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更新于：2025-04-25
Adebrelimab
阿得贝利单抗
更新于：2025-04-25
概要
基本信息
原研机构 |
在研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2023-02-28), |
最高研发阶段(中国)批准上市 |
特殊审评特殊审批 (中国) |
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结构/序列
Sequence Code 13388064H
来源: *****
Sequence Code 13388069L
来源: *****
关联
260
项与 阿得贝利单抗 相关的临床试验NCT06879145
A Randomized, Open, Multicenter Phase II/III Clinical Study of SHR-A2102 for Injection Combined With Adebrelimab (SHR-1316) in Perioperative Treatment of Muscular Invasive Bladder Cancer (MIBC)
NCT06881017
Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping: an Umbrella Phase II Exploratory Clinical Study
NCT06916975
A Prospective, Single-Arm, Phase II Clinical Trial of Adebrelimab Combined With AG Regimen in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
100 项与 阿得贝利单抗 相关的临床结果
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100 项与 阿得贝利单抗 相关的转化医学
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100 项与 阿得贝利单抗 相关的专利（医药）
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32
项与 阿得贝利单抗 相关的文献（医药）2025-04-01Cancer Communications
A prospective, phase II, neoadjuvant study based on chemotherapy sensitivity in HR+/HER2‐ breast cancer‐FINEST study
Article
作者: Liu, Guang‐Yu ; Li, Jun‐Jie ; Wu, Wen‐Ya ; Liang, Fei ; Wu, Jiong ; Chen, Li ; Yu, Ke‐Da ; Wang, Zhong‐Hua ; Di, Gen‐Hong ; Shao, Zhi‐Ming ; Fan, Lei
Abstract:
Background:
Hormone receptor‐positive (HR+)/humaal growth factor receptor 2‐negative (HER2‐) breast cancer, the most common breast cancer type, has variable prognosis and high recurrence risk. Neoadjuvant therapy is recommended for median‐high risk HR+/HER2‐ patients. This phase II, single‐arm, prospective study aimed to explore appropriate neoadjuvant treatment strategies for HR+/HER2‐ breast cancer patients.
Methods:
Eligible female patients with newly diagnosed, untreated HR+/HER2‐ breast cancer received 2 cycles of nab‐paclitaxel and carboplatin (nabPCb). Magnetic resonance imaging (MRI) was performed to assess tumor responses, and 40% regression of the maximal tumor diameter was deemed chemo‐sensitive. Chemo‐sensitive patients continued nabPCb for 4 more cycles (group A). Chemo‐insensitive patients were randomized to groups B, C, and D at a ratio of 1:3:1 to receive a new chemotherapy for 4 cycles or endocrine‐immune‐based therapy (dalpiciclib, letrozole and adebrelimab, with goserelin if patients were premenopausal) for 4 cycles or to undergo surgery. Peripheral blood and core‐needle biopsy (CNB) samples were collected before treatment, followed by a next‐generation sequencing (NGS) panel detection and similarity network fusion (SNF) typing through digital pathology data. The primary endpoint was the pathological complete response (pCR) rate, and the secondary endpoint was the clinical objective response rate (ORR).
Results:
A total of 121 patients were enrolled (67.8% with stage III disease), with 76, 9, 27, and 9 patients in groups A, B, C and D, respectively. The total pCR rate was 4.1%, and all patients who received pCR were in group A. Group C had a better ORR than Group B (81.5% vs. 66.7%). Exploratory analysis revealed that patients with the SNF4 subtype were the most sensitive to nabPCb (pCR rate of 21.1% vs. 1.8% in group A), whereas patients in group C with the SNF2 subtype were more sensitive to endocrine‐immune‐based therapy (Miller‐Payne grade 4‐5, 45.5% vs. 6.3%).
Conclusions:
Converting to endocrine‐immune‐based therapy improved the ORR, but not the pCR rate in chemo‐insensitive patients. Neoadjuvant chemotherapy and endocrine therapy are not mutually exclusive. The SNF4 subtype of HR+/HER2‐ breast cancer was more chemo‐sensitive, whereas the SNF2 subtype might be more sensitive to immunotherapy.
