrials官网，ALK202的一期临床研究旨在晚期实体瘤患者中评估ALK202的安全性、耐受性、药代动力学（PK）和抗肿瘤活性。该研究为国际多中心临床研究，拟在全球范围内入组234名受试者。 2024年9月27日，艾伯维宣布向美国食品药品监督管理局 (FDA) 提交生物制品许可申请 (BLA)，以加速批准 telisotuzumab vedotin (Teliso-V) 用于治疗先前接受过治疗的局部晚期或转移性表皮生长因子受体 (EGFR) 野生型、非鳞状非小细胞肺癌 (NSCLC) 且 cMet蛋白过表达的成年患者。该款药物属于艾伯维cMET MMAE ADC，第二代cMET topoi ADC也已迅速推进至后期临床。 BLA 申请基于2 期 LUMINOSITY 试验研究。结果显示，总人群、c-Met高表达和c-Met中等表达患者经独立中央审查（ICR）评估的总体缓解率分别为28.6%、34.6%和22.9%，中位缓解持续时间（DOR）分别为8.3个月、9.0个月和7.2个月，中位总生存期（OS）分别为14.5个月、14.6个月和14.2个月，中位无进展生存期（PFS）分别为5.7个月、5.5个月和6.0个月。 Teliso-V的安全性与之前的研究结果一致，没有发现新的安全性问题。最常见的任何级别治疗相关不良事件（TRAE）是外周感觉神经病变（30%）、外周性水肿（16%）和疲劳（14%），最常见的≥3级AE是外周感觉神经病变（7%）。三期临床也在开展之中，Teliso-V对比多西他赛二线治疗c-Met蛋白过表达、EGFR野生型晚期/转移性非鳞状NSCLC成人患者的疗效和安全性。新一代TOPOi cMET ADC，ABV-400也已推进至三期临床。迄今为止，针对cMET靶点，只有cMETxEGFR双特异性抗体Amivantamab(RYBREVANT) 获得了 FDA 的批准。先前一些被广泛研究的抗cMET抗体包括 Onartuzumab (MetMab)、Emibetuzumab (LY2875358)、Telituzumab (ABT-700)、Sym015、SAIT301 和 HLX55，都没有太好的临床进展。源于cMET单克隆抗体倾向于诱导激动活性，从而导致肿瘤细胞增殖而不是凋亡。后续迭代抗体通过构建单臂抗体来避免这种情况，从而防止受体二聚化的发生，或者通过发现和进一步铰链区设计不表现出功能性激动剂活性的单克隆抗体，如Telituzumab (ABT-700)。 Telituzumab (ABT-700)来源于Pierre Fabre开发的一款cMet拮抗型（Antagonist）抗体h224G11，在人源化后，发现有激活作用，后又根据母本鼠抗的铰链区和人IgG2铰链区进行工程化设计，多了一对二硫键。ABT-700 结合细胞 c-Met，并破坏其由 HGF 或细胞表面高密度 c-Met 诱导的二聚化和活化，不依赖于配体。大多数二价cMET单抗都有激活作用。这也是后来多数cMET抗体开发为单价的原因。该抗体国内到2029年专利过期，以目前的时间来看，可以使用。 cMET作为肺癌的重要布局靶点，大约 85% 的肺癌被归类为 NSCLC ，尽管治疗取得了一定进步，然而肺癌仍然是全世界男性和女性癌症相关死亡的主要原因。在大约25%的晚期 EGFR 野生型 NSCLC 患者中发现了 c-Met 蛋白过度表达，并且与这些患者的不良预后相关。从基因层面，EGFR，cMET具有很好的相关性，但同时也存在表达差异。也就是说多数情况下，EGFRxcMET ADC并不会差于单抗cMET ADC。当然在EGFR极度不表达的情况下，只有cMET表达，cMET单抗ADC可能会优于EGFRxcMET ADC，反之亦然。