预约演示
更新于：2026-02-09
Pembrolizumab
帕博利珠单抗
更新于：2026-02-09
概要
基本信息
药物类型 单克隆抗体 |
别名 Lambrolizumab、Pembrolizumab (Genetical Recombination)、Pembrolizumab (genetical recombination) (JAN) + [11] |
靶点 |
作用方式 抑制剂 |
作用机制 PD-1抑制剂(细胞程序性死亡-1抑制剂) |
在研适应症 |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2014-09-04), |
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 (美国)、优先药物（PRIME） (欧盟)、孤儿药 (日本)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、突破性疗法 (中国)、优先审评 (美国)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国) |
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结构/序列
Sequence Code 93660H
来源: *****
Sequence Code 93670L
来源: *****
关联
2,569
项与 帕博利珠单抗 相关的临床试验NCT05077215
A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab vs. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer
NCT05106127
A Phase 2, Open-Label, Safety Lead-In With Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab
NCT07275216
Phase 2 Study of Pembrolizumab With Chemotherapy in Frail Patients With Newly Diagnosed Classical Hodgkin Lymphoma
100 项与 帕博利珠单抗 相关的临床结果
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100 项与 帕博利珠单抗 相关的转化医学
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100 项与 帕博利珠单抗 相关的专利（医药）
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9,390
项与 帕博利珠单抗 相关的文献（医药）2026-12-31ANNALS OF MEDICINE
Application of artificial intelligence in head and neck squamous cell carcinoma
Review
作者: Tian, Jiaxin ; Wang, Peipei ; Zheng, Guowan ; Chen, Yunzhao ; Ren, Xinxin
Background: Head and neck squamous cell carcinoma (HNSCC) emerges from the mucosal linings of the paranasal sinuses, nasal cavities, oral cavity, nasopharynx, oropharynx, hypopharynx and larynx. Despite significant advances in understanding its epidemiology, pathogenesis and treatment strategies, the survival rate of HNSCC has shown little improvement over the last 40 years, maintaining a 5-year survival outcome of approximately 50%. Although the emergence of immunotherapies, such as pembrolizumab-FDA-approved for first-line HNSCC treatment-has shown promise in enhancing therapeutic outcomes and patient prognosis, merely a limited portion of individuals with HNSCC experience advantages from these therapeutic approaches.Main body: Consequently, the need for novel biomarkers to refine treatment selection is increasingly urgent. The swift progress of artificial intelligence (AI) in medicine has enabled large-scale biomarker screening and the creation of predictive models, which are critical for identifying immunotherapy responders and predicting patient outcomes. This review summarizes current immunotherapeutic approaches in HNSCC and examines the role of AI in advancing immunotherapy strategies.Discussion: Furthermore, it discusses the challenges, opportunities and strategies associated with integrating AI into clinical practice. Finally, the review highlights the transformative potential of AI in HNSCC immunotherapy and offers perspectives on its future applications.
2026-12-31PLATELETS
Immune thrombocytopenia triggered by dostarlimab in a patient with endometrial carcinoma: first reported case
Article
作者: Pazmiño-Zambrano, M. Belén ; García-Jaén, Pablo ; González-Porras, José Ramón ; Bastida, José María ; Fernández-Sánchez, Adolfo ; Reguera-Puertas, Pablo ; Puerta-Vázquez, Carlos
Immune checkpoint inhibitors (ICIs) have transformed the treatment landscape for various malignancies, but they are associated with a range of immunerelated adverse events, including rare hematological complications. Immune thrombocytopenia (ITP) has been reported with other antiPD1 agents such as nivolumab and pembrolizumab, but to date, no cases have been described with dostarlimab. We report the first case of ITP in a patient receiving dostarlimab for relapsed endometrial carcinoma. A 55yearold woman developed severe thrombocytopenia (3 × 109/L) accompanied by rectal bleeding, resulting in a lifethreatening condition. Secondary causes were excluded, and bone marrow findings supported a diagnosis of ITP. Initial treatment with highdose corticosteroids and intravenous immunoglobulin achieved only a partial response, while sustained platelet recovery was obtained with the addition of romiplostim. The patient remained on dostarlimab following hematological recovery without further episodes of ITP. This case highlights a potentially lifethreatening adverse effect of a widely used immunotherapy and underscores the importance of early recognition and timely escalation of treatment in ICIinduced ITP.
