Phase 1b, Open-label, Dose Escalation and Cohort Expansions Trial ofNaptumomab Estafenatox (NAP, ABR-217620) in Combination withDurvalumab (MEDI4736) in Subjects with Selected Advanced or MetastaticSolid Tumors - 127-CL-01(NT-NAP-101)

开始日期2025-03-17

申办/合作机构

NeoTX Therapeutics Ltd.

[+1]

NCT05894447

/ Withdrawn临床1期IIT

A Phase 1 Trial of Naptumomab Estafenatox (NAP) in Combination With Pembrolizumab (Pembro) Preceded by Obinutuzumab (Obi) in Patients With Urothelial Cancers

The main purpose of this study is to test the safety and tolerability of naptumomab estafenatox (NAP), the planned experimental (investigational) drug, in combination with pembrolizumab following a single pretreatment with Obinutuzumab (Obi), and determine its side effects and effects on urothelial cancer. It is hypothesized that adding NAP will make pembrolizumab more effective. Participants will receive 2 infusions of Obi prior to the treatment of NAP in combination with pembrolizumab. This treatment is given in 21-day cycles for 6 cycles with NAP administered daily for 4 consecutive days, Days 1-4, + pembrolizumab given on day 2 of each cycle. After these six cycles of therapy, participants will continue to receive pembrolizumab every 3 weeks, without NAP, for a total number of up to 34 pembrolizumab administrations since cycle 1. After the treatment of Obi is completed, participants will start NAP in combination with pembrolizumab and continue that treatment in a 28 day cycle period. NAP will be given for a total of 6 cycles and pembrolizumab will be given every 21 days for a total of up to 2 years. After stopping treatment, participants have follow-up visits or phone calls about every 12 weeks until the study is closed.

开始日期2023-11-01

申办/合作机构

Weill Medical College of Cornell University

[+1]

NCT04880863

/ Completed临床2期

Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP) in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 2a Open-Label, Multicenter Trial of Naptumomab Estafenatox (NAP), following Obinutuzumab Pretreatment, on Days -13 and -12. NAP will be administered on Days 1-4 of treatment cycles 1-6, followed by docetaxel on Day 5. Starting cycle 7, NAP at a higher dose will be administered on Day 1 only and docetaxel on Day 2, in 21 days treatment cycles. When NAP is administered as monotherapy and not earlier than cycle 7, NAP will be administered on Day 1 only and cycles will be of 28 days treatment cycle.

开始日期2021-10-26

申办/合作机构

NeoTX Therapeutics Ltd.

[+1]

100 项与他那莫单抗相关的临床结果

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100 项与他那莫单抗相关的转化医学

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100 项与他那莫单抗相关的专利（医药）

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项与他那莫单抗相关的文献（医药）

2025-12-01·Journal of Gastrointestinal Cancer

The Efficacy and Safety of Nivolumab Combined with Nab-Paclitaxel or Oxaliplatin as a First-Line Treatment for Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Cancer

Article

作者: Ye, Sisi ; Li, Shuman ; Li, Juan ; Zhang, Ying ; Shi, Weiwei ; Liu, Rongrui

OBJECTIVE:

This study aims to assess the therapeutic efficacy and safety of nivolumab combined with chemotherapy as a first-line treatment for advanced or metastatic gastric cancer, specifically comparing the outcomes of oxaliplatin-based versus albumin-bound paclitaxel (nab-paclitaxel)-based therapies.

METHODS:

We retrospectively analyzed 93 patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma treated at the First Medical Center of Chinese PLA General Hospital from September 2017 to November 2022. Patients were categorized into the nivolumab + oxaliplatin (N-OX group) or nivolumab + nab-paclitaxel (N-AP group) based on the chemotherapy regimen. Progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety were evaluated as endpoints.

RESULTS:

At the end of the follow-up period on September 31, 2023, we reported an ORR of 65.6% and DCR of 95.7% across all patients. The median PFS was 8.4 months, with no significant difference between the N-OX and N-AP groups (median, 7.8 vs 9.5 months; P = 0.450). Notably, patients with diffuse gastric cancer in N-AP group showed a 44.7% reduction in tumor progression risk compared with the N-OX group (P = 0.046). The overall safety profile was acceptable in two groups.

CONCLUSIONS:

Our study suggested that nivolumab combined with chemotherapy was effective and safe as a first-line intervention for advanced gastric cancer. While both oxaliplatin and nab-paclitaxel regimens showed similar efficacy, the nab-paclitaxel may offer additional benefits for patients with diffuse gastric cancer. Further research is encouraged to confirm these findings and refine treatment strategies.