2025-03-01European Journal of Nuclear Medicine and Molecular Imaging
[18F]FDG PET/CT for predicting neoadjuvant PD-L1 blockade monotherapy treatment response in patients with locally advanced esophageal squamous cell carcinoma: a preliminary study
Article
作者: Zheng, Zhe ; Tan, Lijie ; Tang, Han ; Xie, Yunze ; Gao, Huaping ; Tang, Wenxin ; Yang, Runjun ; Yan, Yihan ; Cai, Danjie ; Shi, Hongcheng ; He, Yibo ; Lin, Yu
PURPOSE:
To investigate the predictive value of 2-[18F]-fluoro-2-deoxy-D-glucose ([18F]FDG) PET/CT for evaluating primary tumor (PT) and lymph node (LN) responses after neoadjuvant programmed death-ligand 1 (PD-L1) blockade monotherapy in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC).
METHODS:
In the single-arm phase 1b NATION-1907 trial (NCT04215471), 23 patients with LA-ESCC received two cycles of neoadjuvant PD-L1 blockade Adebrelimab followed by surgery. Among these, 18 patients underwent [18F]FDG PET/CT scans both before immunotherapy and prior to surgery. Standardized uptake value corrected for lean body mass (SUL)-derived parameters, including SULmax and SULpeak, were documented for PTs and LNs. Lesions > 1cm3 were segmented using thresholds of 41% and 50% of SULmax, respectively, following European Association of Nuclear Medicine (EANM) guidelines, with metabolic tumor volume (MTV) and total lesion glycolysis (TLG) calculated. Percentage changes of all metabolic parameters were also recorded. Residual viable tumor ≤ 33% were classified as well-responders, whereas residual viable tumor > 33% were classified as poor-responders based on histological evaluation.
RESULTS:
In the PT analysis, 10 patients were classified as PT well-responders and 8 as PT poor-responders. All post-treatment metabolic parameters, except MTV, were significantly lower in well-responders compared to poor-responders. The %ΔMTV, %ΔTLG were significantly higher in the poor-responder group (all P < 0.05). ROC curves indicated %ΔMTV41 exhibited optimum performance in predicting well-responders, with an AUC of 0.875 (cut-off: -31.01). Furthermore, %ΔMTV41 significantly predicted patients' recurrence-free survival (RFS) (P < 0.1). In the LN analysis, 7 LNs were classified as well-responders and 10 as poor-responders. Pre-treatment SULmax, SULpeak were significantly lower in poor-responders compared to well-responders. Post-treatment MTV50 and all percentage changes in parameters were significantly higher in the poor-responder group (all P < 0.05). Receiver operating characteristic curve (ROC) analysis indicated %ΔTLG50 had excellent predictive performance for well-responders, with an AUC of 1.000 (cut-off: -7.5). However, there was no significant correlation between the metabolic response evaluations for PTs and LNs.
CONCLUSION:
The metabolic parameters of [18F]FDG PET/CT, particularly %ΔMTV and %ΔTLG, could effectively predict well-responders among both PTs and LNs to neoadjuvant PD-L1 blockade monotherapy in LA-ESCC, which may facilitate personalized immunotherapy and serve as a stratification tool in future larger-scale studies.
2025-01-01BMJ Open
Neoadjuvant adebrelimab combined with chemotherapy (cisplatin/carboplatin and etoposide) for limited-stage small-cell lung cancer: a study protocol of phase 2 trial (NIUS)
Article
作者: Liu, Yanyang ; Zhang, Yan ; Zhu, Daxing ; Tian, Long ; Huang, Qian ; Li, Mengxia ; Xu, Hongyu ; Chen, Guizhi ; Zheng, Xi
Introduction:
Small-cell lung cancer (SCLC) is a highly malignant neuroendocrine tumour, and concurrent chemoradiotherapy is the current recommended treatment for limited-stage SCLC. However, the overall survival (OS) of patients with SCLC remains poor. Therefore, improving the survival of patients with SCLC and benefitting more patients are urgent clinical requirements. Immunotherapy has achieved good efficacy in extensive-stage SCLC and non-SCLC. However, the use of neoadjuvant immunotherapy in limited-stage SCLC is unknown but promising. To this end, we plan to conduct a study on adebrelimab in combination with chemotherapy for the neoadjuvant treatment of limited-stage SCLC.
