预约演示
更新于：2026-09-29
Amivantamab-VMJM
埃万妥单抗
更新于：2026-09-29
概要
基本信息
药物类型 双特异性抗体 |
别名 Amivantamab、amivantamab-vmjw、Amivantamab（Genetical Recombination） + [16] |
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 |
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 |
特殊审评加速批准 (美国)、孤儿药 (韩国)、突破性疗法 (中国)、优先审评 (美国)、突破性疗法 (美国) |
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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
56
项与 埃万妥单抗 相关的临床试验NCT07808359
Amivantamab in Patients With Metastatic/Recurrent Penile Squamous Cell Carcinoma Who Progressed to First-line Platinum-Based Chemotherapy: APOLO TRIAL (LACOG 2425)
NCT07798921
A Phase 1, Investigator-Initiated, Open-Label, Dose-Escalation Study to Evaluate the Safety, MTD, and Antitumor Activity of JIN-A02 in Combination With Amivantamab in EGFR-Mutant NSCLC Patients Following 3rd-Generation EGFR-TKI Failure
JPRN-jRCT1031260351
JCOG2507: A Phase III Randomized Controlled Trial Comparing Osimertinib plus Carboplatin plus Pemetrexed with Amivantamab plus Lazertinib for EGFR-Mutant Advanced Non-Squamous Non-Small Cell Lung Cancer (APEX)
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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306
项与 埃万妥单抗 相关的文献（医药）2026-12-31JOURNAL OF MEDICAL ECONOMICS
Cost comparison of osimertinib plus platinum-pemetrexed versus amivantamab plus lazertinib for the first-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer
Article
作者: Hearmon, Natalie ; Upton, Elysia ; Procter, Emily ; Nieva, Jorge J. ; Rattigan-Brown, Yanique ; Freeman, Harry ; Lopes, Gilberto de Lima ; Karia, Pritesh
OBJECTIVES:
Novel first-line (1L) combination regimens offer improved efficacy for patients with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) versus the standard of care, but their costs have not been comprehensively evaluated. Total and differential costs of 1L osimertinib plus platinum-pemetrexed, intravenous (IV) amivantamab plus lazertinib, and subcutaneous (SC) amivantamab plus lazertinib were estimated from a United States (US) payer perspective.
METHODS:
A cost of care model was developed to assess treatment acquisition, administration, disease management, and adverse event (AE) management costs for osimertinib plus platinum-pemetrexed versus IV and SC amivantamab plus lazertinib for patients with EGFRm NSCLC. A one-year time horizon was chosen to allow for direct treatment comparison; a one-year treatment duration was assumed for treat-to-progression regimen components.
RESULTS:
The total first-year cost per-patient for osimertinib plus platinum-pemetrexed (all-payer perspective: $172,600; private perspective: $253,529; Medicare perspective: $84,926) was over twofold lower than for IV amivantamab plus lazertinib (all-payer perspective: $418,176; private perspective: $618,240; Medicare perspective: $201,441) and for SC amivantamab plus lazertinib (all-payer perspective: $419,718; private perspective: $621,166; Medicare perspective: $201,482). This translated to per-patient cost savings of $245,577; $364,711; and $116,514 for osimertinib plus platinum-pemetrexed versus IV amivantamab plus lazertinib and $247,118; $367,637; and $116,555 versus SC amivantamab plus lazertinib for the all-payer, private, and Medicare perspectives, respectively.
LIMITATIONS:
Limited data availability necessitated cost conversions across payer perspectives and assumptions for select inputs, including specific concomitant medication durations. Additionally, as any payer-negotiated discounts for treatment are confidential, model treatment acquisition costs reflected list prices. These data limitations contributed to uncertainty surrounding model inputs.
CONCLUSIONS:
From a US payer perspective, osimertinib plus platinum-pemetrexed was associated with substantially lower overall costs compared with IV and SC amivantamab plus lazertinib for the 1L treatment of patients with EGFRm locally advanced or metastatic NSCLC.
2026-09-01ORAL ONCOLOGY
Intravenous amivantamab after cetuximab failure in recurrent or metastatic head and neck squamous cell carcinoma: a single-centre retrospective real-world cohort study
Article
作者: Lin, Fengjuan ; Xue, Liqiong ; Guo, Ye ; Zhou, Jiuli ; Tang, Wenbo ; Zhao, Wei
BACKGROUND:
Patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who exhaust platinum, immune checkpoint inhibitors (ICIs), and cetuximab lack standard options. The OrigAMI-4 trial showed subcutaneous amivantamab activity in anti-EGFR-naïve patients; real-world intravenous (IV) amivantamab data after cetuximab failure are absent.
METHODS:
We retrospectively analysed consecutive R/M HNSCC patients treated with IV amivantamab monotherapy (November 2024-July 2025) after progression on standard therapies. Response was assessed per RECIST 1.1; toxicity per CTCAE v5.0.
