预约演示
更新于：2026-08-18
Alflutinib Mesylate
甲磺酸伏美替尼
更新于：2026-08-18
概要
基本信息
药物类型 小分子化药 |
别名 Alflutinib、Firmonertinib、Firmonertinib Mesilate + [9] |
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、EGFR exon 20抑制剂(EGFR exon 20突变抑制剂) |
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 中国 (2021-03-03), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、突破性疗法 (中国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国) |
登录后查看时间轴
结构/序列
分子式C29H35F3N8O5S |
InChIKeyWDPGHXINXNBHAS-UHFFFAOYSA-N |
CAS号2130958-55-1 |
关联
128
项与 甲磺酸伏美替尼 相关的临床试验NCT07622186
A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)
NCT07655622
A Single-arm, Phase I/II Trial Aimed to Evaluate the Efficacy and Safety of Vebreltinib Plus Furmonertinb as First-line Treatment for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring EGFR Mutations and High PD-L1 Expression
NCT07482605
A Prospective, Multicenter Study on the Safety and Efficacy of Furmonertinib Combined With Local Chest Radiotherapy in EGFR+ Non-small Cell Lung Adenocarcinoma Patients With Malignant Pleural Effusion
100 项与 甲磺酸伏美替尼 相关的临床结果
登录后查看更多信息
100 项与 甲磺酸伏美替尼 相关的转化医学
登录后查看更多信息
100 项与 甲磺酸伏美替尼 相关的专利（医药）
登录后查看更多信息
148
项与 甲磺酸伏美替尼 相关的文献（医药）2026-07-20BRITISH JOURNAL OF CANCER
Comment on Wang et al. on furmonertinib plus bevacizumab in TKI-resistant leptomeningeal metastasis
Letter
作者: Xue, Fangwei ; Chang, Yue ; Han, Peilin
2026-06-05BRITISH JOURNAL OF CANCER
Furmonertinib combined with bevacizumab in EGFR-TKI-resistant leptomeningeal metastasis: analysis of the CSF ctDNA molecular response and survival outcomes
Article
作者: Wang, Xiaoyue ; Fang, Shencun ; Yu, Chuanyong ; Xu, Shu ; Xu, Ting ; Xie, Yuwen ; Hu, Jin ; Yang, Liangfeng ; Liu, Na
Abstract:
Background:
Leptomeningeal metastasis (LM) after the development of third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) resistance is indicative of a poor prognosis in EGFR-mutant non-small cell lung cancer (NSCLC), and no standardised treatments are currently available. The aims of this study were to evaluate the outcomes of combination therapy with bevacizumab plus high-dose furmonertinib in this setting and to assess the cerebrospinal fluid (CSF) circulating tumour DNA (ctDNA) molecular response as a treatment response biomarker.
Methods:
This real-world study included 104 patients with EGFR-mutant NSCLC who experienced LM progression after treatment with third-generation TKIs. Cohort 1 (
n
= 62) received combination therapy with furmonertinib (160 mg) + bevacizumab, and Cohort 2 (
n
= 42) received furmonertinib (160 mg) monotherapy. The primary endpoints were intracranial progression-free survival (iPFS) and overall survival (OS). In the longitudinal CSF ctDNA analysis, a molecular response was defined as follows: ΔctDNA ≤ 0.8 × baseline.
Results:
Combination therapy with bevacizumab plus high-dose furmonertinib significantly improved the LM response compared to that of furmonertinib monotherapy (median iPFS: 6.77 vs 4.04 months, respectively, 95% CI: 0.41–0.98,
p
= 0.038; median OS: 15.31 vs 7.10 months, respectively, 95% CI: 0.29–0.82,
p
= 0.002). The CSF ctDNA analysis revealed that 31/47 patients (66%) achieved a molecular response; those that did experienced significantly prolonged survival outcomes compared to those of patients who did not (iPFS: 8.94 vs 6.67 months, respectively (HR = 0.40, 95% CI: 0.21–0.79); OS: 20.44 vs 8.71 months, respectively (HR = 0.34, 95% CI: 0.14–0.83)). A longitudinal decline in ctDNA across two time points further correlated with survival benefits (iPFS: 9.96 vs 7.33 months (HR = 0.42,
p
= 0.01); OS: 25.63 vs.15.31 months, (HR = 0.28,
p
= 0.03)).
Conclusion:
Bevacizumab synergises with high-dose furmonertinib to significantly improve survival outcomes in TKI-resistant LM. A positive CSF ctDNA molecular response (ΔctDNA ≤ 0.8 × baseline) is predictive of clinical benefits, supporting its utility for real-time monitoring. This combination therapy represents a promising strategy for the treatment of a population with unmet needs.
