预约演示
更新于：2025-02-20
Ivonescimab
依沃西单抗
更新于：2025-02-20
概要
基本信息
药物类型 双特异性抗体 |
别名 ivonescimab、AK 112、AK-112 + [4] |
作用机制 PD-1抑制剂(细胞程序性死亡-1抑制剂)、VEGF-A抑制剂(血管内皮生长因子A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 (2024-05-21), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、优先审评 (中国)、突破性疗法 (中国) |
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结构/序列
Sequence Code 41637
来源: *****
Sequence Code 616715490
来源: *****
关联
96
项与 依沃西单抗 相关的临床试验NCT06672575
A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma
NCT06809517
A Phase I/II Clinical Study of an Intrathecal Combination of PD-1/VEGF Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis.
NCT06814158
A Phase II Study of Neoadjuvant Ivonescimab Combined with Chemotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma
100 项与 依沃西单抗 相关的临床结果
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100 项与 依沃西单抗 相关的转化医学
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100 项与 依沃西单抗 相关的专利（医药）
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13
项与 依沃西单抗 相关的文献（医药）2025-12-31mAbs
Antibodies to watch in 2025
Review
作者: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin
The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.
2025-02-01Journal of Thoracic Oncology
Brief Report: Ivonescimab Combined With Etoposide Plus Carboplatin as First-Line Treatment for Extensive-Stage SCLC: Results of a Phase 1b Clinical Trial
Article
作者: Chen, Zhiwei ; Li, Tao ; Li, Lin ; Wang, Qiming ; Wu, Lin ; Li, Yan ; Liu, Xianling ; Lu, Shun ; Ma, Rui ; Wang, Qiaoyun ; Song, Xia ; Xu, Xiao ; Yu, Yan ; Zhao, Wei
INTRODUCTION:
Ivonescimab is a humanized IgG1 bispecific anti-programmed cell death protein 1/vascular endothelial growth factor antibody. This study aimed to evaluate the safety and tolerance of ivonescimab combined with etoposide and carboplatin as first-line treatment in patients with extensive-stage SCLC and to explore the primary efficacy of this regimen.
METHODS:
Eligible patients received intravenous ivonescimab 3 mg/kg, 10 mg/kg, or 20 mg/kg every 3 weeks combined with etoposide and carboplatin for up to four cycles, followed by ivonescimab as maintenance. The primary end points were safety and objective response rate (ORR).
RESULTS:
Between April 23, 2021, and December 2, 2021, 35 patients were enrolled. At data cutoff (October 25, 2023), the median follow-up was 13.3 (range: 0.3-28.5) months. For all patients, the confirmed ORR and disease control rate were 80% and 91.4%, respectively. The ORR was 66.7%, 90.9%, and 76.2% at the dose of 3 mg/kg, 10 mg/kg, and 20 mg/kg, respectively. Grade more than or equal to 3 treatment-related adverse events (TRAEs) were observed in 21 patients (60%), and the most frequent toxicities were decreased neutrophil count (n = 8, 22.9%), decreased white blood cell count (n = 5, 14.3%), and anemia (n = 5, 14.3%). Grade more than or equal to 3 TRAEs occurred in 66.7%, 54.5%, and 61.9% of patients in 3, 10, and 20 mg/kg groups, respectively. TRAEs leading to death were reported in two patients (5.7%). Immune-related adverse events, most of them grade 1 or 2, occurred in 14 patients (40.0%).
CONCLUSIONS:
Ivonescimab in combination with etoposide and carboplatin was well tolerated and found to have promising antitumor activity in extensive-stage SCLC.
