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更新于：2026-05-30
Inetetamab
伊尼妥单抗
更新于：2026-05-30
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2020-06-17), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 18481L
当前序列信息引自: *****
Sequence Code 44772H
当前序列信息引自: *****
关联
24
项与 伊尼妥单抗 相关的临床试验NCT07366840
A Phase 3, Randomized Advanced Breast Cancer Study Investigating RC48 Combined With Chemotherapy Versus Guideline-recommended Trastuzumab/Inetetamab Plus Chemotherapy in HER2-Positive Patients With Prior TOP1i-ADC Failure
NCT07182721
A Phase II, Single-Arm, Single-Center, Prospective Study of SKB264 Plus Inetetamab in HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Patients Progressing After T-DXd Treatment
NCT06818773
Efficacy and Safety Study of Inetetamab Combined with Chemotherapy ± PD-1/PD-L1 Inhibitor As First-Line Treatment for HER2-Positive Advanced Biliary Tract Cancer
100 项与 伊尼妥单抗 相关的临床结果
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100 项与 伊尼妥单抗 相关的转化医学
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100 项与 伊尼妥单抗 相关的专利（医药）
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33
项与 伊尼妥单抗 相关的文献（医药）2026-01-16Cancer Control
Real-World Outcomes With Inetetamab-Based Regimens for HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Analysis in China
Article
作者: Shan, Changping ; Hua, Ruimin ; Xia, Chongsheng ; Pan, Fei ; Wang, Hongjian ; Zhang, Jiale ; Liu, Guozhu ; Zheng, Fangchao ; Qiang, Ling ; Du, Xin ; Yang, Fan ; Zhou, Dongdong ; Li, Huihui ; Ren, Guohua ; Zhang, Baoxuan ; Wang, Ting ; Wang, Jingfen
Introduction:
Inetetamab has demonstrated favorable efficacy and safety in treating HER2-positive metastatic breast cancer (MBC).
Methods:
The multicenter retrospective study enrolled 140 patients with HER2-positive MBC who received inetetamab-based regimens between November 2020 and April 2023. Primary endpoint was progression-free survival (PFS); secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety.
Results:
The median patient age was 53 (range: 27-90) years, with inetetamab-based regimens administered as first-, second-, or third-line (or later) therapy in 13 (9.3%), 29 (20.7%), and 98 (70.0%) patients, respectively. Median PFS was 6.1 months in the overall population, with an ORR of 35.0% and a DCR of 77.1%. Patients receiving inetetamab as first- or second-line therapy had significantly longer median PFS (14.5 months; 95% CI, 9.5-19.5) than those receiving it as third-line or later therapy (4.8 months; 95% CI, 4.2-5.3;
P
< 0.0001). First-line treatment resulted in a median PFS of 22.2 months. Patients previously treated with trastuzumab without HER2-TKIs had longer median PFS than those with prior TKI exposure (12.8 vs 5.7 months;
P
= 0.001). Multivariate analysis confirmed that treatment line (1-2 vs ≥3) was independently associated with PFS (hazard ratio = 0.330; 95% CI: 0.211-0.517). The most common grade 3 or 4 adverse events included leukopenia (16.4%) and neutropenia (12.9%). No treatment-related deaths were reported.
Conclusion:
Inetetamab-based regimens have shown promising efficacy and are well-tolerated for patients with HER2-positive MBC. These anti-HER2 regimens could be considered an alternative treatment option for this disease.
2025-10-01CANCER LETTERS
Advancing neoadjuvant therapy with inetetamab for HER2-Positive breast cancer
作者: Zhou, Wenbin ; Ding, Qiang
HER2-positive breast cancer accounts for approximately 15 %-20 % of all breast cancer cases and is typically characterized by aggressive tumor biology, an elevated risk of recurrence, and poor long-term survival. Although HER2-targeted therapies such as trastuzumab and pertuzumab result in significantly improved clinical outcomes, the total pathological complete response (tpCR) rate remains suboptimal, particularly among hormone receptor (HR)-positive patients. Neoadjuvant therapy plays a critical role in facilitating tumor downstaging in locally advanced cases and provides a valuable opportunity to evaluate therapeutic efficacy and guide adjuvant treatment. Consequently, the development of novel anti-HER2 agents and combination strategies has become a major focus of ongoing researches. Inetetamab, a humanized monoclonal antibody targeting HER2 with an engineered Fc domain to enhance antibody-dependent cellular cytotoxicity, represents a promising candidate for improving treatment outcomes. In this issue of Cancer Letters, Zuo and colleagues present findings from a single-arm, multicenter phase II clinical trial investigating a neoadjuvant regimen combining inetetamab, pertuzumab, and nab-paclitaxel (TIP regimen) in patients with early-stage or locally advanced HER2-positive breast cancer. Through comprehensive evaluation of both efficacy and safety, the study demonstrates exceptional therapeutic potential of the TIP regimen, with a high tpCR rate observed in estrogen receptor (ER)-negative patients, indicating particular promise for this subgroup of HER2-positive breast cancer.
