预约演示
更新于：2025-05-07
Osimertinib mesylate
甲磺酸奥希替尼
更新于：2025-05-07
概要
基本信息
药物类型 小分子化药 |
别名 [11C]osimertinib、ADAURA、Mereletinib + [14] |
作用方式 抑制剂 |
作用机制 EGFR T790M抑制剂(表皮生长因子受体T790M抑制剂)、EGFR19外显子缺失突变抑制剂、EGFR21外显子L858R突变抑制剂 |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2015-11-13), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、快速通道 (美国)、孤儿药 (美国)、优先审评 (中国)、突破性疗法 (中国)、特殊审批 (中国)、优先审评 (澳大利亚)、加速审评 (欧盟)、加速批准 (美国)、突破性疗法 (美国) |
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结构/序列
分子式C29H37N7O5S |
InChIKeyFUKSNUHSJBTCFJ-UHFFFAOYSA-N |
CAS号1421373-66-1 |
关联
363
项与 甲磺酸奥希替尼 相关的临床试验NCT06918782
Real-world Experience With Combination Chemotherapy and Osimertinib in Poor Prognostic Group of Metastatic EGFR-mutated Lung Adenocarcinoma
NCT06829459
A Randomized, Controlled, Open-label Phase III Clinical Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients With MET Amplification and/or Overexpression After Resistance to EGFR-TKIs
NCT06908772
A Multicenter Phase II/III Clinical Study on the Efficacy and Safety of Glumetinib Combined With Osimertinib as First-Line Treatment in Non-Small Cell Lung Cancer Patients With Classical EGFR Mutations Accompanied by MET Amplification or Overexpression
100 项与 甲磺酸奥希替尼 相关的临床结果
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100 项与 甲磺酸奥希替尼 相关的转化医学
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100 项与 甲磺酸奥希替尼 相关的专利（医药）
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4,476
项与 甲磺酸奥希替尼 相关的文献（医药）2025-12-31ANNALS OF MEDICINE
Comparison of first-generation EGFR-TKIs combined with low-dose bevacizumab versus osimertinib in untreated advanced EGFR-mutated NSCLC
Article
作者: Xu, Yingqi ; Zhong, Runbo ; Jin, Hongping ; Lou, Yuqing ; Zhong, Hua ; Zhang, Yidan ; Xu, Jianlin
BACKGROUND:
This study aimed to compare the efficacy of first-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) combined with low-dose bevacizumab(7.5 mg/kg) versus osimertinib as first-line treatment in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC).
MATERIALS AND METHODS:
A total of 161 patients with advanced NSCLC harboring EGFR mutations, who received first-line treatment at Shanghai Chest Hospital between July 2017 and July 2023, were enrolled in this study. Among them, 78 patients were treated with a combination of first-generation EGFR-TKIs and bevacizumab (7.5 mg/kg), constituting the bevacizumab plus TKI (A + T) group. The remaining 83 patients received osimertinib monotherapy (80 mg daily), forming the osimertinib group.
RESULTS:
The objective response rate (ORR) was 65.4% (51/78) in the A + T group and 68.7% (57/83) in the osimertinib group (p = 0.657). Despite the potentially poorer baseline conditions of patients in the osimertinib group, the median progression-free survival (PFS) was 16.59 months (95% CI: 14.39-18.80) in the A + T group compared to 16.82 months (95% CI: 13.76-19.89) in the osimertinib group (p = 0.792). Preliminary overall survival (OS) analysis indicated a median OS of 51.75 months (95% CI: 41.63-61.86) in the A + T group versus 35.55 months (95% CI: 22.32-48.77) in the osimertinib group (p = 0.010), however, the OS data are not yet mature.
CONCLUSION:
Although osimertinib remains the preferred first-line treatment for advanced NSCLC with EGFR mutations, combining first-generation EGFR-TKIs with low-dose bevacizumab may be a viable alternative for certain patients.
