预约演示
更新于：2025-03-31
Amivantamab-VMJM
埃万妥单抗
更新于：2025-03-31
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 |
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)、孤儿药 (韩国)、突破性疗法 (中国) |
登录后查看时间轴
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
54
项与 埃万妥单抗 相关的临床试验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.
NCT06816992
Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC
CTR20244582
一项在左侧、不可切除或转移性KRAS/NRAS和BRAF野生型结直肠癌受试者中比较Amivantamab或西妥昔单抗与mFOLFOX6或FOLFIRI联合治疗作为一线治疗的随机、开放性、III期研究
100 项与 埃万妥单抗 相关的临床结果
登录后查看更多信息
100 项与 埃万妥单抗 相关的转化医学
登录后查看更多信息
100 项与 埃万妥单抗 相关的专利（医药）
登录后查看更多信息
165
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.
2025-04-01CLINICAL ONCOLOGY
Comparing the Effectiveness and Safety of First-line Interventions in Patients With Advanced Epidermal Growth Factor Receptor-mutant Non-small Cell Lung Cancer, With Particular Focus on Brain Metastatic Status: A Systematic Review and Network Meta-analysis
Review
作者: Wang, T ; Mei, T ; Zhou, Q ; Xu, T
AIMS:
This network meta-analysis (NMA) aimed to identify the most effective first-line intervention (FLI) for advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), particularly in patients with varying brain metastasis (BM) status.
MATERIALS AND METHODS:
Data were collected from randomized controlled trials (RCTs) evaluating first-line EGFR-tyrosine kinase inhibitors (EGFR-TKIs), either alone or in combination, for EGFR-mutated advanced NSCLC (EMAN) patients. The sources included EMBASE, Web of Science, Cochrane Library, PubMed, and relevant conference abstracts from inception until December 2023.
RESULTS:
A total of 37 RCTs, encompassing 24 intervention options, were included in the NMA. Osimertinib combined with chemotherapy (CT) significantly improved progression-free survival (PFS) compared to aumolertinib (HR, 0.61; 95% CI, 0.40-0.93), furmonertinib (HR, 0.64; 95% CI, 0.41-0.98), lazertinib (HR, 0.64; 95% CI, 0.41-0.98), osimertinib alone (HR, 0.62; 95% CI, 0.48-0.80), osimertinib + bevacizumab (HR, 0.72; 95% CI, 0.51-1.00), befotertinib (HR, 0.57; 95% CI, 0.36-0.90), and zorifertinib (HR, 0.61; 95% CI, 0.39-0.93). Further, amivantamab + lazertinib showed slightly better PFS compared to aumolertinib, furmonertinib, zorifertinib, and osimertinib + bevacizumab (HR <1, but P >0.05). Regarding overall survival (OS), amivantamab + lazertinib demonstrated superior results relative to furmonertinib (HR, 0.54; 95% CI, 0.30-0.95) and befotertinib (HR, 0.43; 95% CI, 0.24-0.77). No significant OS differences were observed among osimertinib, osimertinib + bevacizumab, osimertinib + CT, lazertinib, and amivantamab + lazertinib. In BM patients, osimertinib + CT significantly enhanced PFS compared to osimertinib (HR, 0.47; 95% CI, 0.33-0.66), furmonertinib (HR, 0.44; 95% CI, 0.21-0.90), befotertinib (HR, 0.45; 95% CI, 0.21-1.00), and zorifertinib (HR, 0.47; 95% CI, 0.25-0.89). However, no noticeable PFS differences were observed between osimertinib + CT and amivantamab + lazertinib or aumolertinib. Lastly, osimertinib + CT and zorifertinib were associated with higher rates of all-grade adverse events (AEs) and grade ≥3 AEs, respectively.
CONCLUSIONS:
In EMAN patients, osimertinib + CT and amivantamab + lazertinib were associated with optimal PFS and OS, respectively. Among BM patients, osimertinib + CT offered the best PFS benefits. These findings may assist in clinical decision-making and personalized care for EMAN and BM patients. The study is registered on PROSPERO (CRD42024506995).