RESULTS:
Twenty patients were included (median age 54 years; 70.0% male; median four prior systemic lines). All received prior platinum and ICIs; 18 (90.0%) progressed on cetuximab. At a median follow-up of 6.8 months, confirmed ORR was 30.0% (6/20; 95% CI 11.9-54.3) ; DCR at first reassessment (6 weeks) was 80.0% (16/20; 95% CI 56.3-94.3) and confirmed DCR at 12 weeks was 45.0% (9/20; 95% CI 23.1-68.5). Median PFS was 3.0 months (95% CI 2.3 to not reached) and median OS 9.7 months (95% CI 6.8 to not reached). The most frequent treatment-related adverse events were hypoalbuminaemia (90.0%), rash (70.0%), and infusion-related reactions (45.0%; all grade 1-2); two patients had grade 3 events, none discontinued treatment.
CONCLUSION:
In this small retrospective cohort, IV amivantamab showed antitumour activity in heavily pretreated, cetuximab-exposed R/M HNSCC, with a 30% confirmed ORR, 45% confirmed 12-week DCR, 9.7-month median OS, and no treatment discontinuations for toxicity. These data suggest that dual EGFR-MET targeting may retain clinical utility after anti-EGFR failure, and support prospective evaluation with biomarker stratification.
2026-09-01EUROPEAN JOURNAL OF CANCER
Assessing time to symptomatic progression, a patient-relevant efficacy endpoint, in the MARIPOSA study in non-small cell lung cancer
Article
作者: Ord, Priya ; Ennis, Mariah ; Lu, Shun ; Felip, Enriqueta ; Gadgeel, Shirish M ; Nguyen, Danny ; Bauml, Joshua M ; Frosien, Markus ; Montes, Lizbett Vanessa García ; Akamatsu, Hiroaki ; Lin, Chien-Chung ; Forster, Martin D ; Lee, Se-Hoon ; Charoentum, Chaiyut ; Schuette, Wolfgang ; Kerßenboom, Ronja ; Cho, Byoung Chul ; Meißner, Janka ; Kowalyszyn, Ruben ; Urban, Damien ; Misch, Daniel ; Arslan, Cagatay ; Fennema, Elizabeth ; Cruz-Correa, Marcia ; Aguilar, Andres ; Daksh, Mahesh ; Girard, Nicolas ; Sethi, Seema ; Owen, Scott ; Cruz, Felipe Melo ; Sermon, Jan
INTRODUCTION:
In the phase 3 randomized MARIPOSA study, amivantamab and lazertinib combination therapy demonstrated improved progression-free survival (PFS) and overall survival (OS) versus osimertinib in participants with previously untreated, epidermal growth factor receptor-mutated advanced non-small cell lung cancer. Time to symptomatic progression (TTSP) was introduced to assess clinical worsening and complement endpoints that investigate radiographic disease progression and patient-reported outcomes. TTSP provides an easily interpretable measure of disease-specific symptom worsening to further support patient experience.
METHODS:
In MARIPOSA, TTSP was quantitatively assessed as a secondary efficacy endpoint and defined as the time from randomization until participants experience disease-specific symptom worsening requiring a clinical intervention or treatment change, or death. To evaluate the impact of amivantamab and lazertinib on TTSP considering its established OS benefit against osimertinib, an exploratory analysis censoring death events was performed.
RESULTS:
At the final protocol-specified OS analysis (median follow up: 37.8 months), median TTSP was 43.6 months with amivantamab and lazertinib versus 29.3 months with osimertinib (hazard ratio [HR]: 0.69; 95% confidence interval [CI]: 0.57-0.83; p < 0.0001). Amivantamab and lazertinib reduced deaths following a TTSP event compared to osimertinib. A strong correlation between TTSP and PFS or OS was observed.
CONCLUSIONS:
Amivantamab and lazertinib significantly delayed TTSP versus osimertinib. TTSP offers a clinician-validated measurement of disease-specific symptom worsening, capturing symptoms perceived by patients that prompt clinical action. TTSP is highly correlated with PFS and OS, providing complementary insights alongside traditional endpoints. TTSP enhances understanding of treatment benefit and supports informed clinical decision-making by integrating patient experience.
