预约演示
更新于：2025-03-25
Ipilimumab biosimilar (Innovent Biologics)
伊匹木单抗生物类似药（信达生物）
更新于：2025-03-25
概要
基本信息
药物类型 生物类似药、单克隆抗体 |
别名 Anti-CTLA-4 antibody (Innovent Biologics)、Ipilimumab Biosimilar (Innovent Biologics (Suzhou) Co. Ltd.)、伊匹木单抗生物类似药（信达生物制药（苏州）有限公司） + [4] |
靶点 |
作用方式 抑制剂 |
作用机制 CTLA4抑制剂(细胞毒性T淋巴细胞相关抗原4抑制剂) |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构 |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评优先审评 (中国)、突破性疗法 (中国) |
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结构/序列
Sequence Code 143797L
当前序列信息引自: *****
Sequence Code 9060585H
当前序列信息引自: *****
关联
29
项与 伊匹木单抗生物类似药（信达生物） 相关的临床试验NCT06620822
Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical Trial
NCT06580574
Sintilimab With Selective Combination of Sintilimab, IBI310 and Lenvatinib Used for Organ Preservation in Non-metastatic Gastric or Colon Cancers With Mismatch Repair Deficiency or High Microsatellite Instability
NCT05890742
A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
100 项与 伊匹木单抗生物类似药（信达生物） 相关的临床结果
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100 项与 伊匹木单抗生物类似药（信达生物） 相关的转化医学
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100 项与 伊匹木单抗生物类似药（信达生物） 相关的专利（医药）
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3
项与 伊匹木单抗生物类似药（信达生物） 相关的文献（医药）2025-01-01Med
IBI310 plus sintilimab vs. placebo plus sintilimab in recurrent/metastatic cervical cancer: A double-blind, randomized controlled trial
Article
作者: Tang, Yaling ; Zhang, Guonan ; Huang, Yi ; Ma, Xinyan ; Li, Huayi ; Zhao, Weidong ; Qian, Jianhua ; Xu, Qin ; Zhang, Jieqing ; Zheng, Hong ; Wang, Danbo ; Gao, Qinglei ; Zhou, Hui ; Tang, Ying ; Peng, Zikun ; Qiu, Hui ; Ji, Jianghai ; Yin, Kang ; Liu, Jihong ; Cai, Chujun ; An, Ruifang ; Shen, Yiyang ; Wang, Li ; Zhang, Hongfei ; Wang, Shuyan ; Xie, Han ; Wang, Xia ; Li, Guiling ; Chang, Baoping ; Yuan, Jianlin ; Ma, Cailing ; Sun, Li ; He, Aiqin ; Zhu, Lijing ; Jiao, Xiaofei ; Xu, Yu ; Wang, Ya ; Zhu, Jianqing ; Lou, Ge ; Wang, Jing ; Xia, Bairong ; Ma, Ding ; Duan, Wei ; Lu, Liqin ; Wang, Ke ; Li, Li ; Zhu, Hong ; Cheng, Yan ; Yu, Guohua ; Huang, Jianli ; Huang, Bowen ; Zhang, Youzhong ; Chen, Youguo
BACKGROUND:
It remains unclear whether adding CTLA-4 blockade to PD-1/PD-L1 blockade improves clinical outcomes in cervical cancer (CC).
METHODS:
In this randomized, double-blind, placebo-controlled, phase 2 study (ClinicalTrials.gov: NCT04590599), patients with recurrent/metastatic CC (R/M CC) who experienced disease progression after or during platinum-based chemotherapy were enrolled from 37 centers across China and randomly assigned (1:1), stratified by PD-L1 expression and prior treatment lines, to receive either IBI310 plus sintilimab or placebo plus sintilimab intravenously every 3 weeks for 12 weeks, followed by sintilimab alone. The primary endpoint was the objective response rate (ORR). Pivotal secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.
FINDINGS:
205 patients were randomized to receive IBI310-sintilimab (n = 103) or placebo-sintilimab (n = 102). The ORR difference between the IBI310-sintilimab arm (32.3%, 95% confidence interval [CI]: 23.3%-42.5%) and the placebo-sintilimab arm (23.5%, 95% CI: 15.5%-33.1%) was not significant (p = 0.17). IBI310-sintilimab and placebo-sintilimab exhibited median PFS values of 3.6 (95% CI: 2.7-6.3) and 4.2 months (95% CI: 2.8-6.2), respectively (hazard ratio [HR] = 0.91, 95% CI: 0.65-1.27; p = 0.58). The median OSs were 13.9 months (95% CI: 11.5-25.6) in the IBI310-sintilimab arm and 17.2 months (95% CI: 13.7-25.9) in the placebo-sintilimab arm (HR = 1.12, 95% CI: 0.79-1.58; p = 0.54). Adding IBI310 to sintilimab increased the incidence of grade ≥3 treatment-related adverse events (55% versus 19%).