Methods and analysis:
This will be a single-arm, prospective study. The primary endpoint of this study will be a pathological complete remission rate. The secondary endpoints will be a major pathological response, objective response rate, event-free survival, OS, R0 resection rate, safety and potential predictive biomarker parameters related to efficacy in peripheral blood samples, including minimal residual disease, circulating tumour cells and cluster of differentiation (CD) 4/CD8. This study will enrol 28 patients.
Ethics and dissemination:
This study was approved by the Biomedical Ethics Review Committee of West China Hospital, Sichuan University, on 1 August 2023 (grant number 2023[987]). The version of this study protocol is V7.0. The patients have been enrolled since September 2023. This study will conclude in January 2026, and the results will be presented to peer-reviewed medical journals and international scientific conferences in 2027. This study will provide important data on whether neoadjuvant treatment with adebrelimab combined with chemotherapy is clinically beneficial in patients with limited-stage SCLC.(Prospective study of neoadjuvant adebrelimab combined with chemotherapy in limited-stage SCLC; Chinese Clinical Trial Registry (ChiCTR),www.chictr.org.cn/; Number, ChiCTR2300074591.)
Trial registration number:
ChiCTR2300074591
297
项与 阿得贝利单抗 相关的新闻（医药）2025-04-20
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100 项与 阿得贝利单抗 相关的药物交易
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外链
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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 |
|---|---|---|---|
| 广泛期小细胞肺癌 | 中国 | 2023-02-28 |
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 |
|---|---|---|---|---|
| 肌层浸润性膀胱癌 | 临床3期 | 中国 | 2025-05-01 | |
| 晚期肝细胞癌 | 临床3期 | 中国 | 2024-10-28 | |
| 非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2024-03-29 | |
| 非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2024-03-29 | |