2026-12-01MOLECULAR BIOLOGY REPORTS
Extracellular vesicles-derived LncRNA MAFG-AS1 predicts clinical response to pembrolizumab in patients with advanced urothelial carcinoma
Article
作者: Hitaka, Yukihiro ; Ban, Yoshimasa ; Hirata, Hiroshi ; Shimizu, Kosuke ; Shiraishi, Koji ; Tokunaga, Takanori ; Fujii, Nakanori ; Oka, Shintaro ; Kobayashi, Keita ; Isoyama, Naohito
BACKGROUND:
Pembrolizumab is an important immune checkpoint inhibitor for advanced urothelial carcinoma (aUC). However, there are no established biomarkers to predict its efficacy. Extracellular vesicles (EVs) are liquid bilayer structures released from various cells that contain genetic information such as DNAs, RNAs, and proteins. EVs-derived long non-coding RNAs (lncRNAs) have been reported to be involved play in tumor progression and drug resistance. We investigated whether EVs-derived lncRNA MAFG-AS1 is effective in predicting pembrolizumab efficacy.
METHODS:
The expression of lncRNA MAFG-AS1 was examined in UC tissues from 22 patients who underwent total cystectomy at our institution, and normal urothelial tissues. Functional analysis of lncRNA MAFG-AS1 were performed using bladder cancer cell lines. The relationship between EVs-derived lncRNA MAFG-AS1 expression and clinical response and prognosis was examined in 52 patients treated with pembrolizumab.
RESULTS:
The expression of lncRNA MAFG-AS1 was notably higher in UC tissues than in normal urothelial tissues. LncRNA MAFG-AS1 knockdown in bladder cancer cells by siRNA, significantly decreased cell viability, invasion, and migration. Patients with a clinical response showed significantly a lower EVs-derived lncRNA MAFG-AS1 expression than those with no clinical response. The high EVs-derived lncRNA MAFG-AS1 expression group had significantly worse progression-free and overall survival than the low expression group (Log-rank P = 0.0096 and log-rank P = 0.0349, respectively). In multivariate analysis, high EVs-derived lncRNA MAFG-AS1 expression was a significant risk factor for poor clinical response to pembrolizumab (HR = 3.2, P = 0.0010).
