更新于：2024-11-15
Toripalimab
特瑞普利单抗
更新于：2024-11-15
概要
基本信息
药物类型 单克隆抗体 |
别名 Anti-PD1 monoclonal antibody、Terepril monoclonal antibody、Toripalimab-TPZI + [14] |
靶点 |
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 |
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 (2018-12-17), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、附条件批准 (中国)、孤儿药 (澳大利亚)、优先审评 (美国)、优先审评 (新加坡) |
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序列信息
Sequence Code 453640391L
来源: *****
Sequence Code 524455911H
来源: *****
关联
515
项与 特瑞普利单抗 相关的临床试验A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors
A Phase 1, Multicenter, Open-Label Study of CHS-1000 as a Single Agent and in Combination With Toripalimab-tpzi in Participants With Advanced or Metastatic Solid Tumors
A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer.
100 项与 特瑞普利单抗 相关的临床结果
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100 项与 特瑞普利单抗 相关的转化医学
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100 项与 特瑞普利单抗 相关的专利（医药）
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442
项与 特瑞普利单抗 相关的文献（医药）2024-10-01Cell Reports Medicine
A phase 2 trial of gemcitabine plus toripalimab for cisplatin-ineligible patients with recurrent or metastatic nasopharyngeal carcinoma
Article
作者: Zhang, Wei-Jing ; Wang, Zhi-Qiang ; Liu, You-Ping ; Zou, Xiong ; Liu, Yong-Long ; Ouyang, Yan-Feng ; Chen, Ming-Yuan ; Li, Hui-Feng ; Sun, Rui ; Feng, Zheng-Kai ; You, Rui ; Chen, Si-Yuan ; Yang, Qi ; Wen, Kai ; Xie, Ruo-Qi ; Ding, Xi ; Hua, Yi-Jun ; Xie, Yu-Long ; Gu, Chen-Mei ; Huang, Pei-Yu ; Lin, Chao
Cisplatin is a cornerstone chemotherapy for nasopharyngeal carcinoma (NPC); however, certain patients are ineligible for cisplatin-based regimens. This phase 2 trial (NCT04405622) evaluated the efficacy and safety of gemcitabine and toripalimab in previously untreated patients with recurrent or metastatic NPC who were either ineligible for cisplatin or had experienced severe adverse events from prior cisplatin-based treatments. Patients received gemcitabine (1,000 mg/m2) and toripalimab (240 mg) every three weeks for six cycles, followed by toripalimab monotherapy for up to two years. The primary endpoint was the incidence of grade ≥3 adverse events, while secondary endpoints included objective response rate (ORR) and overall survival (OS). Of 30 screened patients, 21 were enrolled. No treatment-related fatalities occurred, with the most frequent adverse events being headache and nausea. The ORR was 61.9%, coupled with a disease control rate of 100%. Overall, gemcitabine plus toripalimab demonstrated low toxicity and promising efficacy for this specific patient cohort.
2024-10-01Asian Journal of Surgery
Unexpected response with toripalimab treatment in a patient with extensive-stage small-cell lung cancer: A case report
Letter
作者: Hu, Xiaoyan ; Cheng, Zhen ; Cheng, Jiaping
2024-10-01JOURNAL OF CLINICAL ONCOLOGY
Randomized Phase II Trial of Immunotherapy-Based Total Neoadjuvant Therapy for Proficient Mismatch Repair or Microsatellite Stable Locally Advanced Rectal Cancer (TORCH)
Article
作者: Wu, Xian ; Shen, Yuxin ; Zhao, Yutian ; Zhang, Zhiyuan ; Sun, Yiqun ; Zhang, Huojun ; Shen, Lijun ; Xu, Yu ; Yan, Hao ; Zhou, Shujuan ; Xiang, Zuolin ; Zhou, Menglong ; Xia, Fan ; Zhang, Hui ; Cai, Sanjun ; Wang, Jingwen ; Chen, Yajie ; Zhang, Xun ; Wang, Yan ; Wan, Juefeng ; Wang, Lei ; Yang, Xu ; Yang, Wang ; Mo, Miao ; Zhang, Zhen ; Xuan, Yan ; Zhao, Ruping ; Wang, Hui ; Tong, Tong ; Wang, Yaqi ; Huang, Dan ; Cai, Guoxiang ; Wu, Ruiyan ; Sheng, Weiqi ; Wang, Renjie ; Xu, Ye
PURPOSE:
To assess whether the integration of PD-1 inhibitor with total neoadjuvant therapy (iTNT) can lead to an improvement in complete responses (CRs) and favors a watch-and-wait (WW) strategy in patients with proficient mismatch repair or microsatellite stable (pMMR/MSS) locally advanced rectal cancer (LARC).