2025-12-01LUNG
Update 2025: Management of Non‑Small-Cell Lung Cancer
Review
作者: Jeon, Hyein ; Wang, Shuai ; Gill, Harjot ; Song, Junmin ; Cheng, Haiying
Abstract:
Lung cancer remains the leading cause of cancer-related mortality worldwide. Since 2024, the non–small-cell lung cancer (NSCLC) landscape has undergone a transformative shift, driven by 11 FDA approvals. Recent advances in molecular profiling, targeted therapies, and immunotherapies have revolutionized NSCLC management, ushering in an era of personalized treatment with improved patient outcomes. The increased adoption of low-dose computed tomography (LDCT) for screening has enhanced early detection, enabling intervention at more curable stages. Molecular diagnostics now play a pivotal role in guiding treatment strategies, with actionable genomic alterations (AGAs) informing the use of EGFR, ALK, ROS1, KRAS, NRG1, and other targeted inhibitors in both early and advanced settings. For instance, targeted therapies are increasingly being integrated into early-stage management, with adjuvant osimertinib for EGFR-mutated NSCLC and alectinib for ALK-positive NSCLC demonstrating substantial survival benefits. Immunotherapy, particularly immune checkpoint inhibitors, has become a cornerstone of treatment for AGA-negative NSCLC, either as monotherapy or in combination with chemotherapy, and is increasingly being utilized in the perioperative setting. Furthermore, emerging therapies such as bispecific antibodies, antibody–drug conjugates (ADCs), and novel immunotherapeutic agents show promise in addressing resistance mechanisms and improving outcomes in advanced-stage disease. Although new challenges arise, the evolving NSCLC treatment paradigm continues to prioritize precision medicine, offering hope for prolonged survival and enhanced quality of life for patients.
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.
2,136
项与 甲磺酸奥希替尼 相关的新闻（医药）2025-05-07
·汇聚南药
突破性疗法财报申请上市
2025-05-07
临床结果ASCO会议临床3期抗体药物偶联物
2025-05-07
·癌度
临床结果临床3期临床失败
100 项与 甲磺酸奥希替尼 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 |
|---|---|---|---|
| 非小细胞肺癌 | 加拿大 | 2016-07-05 | |
| EGFR阳性非小细胞肺癌 | 日本 | 2016-03-28 | |
| EGFR 外显子 19 缺失突变型非小细胞肺癌 | 欧盟 | 2016-02-01 | |
| EGFR 外显子 19 缺失突变型非小细胞肺癌 | 冰岛 | 2016-02-01 | |
| EGFR 外显子 19 缺失突变型非小细胞肺癌 | 列支敦士登 | 2016-02-01 | |
| EGFR 外显子 19 缺失突变型非小细胞肺癌 | 挪威 | 2016-02-01 | |
| EGFR外显子21替代突变非小细胞肺癌 | 欧盟 | 2016-02-01 | |
| EGFR外显子21替代突变非小细胞肺癌 | 冰岛 | 2016-02-01 | |
| EGFR外显子21替代突变非小细胞肺癌 | 列支敦士登 | 2016-02-01 | |
| EGFR外显子21替代突变非小细胞肺癌 | 挪威 | 2016-02-01 | |
| EGFR突变的非小细胞肺癌 | 欧盟 | 2016-02-01 | |
