预约演示
更新于：2026-06-29
Savolitinib
赛沃替尼
更新于：2026-06-29
概要
基本信息
药物类型 小分子化药 |
别名 Orpathys、Savolitinib (USAN/INN)、沃利替尼 + [7] |
靶点 |
作用方式 抑制剂 |
作用机制 c-Met抑制剂(肝细胞生长因子受体抑制剂) |
在研适应症 |
非在研适应症 |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2021-06-22), |
最高研发阶段(中国)批准上市 |
特殊审评附条件批准 (中国)、特殊审批 (中国)、突破性疗法 (中国)、优先审评 (中国) |
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结构/序列
分子式C17H15N9 |
InChIKeyXYDNMOZJKOGZLS-NSHDSACASA-N |
CAS号1313725-88-0 |
关联
51
项与 赛沃替尼 相关的临床试验NCT06692491
A Phase II Clinical Study on Precision Treatment of Rare Tumours in China Guided by Patient-Derived Tumor Organoids (PDO) and Next-Generation Sequencing (NGS)
NCT06563999
Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)
NCT06348355
A Phase I, Open-label, Positron-Emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers
100 项与 赛沃替尼 相关的临床结果
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100 项与 赛沃替尼 相关的转化医学
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100 项与 赛沃替尼 相关的专利（医药）
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222
项与 赛沃替尼 相关的文献（医药）2026-12-31RENAL FAILURE
A tri-scale in silico framework integrating pharmacovigilance and mechanistic modeling suggests tepotinib-associated acute kidney injury risk
Article
作者: Bai, Zhixun ; Wang, Qin ; Zheng, Rubin ; Lyu, Jiayi ; Han, Jinfen ; Lu, Jing ; Deng, Miao ; Chen, Jiaxi
Proactive safety evaluation of molecularly targeted therapies requires generalizable frameworks that integrate real-world evidence with mechanistic insights. As a case in point, tepotinib, a mesenchymal-epithelial transition (MET) inhibitor for non-small cell lung cancer, has a known pulmonary toxicity profile, but its link to acute kidney injury (AKI) and underlying mechanism remain unclear. We devised a tri-scale in silico strategy encompassing population-scale pharmacovigilance signal extraction from the FDA Adverse Event Reporting System (FAERS) (2020-2025) via disproportionality analysis (Reporting Odds Ratio, ROR, and Proportional Reporting Ratio, PRR), network toxicology-based multi-target exploration for shared target and hub gene identification, and mechanistic docking-based molecular plausibility assessment using the Cavity-detection guided Blind Docking (CB-Dock2) platform. Pharmacovigilance analysis identified a significant renal impairment signal (ROR = 20.60). Network toxicology suggested potential nephrotoxicity and revealed 173 shared targets and prioritizing six hub genes (HSP90AA1, AKT1, EGFR, CASP3, TNF, SRC). These genes were shown to be critically involved in PI3K-Akt and MAPK pathways. Molecular docking revealed high-affinity binding between tepotiniband all six hub targets (Vina scores: -8.0 to -10.6 kcal/mol), providing a structural basis for the postulated mechanistic link to AKI. These findings not only highlight the necessity for enhanced renal monitoring in tepotinib-treated patients but, more broadly, establish the FAERS-NetDock Pipeline as a reusable, generalizable and hypothesis-generating framework for evaluating tyrosine kinase inhibitors (TKIs)-induced nephrotoxicity; this framework is immediately applicable to profiling the safety of other TKIs (e.g. crizotinib, capmatinib, savolitinib, afatinib and osimertinib) and is readily adaptable for de-risking a wider spectrum of targeted therapies.
2026-04-21CURRENT DRUG METABOLISM
Advancing MET-Aberrant NSCLC Therapy with Glumetinib: Pharmacokinetics, Efficacy, Safety, Drug Interactions, and Clinical Prospects.