CONCLUSIONS:
Compared to single-agent PD-1/PD-L1 blockade, dual blockade of CTLA-4 and PD-1/PD-L1 did not significantly improve clinical outcomes in R/M CC.
FUNDING:
This work was funded by Innovent Biologics (Suzhou).
2024-07-01The Innovation
IBI310 (anti-CTLA-4 antibody) monotherapy or in combination with sintilimab in advanced melanoma or urothelial carcinoma
Article
作者: Yang, Yue ; Shen, Yuping ; Li, Juan ; Wei, Xiaoting ; Si, Lu ; Guo, Jun ; Tang, Bixia ; Chi, Zhihong ; Zheng, Shirui ; Zhou, Li ; Mao, Lili ; Guo, Qun ; Li, Siming ; Lian, Bin ; Cui, Chuanliang ; Yan, Xieqiao ; Wang, Xuan
IBI310 is a recombinant fully human IgG1 antibody against cytotoxic T lymphocyte antigen 4. This study was conducted to evaluate IBI310 monotherapy or combination therapy with sintilimab in the patients with advanced melanoma or urothelial carcinoma (UC). Patients in phase 1a received IBI310 at 0.3/1/2/3 mg/kg intravenously (IV) every 3 weeks (Q3W) following the accelerated titration and 3 + 3 escalation design. Patients in phase 1b received IBI310 (1/2/3 mg/kg IV, Q3W) plus sintilimab (200 mg IV, Q3W) for four cycles, followed by sintilimab maintenance therapy. The phase 1b expansion of IBI310 plus sintilimab was performed in patients with advanced melanoma or UC. Overall, 53 patients were enrolled, including 10 patients with melanoma in phase 1a, 34 with melanoma, and 9 with UC in phase 1b. Overall, 94.3% of patients (50/53) experienced at least one treatment-related adverse event (TRAE) with most being grade 1-2; 26.4% of patients (14/53) experienced grade 3 or higher TRAEs. In phase 1a, the disease control rate (DCR) was 50.0% (95% confidence interval [CI], 18.7%-81.3%). In phase 1b, the objective response rate (ORR) and DCR were 17.6% (95% CI, 6.8%-34.5%) and 44.1% (95% CI, 27.2%-62.1%), respectively, for melanoma, and were 22.2% (95% CI, 2.8%-60.0%) and 66.7% (95% CI, 29.9%-92.5%), respectively, for UC. IBI310 monotherapy or combination therapy with sintilimab was well tolerated with favorable antitumor activity across patients with advanced melanoma and UC.
2024-02-01Cancer medicine
A phase Ib study evaluating the safety and efficacy of IBI310 plus sintilimab in patients with advanced non‐small‐cell lung cancer who have progressed after anti‐PD ‐1/L1 therapy
Article
作者: Yao, Jun ; Long, Jianlin ; Chen, Ye ; Zhao, Jun ; Cui, Jiuwei ; Meng, Rui ; Liu, Ziling ; Zhao, Yuguang ; Li, Li ; Zang, Aimin ; Guo, Qun ; Mao, Yong ; Chen, Xiao ; Luo, Yang ; Wu, Di
Abstract:
Background:
The development of immune checkpoint inhibitors has made a significant breakthrough in the treatment of non‐small‐cell lung cancer (NSCLC). However, there remains a huge unmet clinical need for patients with acquired resistance after initial treatment response.
Methods:
This study evaluated the combination of IBI310 (an anti‐cytotoxic T lymphocyte‐associated antigen‐4 [CTLA‐4] antibody) and sintilimab (an anti‐programmed death 1 [PD‐1]) antibody) in NSCLC patients who have previously been treated with anti‐PD‐1/ligand (L)1 and acquired resistance. The patients were randomly assigned to receive either a lower dose of IBI310 (1 mg/kg Q3W, cohort A) or a higher dose of IBI310 (3 mg/kg Q3W, cohort B) in combination with sintilimab (200 mg Q3W). The primary endpoints of the study were objective response rate (ORR) assessed by RECISTv1.1 and safety, while secondary endpoints included disease control rate (DCR), progression‐free survival (PFS), and overall survival (OS).
Results:
As of November 2, 2023, the study had enrolled 30 patients, with 15 patients in each cohort. The ORR was 13.3% (2/15, 95% confidence interval [CI], 1.7–40.5) in cohort B. DCR were 46.7% (95% CI, 21.3–73.4) and 66.7% (95% CI, 38.4–88.2) in cohorts A and B, respectively. In cohorts A and B of this trial, the median follow‐up times were 4.2 and 5.6 months, respectively. Median PFS was 1.45 (95% CI, 1.35–2.73) versus 2.73 (95% CI, 1.41–4.90) months for cohort A versus B; the median OS was 7.03 (95% CI, 3.09–not calculable [NC]) months in cohort A and 8.90 (95% CI, 5.13–NC) months in cohort B. Of the 30 patients, 86.7% in both cohorts experienced treatment‐related adverse events (TRAEs) with Grade ≥3 TRAEs occurring in 40% and 53.3% of patients in cohorts A and B, respectively.