CONCLUSIONS:
The EVs-derived lncRNA MAFG-AS1 may be an effective less-invasive biomarker for predicting the efficacy of pembrolizumab in aUC.
100 项与 帕博利珠单抗 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 |
|---|---|---|---|
| 局部晚期头颈部鳞状细胞癌 | 冰岛 | 2025-10-30 | |
| 局部晚期头颈部鳞状细胞癌 | 列支敦士登 | 2025-10-30 | |
| 局部晚期头颈部鳞状细胞癌 | 挪威 | 2025-10-30 | |
| 不可切除的肝细胞癌 | 中国 | 2025-06-10 | |
| 不可切除的胸膜恶性间皮瘤 | 冰岛 | 2025-04-16 | |
| 不可切除的胸膜恶性间皮瘤 | 挪威 | 2025-04-16 | |
| 不可切除的尿路上皮癌 | 欧盟 | 2024-07-25 | |
| 不可切除的尿路上皮癌 | 冰岛 | 2024-07-25 | |
| 不可切除的尿路上皮癌 | 列支敦士登 | 2024-07-25 | |
| 不可切除的尿路上皮癌 | 挪威 | 2024-07-25 | |
| 晚期子宫内膜癌 | 美国 | 2024-06-17 | |
| MSI-H 子宫内膜癌 | 美国 | 2024-06-17 | |
| 错配修复缺陷子宫内膜癌 | 美国 | 2024-06-17 | |
| 晚期胃癌 | 日本 | 2024-05-17 | |
| 复发性胃癌 | 日本 | 2024-05-17 | |
| 不能切除的胆道癌 | 加拿大 | 2024-05-09 | |
| 晚期胆道癌 | 中国 | 2024-01-30 | |
| 局部晚期胆管癌 | 中国 | 2024-01-30 | |
| 胃腺癌 | 挪威 | 2023-12-20 | |
| HER2阴性胃癌 | 美国 | 2023-11-16 |
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 |
|---|---|---|---|---|
| 复发性铂耐药性卵巢癌 | 申请上市 | 美国 | 2025-10-20 | |
| 小肠癌 | 申请上市 | 欧盟 | 2022-03-25 | |
| 铂耐药上皮性卵巢癌 | 临床3期 | 澳大利亚 | 2022-01-10 | |
| 铂耐药上皮性卵巢癌 | 临床3期 | 奥地利 | 2022-01-10 | |
| 铂耐药上皮性卵巢癌 | 临床3期 | 新加坡 | 2022-01-10 | |
| 铂耐药上皮性卵巢癌 | 临床3期 | 英国 | 2022-01-10 | |
| 卵巢上皮癌 | 临床3期 | 美国 | 2021-12-13 | |
| 卵巢上皮癌 | 临床3期 | 日本 | 2021-12-13 | |
| 卵巢上皮癌 | 临床3期 | 比利时 | 2021-12-13 | |
| 卵巢上皮癌 | 临床3期 | 加拿大 | 2021-12-13 |
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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 | 28 | (Arm A - Pembrolizumab and Defactinib) | 糧顧繭憲壓範鹹鬱繭衊 = 積簾夢鑰構願蓋繭築繭 鏇繭糧積範鹹醖蓋窪齋 (鬱選壓鑰鏇構築遞衊壓, 鹹餘蓋襯築鏇觸膚衊艱 ~ 襯遞網積願餘顧餘鬱襯) 更多 | - | 2026-02-04 | ||
(Arm B - Pembrolizumab) | 糧顧繭憲壓範鹹鬱繭衊 = 構窪淵憲觸醖蓋壓醖願 鏇繭糧積範鹹醖蓋窪齋 (鬱選壓鑰鏇構築遞衊壓, 繭廠衊網壓夢網膚蓋襯 ~ 積糧醖糧積膚網鏇淵醖) 更多 | ||||||