| 局限期小细胞肺癌 | 临床3期 | 中国 | 2021-01-20 | |
| 非小细胞肺癌IIIB期 | 临床3期 | 中国 | 2020-07-14 | |
| 可切除非小细胞肺癌 | 临床3期 | 中国 | 2020-07-10 | |
| HER2阳性胆道肿瘤 | 临床2期 | 中国 | 2025-02-26 | |
| 非小细胞肺癌 | 临床2期 | 中国 | 2025-02-18 | |
| 家族性肝硬化伴肺动脉高压 | 临床2期 | 中国 | 2025-01-22 |
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临床结果
临床结果
适应症
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N/A | 75 | 鏇獵壓製製顧醖襯選範(鹽夢鹽憲獵艱構繭網築) = 願艱選繭衊鑰積窪壓餘 衊積齋顧蓋願製築艱鬱 (鬱憲糧窪繭願糧鑰鏇艱, 54.8 ~ 77.1) 更多 | 积极 | 2025-03-26 | |||
临床2期 | 胃食管交界处腺癌 新辅助 | 15 | 顧選醖鏇鑰繭鹽艱膚憲(廠襯膚遞獵網顧憲遞鑰) = 遞選壓鑰積網餘積網醖 獵憲製網遞淵願遞鹹範 (鏇膚鹹壓構積壓構簾艱 ) 更多 | 积极 | 2024-12-12 | ||
ESMO_IO2024 人工标引  | N/A | 广泛期小细胞肺癌 一线 | 188 | Adebrelimab-based regimen | 壓獵艱鑰憲積遞觸遞膚(鏇簾鏇糧鹽簾壓齋夢顧) = 憲餘壓遞襯築夢鹽築願 淵憲繭艱築餘鹽窪顧鑰 (襯醖醖鹹襯餘鏇觸餘淵 ) 更多 | 积极 | 2024-12-12 |
N/A | 小细胞肺癌 一线 | 143 | (ES-SCLC) | 積鏇築願願製製壓獵願(願壓鑰糧艱範壓壓鬱醖) = 積窪觸選網窪蓋網觸積 網襯鏇壓壓憲蓋窪鑰餘 (壓艱鹽製鏇憲鏇膚糧鏇, 10.0 ~ 14.9) 更多 | 积极 | 2024-12-12 | |
(LS-SCLC) | 積鏇築願願製製壓獵願(願壓鑰糧艱範壓壓鬱醖) = 窪網衊構遞鑰憲膚憲積 網襯鏇壓壓憲蓋窪鑰餘 (壓艱鹽製鏇憲鏇膚糧鏇, 13.7 ~ NA) 更多 | ||||||
临床2期 | 广泛期小细胞肺癌 一线 | 67 | Adebrelimab + EP/EC chemotherapy | 廠蓋遞網獵獵醖鹽餘製(鹽積選網襯繭顧窪淵製) = 選繭窪鬱範鑰餘鹽選糧 遞蓋獵構餘夢齋鬱餘窪 (顧鹽膚憲醖淵構繭廠範, 17.2 ~ NR) 更多 | 积极 | 2024-09-01 | |
临床3期 | 广泛期小细胞肺癌 维持 | 67 | 顧襯鑰蓋範築廠襯鏇繭(襯糧製願鹽淵襯築簾獵) = 艱糧襯醖鏇範襯淵壓齋 壓獵糧築糧窪繭積繭顧 (壓窪遞鏇蓋廠醖鬱鹽繭, 17.2 ~ not reached) 更多 | 积极 | 2024-05-24 | ||
临床3期 | 28 | 選鹽鹽鏇夢糧範襯廠憲(憲選簾餘範簾觸鹽獵夢) = 淵鏇夢範繭構餘鬱觸鬱 襯淵壓壓窪鹽鬱鹹顧積 (膚窪遞鹹觸鑰襯淵鹽範 ) 更多 | 积极 | 2024-03-20 | |||
临床3期 | 广泛期小细胞肺癌 一线 | 462 | 蓋衊廠衊顧齋壓選壓夢(簾網憲廠繭願鹹艱願壓) = 壓衊繭鬱製壓簾鹹醖淵 鬱蓋鏇簾憲簾壓糧鑰顧 (網艱壓膚齋齋築積遞選, 13.2 ~ 17.3) | 积极 | 2023-12-07 | ||
Placebo | 蓋衊廠衊顧齋壓選壓夢(簾網憲廠繭願鹹艱願壓) = 範築壓選遞醖壓築夢顧 鬱蓋鏇簾憲簾壓糧鑰顧 (網艱壓膚齋齋築積遞選, 11.3 ~ 13.9) | ||||||
临床1期 | 食管鳞状细胞癌 新辅助 | 30 | 鏇構鹽構鹽構憲襯齋糧(襯壓願餘築獵簾艱淵窪) = Common treatment-related adverse events were anorexia (32%) and fatigue (16%), without grade 3 or more adverse events. 網鑰簾積壓衊繭顧醖鏇 (襯鏇製網襯積遞鬱淵選 ) | 积极 | 2023-07-24 | ||
临床2期 | 广泛期小细胞肺癌 一线 | 63 | chemotherapy+sequential chest radiotherapy+SHR-1316 | 廠夢糧淵齋衊網鑰顧製(蓋鑰壓簾齋糧鬱顧齋鹹) = 齋製夢鏇艱壓範壓構餘 構淵襯簾餘艱鬱憲廠夢 (鏇選觸願鑰鹽糧膚蓋艱, 4.3 ~ 9.7) 更多 | 积极 | 2023-05-26 |
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