Conclusion:
IBI310 3 mg/kg Q3W plus sintilimab was effective in a small number of previously treated anti‐PD‐1/L1‐resistant NSCLC patients.
100 项与 伊匹木单抗生物类似药（信达生物） 相关的药物交易
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外链
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研发状态
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 |
|---|---|---|---|---|
| 错配修复缺陷或微高卫星不稳定性结肠癌 | 申请上市 | 中国 | 2025-02-22 | |
| 错配修复缺陷或微高卫星不稳定性结肠癌 | 申请上市 | 中国 | 2025-02-22 | |
| 晚期肝细胞癌 | 临床3期 | 中国 | 2021-02-01 | |
| 肢端雀斑恶性黑色素瘤 | 临床3期 | 中国 | 2020-04-17 | |
| 黑色素瘤 | 临床3期 | 中国 | 2020-04-17 | |
| 晚期胆道癌 | 临床2期 | 中国 | 2023-03-10 | |
| 鼻咽癌 | 临床2期 | 中国 | 2021-07-07 | |
| 晚期宫颈癌 | 临床2期 | 中国 | 2020-11-23 | |
| 错配修复缺陷或微卫星高度不稳定性结直肠癌 | 临床2期 | 中国 | 2020-08-07 | |
| 晚期胃食管交界处腺癌 | 临床2期 | 中国 | 2019-12-13 |
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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1期 | 错配修复缺陷或微卫星高度不稳定性结直肠癌 Deficient DNA Mismatch Repair (dMMR) | MSI-High | 101 | 遞壓鹽遞觸製蓋鹽鏇製(鹹願衊觸糧積窪獵窪遞) = 鬱網襯廠衊簾築簾製鬱 憲鹽鬱齋遞繭憲獵膚襯 (廠鏇獵衊範築憲範鏇鹹 ) 更多 | 积极 | 2024-06-02 | ||
遞壓鹽遞觸製蓋鹽鏇製(鹹願衊觸糧積窪獵窪遞) = 蓋淵範製繭遞遞夢壓醖 憲鹽鬱齋遞繭憲獵膚襯 (廠鏇獵衊範築憲範鏇鹹 ) 更多 | |||||||
临床1期 | 101 | 襯糧網鏇獵鏇繭願襯襯(網夢夢艱鹽憲鏇衊醖願) = 網繭鹽構鹹範鑰餘遞壓 壓網願淵願膚積構窪襯 (憲鬱壓鹹構憲築鹹鑰鏇, 66.3 ~ 90.0) 更多 | 积极 | 2024-05-24 | |||
Sintilimab 200 mg Q3W | 襯糧網鏇獵鏇繭願襯襯(網夢夢艱鹽憲鏇衊醖願) = 製壓淵遞夢糧製壓蓋築 壓網願淵願膚積構窪襯 (憲鬱壓鹹構憲築鹹鑰鏇, 32.5 ~ 63.3) 更多 | ||||||
临床2期 | 49 | 製襯壓製獵醖醖構齋窪(醖鬱蓋淵築鏇製夢獵衊) = 夢艱壓襯觸憲壓壓窪膚 鑰淵夢淵憲鏇鑰構鹽積 (鑰壓鹽鏇襯憲積選窪餘 ) 更多 | 积极 | 2023-10-23 | |||
(treatment-naïve) | 窪鹽遞顧膚觸餘獵壓鹽(簾獵壓顧顧襯蓋鏇淵選) = 淵鹽夢觸鑰廠齋鏇齋遞 鹹醖艱齋鹹選製壓製積 (鹽鬱襯獵鏇襯壓範淵鹹, 40.6 ~ 79.8) 更多 | ||||||
临床1期 | 29 | 醖窪蓋構窪築選遞範觸(製襯願積憲夢願鹹衊壓) = 獵壓淵蓋餘鹹積繭艱齋 鑰艱鬱襯膚糧範網襯鬱 (製鹽鑰選膚簾觸遞襯鹹 ) 更多 | 积极 | 2022-01-19 | |||
临床1期 | 44 | 觸餘築齋遞繭膚觸鹽糧(遞醖壓淵鹹衊觸製窪選) = part A: only one treatment-related AE (TRAE) of grade 3 (gamma glutamyltransferase increased); part B: ≥grade 3 TRAE occurred in 20.6% of 34 pts 簾簾膚鏇築鹹網積鹽膚 (鬱築夢襯積壓鬱遞獵積 ) 更多 | 积极 | 2021-09-16 | |||
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