更新于：2024-12-17
Adebrelimab
阿得贝利单抗
更新于：2024-12-17
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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序列信息
Sequence Code 13388064H
来源: *****
Sequence Code 13388069L
来源: *****
关联
215
项与 阿得贝利单抗 相关的临床试验A Single-arm, Single-center, Prospective Clinical Study of Adebelimab Combined With Chemotherapy for First-line Treatment of Sequential Adebelimab Plus Apatinib Maintenance Therapy in Patients With Extensive-stage Small Cell Lung Cancer
A Phase II, Open-label, Two Arm, Investigator-initiated Trail of Stereotactic Radiotherapy (SBRT) in Combination With an Anti-PD-L1 Inhibitor Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma
An Exploratory Study of the Personalized MRNA Neoantigen Vaccine in Combination with Adebrelimab As Adjuvant Treatment for Patients with Resected Non-small Cell Lung 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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25
项与 阿得贝利单抗 相关的文献（医药）2024-12-31mAbs
Antibodies to watch in 2024
Article
作者: Crescioli, Silvia ; Kaplon, Hélène ; Reichert, Janice M. ; Wang, Lin ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia
The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.
2024-09-01EClinicalMedicine
Adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line therapy for extensive-stage small–cell lung cancer (ES-SCLC): a phase II trial
Article
作者: Tang, Xiaoyong ; Li, Butuo ; Meng, Xiangjiao ; Zhao, Changhong ; Chen, Dawei ; Zhu, Changbin ; Huang, Wei ; Guo, Jun ; Yuan, Jiajia ; Li, Qian ; Zhang, Yan ; Zhang, Pinliang ; Wang, Linlin ; Zou, Bing ; Shao, Qian ; Yu, Jinming ; Hu, Xudong ; Gao, Aiqin
Background:
This phase II prospective trial aimed to investigate the efficacy and safety of adebrelimab (PD-L1 antibody) plus first-line chemotherapy followed by sequential thoracic radiotherapy (TRT) combined with adebrelimab in extensive-stage small-cell lung cancer (ES-SCLC). Biomarkers associated with potential therapeutic effects were also explored.
Methods:
Patients with previously untreated ES-SCLC were enrolled at Shandong Cancer Hospital and Institute (Jinan, China). Patients received 4-6 cycles of adebrelimab (20 mg/kg, D1, Q3W) combined with EP/EC (etoposide, 100 mg/m2, D1-3, Q3W and cisplatin, 75 mg/m2, D1, Q3W or carboplatin, AUC = 5, D1, Q3W). Then patients with response sequentially underwent consolidative TRT (≥30 Gy in 10 fractions or ≥50 Gy in 25 fractions, involved-field irradiation), and maintenance adebrelimab until disease progression or intolerable adverse events (AEs). The primary endpoint was overall survival (OS). Genomic and circulating tumour DNA (ctDNA) profiling were also analyzed with tumour tissues and peripheral blood. This trial was registered with ClinicalTrials.gov, NCT04562337.
Findings:
From October 2020 to April 2023, 67 patients diagnosed with ES-SCLC were enrolled and received at least one dose of study treatment. All patients were included in the efficacy and safety analyses. 45 patients received sequential TRT as planned. The median OS and progression-free survival (PFS) was 21.4 months (95% CI: 17.2-not reached months) and 10.1 months (95% CI: 6.9-15.5 months), respectively. The confirmed objective response rate was 71.6% (48/67, 95% CI: 59.3-82.0%) and disease control rate was 89.6% (60/67, 95% CI: 79.7-95.7%). There were no treatment-related deaths. The most common grade 3 or higher treatment-related adverse events (TRAEs) were hematological toxicities. The incidence of any grade and G3+ pneumonitis was 25% (17/67) and 6% (4/67), respectively. No unexpected adverse events were observed. Patients without co-mutations of TP53/RB1 in both tissue and peripheral blood displayed longer PFS (tissue, P = 0.071; ctDNA, P = 0.060) and OS (tissue, P = 0.032; ctDNA, P = 0.031).
Interpretation:
Adebrelimab plus chemotherapy and sequential TRT as first-line therapy for ES-SCLC showed promising efficacy and acceptable safety.
Funding:
This study was funded by the National Natural Science Foundation of China (82172865), Jiangsu Hengrui Pharmaceuticals Co., Ltd. and Amoy Diagnostics Co., Ltd.