临床1期 | 5 | Stereotactic Body Radiotherapy (SBRT)+Pembrolizumab (Initial Safety Cohort) | 醖廠鏇淵憲繭鑰醖鑰簾 = 獵鬱範窪憲醖範觸簾醖 夢膚鹽積獵構遞艱製醖 (鬱築積觸蓋廠鹹膚窪獵, 築醖齋願鑰遞糧遞艱顧 ~ 鹽餘願願蓋簾簾鹹膚憲) 更多 | - | 2026-02-04 | ||
Stereotactic Body Radiotherapy (SBRT)+Pembrolizumab (Expansion Cohort) | 餘簾選積簾窪膚壓鹽醖 = 襯襯餘簾憲襯蓋餘襯願 淵齋憲構憲廠製獵願艱 (糧襯選觸蓋鹹獵膚夢鏇, 窪獵齋製鬱簾壓膚淵築 ~ 觸願築範淵簾糧簾範醖) 更多 | ||||||
临床2期 | 27 | 選憲遞蓋衊顧鏇觸遞襯(鑰觸製鹹壓鹽範糧觸餘) = 夢壓襯齋顧選顧壓網壓 觸廠鹽鬱鬱鬱壓衊簾獵 (鹹網鬱窪窪廠壓艱鬱鑰, 21 ~ 61) 更多 | 积极 | 2026-02-01 | |||
临床1期 | 2 | Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#)+Pembrolizumab (Dose Escalation Cohort - DOSE LEVEL 1) | 膚製鹽積選顧廠製選製 = 觸餘醖願膚艱鏇艱範餘 簾顧範膚醖顧糧餘構構 (艱醖簾鏇廠鑰範淵範願, 獵鹹夢獵膚網選壓範遞 ~ 築蓋選積醖願膚窪窪醖) 更多 | - | 2026-01-29 | ||
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#)+Pembrolizumab (Dose Escalation Cohort - DOSE LEVEL 2) | 壓鏇膚構構鑰鹽憲鹽願(鹽窪遞壓鏇夢鹹鬱觸獵) = 獵鑰鏇繭餘選窪構壓遞 獵醖鹹夢遞願願顧夢構 (構積鹽艱淵鏇糧遞獵築, 艱範衊餘衊鹹鬱淵餘窪 ~ 糧餘範選簾網繭範襯鑰) 更多 | ||||||
临床1/2期 | 16 | 範選淵願範蓋餘顧鑰觸 = 鬱鹹鹽夢壓選淵繭鹹鹹 窪繭膚簾鹽鏇遞窪餘簾 (齋醖積壓艱鹹膚鬱齋遞, 觸餘遞觸鹹齋糧積鹹鑰 ~ 廠糧壓醖糧醖廠齋鹹夢) 更多 | - | 2026-01-29 | |||
临床1/2期 | 18 | Radiotherapy+Pembrolizumab | 蓋繭醖蓋選簾壓顧糧簾 = 鑰構鬱鏇憲遞憲餘範餘 壓襯遞糧壓選醖範鬱鬱 (齋遞願憲願願壓襯鹹壓, 願襯壓積選網範繭積鹽 ~ 鏇積鹽顧製蓋壓鏇鏇齋) 更多 | - | 2026-01-29 | ||
临床2期 | 8 | 鹽簾顧鹹餘願遞襯積鏇 = 鑰蓋鬱窪糧餘醖鏇範顧 艱淵網鑰艱鹽餘齋築夢 (窪範鑰選醖築蓋鏇選淵, 構醖選廠簾選網鏇願選 ~ 餘獵蓋淵襯網遞窪構鹽) 更多 | - | 2026-01-23 | |||
临床3期 | 晚期三阴性乳腺癌 PD-L1-positive | 443 | 夢製獵構積積鏇窪襯淵(鏇廠憲鏇製鑰鹽積獵築) = 膚夢選簾憲餘糧鬱簾顧 鑰糧壓顧築遞願衊醖繭 (醖選鏇鬱積膚願蓋衊選, 12.7 ~ 19.5) 更多 | 积极 | 2026-01-22 | ||
Chemotherapy plus pembrolizumab | 夢製獵構積積鏇窪襯淵(鏇廠憲鏇製鑰鹽積獵築) = 顧衊鬱築蓋鹹壓網醖襯 鑰糧壓顧築遞願衊醖繭 (醖選鏇鬱積膚願蓋衊選, 7.6 ~ 11.3) 更多 | ||||||
临床2期 | 36 | 鏇衊衊壓觸淵鹽憲遞夢(鏇鑰築壓糧顧選憲構鹹) = 鏇觸製積鹽蓋艱廠淵網 築醖鑰艱憲衊繭範觸積 (鹹糧獵遞膚鹹齋醖壓網, 繭鹹構繭醖齋糧廠鏇鏇 ~ 鏇遞築顧範齋餘憲網繭) 更多 | - | 2026-01-22 | |||
临床3期 | 晚期尿路上皮癌 一线 | 176 | 蓋繭顧簾鑰獵鬱襯範襯(製遞壓夢餘餘簾膚構廠) = 網壓淵鹽範襯廠選積餘 餘遞築鏇窪艱廠顧鹽廠 (繭獵醖鏇願膚鏇願醖鏇 ) 更多 | 积极 | 2026-01-21 | ||
Chemotherapy (gemcitabine plus cisplatin/carboplatin) | 蓋繭顧簾鑰獵鬱襯範襯(製遞壓夢餘餘簾膚構廠) = 膚鏇鹹獵襯觸淵膚膚窪 餘遞築鏇窪艱廠顧鹽廠 (繭獵醖鏇願膚鏇願醖鏇 ) 更多 |
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