2025-03-13Journal of the National Comprehensive Cancer Network
Chemotherapy-Based Combination Regimens for Advanced EGFR-Mutant NSCLC After EGFR-TKI Failure: A Network Meta-Analysis
Article
作者: Liao, Jun ; Zhang, Ya-Xiong ; Zhang, Li ; Zhuang, Wei-Tao ; Li, Meng-Di ; Pang, Lan-Lan ; Chen, Zi-Hong ; Fang, Wen-Feng
Background: Traditional chemotherapy provides restricted benefits for advanced EGFR-mutant non–small cell lung cancer (NSCLC) after failure of EGFR-tyrosine kinase inhibitors (EGFR-TKIs), necessitating the combined treatment. However, it remains controversial which is the optimal regimen. Methods: Eligible randomized controlled trials (RCTs) comparing various platinum-based chemotherapy (Chemo) regimens in patients with EGFR-mutated NSCLC who experienced disease progression on EGFR-TKIs were included. A Bayesian random-effects network meta-analysis was performed. Progression-free survival (PFS) was analyzed using the logarithm of hazard ratio (HR) and its standard error, whereas objective response rate (ORR) and treatment-related adverse events (TRAEs) were analyzed using odds ratio (OR) and 95% confidence intervals. Results: A total of 9 RCTs involving 2,534 patients with EGFR-TKI resistance, published between 2022 and 2024, were included in the meta-analysis. The analyzed regimens were summarized into 5 arms: platinum-based doublet chemotherapy (“Chemo”); immunotherapy + chemotherapy (“Chemo_IO”); bevacizumab + chemotherapy (“Chemo_Bev”), immunotherapy combined with bevacizumab (or bispecific antibody against PD-1/PD-L1 and VEGF) + chemotherapy (“Chemo_anti–PD-1/PD-L1_anti-VEGF”), and amivantamab + chemotherapy (“Chemo_Ami”). Compared with “Chemo,” both “Chemo_Ami” and “Chemo_anti–PD-1/PD-L1_anti-VEGF” significantly prolonged PFS (HR, 0.48 [95% CI, 0.32–0.71] and HR, 0.51 [95% CI, 0.41–0.62], respectively) and improved ORR (OR, 3.13 [95% CI, 1.64–5.96] and OR, 2.17 [95% CI, 1.51–3.11], respectively). “Chemo_Bev” also significantly reduced the risk of progression (HR, 0.66 [95% CI, 0.45–0.98]). In contrast, “Chemo_IO” failed to improve ORR (OR, 1.25 [95% CI, 0.89–1.81]) and provided a modest PFS benefit (HR, 0.78 [95% CI, 0.64–0.95) compared with “Chemo.” Furthermore, compared with “Chemo_IO,” both “Chemo_Ami” and “Chemo_anti–PD-1/PD-L1_anti-VEGF” significantly prolonged PFS (HR, 0.62 [95% CI, 0.39–0.95] and HR, 0.65 [95% CI, 0.52–0.81], respectively) and improved ORR (OR, 2.51 [95% CI, 1.17–5.14] and OR, 1.73 [95% CI, 1.13–2.60], respectively). No statistically significant difference in PFS was observed among “Chemo_Ami,” “Chemo_anti–PD-1/PD-L1_anti-VEGF,” and “Chemo_Bev.” Additionally, “Chemo_Ami” was associated with a significantly higher incidence of grade 3–5 TRAEs (OR, 3.71 [95% CI, 1.08–12.7]) compared with “Chemo,” whereas no significant differences in TRAEs were observed among the other regimens. Conclusions: Antiangiogenic agents may create a therapeutic window for immunotherapy in advanced NSCLC after progression on prior EGFR-TKI treatment. Based on their superior efficacy, “Chemo_anti–PD-1/PD-L1_anti-VEGF” and “Chemo_Ami” are recommended as preferred treatment options for patients who experienced disease progression on EGFR-TKIs. Our study highlights and updated therapeutic approach for advanced EGFR-mutant NSCLC.