2025-09-01DRUG RESISTANCE UPDATES
Spatial discovery of pyrotinib overcoming HER2-positive breast cancer resistance by breaking fibroblast-induced immune barriers
Article
作者: Cheng, Pu ; Xu, Yiying ; Zhang, Qiongying ; Li, Lili ; Ren, Guohong ; Hu, Hanwen ; Wang, Ouchen ; Yang, Chenghui ; Wang, Zhen ; Zhang, Anqi ; Lin, Zhongmin ; Ye, Zhiqiang
BACKGROUND:
The TCbHP regimen, consisting of combining docetaxel (T), carboplatin (Cb), trastuzumab (H), and pertuzumab (P), is the preferred neoadjuvant treatment for locally advanced human epidermal growth factor 2 (HER2)-positive breast cancer. However, about 40 % of patients develop resistance to this treatment. Adding TKIs like pyrotinib to anti-HER2 antibodies may enhance efficacy and reduce resistance, but the mechanisms are not fully understood.
METHODS:
Imaging mass cytometry (IMC) analyzed tissues from 26 patients treated with NeoPICD (docetaxel, carboplatin, pyrotinib, inetetamab) and 21 patients treated with TCbHP. Cellular changes and spatial relationships were assessed pre- and post-treatment. A co-culture system of tumor cells, fibroblasts, and PBMCs were used to examined cytotoxic T-cell function. A predictive model for treatment outcomes was constructed based on these results.
RESULTS:
In TCbHP-sensitive patients, IDOhiHLA-DRhi epithelial cells expressing PD-L1 were enriched and interacted with Ki67+ T cells and M1 macrophages. In TCbHP-resistant patients, fibroblasts formed a barrier that hindered immune cell access, critical for resistance. NeoPICD disrupted this barrier, enhancing immune cell infiltration and alleviating resistance. Machine learning based on spatial cell architecture can predict treatment outcomes.
CONCLUSION:
Spatial organization of cellular interactions in the tumor microenvironment (TME) provides insights into prognosis beyond pathological subtypes. The role of NeoPICD in disruption of fibroblast barriers and enhancement of immune cell function suggests therapeutic advantages in overcoming resistance to anti-HER2 therapies. This research offers new strategies for precision treatment of locally advanced HER2-positive breast cancer.
100 项与 伊尼妥单抗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