2025-06-18·ACS Applied Materials & Interfaces

Reprogramming Tumor-Associated Macrophage by Ornithine Decarboxylase Inhibitor and Immune Checkpoint for Orthotopic Glioblastoma Photothermal Immunotherapy

Article

作者: Fang, Xiaohong ; Han, Jie ; Liu, Yang ; Zhou, Wei ; Li, Haorong ; Zhang, Xiaoling ; Yu, Jin ; Jiang, Ruibin ; Zhang, Xiaoli

Immune-suppressive tumor-associated macrophages (TAMs) that infiltrate the tumor microenvironment (TME), along with the presence of the blood-brain barrier (BBB), influence the effectiveness of immunotherapy for glioblastoma. In this study, we report the use of difluoromethylornithine (DFMO), aPD-L1, and Indocyanine Green (ICG) in combination with target TAMs for their repolarization. DFMO repolarizes TAMs by inhibiting the expression of aconitate decarboxylase 1 (ACOD1), while aPD-L1 blocks the PD-1/PD-L1 immune checkpoint on TAMs, achieving efficient phenotypic switching and enhancing the phagocytic activity against glioblastoma (GBM). When combined with the photothermal agent ICG, the photothermal effect induces immunogenic tumor cell death and further strengthens the repolarization of TAMs. This increases the conversion efficiency of TAMs, reverses immune suppression at the tumor site, and transforms the anti-inflammatory "cold" tumor into a pro-inflammatory "hot" tumor. This approach showed better therapeutic effects in an orthotopic glioma model in mice, with the repolarization of our combined treatment DFMO + N-aP@ICG (nanovesicles containing aPD-L1 and ICG), increasing by 179% compared to other combined treatments for glioma. In summary, we propose this innovative immunotherapy for glioma, which effectively penetrates the blood-brain barrier, targets M2-TAMs, enhances the aPD-L1 immune response, and inhibits the proliferation of glioma.

2023-06-01·Journal of neurophysiology

Strength-duration properties and excitability of motor and sensory axons across different target thresholds.

Article

作者: Shimatani, Yoshimitsu ; Matamala, José Manuel ; Kiernan, Matthew C ; Lin, Cindy Shin-Yi

The present series of studies aimed to investigate the biophysical basis underlying differences in behavior between motor and sensory axons at different target response levels. In 24 healthy individuals, axonal excitability protocols measured strength-duration properties and latent addition across several axonal populations, with target amplitudes set at 10%, 20%, 40%, and 60%. Strength-duration time constants (SDTCs) were typically longer at lower target levels for both motor and sensory axons. Threshold change at 0.2 ms during assessment of latent addition, representing a persistent Na⁺ current (Na_p), was higher in sensory axons. Passive membrane properties were not different across target levels. Significant relationships were evident between the threshold change at 0.2 ms and SDTC across all target levels for motor and sensory axons. These differences were explored using mathematical modeling of excitability data. With decreasing target size, as the internodal leak conductance increased in sensory axons, the Barrett-Barrett conductance decreased, whereas the hyperpolarization-activated cation current (I_h) channels became more depolarized. A similar pattern was observed in motor axons. As such, it was concluded that Na_p was not responsible for the differences observed in SDTC between different target levels, although within specific target levels, Na_p changes contributed to the variability of SDTC. This study provides a comprehensive assessment of Na_p current, SDTC, and outlines key factors operating at different target levels in motor and sensory axons. Findings from the present study may point to the contributing factors of symptom development in human neuropathy.NEW & NOTEWORTHY This study provides a comprehensive assessment concerning the strength-duration behavior of motor and sensory axons at differing target levels of the compound nerve response. Strength-duration time constant was increased at lower target response levels particularly for sensory axons, whereas threshold change at 0.2 ms and passive membrane properties were not different. The results have established templates for axonal behavior in normal human axons, demonstrating altered adaptive responses, presumably secondary to different patterns of nerve activation.