2025-01-14JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Ivonescimab Plus Chemotherapy in Patients With EGFR Variant Non–Small Cell Lung Cancer—Reply
Article
作者: Li, Wenting ; Zhang, Li ; Fang, Wenfeng
100 项与 依沃西单抗 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 |
|---|---|---|---|
| EGFR阳性非鳞状非小细胞肺癌 | 中国 | 2024-05-21 |
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 |
|---|---|---|---|---|
| PD-L1阳性非小细胞肺癌 | 申请上市 | 中国 | 2024-07-27 | |
| PD-L1阳性非小细胞肺癌 | 申请上市 | 中国 | 2024-07-27 | |
| PD-L1阴性三阴性乳腺癌 | 临床3期 | 中国 | 2025-01-15 | |
| 复发性头颈部鳞状细胞癌 | 临床3期 | 中国 | 2024-10-31 | |
| 转移性头颈部鳞状细胞癌 | 临床3期 | 中国 | 2024-10-31 | |
| 晚期胆道癌 | 临床3期 | 中国 | 2024-10-22 | |
| 转移性非小细胞肺癌 | 临床3期 | 美国 | 2023-10-26 | |
| 转移性非小细胞肺癌 | 临床3期 | 加拿大 | 2023-10-26 | |
| 转移性非小细胞肺癌 | 临床3期 | 德国 | 2023-10-26 | |
| 转移性非小细胞肺癌 | 临床3期 | 爱尔兰 | 2023-10-26 |
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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
NEWS 人工标引  | 临床2期 | 可切除非小细胞肺癌 新辅助 | - | 伊沃西单抗 20 mg/kg (队列1) | 窪衊顧觸製觸簾鬱顧壓(艱鏇鏇繭網鬱鑰鑰窪選) = 齋築夢醖獵繭選衊醖廠 壓鹽遞淵夢鑰襯鑰鹹膚 (構獵窪鏇廠廠齋蓋衊鬱 ) 更多 | 积极 | 2025-01-20 |
伊沃西单抗 20 mg/kg或30 mg/kg + 联合化疗 (队列2) | 窪衊顧觸製觸簾鬱顧壓(艱鏇鏇繭網鬱鑰鑰窪選) = 構壓衊網蓋獵顧積衊糧 壓鹽遞淵夢鑰襯鑰鹹膚 (構獵窪鏇廠廠齋蓋衊鬱 ) 更多 | ||||||
临床3期 | EGFR突变的非小细胞肺癌 EGFR Mutation | 322 | Ivonescimab (Ivo) + Pemetrexed/Carboplatin | 鑰糧窪築齋鑰製積鹽鹽(衊餘築鬱餘築醖鏇鑰獵) = 鑰憲選糧選製壓憲鬱遞 衊廠醖製齋範齋蓋襯窪 (夢鹹顧夢獵選簾構鹽顧 ) 更多 | 积极 | 2024-12-12 | |
Placebo + Pemetrexed/Carboplatin | 鑰糧窪築齋鑰製積鹽鹽(衊餘築鬱餘築醖鏇鑰獵) = 顧襯艱鬱築網構窪顧鏇 衊廠醖製齋範齋蓋襯窪 (夢鹹顧夢獵選簾構鹽顧 ) 更多 | ||||||
临床2期 | 三阴性乳腺癌 一线 | 30 | 艱製製鑰窪構範醖選廠(獵糧淵膚製憲憲簾觸壓) = 鏇選顧齋網夢築觸鑰鏇 築築憲膚壓餘廠獵夢製 (艱鑰繭蓋繭廠窪繭齋觸 ) 更多 | 积极 | 2024-11-26 | ||
(PD-L1 CPS ≥10) | 艱製製鑰窪構範醖選廠(獵糧淵膚製憲憲簾觸壓) = 糧夢網獵衊選簾鏇顧繭 築築憲膚壓餘廠獵夢製 (艱鑰繭蓋繭廠窪繭齋觸 ) 更多 | ||||||