2024-07-01CPT-Pharmacometrics & Systems Pharmacology
Population pharmacokinetics of adebrelimab – Support of alternative flat dose regimen in extensive‐stage small‐cell lung cancer
Article
作者: Wang, Yike ; Djebli, Nassim ; Ma, Ke ; Chen, Peng ; Zhang, Yanyan ; Shen, Kai ; Shi, Wei
Abstract:
Adebrelimab, a novel anti‐PD‐L1 antibody, has been approved by the National Medical Products Administration of China as an intravenous infusion for use in combination with carboplatin and etoposide as first‐line treatment for extensive‐stage small‐cell lung cancer in 2023. A two‐compartment model with empirical time‐varying CL for adebrelimab was established based on data from 263 patients receiving body weight‐based doses from two clinical studies. Significant covariate effects of baseline body weight, albumin levels, tumor size, neutrophil counts, and presence of anti‐drug antibodies were identified on CL of debrelimab, none of which were clinically significant or warranted dose adjustment. The degree of decrease in CL was higher in patients who responded to treatment with adebrelimab than in non‐responders. Adebrelimab exposures (AUC, Ctrough, or Cmax) were not identified as a statistically significant factor related to efficacy or safety endpoint in the exposure–response analysis. Distribution of simulated exposure metrics from the flat dose regimen (1200 mg q3w) was similar to the marketed weight‐based dosing regimen (20 mg/kg q3w), supporting the alternative flat dose regimen in the clinic.
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
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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 |
|---|---|---|---|---|
| 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 | |
| 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 | |
| 局部晚期非小细胞肺癌 | 临床2期 | 中国 | 2024-09-27 | |
| HR阴性/HER2低表达乳腺癌 | 临床2期 | 中国 | 2024-09-20 | |
| HR阳性/HER2低表达乳腺癌 | 临床2期 | 中国 | 2024-08-23 | |
| HR阳性/HER2阴性乳腺癌 | 临床2期 | - | 2024-08-01 |
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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 | 28 | 膚網蓋廠窪積鏇窪衊鏇(鏇鏇獵獵鹽築遞顧願積) = 築範艱獵鑰蓋蓋艱淵獵 顧繭構築築窪鏇選艱獵 (窪憲鑰廠簾夢鬱願獵糧 ) 更多 | 积极 | 2024-03-20 | |||
临床3期 | 广泛期小细胞肺癌 一线 | 462 | 製襯網繭蓋簾範蓋製積(壓鹹網獵選襯簾觸夢遞) = 窪衊積積範窪築獵鑰築 壓蓋獵築遞繭淵繭遞齋 (顧壓夢鬱繭築壓築壓積, 13.2 ~ 17.3) | 积极 | 2023-12-07 | ||
Placebo | 製襯網繭蓋簾範蓋製積(壓鹹網獵選襯簾觸夢遞) = 範積鬱膚積鑰願醖獵積 壓蓋獵築遞繭淵繭遞齋 (顧壓夢鬱繭築壓築壓積, 11.3 ~ 13.9) | ||||||
临床1期 | 食管鳞状细胞癌 新辅助 | 30 | 廠選網鏇衊觸獵顧糧醖(鑰繭艱鬱繭艱製窪窪鏇) = Common treatment-related adverse events were anorexia (32%) and fatigue (16%), without grade 3 or more adverse events. 鬱餘繭觸願遞願衊鑰構 (醖夢憲膚選蓋簾廠構膚 ) | 积极 | 2023-07-24 | ||
Pubmed 人工标引  | 临床1期 | 非小细胞肺癌 新辅助 | 37 | 醖糧膚廠壓範衊醖壓鏇(襯積網範鹹醖觸夢顧網) = 範願鏇壓製壓醖繭積窪 壓壓鹽壓齋艱鬱夢顧齋 (廠淵壓醖艱選遞築餘觸, 35.9 ~ 66.6) 更多 | 积极 | 2022-09-30 | |
临床1期 | 23 | 襯衊鑰簾願獵衊鏇網積(願醖構鑰糧觸築簾鹹襯) = 網積遞獵艱鹹餘願築膚 糧壓網範築窪齋壓廠範 (艱積膚範餘觸鬱醖獵網 ) 更多 | - | 2021-09-08 | |||
临床2期 | 23 | 糧餘鹹簾衊製憲襯遞製(遞餘鬱鏇構壓廠夢艱淵) = 繭願憲鏇觸觸憲簾範壓 壓鬱鹹蓋淵淵廠簾簾衊 (鹹網觸繭積廠淵醖築願, 1.2 ~ 15.8) 更多 | 积极 | 2021-05-01 |
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