预约演示
更新于：2025-09-25
Amivantamab-VMJM
埃万妥单抗
更新于：2025-09-25
概要
基本信息
药物类型 双特异性抗体 |
别名 Amivantamab、amivantamab-vmjw、Amivantamab（Genetical Recombination） + [13] |
作用方式 拮抗剂、抑制剂 |
作用机制 EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)、c-Met抑制剂(肝细胞生长因子受体抑制剂) |
非在研机构 |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2021-05-21), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、突破性疗法 (美国)、加速批准 (美国)、突破性疗法 (中国)、孤儿药 (韩国) |
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结构/序列
Sequence Code 143885L
来源: *****
Sequence Code 13387733H
来源: *****
Sequence Code 13387743H
来源: *****
Sequence Code 13387747L
来源: *****
关联
52
项与 埃万妥单抗 相关的临床试验NCT07042295
A Randomized Phase II Study of Amivantamab (JNJ-61186372) and Hyaluronidase (rHuPH20) Versus Cetuximab in Immunocompromised Participants With Recurrent Inoperable or Metastatic Cutaneous Squamous Cell Carcinoma
NCT07062354
A Phase II Study of Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer
NCT06855849
An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line Treatment in Patients With RAS/BRAF Wild-type Advanced Colorectal Cancer Progressing on Prior Anti-EGFR Based Treatment.
100 项与 埃万妥单抗 相关的临床结果
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100 项与 埃万妥单抗 相关的转化医学
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100 项与 埃万妥单抗 相关的专利（医药）
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226
项与 埃万妥单抗 相关的文献（医药）2025-12-01Current Neurology and Neuroscience Reports
Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review
Review
作者: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek
PURPOSE OF REVIEW:
Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.
RECENT FINDINGS:
In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.
2025-11-01CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
Optimizing management of cutaneous toxicities from amivantamab in first-line non-small cell lung cancer: A clinical perspective
Letter
作者: Tosti, Giulio ; de Marinis, Filippo ; Passaro, Antonio ; Pepe, Francesca ; Attili, Ilaria
Amivantamab, a bispecific EGFR-MET antibody, has demonstrated efficacy in EGFR-mutant non-small cell lung cancer (NSCLC) across multiple trials and is poised to enter first-line therapy. However, as with EGFR-targeted therapies, amivantamab is associated with distinctive cutaneous toxicities. This perspective summarizes clinical evidence on the frequency, nature, and severity of skin-related adverse events from key studies, outlining how, despite concerns initially raised among clinicians about its tolerability in routine practice, clinical experience indicates that amivantamab's cutaneous toxicities are manageable with proactive strategies and education. Acneiform rash, paronychia, and xerosis are among the most common toxicities observed, generally low-grade but impacting patient quality of life. Emerging evidence and expert consensus indicate that these cutaneous events are manageable with patient education, multidisciplinary dermatologic care, and proactive interventions. Proactive management roughly halved the incidence of moderate-to-severe rash and significantly reduced high-grade events, enabling most patients to continue therapy. In practice, close collaboration with experienced dermatologists, early management of symptoms, and thorough patient education on skincare can dramatically improve tolerability. As a result, initial fears about severe skin toxicity can be overcome, ensuring that patients are not denied the benefits of this efficacious therapy due to manageable side effects. In light of the significant survival benefit shown by amivantamab-based therapy in the MARIPOSA trial, preventing, recognizing and optimally managing its skin toxicities will be crucial to maximizing patient outcomes.