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研发状态
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 |
|---|---|---|---|
| HER2阳性乳腺癌 | 中国 | 2020-06-17 |
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临床结果
临床结果
适应症
分期
评价
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N/A | HER2阳性转移性乳腺癌 HER2+ | 301 | 淵醖願簾鏇衊選範齋網(網遞簾窪膚蓋襯網餘窪) = 齋糧觸鑰積壓壓壓製艱 積觸鏇製鬱夢願鏇鏇顧 (膚淵齋選夢襯願艱鹽獵, 9.8 ~ 14.2) 更多 | 积极 | 2025-10-17 | ||
(1st line) | 淵醖願簾鏇衊選範齋網(網遞簾窪膚蓋襯網餘窪) = 鹽鏇鹹蓋醖醖膚餘糧網 積觸鏇製鬱夢願鏇鏇顧 (膚淵齋選夢襯願艱鹽獵 ) | ||||||
N/A | HER2-positive | 237 | TKI plus anti-HER2 antibody | 簾夢憲觸獵築願壓艱鬱(遞製壓鹽構鏇齋齋觸鹽) = 蓋憲遞繭糧構蓋顧艱夢 構窪餘醖壓網製窪鏇範 (構遞窪糧築糧鹽壓醖夢 ) 更多 | 不佳 | 2025-10-17 | |
TKI | 簾夢憲觸獵築願壓艱鬱(遞製壓鹽構鏇齋齋觸鹽) = 選簾蓋壓鹹餘觸選襯網 構窪餘醖壓網製窪鏇範 (構遞窪糧築糧鹽壓醖夢 ) 更多 | ||||||
临床2期 | 44 | 夢製鏇壓簾廠積淵廠簾(膚願醖蓋遞窪憲網廠餘) = 衊觸膚簾鏇網鑰衊鹽範 範顧襯鹹窪獵廠夢範鹹 (觸鏇顧蓋選窪鹽淵窪製 ) | 积极 | 2025-05-30 | |||
Trastuzumab | 夢製鏇壓簾廠積淵廠簾(膚願醖蓋遞窪憲網廠餘) = 遞鑰鬱餘獵遞積鏇鏇鹽 範顧襯鹹窪獵廠夢範鹹 (觸鏇顧蓋選窪鹽淵窪製 ) | ||||||
临床2期 | 62 | 繭壓選網製夢鹹簾衊窪(製餘壓醖遞製鑰繭鏇壓) = 範鏇簾鏇醖築鬱鏇襯憲 艱築淵繭鑰糧艱窪餘觸 (蓋鬱構簾顧憲壓醖窪鏇, 43.3 ~ 69.0) 更多 | 积极 | 2025-05-01 | |||
SABCS2024 | NEWS 人工标引  | N/A | HER2阳性转移性乳腺癌 HER2 Positive | 90 | 蓋鹹憲鬱艱齋醖網鑰構(餘願鏇鏇醖鹹鹽製蓋範) = 獵鬱鹹繭鹹憲鹹蓋蓋壓 鏇繭構製醖鹹鹽鹹獵膚 (鏇構餘鹽選餘願觸艱淵, 7.3 ~ 17) 更多 | 积极 | 2024-11-26 | |
(brain metastases) | 蓋鹹憲鬱艱齋醖網鑰構(餘願鏇鏇醖鹹鹽製蓋範) = 簾醖鹹廠選獵積淵網積 鏇繭構製醖鹹鹽鹹獵膚 (鏇構餘鹽選餘願觸艱淵, 4.7 ~ 19.3) 更多 | ||||||
临床2期 | 39 | 蓋築鹽鏇獵餘繭積艱選(醖繭衊構製鏇遞網廠選) = 獵窪蓋顧網襯醖醖襯襯 鬱鏇構鹹鹽遞選構鬱鑰 (簾獵範衊膚鏇範觸齋衊 ) 更多 | 积极 | 2024-09-16 | |||
Neoadjuvant treatment with TCbIP | 蓋築鹽鏇獵餘繭積艱選(醖繭衊構製鏇遞網廠選) = 積鏇築夢蓋簾衊淵膚鑰 鬱鏇構鹹鹽遞選構鬱鑰 (簾獵範衊膚鏇範觸齋衊 ) | ||||||
N/A | HER2阳性转移性乳腺癌 HER2-positive | 500 | Inetetamab | 觸網簾夢鹹鏇鹽醖廠窪(顧願膚鑰夢糧齋願遞製) = leukopenia was generally well-tolerated 顧餘範築鑰壓襯齋繭鏇 (鹽繭積鹹鹹鑰鹽齋壓鬱 ) 更多 | 积极 | 2024-09-16 | |
Inetetamab + Tyrosine Kinase Inhibitors + Chemotherapy | |||||||
临床2期 | - | 壓糧廠選蓋選觸淵淵淵(遞糧壓蓋顧築構膚憲製) = 繭襯壓繭鹹遞顧觸鏇顧 廠構獵鑰範齋觸積簾窪 (夢構鹽膚夢製醖夢觸網 ) 更多 | 积极 | 2024-07-22 | |||
壓糧廠選蓋選觸淵淵淵(遞糧壓蓋顧築構膚憲製) = 網膚蓋蓋築製繭構鬱構 廠構獵鑰範齋觸積簾窪 (夢構鹽膚夢製醖夢觸網 ) 更多 | |||||||
临床2期 | 28 | 顧觸選餘齋鹽齋廠餘願(窪築觸壓繭窪網廠願觸) = 鹹壓膚繭餘壓壓糧膚製 襯遞構網鑰構窪積製糧 (蓋繭簾範齋獵鑰夢製繭 ) 更多 | 积极 | 2024-05-24 | |||
顧觸選餘齋鹽齋廠餘願(窪築觸壓繭窪網廠願觸) = 繭鹽遞遞餘鏇糧壓壓鹽 襯遞構網鑰構窪積製糧 (蓋繭簾範齋獵鑰夢製繭 ) 更多 | |||||||
临床2期 | HER2阳性乳腺癌 HER2 Positive | 30 | 餘鏇獵範蓋遞繭簾鏇齋(夢遞願鏇願夢餘衊醖壓) = 築膚鬱選選衊衊簾製夢 顧夢壓獵鹽鹹淵窪顧蓋 (願鹽鬱糧夢獵網鹽顧鑰, 4.15 ~ 13.12) 更多 | 积极 | 2024-01-01 |
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