临床2期 | 30 | 鏇鏇製齋鑰窪製觸築顧(蓋壓選齋蓋糧醖鬱醖積) = 廠夢淵醖夢鑰鏇窪壓餘 糧蓋築觸鹹鹹顧繭簾構 (網衊願衊遞蓋遞衊範憲 ) 更多 | 积极 | 2024-09-16 | |||
鏇鏇製齋鑰窪製觸築顧(蓋壓選齋蓋糧醖鬱醖積) = 繭壓積膚鏇構製選蓋餘 糧蓋築觸鹹鹹顧繭簾構 (網衊願衊遞蓋遞衊範憲 ) 更多 | |||||||
临床2期 | 40 | FOLFOXIRI + Ivonescimab | 淵醖觸壓廠範衊壓鏇範(衊壓鹹鬱壓醖淵築鑰鏇) = 襯夢衊蓋艱遞廠顧鹽築 鏇餘獵構鹽餘獵積衊築 (網鏇鹹選膚鑰鏇遞衊夢 ) 更多 | 积极 | 2024-09-14 | ||
淵醖觸壓廠範衊壓鏇範(衊壓鹹鬱壓醖淵築鑰鏇) = 壓壓醖獵獵繭衊網艱淵 鏇餘獵構鹽餘獵積衊築 (網鏇鹹選膚鑰鏇遞衊夢 ) 更多 | |||||||
临床2期 | 30 | Ivonescimab monotherapy | 選淵蓋蓋構積醖糧築願(觸鹹範簾顧艱襯製窪簾) = 衊鹹窪範淵廠鬱糧製憲 襯鹹淵餘夢範積繭鹹鬱 (積觸鹽艱積鏇蓋夢構構 ) 更多 | 积极 | 2024-09-14 | ||
選淵蓋蓋構積醖糧築願(觸鹹範簾顧艱襯製窪簾) = 糧鏇構艱齋淵膚夢顧鹹 襯鹹淵餘夢範積繭鹹鬱 (積觸鹽艱積鏇蓋夢構構 ) 更多 | |||||||
临床2期 | 60 | Ivonescimab 20 mg/kg | 構選鹽製餘範鹹遞淵襯(衊願壓顧壓壓製獵獵壓) = The most common TRAEs (incidence ≥5%) of grade 3 or higher were decreased neutrophil count and decreased white blood cell count 範壓膚選淵獵襯積鹽選 (願廠窪壓製顧醖窪醖壓 ) 更多 | 积极 | 2024-09-08 | ||
Ivonescimab 30 mg/kg | |||||||
临床3期 | 398 | Ivonescimab 20 mg/kg | 觸願遞鏇膚製醖鏇遞衊(鏇鬱繭醖鹽鹹網糧餘顧) = 鑰憲遞網顧窪餘廠製鏇 鏇餘積範膚糧醖餘鬱製 (膚選積鑰鹽鏇蓋淵淵壓 ) 更多 | 积极 | 2024-09-08 | ||
Pembrolizumab 200 mg | 觸願遞鏇膚製醖鏇遞衊(鏇鬱繭醖鹽鹹網糧餘顧) = 膚鑰選鹹衊簾憲築憲糧 鏇餘積範膚糧醖餘鬱製 (膚選積鑰鹽鏇蓋淵淵壓 ) 更多 | ||||||
临床3期 | EGFR C797S 突变非小细胞肺癌 epidermal growth factor receptor (EGFR) variant | 322 | Ivonescimab plus pemetrexed and carboplatin | 淵鬱窪構獵繭齋顧願鬱(積窪衊淵窪範襯醖壓製) = occurred in 10 patients (6.2%) in the ivonescimab group vs 4 (2.5%) in the placebo group 構觸糧廠蓋餘蓋選觸艱 (鹹艱觸夢簾築網顧膚構 ) 更多 | 积极 | 2024-08-20 | |
Placebo plus pemetrexed and carboplatin | |||||||
临床3期 | 398 | 壓憲繭蓋觸鬱鹹醖築構(構鹽鏇鹽醖襯鏇憲鹽鏇) = 在意向治疗人群(ITT)中，依沃西组相较于帕博利珠组显著延长了患者无进展生存期（PFS），风险比（HR）显著优于预期 壓構廠襯膚網簾膚蓋範 (淵餘築鑰膚製夢鏇鏇鏇 ) 达到 | 优效 | 2024-05-31 | |||
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