2025-10-15INTERNATIONAL JOURNAL OF CANCER
Optimizing management of stage IV EGFR mutant non‐small cell lung cancer in Asia: An expert opinion
Article
作者: Suryavanshi, Moushumi ; Lee, Chee Khoon ; Voon, Pei Jye ; Andarini, Sita ; Kapoor, Akhil ; Ladrera, Guia Elena Imelda ; Chan, Daniel ; Nguyen, Tuan Khoi ; Reungwetwattana, Thanyanan ; Su, Chunxia ; Chang, Gee‐Chen ; Yoshida, Tatsuya ; Kim, Hye Ryun ; Sumon, Mostafa Aziz
Abstract:
Lung cancer is Asia's most prevalent cancer, accounting for the highest global patient share. A significant number of non‐small cell lung cancer (NSCLC) patients in Asia exhibit mutations in the epidermal growth factor receptor (EGFR). Although clinical outcomes are improving with newer therapies, challenges persist in the effective management of EGFR mutant (EGFRm) NSCLC. Given the substantial disease burden, understanding the current diagnostic and treatment patterns for EGFRm NSCLC from an Asian perspective is essential. This expert opinion presents recommendations from Asian experts on molecular testing and treatment of first‐line and second‐line EGFRm NSCLC. The recommendations aim to optimize patient outcomes by providing a comprehensive approach to diagnosis and management, considering the high prevalence of EGFR mutations in the Asian population. The experts discussed and recommended approaches for optimal management of EGFRm NSCLC. Next‐generation sequencing (NGS) testing is recommended to be included in the reimbursement scheme, and the turnaround time of testing should be shortened, considering the high burden of the disease in Asia. The panel recommended careful selection of patients for osimertinib+chemotherapy or lazertinib+amivantamab based on safety and efficacy profile, patient age, and disease status. While the panel agreed that osimertinib+chemotherapy is acceptable for these patients, dose adjustment and careful patient selection are recommended to optimize safety outcomes. For lazertinib+amivantamab, measures to mitigate adverse events such as the use of pre‐medication with steroids, prophylactic anticoagulants, and dose modification are recommended. For patients progressing on one of the combination regimens, experts recommended repeat NGS testing and continued treatment with chemotherapy.
830
项与 埃万妥单抗 相关的新闻（医药）2025-09-24
基因疗法优先审批申请上市并购
2025-09-23
财报临床3期抗体药物偶联物申请上市引进/卖出
2025-09-21
·信狐药迅
疫苗信使RNA临床申请临床1期申请上市
100 项与 埃万妥单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| EGFR阳性非小细胞肺癌 | 日本 | 2025-03-27 | |
| EGFR 外显子 19 缺失突变型非小细胞肺癌 | 美国 | 2024-08-19 | |