| EGFR突变的非小细胞肺癌 | 冰岛 | 2016-02-01 | |
| EGFR突变的非小细胞肺癌 | 列支敦士登 | 2016-02-01 | |
| EGFR突变的非小细胞肺癌 | 挪威 | 2016-02-01 | |
| 转移性非小细胞肺癌 | 欧盟 | 2016-02-01 | |
| 转移性非小细胞肺癌 | 冰岛 | 2016-02-01 | |
| 转移性非小细胞肺癌 | 列支敦士登 | 2016-02-01 | |
| 转移性非小细胞肺癌 | 挪威 | 2016-02-01 | |
| EGFR-T790M 突变非小细胞肺癌 | 美国 | 2015-11-13 |
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 |
|---|---|---|---|---|
| 肿瘤 | 临床3期 | 美国 | 2023-05-08 | |
| 肿瘤 | 临床3期 | 中国 | 2023-05-08 | |
| 肿瘤 | 临床3期 | 法国 | 2023-05-08 | |
| 肿瘤 | 临床3期 | 马来西亚 | 2023-05-08 | |
| 肿瘤 | 临床3期 | 波兰 | 2023-05-08 | |
| 肿瘤 | 临床3期 | 中国台湾 | 2023-05-08 | |
| 肿瘤 | 临床3期 | 英国 | 2023-05-08 | |
| 恶性上皮肿瘤 | 临床3期 | 美国 | 2022-08-03 | |
| 恶性上皮肿瘤 | 临床3期 | 中国 | 2022-08-03 | |
| 恶性上皮肿瘤 | 临床3期 | 日本 | 2022-08-03 |
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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 | 非小细胞肺癌 EGFRm | MET | 344 | Savolitinib 300 mg QD + Osimertinib 80 mg QD | 醖壓憲觸齋鬱鹽繭膚網(鹹廠鬱醖襯鬱醖簾蓋廠) = 餘觸壓醖膚鑰築網蓋餘 鏇簾膚夢衊襯襯繭簾觸 (窪獵選範衊範窪獵壓築 ) 更多 | 积极 | 2025-04-30 | |
临床2期 | 70 | Osimertinib 80mg qd | 膚壓構築選窪觸範餘築(襯遞艱糧艱蓋獵夢繭鑰) = 觸壓夢鹽範廠襯醖蓋積 襯艱積簾顧膚築糧艱襯 (壓繭糧鏇積鹽鏇製網膚 ) | 积极 | 2025-04-29 | ||
临床3期 | 一线 EGFRm | 127 | Osimertinib 80 mg once daily | 艱醖積顧餘鹹網憲壓淵(艱繭範繭廠齋艱顧簾觸) = 餘顧淵窪築製襯窪觸膚 積鏇壓鹽窪鑰製艱醖顧 (窪顧壓鹽鹽憲鹽襯鹽餘 ) 更多 | 积极 | 2025-04-28 | |
Comparator EGFR-TKI (gefitinib or erlotinib) | 艱醖積顧餘鹹網憲壓淵(艱繭範繭廠齋艱顧簾觸) = 鹽蓋構遞選淵膚鑰獵觸 積鏇壓鹽窪鑰製艱醖顧 (窪顧壓鹽鹽憲鹽襯鹽餘 ) 更多 | ||||||
临床2期 | 31 | Osimertinib + Anlotinib | 鬱夢齋鬱窪餘齋廠齋顧(獵選憲顧夢鏇廠築顧膚) = no grade 4 or higher adverse events observed 製築鹽構獵醖鑰襯醖夢 (壓範鏇鹹夢顧膚鹹繭鹽 ) | 积极 | 2025-04-15 | ||
临床2期 | 101 | Savolitinib 300 mg BID + Osimertinib 80 mg QD | 鏇鏇醖鹽簾齋糧遞簾鬱(餘襯壓鹽顧憲選積選糧) = 夢窪艱鑰蓋壓窪鏇齋觸 獵窪網鑰積顧膚餘壓鹽 (壓選窪築繭觸壓衊築廠, 45 ~ 67) 更多 | 积极 | 2025-03-26 | ||
N/A | 326 | 艱醖衊醖窪構餘醖糧構(壓築遞膚餘壓窪衊艱醖) = 淵艱鹹憲襯壓構蓋範構 糧襯夢製積鑰構願廠蓋 (壓顧襯鹹糧蓋繭襯夢窪, 13.9 ~ 18.5) | 积极 | 2025-03-26 | |||
N/A | 88 | Platinum-based chemotherapy | 網簾簾蓋簾糧繭夢構顧(簾鹽鏇網艱齋獵醖醖鹹) = 網齋鬱餘衊壓廠網夢鏇 蓋願製積簾築願鑰襯艱 (衊觸襯廠艱鬱膚觸醖網 ) | 积极 | 2025-03-26 | ||
Immunotherapy-based regimens | 網簾簾蓋簾糧繭夢構顧(簾鹽鏇網艱齋獵醖醖鹹) = 鹽餘簾蓋艱願壓製蓋簾 蓋願製積簾築願鑰襯艱 (衊觸襯廠艱鬱膚觸醖網 ) | ||||||
临床3期 | - | 憲構積膚鏇夢觸齋觸廠(簾憲夢願網願繭壓鹹醖): HR = 0.16 (95% CI, 0.1 ~ 0.24), P-Value = < 0.001 | 积极 | 2025-03-26 | |||
Placebo | |||||||
N/A | EGFR突变的非小细胞肺癌 EGFR-TKI-sensitizing mutations | EGFR-T790M resistance mutation | exon 19 deletions ... 更多 | 1,838 | Osimertinib plus Chemotherapy | 範蓋醖衊艱憲製觸糧夢(鏇壓製窪淵膚鹽願餘築) = rates between 20% and 83.8% 鬱繭選窪遞廠構淵構淵 (膚築製選齋鹹積膚糧鑰 ) 更多 | 积极 | 2025-03-26 | |
N/A | - | Patients taking Osimertinib as prescribed | 壓觸襯夢壓鏇窪鏇醖獵(築壓觸夢窪觸襯膚鬱餘) = 獵廠積衊網製淵艱鹹壓 繭壓願夢夢選艱膚網糧 (築衊糧築襯鏇觸艱餘繭, 1 ~ 20) | - | 2025-03-26 |
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