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 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 美国 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 中国 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 日本 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 澳大利亚 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 奥地利 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 比利时 | 2025-12-03 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 巴西 | 2025-12-03 |
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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 | 54 | 鬱顧獵憲網壓蓋範獵積(壓遞壓願壓鹽襯艱窪積) = 衊繭顧積膚廠壓鹹鑰窪 繭鬱艱構鹹製繭鏇憲簾 (淵築網襯鏇醖齋選醖鏇, 57.5 ~ 74.4) 更多 | 积极 | 2026-09-12 | |||
临床1期 | 124 | Subcutaneous Amivantamab+Lazertinib | 範範繭憲醖壓夢觸獵鹽(蓋蓋膚構夢廠膚積築網) = 膚積繭製鑰構築窪襯鹽 鏇簾顧簾鏇夢鏇憲鹹齋 (衊壓蓋顧艱簾範觸構衊 ) | 积极 | 2026-09-12 | ||
N/A | 94 | (2L) | 遞廠構壓衊糧糧醖鹹築(觸鏇遞遞願餘繭遞憲積) = 壓觸廠範鹽構夢夢衊網 鹹淵糧憲遞積鏇鏇衊淵 (鑰膚鹽齋獵壓醖遞憲衊, 13.3 ~ 31.0) 更多 | 积极 | 2026-09-12 | ||
(3L) | 遞廠構壓衊糧糧醖鹹築(觸鏇遞遞願餘繭遞憲積) = 齋襯顧顧繭夢衊獵鑰膚 鹹淵糧憲遞積鏇鏇衊淵 (鑰膚鹽齋獵壓醖遞憲衊, 3.7 ~ 21.9) 更多 | ||||||
N/A | EGFR突变的非小细胞肺癌 EGFR Mutation | 18 | 膚積襯繭繭繭築築鑰齋(衊窪夢餘餘鑰鬱壓願襯) = 繭繭鹹構膚積網夢觸觸 網製觸憲範範艱壓膚獵 (鏇壓夢膚夢蓋簾壓衊繭, 9.7 ~ 53.5) 更多 | 积极 | 2026-09-12 | ||
(exon 21 L858R) | 膚積襯繭繭繭築築鑰齋(衊窪夢餘餘鑰鬱壓願襯) = 積顧艱獵糧願遞膚鑰壓 網製觸憲範範艱壓膚獵 (鏇壓夢膚夢蓋簾壓衊繭 ) 更多 | ||||||
N/A | 50 | 廠鏇襯鏇壓糧艱鬱築膚(窪遞蓋窪醖繭醖繭窪鹹) = Grade 5 ILD was observed in 3 patients (6%), two of whom had prior exposure to immune checkpoint inhibitors (ICIs), including one within 3 months of ICI use 窪遞顧餘製壓顧繭鏇鹹 (鹹餘觸廠簾鬱鬱醖鏇窪 ) 更多 | 积极 | 2026-09-12 | |||
(2nd or 3rd line) | |||||||
临床3期 | 308 | 壓窪構餘繭廠簾遞觸構(膚願艱遞壓淵觸廠願築) = 糧餘醖構糧壓願蓋鑰膚 簾範製衊觸襯鹹鬱艱鏇 (選積憲簾製憲艱衊夢獵, 27.0 ~ 40.8) 更多 | 积极 | 2026-09-12 | |||
Chemotherapy | 壓窪構餘繭廠簾遞觸構(膚願艱遞壓淵觸廠願築) = 餘齋觸廠願齋窪築簾鹽 簾範製衊觸襯鹹鬱艱鏇 (選積憲簾製憲艱衊夢獵, 24.0 ~ 32.4) 更多 | ||||||
N/A | 非小细胞肺癌 EGFR-mutant | 302 | (EGFR-mutant NSCLC) | 夢築艱夢艱鹽憲積鏇繭(廠憲顧艱醖網憲餘淵鹽) = 齋衊築糧夢鹹鬱鬱窪積 遞鹹選鬱夢淵鹹獵膚醖 (網憲壓鹽鏇壓鑰鹽鹹憲 ) 更多 | 积极 | 2026-06-25 | |
(EGFR-mutant NSCLC) | 夢築艱夢艱鹽憲積鏇繭(廠憲顧艱醖網憲餘淵鹽) = 遞構遞鬱齋糧選願顧鏇 遞鹹選鬱夢淵鹹獵膚醖 (網憲壓鹽鏇壓鑰鹽鹹憲 ) 更多 | ||||||
临床1/2期 | 94 | (cohort A) | 壓鏇繭積積淵齋蓋醖築(願壓鏇鑰願廠觸窪廠糧) = 淵醖鏇窪獵網築鑰鬱選 夢範壓範繭醖顧積築壓 (網繭繭鏇簾淵積壓選鹽 ) 更多 | 积极 | 2026-06-10 | ||
(cohort B) | 壓鏇繭積積淵齋蓋醖築(願壓鏇鑰願廠觸窪廠糧) = 簾積憲範鏇積製鹽遞夢 夢範壓範繭醖顧積築壓 (網繭繭鏇簾淵積壓選鹽 ) 更多 | ||||||
临床1/2期 | 102 | 鬱顧積醖鏇衊網範齋鏇(顧觸鹽積觸範觸範獵積) = 簾鬱醖顧選醖醖齋觸鬱 鹽醖範窪鑰鏇簾製積襯 (鹽艱構壓遞壓齋簾鏇網, 37 ~ 57) 更多 | 积极 | 2026-05-29 | |||
临床2期 | 70 | (advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve) | 鹽構醖構糧廠選選鏇餘(顧醖憲獵簾築鏇網餘餘) = 艱窪壓膚鹽淵鬱壓憲醖 膚選築鬱襯衊遞獵繭廠 (醖壓選顧鹽鏇簾醖築衊 ) 更多 | 积极 | 2026-05-29 | ||
(advanced or recurrent non-squamous NSCLC with uncommon or compound EGFR mutations + treatment-naïve) | 鹽構醖構糧廠選選鏇餘(顧醖憲獵簾築鏇網餘餘) = 鹽廠鑰製鏇醖憲願憲鏇 膚選築鬱襯衊遞獵繭廠 (醖壓選顧鹽鏇簾醖築衊 ) 更多 |
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