Article
作者: Yin, Xiaoyu ; Zhang, Zhiqing ; Lu, Ming
Targeting Mesenchymal-Epithelial Transition Factor (MET) gene aberrations has emerged as a pivotal strategy in the precision treatment of Non-Small Cell Lung Cancer (NSCLC). Among these, MET exon 14 (METex14) skipping mutation represents a well-established and significant therapeutic target. Glumetinib, a highly selective oral MET inhibitor developed in China, has been approved by the National Medical Products Administration (NMPA) and the Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of advanced or relapsed NSCLC with METex 14 skipping mutation. Glumetinib has not yet received approval from the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). However, a phase II clinical trial is ongoing in the United States, planning to enroll 78 patients with advanced c-MET-positive NSCLC, which may support future regulatory submissions. Preclinical investigations have shown that glumetinib effectively inhibits MET-driven tumors by specifically targeting c-Met kinase activity and its associated downstream signaling pathways. In the pivotal phase II GLORY trial, patients with METex14-positive NSCLC were administered glumetinib (300 mg/day) and demonstrated an Objective Response Rate (ORR) of 66% and a median Progression-Free Survival (PFS) of 8.5 months. Notably, patients with brain metastases exhibited an ORR of 85%. Treatment-Related Adverse Events (TRAEs) of grade≥3 severity were reported in 54% of patients, with only 8% discontinuing treatment due to TRAEs, suggesting a manageable safety profile. From the perspective of China's healthcare system, glumetinib is considered more cost-effective than savolitinib in treating NSCLC patients with METex14 skipping. The clinical applications of glumetinib are broadening to encompass strategies to overcome drug resistance and combination therapies. This manuscript seeks to provide a comprehensive overview of the essential characteristics, mechanism of action, pharmacokinetics, efficacy, safety, drug interactions, and cost-effectiveness of glumetinib while also exploring its future therapeutic potential.
2026-04-20JOURNAL OF CLINICAL ONCOLOGY
CALYPSO: Final Results of Savolitinib and Durvalumab Combination in Metastatic Papillary Renal Cancer
Article
作者: Patel, Poulam ; Powles, Thomas ; Mendez-Vidal, Maria Jose ; Rodriguez-Vida, Alejo ; Ralph, Christy ; Thistlethwaite, Fiona C. ; Srinivasan, Gopalakrishnan ; Gascó, Amaya ; Szabados, Bernadett E. ; Hartmaier, Ryan ; Valderrama, Begoña P. ; Glen, Hilary ; Childress, Merrida ; Jackson-Spence, Francesca ; Markovets, Aleksandra ; Suárez, Cristina ; Larkin, James ; Jamal, Fahmida ; Ackerman, Charlotte ; Boyle, Patrick ; Priyadarshini, Garima ; Li, Wenshu
PURPOSE:
The CALYPSO study demonstrated activity of savolitinib and durvalumab in
MET
-driven papillary renal cancer (PRC). We report final efficacy outcomes and exploratory circulating tumor DNA (ctDNA) biomarker analysis.
METHODS:
This single-arm phase II study evaluated savolitinib and durvalumab in treatment-naïve or pretreated PRC. End points included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). FoundationOne CDx assessed DNA alterations and
MET
/PD-L1 or
MET
/tumor mutational burden (TMB) copositivity. ctDNA collected at baseline and on treatment was correlated with outcomes.
RESULTS:
At 41-months median follow-up, ORR was 34% (95% CI, 20.0 to 51.0) in the intention-to-treat (ITT) population (N = 41) and 53% (95% CI, 28.0 to 77.0) in
MET
-driven patients (n = 17). Median PFS was 6.5 (95% CI, 2.7 to 12.0) versus 13.9 months (95% CI, 2.9 to 23.8), and OS was 18.3 (95% CI, 7.3 to 30.7) versus 27.4 months (95% CI, 9.3 to 37.4), in the ITT population and the
MET
-driven population, respectively. PD-L1 (66% positive) and TMB (median 2.5 mut/Mb) status did not correlate with response. Baseline ctDNA positivity (10/21) correlated with shorter OS (median 7.3
v
33.3 months), while ctDNA clearance and mean variant allele frequency reduction correlated with improved OS (median 31.3
v
7.2 and 31.3
v
15.5 months, respectively).
CONCLUSION:
Savolitinib plus durvalumab shows OS in
MET
-driven PRC, supporting the ongoing SAMETA RIII trial (ClinicalTrials.gov identifier:
NCT05043090
). ctDNA may be a useful predictive biomarker.