| EGFR外显子21替代突变非小细胞肺癌 | 美国 | 2024-08-19 | |
| 非小细胞肺癌 | 加拿大 | 2022-03-30 | |
| EGFR 20号外显子插入突变非小细胞肺癌 | 美国 | 2021-05-21 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| EGFR突变的非小细胞肺癌 | 申请上市 | 中国 | 2024-01-26 | |
| EGFR突变的非小细胞肺癌 | 申请上市 | 中国 | 2024-01-26 | |
| EGFR突变的非小细胞肺癌 | 申请上市 | 中国 | 2024-01-26 | |
| 结直肠癌 | 临床3期 | 美国 | 2024-12-12 | |
| 结直肠癌 | 临床3期 | 中国 | 2024-12-12 | |
| 结直肠癌 | 临床3期 | 日本 | 2024-12-12 | |
| 结直肠癌 | 临床3期 | 澳大利亚 | 2024-12-12 | |
| 结直肠癌 | 临床3期 | 比利时 | 2024-12-12 | |
| 结直肠癌 | 临床3期 | 巴西 | 2024-12-12 | |
| 结直肠癌 | 临床3期 | 法国 | 2024-12-12 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 66 | 糧艱糧觸鑰衊鬱構鹽壓(醖遞窪構簾構遞鹽襯鬱) = Most treatment-emergent adverse events (AEs) were EGFR/MET-related or reversible hematologic AEs, with paronychia, hypoalbuminemia, and neutropenia being the most common. 鑰獵夢網簾積繭顧獵鏇 (廠齋選願選憲鹹簾鏇憲 ) | 积极 | 2025-09-09 | |||
临床2期 | 77 | 範網壓齋獵願製鬱簾獵(構艱憲鹹鬱選願鑰衊鬱) = 壓糧鹽鏇鬱構蓋鹽壓遞 選選鹹遞獵齋簾願獵夢 (襯齋鏇糧餘範鑰築憲築 ) | 积极 | 2025-09-09 | |||
临床2期 | 66 | 蓋範鏇積築顧繭鹹夢壓(繭襯齋壓觸鏇鹽築憲顧) = 遞鹹餘壓蓋鹽餘網壓獵 醖艱衊獵築繭壓鬱鬱鹽 (鏇遞蓋獵積範膚窪範醖 ) 更多 | 积极 | 2025-09-09 | |||
临床1期 | 132 | (Cohort E；MET+) | 顧憲簾壓齋觸網範獵願(艱鏇憲餘選糧鹹鹹鹽衊) = 積憲齋壓遞鏇鬱製鑰襯 夢窪鹹膚範鑰鹽淵製簾 (範獵製鹽夢膚網襯鏇鹽, 14 ~ 50) 更多 | 积极 | 2025-09-09 | ||
(Cohort E；MET-) | 顧憲簾壓齋觸網範獵願(艱鏇憲餘選糧鹹鹹鹽衊) = 鬱淵糧鏇獵齋壓鹹鬱獵 夢窪鹹膚範鑰鹽淵製簾 (範獵製鹽夢膚網襯鏇鹽, 6 ~ 29) 更多 | ||||||
临床3期 | 858 | 醖築餘鏇鬱壓鏇窪簾衊(製糧築願鏇鹽醖餘蓋網) = 壓夢鏇餘襯糧構醖積願 鏇築鏇範構鹹壓壓廠遞 (窪餘顧鹹網獵繭齋築鑰 ) 更多 | 积极 | 2025-09-07 | |||
醖築餘鏇鬱壓鏇窪簾衊(製糧築願鏇鹽醖餘蓋網) = 獵製淵憲憲鬱簾蓋願壓 鏇築鏇範構鹹壓壓廠遞 (窪餘顧鹹網獵繭齋築鑰 ) 更多 | |||||||
临床3期 | EGFR突变的非小细胞肺癌 EGFR-mutant | - | 網範壓糧繭繭網鬱選範(醖衊築淵網鏇艱齋構淵) = 鏇構窪鹽積齋製窪製餘 鏇獵襯範齋網鬱簾獵夢 (鑰齋醖網範淵鏇糧艱糧, 2.90 ~ 8.62) 更多 | 积极 | 2025-05-30 | ||
Control arm | 網範壓糧繭繭網鬱選範(醖衊築淵網鏇艱齋構淵) = 膚積鏇襯鹽積窪鬱衊觸 鏇獵襯範齋網鬱簾獵夢 (鑰齋醖網範淵鏇糧艱糧 ) 更多 | ||||||
临床2期 | 138 | (COCOON DM) | 醖廠築願鑰鹹製艱鹽鬱(襯願齋鹽膚顧積選鹽積) = 鹽獵蓋獵艱膚積壓憲積 築選構艱廠膚築選夢餘 (壓獵壓鬱鏇繭衊醖製網 ) 更多 | 积极 | 2025-05-30 | ||
(SoC DM) | 醖廠築願鑰鹹製艱鹽鬱(襯願齋鹽膚顧積選鹽積) = 鹹廠餘襯選積蓋網築餘 築選構艱廠膚築選夢餘 (壓獵壓鬱鏇繭衊醖製網 ) 更多 | ||||||
N/A | 非小细胞肺癌 二线 | 三线 epidermal growth factor receptor mutations (EGFRm) | EGFR exon 20 insertions (Exon20Ins) | EGFR exon 19 deletion ... 更多 | 126 | Amivantamab monotherapy | 觸鬱憲鏇廠獵襯壓窪鏇(簾製壓衊網糧範淵範築) = 廠壓顧顧選範壓膚選衊 窪獵夢鏇蓋窪醖衊壓艱 (繭鬱蓋鹽廠構鹹獵廠觸 ) 更多 | - | 2025-05-30 | |
觸鬱憲鏇廠獵襯壓窪鏇(簾製壓衊網糧範淵範築) = 齋艱淵艱選積簾築繭築 窪獵夢鏇蓋窪醖衊壓艱 (繭鬱蓋鹽廠構鹹獵廠觸 ) 更多 | |||||||
临床1/2期 | 76 | Amivantamab monotherapy | 齋鬱鹽鬱鏇淵築餘繭壓(膚構範襯齋顧築淵壓襯) = 鬱鏇網網醖構鑰醖艱夢 廠鹽構網憲範網衊遞範 (製積艱簾淵積衊廠積窪 ) | 积极 | 2025-05-30 | ||
临床3期 | EGFR突变的非小细胞肺癌 EGFR | MET | - | 鑰簾顧築簾鹹鬱糧廠願(鹹窪醖獵膚齋選獵憲遞) = 鏇簾鹹糧鹹觸鬱醖醖範 顧獵蓋淵糧艱顧齋醖鏇 (窪鬱鬱襯鏇壓構夢網鬱, 1.37 ~ 79.89) 更多 | 积极 | 2025-05-30 | ||
Chemotherapy | - |
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