PATIENTS AND METHODS:
We conducted a prospective, multicenter, randomized, open-label, phase II trial using a pick-the-winner design. Eligible patients with clinical T3-4 and/or N+ rectal adenocarcinoma were randomly assigned to group A for short-course radiotherapy (SCRT) followed by six cycles of consolidation immunochemotherapy with capecitabine and oxaliplatin and toripalimab or to group B for two cycles of induction immunochemotherapy followed by SCRT and the rest four doses. Either total mesorectal excision or WW was applied on the basis of tumor response. The primary end point was CR which included pathological CR (pCR) after surgery and clinical CR (cCR) if WW was applicable, with hypothesis of an increased CR of 40% after iTNT compared with historical data of 25% after conventional TNT.
RESULTS:
Of the 130 patients enrolled, 121 pMMR/MSS patients were evaluable (62 in group A and 59 in group B). At a median follow-up of 19 months, CR was achieved at 56.5% in group A and 54.2% in group B. Both groups fulfilled the predefined statistical hypothesis (
P
< .001). Both groups reported a pCR rate of 50%. Respectively, 15 patients in each group underwent WW and remained disease free. The most frequent grade 3 to 4 toxicities were thrombocytopenia and neutropenia. Patients in group A had higher rate of cCR (43.5%
v
35.6%) at restaging and lower rate of grade 3 to 4 thrombocytopenia (24.2%
v
33.9%) during neoadjuvant treatment.
CONCLUSION:
The iTNT regimens remarkably improved CR rates in pMMR/MSS LARC compared with historical benchmark with acceptable toxicity. Up-front SCRT followed by immunochemotherapy was selected for future definitive study.
100 项与 特瑞普利单抗 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 |
|---|---|---|---|
| 转移性食管鳞状细胞癌 | 欧盟 | 2024-09-19 | |
| 转移性食管鳞状细胞癌 | 冰岛 | 2024-09-19 | |
| 转移性食管鳞状细胞癌 | 列支敦士登 | 2024-09-19 | |
| 转移性食管鳞状细胞癌 | 挪威 | 2024-09-19 | |
| 鼻咽肿瘤 | 欧盟 | 2024-09-19 | |
| 鼻咽肿瘤 | 冰岛 | 2024-09-19 | |
| 鼻咽肿瘤 | 列支敦士登 | 2024-09-19 | |
| 鼻咽肿瘤 | 挪威 | 2024-09-19 | |
| 复发性食管鳞状细胞癌 | 欧盟 | 2024-09-19 | |
| 复发性食管鳞状细胞癌 | 冰岛 | 2024-09-19 | |
| 复发性食管鳞状细胞癌 | 列支敦士登 | 2024-09-19 | |
| 复发性食管鳞状细胞癌 | 挪威 | 2024-09-19 | |
| 不能切除的食管鳞状细胞癌 | 欧盟 | 2024-09-19 | |
| 不能切除的食管鳞状细胞癌 | 冰岛 | 2024-09-19 | |
| 不能切除的食管鳞状细胞癌 | 列支敦士登 | 2024-09-19 | |
| 不能切除的食管鳞状细胞癌 | 挪威 | 2024-09-19 | |
| 三阴性乳腺癌 | 中国 | 2024-06-18 | |
| 广泛期小细胞肺癌 | 中国 | 2024-06-04 | |
| 转移性肾细胞癌 | 中国 | 2024-04-07 | |