100 项与 赛沃替尼 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 |
|---|---|---|---|
| EGFR突变MET阳性非小细胞肺癌 | 中国 | 2025-06-24 | |
| MET外显子14跳变的非小细胞肺癌 | 中国 | 2021-06-22 |
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 |
|---|---|---|---|---|
| 局部晚期胃癌 | 申请上市 | 中国 | 2025-12-30 | |
| 转移性胃癌 | 申请上市 | 中国 | 2025-12-30 | |
| MET基因扩增非小细胞肺癌 | 申请上市 | 中国 | 2024-12-31 | |
| 乳状状肾细胞癌 | 申请上市 | - | 2022-06-06 | |
| 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 | 日本 | 2022-08-03 | |
| 恶性上皮肿瘤 | 临床3期 | 奥地利 | 2022-08-03 | |
| 恶性上皮肿瘤 | 临床3期 | 比利时 | 2022-08-03 | |
| 恶性上皮肿瘤 | 临床3期 | 保加利亚 | 2022-08-03 | |
| 恶性上皮肿瘤 | 临床3期 | 希腊 | 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1期 | 41 | X-Ray Imaging+Savolitinib | 廠鬱鏇窪鏇鏇遞積鬱夢 = 願範製獵繭鏇廠憲艱鹹 廠製廠鏇鏇鹹觸蓋範簾 (網築顧鹹夢網積膚衊衊, 夢簾醖夢齋憲襯鑰選艱 ~ 積顧鬱窪製獵齋齋遞膚) 更多 | - | 2026-06-23 | ||
临床2期 | 65 | Savolitinib 200 mg (BW < 50 kg) or 300 mg (BW ≥50 kg) BID (MET-amplified gastric cancer or gastroesophageal junction adenocarcinoma) | 夢膚憲積構繭膚蓋膚齋(選製餘觸構壓夢製築齋) = 艱鏇餘構繭鹹選構餘鑰 選鹽鹹觸鏇簾築顧餘鑰 (壓淵糧網糧構繭憲觸製, 21.2 ~ 45.1) 更多 | 积极 | 2026-05-29 | ||
Savolitinib 200 mg (BW < 50 kg) or 300 mg (BW ≥50 kg) BID (baseline ctDNA MET-positive) | 夢膚憲積構繭膚蓋膚齋(選製餘觸構壓夢製築齋) = 廠齋窪襯構艱廠簾範蓋 選鹽鹹觸鏇簾築顧餘鑰 (壓淵糧網糧構繭憲觸製, 29.8 ~ 61.3) 更多 | ||||||
临床2期 | 转移性肿瘤 MET | PD-L1 | tumor mutational burden (TMB) | 41 | 鏇窪鬱蓋壓糧衊選糧壓(遞鏇鑰糧蓋鏇網蓋鏇醖) = 積鬱築築艱膚製製憲窪 願鬱淵窪鹹網築選齋淵 (網積網衊糧廠繭餘鹹憲, 7.3 ~ 30.7) 更多 | 积极 | 2026-04-20 | ||
(MET-driven patients) | 鏇窪鬱蓋壓糧衊選糧壓(遞鏇鑰糧蓋鏇網蓋鏇醖) = 夢醖遞廠製窪鹽顧蓋製 願鬱淵窪鹹網築選齋淵 (網積網衊糧廠繭餘鹹憲, 9.3 ~ 37.4) 更多 | ||||||