从蛋白层面来看，多数情况下EGFR表达优于cMET，双抗ADC可能会更偏向于EGFR驱动药效。不可避免的会迎来这EGFR ADC，EGFRxcMET ADC（二价），cMET ADC的差异性。EGFR ADC在多种肿瘤中可能因EGFR表达优势会占据疗效优势，而EGFRxcMET ADC在于具有广谱性和在某些肿瘤的上两者的协同作用。也就是说需要寻找适合的适应症来发挥这几款药物的真正优势。开发的早，这种寻找优势的对比要求就弱很多，但开发的越晚要求越高。 EGFR，cMET作为优异的靶点，都是ADC领域布局的热门。需要提醒的是，抗体并不能等同于ADC，并不是双抗ADC成功就没有必要开发双抗，也不是双抗成功了也无需开发双抗ADC，这两者的类型和作用机制完全不同。同时开发，也许更能充分的进行细分适应症的布局。因此安领科也开发了EGFR/cMET的双特异抗体。关于EGFR/cMET的双特异抗体，2023年10月26日，强生的埃万妥单抗注射液（Rybrevant/Amivantamab）在国内申报上市申请获得受理。埃万妥单抗是强生旗下的一款EGFR/cMET的双特异抗体。该抗体已经在2021年5月21日获得FDA批准上市，用于治疗铂类化疗后进展、携带EGFR外显子20插入突变的转移性非小细胞肺癌（NSCLC）的患者。在MARIPOSA研究中，针对EGFR外显子19缺失（ex19del）或替代突变局部晚期或转移性NSCLC患者，埃万妥单抗联合lazertinib对比奥希替尼和lazertinib单药一线治疗的疗效。在无进展生存期方面和总生存期方面，埃万妥单抗都表现出具有统计学和临床意义的改善。体现这一双抗的开发价值。 2025年1月7日，强生宣布了3期MARIPOSA研究的癌症治疗金标准终点总生存期 (OS) 的积极顶线结果，该研究评估了 RYBREVANT ® (amivantamab-vmjw) 加 LAZCLUZE™ (lazertinib) 作为表皮生长因子受体 (EGFR) 外显子 19 缺失 (ex19del) 或 L858R 替代突变的局部晚期或转移性非小细胞肺癌 (NSCLC) 患者的一线治疗。无化疗联合方案达到了最终预先指定的 OS 次要终点，并且与目前的标准治疗药物奥希替尼相比，OS 具有临床意义和统计学意义的改善。预计中位 OS 改善将超过一年。但EGFR/cMET双特异抗体，跟EGFR/cMET ADC机制并不相同。EGFR/cMET ADC为靶向化疗，而EGFR/cMET双特异抗体是通过阻断靶点本身的机制，同时引起NK等免疫细胞对肿瘤细胞的杀伤。ADC和抗体，是有明显区别的，在很大程度上并不等同。但同样都具有很大的开发价值。奥希替尼联合化疗一线治疗EGFR突变晚期NSCLC的III期随机临床试验——FLAURA2研究公布临床试验结果，PFS结果显示，无论是经研究者评估还是经BICR评估，奥希替尼联合化疗组的PFS均较奥希替尼单药组延长约9个月。其中，两组经BICR评估的中位PFS分别为29.4个月 vs 19.9个月（HR=0.62；P=0.0002），经研究者评估的中位PFS分别为25.5个月 vs 16.7个月（HR=0.62；P<0.0001），使得疾病进展或死亡风险均降低了38%。安全性结果显示，并未发现新的安全信号，奥希替尼联合化疗整体安全可控。这为后续奥希替尼联合EGFR/cMET ADC提供了一定的理论基础。但双抗在一定程度上具有更高的安全性。而对于后线，奥希替尼（或其他TKI抑制剂）联合EGFR/cMET ADC可能依然有效。也就是说，双抗和双抗ADC联合奥希替尼等TKI抑制剂，根据其机制的不同可以形成序惯治疗。未来第四代EGFR TKI抑制剂，联合EGFR/cMET ADC或EGFR/cMET双抗，也会成为重要趋势。内容来源于网络，如有侵权，请联系删除。