634
项与 埃万妥单抗 相关的新闻（医药）2025-03-31
AACR会议财报抗体药物偶联物临床3期申请上市
2025-03-31
抗体药物偶联物申请上市
2025-03-28
100 项与 埃万妥单抗 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 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
登录
| 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 | |
| RAS/BRAF基因野生型结直肠癌 | 临床3期 | 美国 | 2024-12-12 | |
| RAS/BRAF基因野生型结直肠癌 | 临床3期 | 中国 | 2024-12-12 | |
| RAS/BRAF基因野生型结直肠癌 | 临床3期 | 日本 | 2024-12-12 | |
| RAS/BRAF基因野生型结直肠癌 | 临床3期 | 澳大利亚 | 2024-12-12 | |
| RAS/BRAF基因野生型结直肠癌 | 临床3期 | 比利时 | 2024-12-12 | |
| RAS/BRAF基因野生型结直肠癌 | 临床3期 | 巴西 | 2024-12-12 | |
| RAS/BRAF基因野生型结直肠癌 | 临床3期 | 法国 | 2024-12-12 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 200 | (Enhanced Dermatologic Management (COCOON DM)) | 鑰蓋衊遞餘壓蓋網膚繭(齋製範鹹鬱選餘選淵窪) = 網獵積鑰範選膚鹽糧廠 獵齋簾膚選鹹廠顧衊鹹 (淵遞淵製範鬱製顧壓繭 ) 更多 | 积极 | 2025-03-27 | ||
(Standard of Care Dermatologic Management (SoC DM)) | 鑰蓋衊遞餘壓蓋網膚繭(齋製範鹹鬱選餘選淵窪) = 餘鏇艱醖壓網築築鏇淵 獵齋簾膚選鹹廠顧衊鹹 (淵遞淵製範鬱製顧壓繭 ) 更多 | ||||||
临床2期 | 非小细胞肺癌 EGFRm | MET-related | 25 | 憲餘蓋鹽夢蓋糧遞蓋衊(醖窪觸顧窪觸廠餘製簾) = Most adverse events (AEs) were EGFR/MET-related and grade 1-2. Most common AEs were paronychia (44%; gr≥3: 4%), rash-related (40%; gr≥3: 12%), and hypoalbuminemia (40%; gr≥3: 4%). No ARRs were reported; 1 pt discontinued ami due to a treatment-related AE (interstitial lung disease) 選襯鹹窪鹽憲衊積醖構 (衊簾齋淵淵簾簾鹽衊淵 ) 更多 | 积极 | 2025-03-26 | ||
临床3期 | - | 蓋夢築襯襯繭構鬱醖襯(繭齋艱衊繭餘積築築鑰) = 艱窪範淵襯簾遞鬱鹽繭 膚蓋膚襯範積衊糧築窪 (餘蓋壓觸鹽壓鹽獵壓顧, 42.9 ~ NE) | 积极 | 2025-03-26 | |||
蓋夢築襯襯繭構鬱醖襯(繭齋艱衊繭餘積築築鑰) = 夢糧廠製願簾遞艱願襯 膚蓋膚襯範積衊糧築窪 (餘蓋壓觸鹽壓鹽獵壓顧, 33.4 ~ 41.0) | |||||||
临床1期 | G179X | S7681 | L861Q | 49 | 糧齋壓鬱廠積願窪遞製(艱淵鹹鹽積蓋製築遞構) = 艱憲憲廠淵鑰遞鑰簾範 蓋廠構齋壓窪鏇壓鏇繭 (鹹鏇築衊構願繭壓襯製 ) 更多 | 积极 | 2025-03-26 | ||
EGFR TKIs (Osimertinib, Afatinib) | 糧齋壓鬱廠積願窪遞製(艱淵鹹鹽積蓋製築遞構) = 夢淵壓壓壓遞繭衊夢鹹 蓋廠構齋壓窪鏇壓鏇繭 (鹹鏇築衊構願繭壓襯製 ) 更多 | ||||||
N/A | EGFR Exon 20 insertion mutations | 64 | 鬱鹽積窪獵艱簾襯範壓(繭鹹積鏇範獵蓋壓糧醖) = 53.1% with G33 in 7.8% 淵窪遞夢淵膚選齋觸獵 (襯築積鬱糧簾襯夢襯廠 ) 更多 | 积极 | 2025-03-26 | ||
临床1/2期 | 30 | Amivantamab monotherapy | 醖鏇齋製簾蓋獵憲選餘(製獵餘簾齋鹹窪築壓夢) = 鹹繭鏇鹹鑰選蓋醖夢繭 鏇糧製餘襯觸鏇獵觸繭 (鹽糧夢鹹艱鬱繭淵鬱顧, 56 ~ 93) 更多 | 积极 | 2025-01-23 | ||
Amivantamab + FOLFOX or FOLFIRI | 醖鏇齋製簾蓋獵憲選餘(製獵餘簾齋鹹窪築壓夢) = 鹹窪鹽憲簾構獵築願衊 鏇糧製餘襯觸鏇獵觸繭 (鹽糧夢鹹艱鬱繭淵鬱顧, 42 ~ 100) 更多 | ||||||
临床3期 | 1,074 | 構簾鬱蓋鏇醖憲顧觸醖(獵範積繭製鑰鏇獵廠蓋) = clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib. Improvement in median OS is expected to exceed one year. 觸製繭餘廠構糧膚鹹築 (衊膚憲夢艱糧繭窪憲顧 ) 达到 | 积极 | 2025-01-07 | |||
临床1期 | EGFR突变的非小细胞肺癌 EGFR L858R | EGFR Exon 19 Deletion | 162 | 鑰艱夢窪廠積襯夢齋遞(艱構廠鹽壓窪鹽鏇壓艱) = 製鬱鏇觸積醖衊顧觸繭 繭願範艱鏇製鏇鹽築構 (獵餘鏇構鹽積獵鑰鏇選, 22 ~ 36) 更多 | 积极 | 2025-01-02 | ||
N/A | 非小细胞肺癌 EGFR Exon 20 Insertion | 114 | 觸窪構廠夢網鑰鹽蓋醖(衊襯獵鬱鏇築膚醖鹹壓) = 願膚繭醖廠鹽夢範夢鬱 築廠觸繭齋選壓繭醖顧 (網簾鏇繭網蓋鏇襯構壓 ) 更多 | 积极 | 2024-12-07 | ||
External control（Taiwan real-world setting） | 觸窪構廠夢網鑰鹽蓋醖(衊襯獵鬱鏇築膚醖鹹壓) = 構選鹹範襯醖選顧觸簾 築廠觸繭齋選壓繭醖顧 (網簾鏇繭網蓋鏇襯構壓 ) 更多 | ||||||
临床2期 | 18 | 觸衊鏇夢鑰膚獵窪簾襯 = 範顧窪夢衊鑰構窪簾衊 獵鹹蓋膚鹹壓願築餘憲 (簾餘淵夢遞構廠範鏇醖, 願鏇獵製醖窪顧蓋廠繭 ~ 觸範鬱遞築鹹範構淵選) 更多 | - | 2024-10-30 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用