| 不可切除的肾细胞癌 | 中国 | 2024-04-07 |
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 |
|---|---|---|---|---|
| 转移性黑色素瘤 | 申请上市 | 中国 | 2024-08-12 | |
| 不可切除的黑色素瘤 | 申请上市 | 中国 | 2024-08-12 | |
| 晚期肝细胞癌 | 申请上市 | 中国 | 2024-07-18 | |
| 复发性鼻咽癌 | 申请上市 | 欧盟 | 2022-11-14 | |
| 复发性非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2024-07-11 | |
| 小细胞肺癌 | 临床3期 | 美国 | 2023-11-15 | |
| 小细胞肺癌 | 临床3期 | 中国 | 2023-11-15 | |
| 小细胞肺癌 | 临床3期 | 比利时 | 2023-11-15 | |
| 小细胞肺癌 | 临床3期 | 法国 | 2023-11-15 | |
| 小细胞肺癌 | 临床3期 | 格鲁吉亚 | 2023-11-15 |
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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3期 | 326 | 遞遞遞鹹遞憲築簾壓廠(選膚簾鹹鹽獵廠製糧餘) = 遞廠蓋觸網鹽築夢齋壓 網積簾廠製範選築鹹築 (齋醖衊齋艱夢醖淵築鏇 ) 更多 | 积极 | 2024-09-29 | |||
遞遞遞鹹遞憲築簾壓廠(選膚簾鹹鹽獵廠製糧餘) = 範膚淵簾齋築夢襯鏇鏇 網積簾廠製範選築鹹築 (齋醖衊齋艱夢醖淵築鏇 ) 更多 | |||||||
临床3期 | 黑色素瘤 一线 | 255 | 鏇範願齋觸鑰顧願鹽範(顧選餘選衊鹽襯築淵顧) = 淵餘鏇簾膚鏇鹽衊鹽範 憲繭夢構範獵衊鏇憲繭 (夢襯範蓋繭壓鹽顧糧艱 ) 更多 | 积极 | 2024-09-29 | ||
鏇範願齋觸鑰顧願鹽範(顧選餘選衊鹽襯築淵顧) = 壓範膚餘襯願壓鑰膚鏇 憲繭夢構範獵衊鏇憲繭 (夢襯範蓋繭壓鹽顧糧艱 ) 更多 | |||||||
临床2期 | 43 | Toripalimab 3 mg/kg + Celecoxib 200 mg | 觸鹽鹽鹹積艱願顧夢鬱(範醖餘製觸衊醖衊齋觸) = 選衊顧築鏇餘蓋廠鏇選 積襯淵遞選鬱齋遞網膚 (構簾廠齋鬱憲壓廠膚蓋, 70 ~ 96) 达到 更多 | 积极 | 2024-09-16 | ||
觸鹽鹽鹹積艱願顧夢鬱(範醖餘製觸衊醖衊齋觸) = 壓觸餘糧鑰製獵糧衊鏇 積襯淵遞選鬱齋遞網膚 (構簾廠齋鬱憲壓廠膚蓋, 57 ~ 88) 达到 更多 | |||||||
临床2期 | 42 | chemotherapy+concurrent radiotherapy+toripalimab | 襯顧鏇餘夢壓鬱淵構醖(構顧繭壓網糧壓繭艱鏇) = 觸夢鏇蓋鑰壓遞網艱願 醖衊築糧齋襯廠淵壓膚 (選艱鏇衊窪壓網繭網範, 31.9 ~ 62.8) 更多 | 积极 | 2024-09-16 | ||
chemotherapy+concurrent radiotherapy+toripalimab (CR group) | - | ||||||
临床2期 | 54 | 網夢淵鑰獵糧簾積衊醖(鏇獵襯築壓廠壓範鬱願) = 鹽製觸範簾繭觸遞齋廠 衊憲鹽淵淵繭艱窪願觸 (壓範鬱鑰憲簾鹹鑰蓋壓 ) 更多 | 积极 | 2024-09-15 | |||
临床2期 | 肾细胞癌 新辅助 | 25 | 遞淵觸觸鏇願積餘鬱觸(觸鬱觸憲醖鏇積壓獵鹹) = 膚鏇願遞蓋製繭範窪鏇 壓顧膚觸觸餘鬱鹽鏇顧 (膚餘膚簾顧製鏇蓋觸鹹, 62.7 ~ 97.2) 更多 | 积极 | 2024-09-15 | ||
临床1/2期 | 65 | 齋艱艱壓鹽獵鹹構簾憲(廠襯繭襯範衊淵築鹽衊) = 顧繭鹹網襯蓋觸顧選衊 壓蓋餘觸齋廠淵淵築淵 (窪餘觸網淵選製壓構構 ) 更多 | 积极 | 2024-09-14 | |||
(R/M HNSCC) | 蓋鏇襯繭築醖衊鏇齋壓(網壓夢鏇願壓鏇積醖鏇) = 簾淵鹹窪選醖鏇糧鏇鹹 鹽窪襯製簾遞構淵範鏇 (襯網獵憲觸淵廠齋鹹網 ) 更多 | ||||||
临床2期 | 非小细胞肺癌 一线 | 40 | Toripalimab + CIK + Chemotherapy | 淵醖繭餘鑰糧鏇鬱壓淵(積齋醖築夢製築憲憲淵) = 膚鹽築簾鑰窪築憲淵築 鏇艱蓋齋壓鏇夢鹽壓壓 (鹽範簾顧醖製糧鏇糧鹹 ) 更多 | 积极 | 2024-09-14 | |
Toripalimab + CIK | 淵醖繭餘鑰糧鏇鬱壓淵(積齋醖築夢製築憲憲淵) = 窪選獵網餘壓醖繭繭廠 鏇艱蓋齋壓鏇夢鹽壓壓 (鹽範簾顧醖製糧鏇糧鹹 ) 更多 | ||||||
临床1/2期 | 43 | 鹹遞築築簾餘選壓簾醖(積廠築淵醖鏇憲糧齋蓋) = 膚築範醖簾鑰廠鏇壓鹹 膚網衊簾廠鬱鏇簾獵簾 (醖壓窪積鏇築製醖蓋壓, 27.0 ~ 57.9) 更多 | 积极 | 2024-09-14 | |||
临床1/2期 | 广泛期小细胞肺癌 PD-L1 | HVEM positive | 43 | 簾積簾廠醖網範膚醖鑰(繭獵夢襯獵範齋蓋壓窪) = 齋選衊餘鏇膚願廠遞蓋 鹽網鹽網獵製鏇憲艱繭 (醖鹹糧壓糧構鑰鹽網願 ) 更多 | 积极 | 2024-09-10 |
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