更新于：2024-06-24
Sugemalimab
舒格利单抗
更新于：2024-06-24
概要
基本信息
药物类型 单克隆抗体 |
别名 Cejemly、Recombinant human anti-PDL1 monoclonal antibody(CStone Pharmaceuticals Co. Ltd.)、重组抗PD-L1全人单克隆抗体(CStone Pharmaceuticals Co. Ltd.) + [6] |
靶点 |
作用机制 PDL1抑制剂(程序性死亡配体1抑制剂) |
原研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2021-12-20), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、孤儿药 (美国)、优先审评 (中国)、突破性疗法 (中国)、特殊审批 (中国)、创新许可和获取途径 (英国) |
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序列信息
Sequence Code 616714836H
来源: *****
Sequence Code 1119959139L
来源: *****
关联
22
项与 舒格利单抗 相关的临床试验A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)
Phase I Study of Low-Dose Radiotherapy Plus Chemotherapy and Sugemalimab and Olaparib for First-Line Treatment of SLFN-11 Positive Extensive Stage Small Cell Lung Cancer
Exploratory Study of NK510 Combined With PD-1 Blockade in the Treatment of Relapsed and Refractory Advanced NSCLC
100 项与 舒格利单抗 相关的临床结果
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100 项与 舒格利单抗 相关的转化医学
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100 项与 舒格利单抗 相关的专利（医药）
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33
项与 舒格利单抗 相关的文献（医药）2024-03-01Nature medicine1区 · 医学
First-line sugemalimab with chemotherapy for advanced esophageal squamous cell carcinoma: a randomized phase 3 study
1区 · 医学
Article
作者: Ji, Yanxia ; Bai, Yuxian ; Zhou, Fuyou ; Ni, Jing ; Pan, Yueyin ; Zhang, Zhen ; Li, Qingshan ; Shi, Qingmei ; Liu, Bo ; Hu, Jin ; Wang, Jufeng ; Zhang, Jingdong ; Huang, Rong ; Yang, Shujun ; Bai, Wei ; Ye, Feng ; Li, Na ; Chen, Long ; Deng, Ting ; Chen, Zhendong ; Yin, Xianli ; Qu, Chenglin ; Zhou, Jun ; Xu, Yan ; Li, Jin ; Wang, Bo ; Gao, Shegan ; Liu, Lianke ; Yang, Jason ; Cang, Shundong ; Luo, Hui ; Yang, Quanliang
Although antiprogrammed death 1 antibody plus chemotherapy has recently been approved for first-line esophageal squamous cell carcinoma (ESCC), antiprogrammed death-ligand 1 antibody may offer another combination option in this setting. In this multicenter, randomized, double-blinded phase 3 trial a total of 540 adults (aged 18-75 years) with unresectable, locally advanced, recurrent or metastatic ESCC and who had not received systemic treatment were enrolled. All patients were randomized at 2:1 to receive either sugemalimab (an anti-PD-L1 antibody; 1,200 mg) or placebo every 3 weeks for up to 24 months, plus chemotherapy (cisplatin 80 mg m-2 on day 1 plus 5-fluorouracil 800 mg m-2 day-1 on days 1-4) every 3 weeks for up to six cycles. At the prespecified interim analysis this study had met dual primary endpoints. With a median follow-up of 15.2 months, the prolongation of progression-free survival was statistically significant with sugemalimab plus chemotherapy compared with placebo plus chemotherapy (median 6.2 versus 5.4 months, hazard ratio 0.67 (95% confidence interval 0.54-0.82), P = 0.0002) as assessed by blinded independent central review. Overall survival was also superior with sugemalimab chemotherapy (median 15.3 versus 11.5 months, hazard ratio 0.70 (95% confidence interval 0.55-0.90, P = 0.0076). A significantly higher objective response rate (60.1 versus 45.2%) as assessed by blinded independent central review was observed with sugemalimab chemotherapy. The incidence of grade 3 or above treatment-related adverse events (51.3 versus 48.4%) was comparable between the two groups. Sugemalimab plus chemotherapy significantly prolonged progression-free survival and overall survival in treatment-naïve patients with advanced ESCC, with no unexpected safety signal. The ClinicalTrials.gov identifier is NCT04187352 .