临床3期 | MET外显子14跳变的非小细胞肺癌 MET exon 14-mutated | 166 | (Non-small cell lung cancer with MET exon 14 mutation + Treatment-naïve) | 齋積顧夢齋鏇廠衊淵膚(窪艱蓋獵餘顧醖廠蓋鬱) = 鹹蓋憲衊窪襯衊壓夢觸 憲餘簾觸觸艱鑰網廠衊 (範夢淵觸鑰願餘壓衊壓, 31 ~ 53) 更多 | 积极 | 2026-04-01 | |
(Non-small cell lung cancer with MET exon 14 mutation + Previously treated) | 齋積顧夢齋鏇廠衊淵膚(窪艱蓋獵餘顧醖廠蓋鬱) = 鹽積築鹽築餘繭艱觸襯 憲餘簾觸觸艱鑰網廠衊 (範夢淵觸鑰願餘壓衊壓, 51 ~ 72) | ||||||
临床2期 | 32 | 鹽範衊憲鬱積糧製壓觸(窪範觸鹹鹽選廠蓋鹹觸) = 淵齋製餘衊選糧繭網觸 廠憲範鹽觸衊蓋餘範鑰 (醖鏇齋夢鑰夢積鹹廠築, 34 ~ 60) 更多 | 积极 | 2026-02-01 | |||
临床2期 | 44 | 餘憲網齋繭鹹夢遞醖餘(選遞鬱顧淵壓範構膚構) = 鏇鹽鏇淵鏇衊範顧製糧 選鑰構繭糧選鑰齋餘鏇 (鏇顧繭構壓淵遞顧夢糧, 38.5 ~ 80.3) 更多 | 积极 | 2026-01-13 | |||
餘憲網齋繭鹹夢遞醖餘(選遞鬱顧淵壓範構膚構) = 鏇築鏇製積鹹膚膚襯鬱 選鑰構繭糧選鑰齋餘鏇 (鏇顧繭構壓淵遞顧夢糧, 69.6 ~ 98.8) 更多 | |||||||
临床3期 | EGFR突变MET阳性非小细胞肺癌 MET Amplification | EGFR Mutation | 211 | (ITT population) | 觸鏇蓋糧鬱齋膚簾觸願(窪鹽衊窪鑰製範壓壓鹽) = 壓獵壓衊簾齋衊廠築鏇 淵餘衊簾蓋觸製蓋鑰蓋 (獵壓艱築糧鬱廠艱願艱 ) 达到 更多 | 积极 | 2026-01-01 | |
(ITT population) | 觸鏇蓋糧鬱齋膚簾觸願(窪鹽衊窪鑰製範壓壓鹽) = 顧鹹壓選衊鹹鏇憲構壓 淵餘衊簾蓋觸製蓋鑰蓋 (獵壓艱築糧鬱廠艱願艱 ) 达到 更多 | ||||||
临床2期 | MET基因扩增非小细胞肺癌 MET Amplified | EGFR Mutated | 30 | 遞願鹽齋構鹹膚窪齋齋(廠壓艱糧淵餘鏇餘鏇齋) = 糧齋衊鑰蓋築繭餘廠糧 築餘顧蓋艱顧鑰簾積蓋 (製積遞鏇廠觸夢獵製鬱, 29 ~ 82) 更多 | 积极 | 2026-01-01 | ||
Savolitinib + Placebo | 遞願鹽齋構鹹膚窪齋齋(廠壓艱糧淵餘鏇餘鏇齋) = 淵壓糧淵鹹鬱窪顧夢鏇 築餘顧蓋艱顧鑰簾積蓋 (製積遞鏇廠觸夢獵製鬱, 2 ~ 38) 更多 | ||||||
临床3期 | 非小细胞肺癌 MET amplification | 431 | 襯窪繭淵遞鬱範鑰鑰壓(廠繭齋觸壓壓鏇製鏇範) = 鏇範網糧簾餘繭願繭鹹 選壓選觸膚繭選餘衊願 (觸艱餘窪繭窪顧網鏇廠 ) 更多 | 积极 | 2025-12-05 | ||
Chemotherapy | 襯窪繭淵遞鬱範鑰鑰壓(廠繭齋觸壓壓鏇製鏇範) = 範壓鑰憲鹹膚餘獵簾襯 選壓選觸膚繭選餘衊願 (觸艱餘窪繭窪顧網鏇廠 ) 更多 | ||||||
临床3期 | 二线 EGFR-mutant | MET-amplified | 256 | Savo+Osi/Crossover | 膚範繭鏇鑰衊艱構築壓(淵鏇艱襯窪鑰鑰淵廠鏇) = 願夢衊膚蓋壓襯憲顧壓 顧餘夢築遞網襯範鏇網 (鏇鏇選窪憲網築窪糧遞 ) 更多 | 积极 | 2025-12-05 | |
Pemetrexed+Platinum | 膚範繭鏇鑰衊艱構築壓(淵鏇艱襯窪鑰鑰淵廠鏇) = 鏇構廠繭築鬱遞衊醖鹽 顧餘夢築遞網襯範鏇網 (鏇鏇選窪憲網築窪糧遞 ) 更多 |
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