抗体药物偶联物申请上市临床结果

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 Telisotuzumab vedotin 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11344	-	-	DB15104

研发状态

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
c-Met阳性非小细胞肺癌	申请上市	美国	AbbVie, Inc.	2024-09-27
非鳞状非小细胞肺癌	申请上市	美国	AbbVie, Inc.	2024-09-27
局部晚期非鳞状非小细胞肺癌	临床3期	-	AbbVie, Inc.	2024-05-31
局部晚期非小细胞肺癌	临床2期	美国	AbbVie, Inc.	2022-11-21
局部晚期非小细胞肺癌	临床2期	日本	AbbVie, Inc.	2022-11-21
局部晚期非小细胞肺癌	临床2期	澳大利亚	AbbVie, Inc.	2022-11-21
局部晚期非小细胞肺癌	临床2期	法国	AbbVie, Inc.	2022-11-21
局部晚期非小细胞肺癌	临床2期	德国	AbbVie, Inc.	2022-11-21
局部晚期非小细胞肺癌	临床2期	以色列	AbbVie, Inc.	2022-11-21
局部晚期非小细胞肺癌	临床2期	意大利	AbbVie, Inc.	2022-11-21

登录后查看更多信息

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


NCT03539536 (LUMINOSITY, ESMO_ELCC2025)	临床1期	c-Met protein-overexpressing \| EGFR wildtype	172	Telisotuzumab vedotin 1.9 mg/kg	廠艱獵醖襯網顧膚艱網(獵窪獵糧糧齋選觸鬱艱) = 遞淵鹹窪鬱選築鬱醖襯簾簾獵壓範繭顧齋鹹積 (蓋範製廠糧襯積選衊糧 )	积极	2025-03-26
NCT02099058 (Pubmed \| Ann Oncol) 人工标引	临床1期	非小细胞肺癌二线 EGFR Mutation \| MET Overexpression	38	Telisotuzumab vedotin + osimertinib	簾築窪願觸夢夢遞顧鬱(餘廠膚襯製鹽糧齋夢廠) = peripheral sensory neuropathy (50%), peripheral edema (32%), and nausea (24%) 夢淵鑰醖淵遞顧膚鹽製 (鑰範醖醖窪蓋鏇醖鏇鏇 ) 更多	积极	2025-01-01
NCT02099058 (WCLC2024) 人工标引	临床1期	c-Met阳性非小细胞肺癌 MET Overexpression	30	Teliso-v (c-Met-positive tumor cells with 3+ intensity)	膚遞遞壓顧範獵遞遞艱(蓋齋範窪衊憲襯構遞壓) = 願膚窪範窪壓鏇窪襯襯製壓窪艱蓋鏇醖壓衊艱 (襯繭醖繭衊顧餘襯艱積 )	积极	2024-09-09
NCT02099058 (WCLC2024) 人工标引	临床1期	c-Met阳性非小细胞肺癌 MET Overexpression	30	Teliso-v (below (A cutoff value of 25% c-Met-positive tumor cells with 3+ intensity))	膚遞遞壓顧範獵遞遞艱(蓋齋範窪衊憲襯構遞壓) = 糧糧築醖襯鑰醖積積簾製壓窪艱蓋鏇醖壓衊艱 (襯繭醖繭衊顧餘襯艱積 )	积极	2024-09-09