项与他那莫单抗相关的新闻（医药）

2025-12-31

·百度百家

TPBG 靶向：埃托 - 那普妥莫单抗的实体瘤免疫激活与科研价值

TPBG（滋养层糖蛋白，又称5T4 癌胚抗原）是一种高度糖基化的跨膜蛋白，属于特异性肿瘤相关抗原，在非小细胞肺癌、肾细胞癌、结直肠癌等多种实体瘤细胞表面高表达，而在正常成人组织中仅限制性低水平表达。生理状态下，TPBG 参与细胞黏附与迁移调控；在病理场景中，其异常高表达会驱动肿瘤细胞上皮 - 间质转化（EMT）、增强侵袭转移能力，同时参与肿瘤免疫微环境的免疫抑制重塑，是实体瘤精准治疗的特色靶点。埃托 - 那普妥莫单抗（Naptumomab Estafenatox，研发代号 ABR-217620）是一款颠覆传统抗体设计逻辑的抗体 - 超抗原融合蛋白，核心优势在于将靶向 TPBG 的单克隆抗体与葡萄球菌肠毒素 A（SEA）的活性片段进行融合，实现 “靶向定位 + 免疫风暴激活” 的双重功效。其作用机制极具差异化：抗体部分精准识别并结合肿瘤细胞表面的 TPBG，将超抗原片段递送至肿瘤微环境；超抗原则通过交联 T 细胞受体（TCR）与抗原提呈细胞表面的 MHC Ⅱ 类分子，激活大量 T 细胞并募集自然杀伤（NK）细胞等免疫效应细胞，在肿瘤局部形成强烈的免疫激活风暴，特异性杀伤肿瘤细胞，同时诱导机体产生免疫记忆，降低肿瘤复发风险。作为 TPBG 靶向免疫治疗的先驱药物，埃托 - 那普妥莫单抗的研发历程聚焦于非小细胞肺癌、肾细胞癌等难治性实体瘤。临床研究显示，其单药治疗晚期实体瘤患者，能有效激活肿瘤局部免疫应答，部分患者实现肿瘤病灶缩小或稳定，尤其对化疗、靶向治疗耐药的患者展现出潜在的补救治疗价值；与化疗药物联用后，可通过 “化疗杀伤肿瘤细胞 + 免疫激活清除残余病灶” 的协同效应，显著提升患者客观缓解率，延长无进展生存期。此外，针对转移性实体瘤的临床探索也证实，该药物能有效抑制肿瘤远处转移，为晚期患者带来生存获益。近年来，随着肿瘤免疫治疗技术的迭代，埃托 - 那普妥莫单抗的科研价值被持续挖掘。在联合治疗策略中，科研人员发现其与 PD-1/PD-L1 抑制剂联用，可有效打破肿瘤免疫抑制微环境 —— 超抗原激活的 T 细胞能增强免疫检查点抑制剂的应答率，而免疫检查点抑制剂则可解除 T 细胞耗竭状态，二者协同放大抗肿瘤免疫效应，相关临床前研究已展现出显著的协同优势。在药物创新层面，埃托 - 那普妥莫单抗的融合蛋白设计理念为新一代免疫治疗药物研发提供了重要参考。科研人员基于其结构，优化抗体的靶向亲和力与超抗原的免疫激活强度，同时探索与不同超抗原、细胞因子的融合组合，开发出疗效更优、安全性更高的融合蛋白药物；此外，该药物也为双靶点融合蛋白的设计提供了思路，通过构建 TPBG/CD3 双靶向融合蛋白，进一步增强 T 细胞对肿瘤细胞的特异性识别与杀伤能力。在科研领域，科研级埃托 - 那普妥莫单抗（型号 TKYR1029）凭借高纯度、高特异性及稳定的免疫激活活性，成为核心研究工具。其广泛应用于TPBG 靶点验证、肿瘤免疫微环境重塑机制研究、超抗原免疫激活效应评价、实体瘤免疫治疗动物模型构建等场景。例如，在肿瘤免疫机制研究中，可通过埃托 - 那普妥莫单抗靶向激活肿瘤局部免疫，明确超抗原介导的 T 细胞活化对肿瘤细胞杀伤的作用机制；在免疫治疗药物研发中，其可作为阳性对照，验证新型融合蛋白药物的免疫激活能力与抗肿瘤活性。随着肿瘤免疫治疗从 “广谱激活” 向 “精准靶向” 升级，TPBG 靶点的临床价值与科研潜力持续释放。泰克生物依托成熟的重组抗体研发平台与丰富的免疫治疗药物研究经验，推出科研级埃托 - 那普妥莫单抗（TKYR1029），产品严格遵循科研标准，精准匹配 TPBG 相关科研需求，助力科研工作者在实体瘤免疫机制研究、新型免疫疗法研发中高效突破。