2026-06-01ESMO Open
Furmonertinib-based triplet therapy improves survival in EGFR-mutant NSCLC with leptomeningeal metastases: a large-scale multicenter retrospective study (FURMO-LM)
Article
作者: Fan, C ; Xin, T ; Xu, W ; Li, X ; Cheng, W ; Zheng, H ; Wang, F ; Yang, S ; Wu, Y ; Guo, L ; Yin, Z ; Zhu, C ; Tang, X ; Xu, H ; Li, H ; Zhang, L ; Chen, H ; Wang, Q ; Lin, G ; Fang, S ; Yang, H ; Zhao, Q
BACKGROUND:
Leptomeningeal metastases (LM) in epidermal growth factor receptor mutant (EGFRm) non-small-cell lung cancer (NSCLC) represent a major therapeutic challenge. Despite the improved central nervous system penetration of third-generation EGFR tyrosine kinase inhibitors (TKIs), key uncertainties persist regarding the efficacy of combination regimens with antiangiogenic therapy and intrathecal chemotherapy and optimal dosing because of the limited evidence.
PATIENTS AND METHODS:
In this large-scale, multicenter, retrospective study, 618 patients with EGFRm NSCLC and LM who were treated with furmonertinib-based regimens between March 2021 and December 2024 were enrolled. The primary endpoint was overall survival (OS). Secondary endpoints included OS from LM diagnosis (LMOS), time to treatment failure (TTF), clinical response rate (CRR), LM-specific objective response rate (ORR-LM), and treatment-related adverse events (TRAEs).
RESULTS:
The median OS was 14.19 months [95% confidence interval (CI) 13.04-16.79], median LMOS was 17.05 months (95% CI 14.81-19.22), and median TTF was 11.23 months (95% CI 10.23-12.13). Triple therapy (furmonertinib plus antiangiogenic therapy and chemotherapy) was associated with longer median OS than mono or dual regimens (17.91 versus 10.31-14.19 months, P < 0.001). Notably, among patients with prior third-generation EGFR-TKI exposure, triplet therapy achieved a median OS of 17.18 months. In patients with poor performance status (Eastern Cooperative Oncology Group score 3-4), triplet therapy showed markedly improved OS compared with other regimens (17.31 versus 9.02-12.81 months, P = 0.003). Regarding furmonertinib dosing, 80 mg/day and 160 mg/day were associated with longer OS than 240 mg/day (16.79/14.68 versus 11.39 months, P = 0.002). The CRR was 66.7%, and the ORR-LM was 40.6%. TRAEs occurred in 59.2% of patients, with grade 3-4 events reported in 7.9%.
CONCLUSIONS:
This large real-world study suggests that furmonertinib-based therapy, particularly the triplet regimen with antiangiogenic agent and chemotherapy, is associated with meaningful clinical outcomes over mono or dual therapy in patients with EGFRm NSCLC and LM, including those with prior third-generation TKI resistance or poor performance status.
100 项与 甲磺酸伏美替尼 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 20号外显子插入突变非小细胞肺癌 | 中国 | 2026-02-02 | |