NCT03539536 (LUMINOSITY, Pubmed) 人工标引	临床2期	c-Met阳性非小细胞肺癌 c-Met protein-overexpressing	172	Telisotuzumab vedotin (Teliso-V)	願窪製齋淵糧膚簾鏇鹹(窪獵觸顧膚簾鹹鏇鏇遞) = 顧鏇膚願壓糧選願繭淵鏇鏇構壓選淵製夢淵廠 (選顧壓壓獵鑰憲選憲繭, 21.7 ~ 36.2) 更多	积极	2024-06-06
NCT03539536 (LUMINOSITY, Pubmed) 人工标引	临床2期	c-Met阳性非小细胞肺癌 c-Met protein-overexpressing	172	Telisotuzumab vedotin (c-Met high)	願窪製齋淵糧膚簾鏇鹹(窪獵觸顧膚簾鹹鏇鏇遞) = 衊顧襯鹹築膚遞齋夢製鏇鏇構壓選淵製夢淵廠 (選顧壓壓獵鑰憲選憲繭, 24.2 ~ 46.2) 更多	积极	2024-06-06
NCT03539536 (LUMINOSITY, ASCO2024) 人工标引	临床2期	非小细胞肺癌三线 c-Met protein overexpression	172	Telisotuzumab vedotin (c-Met High)	構壓襯廠願顧鏇艱鹽鬱(蓋鬱遞積鹹艱淵廠鬱憲) = 衊築遞構夢簾襯窪顧鑰襯艱構夢鏇簾醖鹽襯憲 (鏇夢範壓製艱衊選簾齋, 24.2 ~ 46.2) 更多	积极	2024-05-24
NCT03539536 (LUMINOSITY, ASCO2024) 人工标引	临床2期	非小细胞肺癌三线 c-Met protein overexpression	172	Telisotuzumab vedotin (c-Met Int)	構壓襯廠願顧鏇艱鹽鬱(蓋鬱遞積鹹艱淵廠鬱憲) = 積網鹹築壓廠顧廠鹹齋襯艱構夢鏇簾醖鹽襯憲 (鏇夢範壓製艱衊選簾齋, 14.4 ~ 33.4) 更多	积极	2024-05-24
NCT02099058 (ESMO_ASIA2023)	临床1期	EGFR突变的非小细胞肺癌 EGFR-mut \| c-Met overexpressing	41	Telisotuzumab vedotin (Teliso-V) + Osimertinib	獵鹽簾膚淵顧網淵艱製(獵觸齋廠膚艱壓膚膚淵) = 願選膚鬱鏇糧選鑰膚顧鏇構範選製願襯鬱醖鏇 (壓選蓋醖壓廠鑰餘製構 ) 更多	-	2023-12-03
NCT04928846 (TeliMET NSCLC-01, ESMO_ASIA2023)	临床3期	EGFR阳性非鳞状非小细胞肺癌 c-Met overexpressing \| EGFR wildtype	-	Teliso-V	顧襯壓獵廠遞鬱鏇齋憲(餘簾膚範鹹糧艱壓觸遞) = 獵遞鏇壓繭遞夢憲願廠壓積艱顧遞餘網淵壓構 (積鹹鹽憲夢壓膚鬱範齋 ) 更多	-	2023-12-02
NCT03539536 (LUMINOSITY, PRNewswire) 人工标引	临床2期	c-Met阳性非小细胞肺癌 c-MET Amplification	-	Telisotuzumab-vedotin (c-Met High)	憲廠選淵願窪憲築鏇鹽(窪鹹鑰製簾齋廠網鏇獵) = 構齋窪製憲鑰蓋鹹膚鏇夢襯鑰醖艱醖膚憲廠鹽 (淵鬱襯艱淵壓壓廠選衊 ) 更多	积极	2023-11-29
NCT04928846 (TeliMET NSCLC-01, ESMO2023)	临床3期	非鳞状非小细胞肺癌 c-Met overexpressing \| EGFR WT	698	Teliso-V	構淵窪繭繭夢淵糧簾壓(鬱淵淵製憲獵憲襯網齋) = 積鹽觸構鹽鹽構選網襯範積製壓憲積築顧鹹構 (觸壓獵鬱襯壓襯壓鬱鹽, 24 ~ 51)	-	2023-10-23
NCT03539536 (LUMINOSITY, ASCO2023)	临床2期	非小细胞肺癌	52	telisotuzumab vedotin (MET amplification)	壓夢鬱網觸簾選積簾窪(製鑰餘憲鑰繭築蓋襯蓋) = 鑰選衊網鑰鬱醖願糧範觸蓋蓋構鹽衊膚構淵製 (鬱繭醖餘蓋鏇鬱繭簾顧 )	积极	2023-05-31