免疫疗法

2025-09-23

·生物世界

Nature子刊：中山大学杨建华/李斌/屈良鹄团队介绍全长非帽RNA测序技术NAP-seq的原理及实验步骤

编辑丨王多鱼排版丨水成文 ENCODE 计划揭示了人类基因组超过 80% 的基因组区域能够转录产生“暗物质”之称的 RNA。根据 RNA 的 5' 端是否具有帽子修饰结构，这些可以被分为两大类：1）帽子结构的（capped RNA，capRNA）；2）非帽 RNA（noncapped RNA，napRNA）。除 mRNA 和部分长非编码外，其余几乎所有均属于 napRNA。这些 napRNA 不仅通过作为非编码 RNA（ncRNA）调控多种生物学过程，还作为加工产物解析特定的 RNA 生物生成过程。然而，由于其长度异质性、末端修饰多样性以及复杂的二级结构等，鉴定这些 napRNA 面临巨大挑战。为应对这一挑战，中山大学生命科学学院杨建华/李斌/屈良鹄教授团队开发了 NAP-seq 技术，并于 2025 年 9 月 17 日在 Nature Protocols 期刊发表了题为：NAP-seq for full-length noncapped RNA sequencing 的论文，系统介绍了该方法的设计原理与实验步骤。图1. NAP-seq的设计原理和实验步骤 NAP-seq 技术具有以下显著优势（图2）： 1）大规模新发现：在人类和小鼠中，分别鉴定出超过 16000 条和 9500 条新的 napRNA，展现出远超传统方法的发现能力。 2）单核苷酸分辨率的全面 napRNA 分析: 定制化接头序列能够同时捕获 napRNA 的两端，从而在单核苷酸分辨率下解析全长序列，并发现具有特征性末端基序和结构元件的 napRNA。 3）高效检测修饰 RNA 与复杂结构 RNA：T4 PNK 和 SuperScript IV 逆转录酶的使用，使 NAP-seq 能够检测多种 RNA 修饰和高度稳定的二级结构RNA。 4）富集低丰度 napRNA：通过基于 RNase H 的去除策略，有效去除高丰度的 rRNA、snoRNA 及其他 ncRNA，去除效率可达 99.9%，从而显著提升低表达 napRNA 的发现率。 5）确保全长 cDNA 合成：巢式逆转录引物设计保证了长链 napRNA 的全长 cDNA 扩增，并最大程度减少错误引物引发的伪影。 6）拓展 napRNA 家族的检测范围: 在建库前设置的片段大小选择（≥100 nt），使 NAP-seq 能够识别数千条被传统小 RNA 测序忽略的长 napRNA（≥100 nt），包括 C/D box RNA、H/ACA box RNA 以及 Pol III 转录 RNA 的新亚类，序列长度可达约 2000 nt。 7) 精确定量与减少偏倚：在接头中引入条形码，有助于消除 PCR 扩增偏倚，并减少因末端连接效率差异导致的序列特异性偏差，实现对 napRNA 的更精准定量。 8) 双平台整合：NAP-seq 结合 Oxford Nanopore 测序（NAP-seq-TGS）与 Illumina 测序（NAP-seq-NGS）的优势，前者实现实时、直接的全长分子分析，后者提供碱基水平的高精度短读长序列。研究人员可根据不同研究需求独立或联合使用两类技术，获得更全面的 napRNA 特征信息。 9) 高效利用样本：相较于 TERA-seq 等全长 RNA 测序方法至少需 75 μg RNA，且仅限 ONT 平台，NAP-seq 仅需 1 μg RNA 即可完成建库，极大拓展了其在有限样本研究中的适用性。 10) 流程化的计算机分析：配套开发 cutAdapter、napSeeker 等软件与分析流程，能够快速发现并注释多类型 napRNA。图2. NAP-seq的技术亮点 NAP-seq 还展现出广泛的新应用前景： 1）临床样本和体液分析：通过检测临床样本及体液（如血浆）中的 napRNA，NAP-seq 可助力发现新型疾病标志物和治疗靶点，为精准医学提供新机遇。 2）极端环境微生物研究：NAP-seq 可用于鉴定极端环境中微生物的多样化 napRNA，揭示新型防御系统及独特生物学机制，为微生物群落研究开辟新方向。 3） RNA 末端加工机制解析：NAP-seq 能够系统表征非帽RNA的末端加工过程，揭示调控 RNA 稳定性、加工及功能的未知机制，为 RNA 生物学研究提供新视角。综上，NAP-seq 作为一种多功能、高精度的测序技术，不仅适用于鉴定任何细胞模型、组织和物种中的调控型 napRNA，还为揭示复杂 RNA 调控途径提供了强大工具，在基础生物学和临床研究领域具有广阔的应用潜力。中山大学生命科学学院杨建华教授、李斌副教授和屈良鹄教授为论文通讯作者，中山大学生命科学学院刘树榕特聘副研究员为论文第一作者，该工作得到实验室其他成员的大力支持。论文链接： https://www.nature.com/articles/s41596-025-01261-6 设置星标，不错过精彩推文开放转载欢迎转发到朋友圈和微信群微信加群为促进前沿研究的传播和交流，我们组建了多个专业交流群，长按下方二维码，即可添加小编微信进群，由于申请人数较多，添加微信时请备注：学校/专业/姓名，如果是PI/教授，还请注明。点在看，传递你的品味