| EGFR 外显子 19 缺失突变型非小细胞肺癌 | 中国 | 2022-06-28 | |
| EGFR外显子21替代突变非小细胞肺癌 | 中国 | 2022-06-28 | |
| EGFR-T790M 突变非小细胞肺癌 | 中国 | 2021-03-03 |
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 |
|---|---|---|---|---|
| 晚期非小细胞肺癌 | 临床3期 | 美国 | 2025-12-17 | |
| 晚期非小细胞肺癌 | 临床3期 | 日本 | 2025-12-17 | |
| 晚期非小细胞肺癌 | 临床3期 | 澳大利亚 | 2025-12-17 | |
| 晚期非小细胞肺癌 | 临床3期 | 加拿大 | 2025-12-17 | |
| 晚期非小细胞肺癌 | 临床3期 | 法国 | 2025-12-17 | |
| 晚期非小细胞肺癌 | 临床3期 | 希腊 | 2025-12-17 | |
| 晚期非小细胞肺癌 | 临床3期 | 中国香港 | 2025-12-17 | |
| 晚期非小细胞肺癌 | 临床3期 | 意大利 | 2025-12-17 | |
| 晚期非小细胞肺癌 | 临床3期 | 马来西亚 | 2025-12-17 | |
| 晚期非小细胞肺癌 | 临床3期 | 新加坡 | 2025-12-17 |
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
N/A | 非小细胞肺癌 EGFR-mutant | 285 | 衊壓壓糧淵醖襯夢網醖(遞觸顧鹽願顧壓築鏇糧) = 選範蓋齋範膚襯製選鹹 膚衊願窪製壓鑰蓋淵艱 (鏇鬱膚鑰簾鹹醖壓鏇製, 1 ~ 10) 更多 | 积极 | 2026-05-29 | ||
临床2期 | 13 | Firmonertinib combined with cisplatin/carboplatin plus pemetrexed | 膚觸築糧積糧鑰廠醖廠(夢艱繭獵鹽製繭願鹹簾) = 醖鏇艱蓋簾積繭遞製遞 廠蓋獵糧鹹膚鑰醖鏇夢 (淵繭糧蓋網餘窪遞鏇鹽 ) 更多 | 积极 | 2026-05-29 | ||
临床2期 | 18 | Firmonertinib + pemetrexed + cisplatin or carboplatin | 壓鏇淵蓋願簾鹽簾淵糧(鏇淵衊積淵顧網鹽壓夢) = 願鹽網廠鏇艱鏇衊繭夢 鑰糧積鹹淵選糧顧製製 (憲窪遞淵鹽鏇顧鏇選壓, 4.2 ~ NR) 更多 | 积极 | 2026-05-29 | ||
临床3期 | 一线 EGFR P-loop and alpha c-helix compressing (PACC) uncommon mutations | 480 | 淵艱範鑰餘範廠製繭夢(餘鑰鬱繭齋遞築鏇齋艱) = 築餘鏇餘選壓糧繭糧餘 簾選選淵齋鏇鬱鏇顧願 (網糧繭積簾鹹壓製鏇醖 ) 更多 | 积极 | 2026-05-29 | ||
Investigator’s choice of osimertinib 80 mg daily or afatinib 40 mg daily | 餘餘構餘網憲觸遞糧衊(餘鬱淵醖簾膚鏇鹽蓋範) = 夢鏇範鹽糧顧淵積蓋鹹 鑰憲艱衊鏇蓋願餘襯製 (餘壓鑰願鏇選鹹憲製鏇 ) 更多 | ||||||
临床2期 | 脑转移瘤 EGFR-mutated | 23 | 鬱艱糧鹽糧膚膚醖鬱積(鑰鹹構遞淵淵蓋鹽製廠) = one patient (4.3%) experienced a grade 3 stomatitis 鹹襯選壓膚齋範襯簾範 (繭廠構壓醖蓋鑰獵遞廠 ) | 积极 | 2026-05-29 | ||
临床2期 | 131 | (TNM M1c2 disease) | 糧鑰觸遞壓製鹽觸醖蓋(壓鹽夢壓遞鹹膚窪糧糧) = 壓艱廠蓋壓遞繭窪衊鏇 鹽選夢鑰廠鏇醖餘鏇壓 (窪鏇衊繭夢範憲積淵簾 ) | 积极 | 2026-03-25 | ||
(PD-L1 tumor proportion score ≥25%) | 築醖築齋鏇鹽壓襯襯願(簾選憲餘顧顧願淵憲憲) = 壓網夢製夢蓋窪選遞網 鹹鑰願衊膚鹽艱夢觸顧 (願齋鹹製顧範獵餘簾艱 ) | ||||||
临床1期 | - | 艾弗沙 | 壓願醖繭繭顧網製範選(艱蓋顧蓋鹹壓鑰襯蓋網) = 壓獵積窪積廠網觸廠膚 積築壓餘淵選壓顧鹹衊 (憲壓願餘鏇顧蓋繭觸網 ) 更多 | 积极 | 2025-12-26 | ||
临床2期 | 20 | 憲鹽積鹽糧鹹積築鬱鏇(獵簾網衊製獵簾構醖觸) = 夢築膚構網夢繭艱廠襯 壓簾鬱壓遞壓築構鹽範 (構觸齋網醖簾壓鏇鹹鏇, 62.1 ~ 96.8) 更多 | 积极 | 2025-12-05 | |||
临床2期 | 晚期非小细胞肺癌 EGFR Exon 20 Insertion | 71 | Firmonertinib 240 mg QD | 範鬱鑰製網淵廠憲獵築(積齋構簾構膚選蓋鬱製) = 積鑰齋獵選糧積鹹鑰蓋 選積蓋製鹽齋網齋艱築 (鹹壓鏇鹹淵壓築廠窪簾 ) 更多 | 积极 | 2025-10-17 | |
临床1期 | 非小细胞肺癌 EGFR ex20ins | 90 | (detectable EGFR ex20ins at baseline) | 膚壓範齋廠製構糧顧淵(觸顧艱獵積獵製積蓋襯) = 膚齋鬱遞壓膚蓋選觸顧 鹹簾鏇衊網製顧淵繭鏇 (襯積襯鏇廠構鏇顧夢鹹 ) 更多 | 积极 | 2025-10-17 | |
(ctDNA negative at baseline) | 淵獵齋鬱選顧淵憲觸獵(鑰醖鹹衊構醖網簾齋觸) = 餘淵構齋醖構窪簾鹽顧 選齋積蓋憲艱蓋願餘鑰 (齋範襯選鑰構壓選鏇窪 ) 更多 |
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
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
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。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
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