信使RNA寡核苷酸核酸药物

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

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KEGG	Wiki	ATC	Drug Bank
-	他那莫单抗	-	DB12807

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适应症	最高研发状态	国家/地区	公司	日期
晚期肾细胞癌	临床3期	保加利亚	Active Biotech AB	2007-01-01
晚期肾细胞癌	临床3期	罗马尼亚	Active Biotech AB	2007-01-01
晚期肾细胞癌	临床3期	俄罗斯	Active Biotech AB	2007-01-01
晚期肾细胞癌	临床3期	乌克兰	Active Biotech AB	2007-01-01
晚期肾细胞癌	临床3期	英国	Active Biotech AB	2007-01-01
转移性非小细胞肺癌	临床2期	美国	NeoTX Therapeutics Ltd.	2021-10-26
膀胱尿路上皮癌	临床1期	美国	NeoTX Therapeutics Ltd.	2023-11-01
晚期恶性实体瘤	临床1期	印度	AstraZeneca PLC	2019-10-10
晚期恶性实体瘤	临床1期	印度	NeoTX Therapeutics Ltd.	2019-10-10
晚期恶性实体瘤	临床1期	以色列	NeoTX Therapeutics Ltd.	2019-10-10

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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


NCT04880863 (NT-NAP-102-1, CTgov)	临床2期	转移性非小细胞肺癌	38	Naptumomab+Obinutuzumab+Docetaxel	鹹醖鏇網壓鹹願願願餘 = 遞淵鏇願繭窪構醖繭鹽齋遞構範選鏇觸廠醖構 (壓鑰糧鏇鑰鹽製鹹壓膚, 蓋糧廠糧餘醖艱願遞築 ~ 夢蓋憲繭製淵範襯網齋) 更多	-	2025-03-03
NCT04880863 (ASCO 12024 \| ASCO 22024) 人工标引	临床2期	非小细胞肺癌	32	Naptumomab estafenatox (NDocetaxeletaxel	顧構壓鬱齋廠鏇鬱膚膚(築廠願艱範憲糧繭鹹憲) = 憲製願膚襯淵選願顧憲遞製鏇蓋憲淵醖窪網觸 (積糧簾鑰鏇選簾鹽構夢, 1.3 ~ 20.8) 更多	积极	2024-05-24
NCT03983954 (AACR2023) 人工标引	临床1期	实体瘤	59	naptumomab estafenatox+durvalumab	憲繭鏇膚鹽醖鬱夢選願(積蓋鬱鏇積膚襯顧醖顧) = 壓選艱鏇夢網獵觸遞遞鹹構鑰糧願製願簾獵鬱 (糧繭糧鏇糧醖鏇窪蓋糧 ) 更多	积极	2023-04-14
NCT00420888 (Pubmed \| Clin Cancer Res) 人工标引	临床2/3期	肾细胞癌	513	IFNα+Naptumomab Estafenatox	餘襯簾鑰鬱窪繭遞壓齋(遞壓鏇網醖壓獵選簾鑰) = 製衊憲築憲齋餘積獵顧糧襯鏇窪夢膚鹹廠蓋膚 (構窪蓋遞膚蓋製膚餘觸 ) 更多	不佳	2016-07-01
NCT00420888 (Pubmed \| Clin Cancer Res) 人工标引	临床2/3期	肾细胞癌	513	IFNα	餘襯簾鑰鬱窪繭遞壓齋(遞壓鏇網醖壓獵選簾鑰) = 願願糧膚齋鬱顧鬱鹹糧糧襯鏇窪夢膚鹹廠蓋膚 (構窪蓋遞膚蓋製膚餘觸 ) 更多	不佳	2016-07-01