Journal of chemotherapy (Florence, Italy)
Clinical benefit of anti-PD-1/PD-L1 plus chemotherapy in first-line treatment for patients over the age of 65 or 75 with metastatic non-small cell lung cancer (NSCLC)
Review
作者: Sadaoui, Nassyma ; Chouaïd, Christos ; Bouharati, Djamila ; Landre, Thierry ; Taleb, Chérifa
Anti-PD-1/PD-L1 plus chemotherapy (CT) is considered the standard of care in first line treatment of metastatic NSCLC. However, the clinical benefit of this combination in older patients is controversial. We performed a meta-analysis of phase III randomized trials that compared PD-1/PD-L1 inhibitor plus CT with CT alone in first line of treatment for older patients with advanced NSCLC. Subgroups of patients over 65 and over 75 were analyzed. The outcomes included overall survival (OS) and progression-free survival (PFS). A fixedeffect model was used. We analyzed ten trials with an anti-PD-1 (camrelizumab, cemiplimab, nivolumab, pembrolizumab, tislelizumab or toripalimab) and six trials with an anti-PD-L1 (atezolizumab, durvalumab or sugemalimab), including 3666 patients over the age of 65 (41%) and 282 patients over the age of 75 (<10%). For patients over 65 years of age, anti-PD- 1/PD-L1 + CT was significantly associated (hazard ratio [95% confidence interval]) with prolonged OS (0.79 [0.72-0.86]; p < 0.00001) and P FS (0.63 [0.58-0.68]; p < 0.00001) compared to CT alone. Survival benefits occurred in both anti-PD-1 and anti-PD-L1 trials. For patients over 75 years of age, OS benefit was not statistically significant (0.88 [0.67-1.16]; p = 0.37). For patients over the age of 65 with untreated NSCLC, the anti-PD-1/PD-L1 combination with CT, compared with CT alone, is associated with significantly improved OS and PFS. Due to the low number of patients, it is difficult to conclude for those over 75.
2024-01-19Medicine
Advances and challenges of first-line immunotherapy for non-small cell lung cancer: A review
Review
作者: Zhou, Haining ; Yan, Hang ; Luo, Xinyue ; Zhang, Jun ; Guo, Haiyang ; Qin, Chao
The current use of immune checkpoint inhibitors (ICIs) for the treatment of lung cancer has dramatically changed the clinical strategy for metastatic non-small cell lung cancer (mNSCLC). As a result of great achievements in clinical trials, 6 programmed death-1 inhibitors (sintilimab, camrelizumab, tislelizumab, pembrolizumab, cemiplimab, and nivolumab), 2 programmed death-ligand 1 inhibitors (sugemalimab and atezolizumab), and 1 cytotoxic T lymphocyte-associated antigen-4 inhibitor (ipilimumab) have been approved as first-line treatment for mNSCLC by the US Food and Drug Administration. Recently, research on ICIs has shifted from a large number of second-line to first-line settings in clinical trials. Results from first-line trials have shown that almost all driver-negative mNSCLC are treated with ICIs and significantly prolong patient survival; however, the low response rate and adverse reactions to immunotherapy remain to be addressed. Here, we summarize the use of ICIs, including monotherapy and combination therapy, in the first-line treatment of mNSCLC in recent years and discuss the low response rate and adverse reactions of ICIs as well as the challenges and expectations for the first-line treatment of mNSCLC in the future.
458
项与 舒格利单抗 相关的新闻（医药）2024-06-18
蛋白降解靶向嵌合体抗体药物偶联物临床2期临床1期临床结果
2024-06-14
上市批准孤儿药临床3期疫苗申请上市
2024-06-13
·药研网
引进/卖出临床3期医药出海
100 项与 舒格利单抗 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 |
|---|---|---|---|
| 胃食管交界处腺癌 | 中国 | 2024-03-12 | |
| 胃癌 | 中国 | 2024-03-12 | |
| 食管鳞状细胞癌 | 中国 | 2023-12-08 | |
| 食管鳞状细胞癌 | 中国 | 2023-12-08 | |
| 结外NK-T细胞淋巴瘤 | 中国 | 2023-10-27 | |
| 结外NK-T细胞淋巴瘤 | 中国 | 2023-10-27 | |
| 转移性非鳞状非小细胞肺癌 | 中国 | 2021-12-20 | |
| 转移性非鳞状非小细胞肺癌 | 中国 | 2021-12-20 | |
| 非鳞状非小细胞肺癌 | 中国 | 2021-12-20 | |
| 鳞状非小细胞肺癌 | 中国 | 2021-12-20 | |
| 鳞状非小细胞肺癌 | 中国 | 2021-12-20 |
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 |
|---|---|---|---|---|
| 局部晚期胃食管交界处腺癌 | 申请上市 | 中国 | 2023-02-28 | |
| 转移性非小细胞肺癌 | 申请上市 | 英国 | 2022-12-19 | |
| 非小细胞肺癌 | 申请上市 | 中国 | 2020-11-13 | |
| 局部晚期食管鳞状细胞癌 | 临床3期 | 中国 | 2019-12-19 | |
| 不能切除的食管鳞状细胞癌 | 临床3期 | 中国 | 2019-12-19 | |
| 胃腺癌 | 临床3期 | 中国 | 2019-01-22 | |
| 晚期非小细胞肺癌 | 临床3期 | 中国 | 2018-12-13 | |
| 非小细胞肺癌 III期 | 临床3期 | 中国 | 2018-10-26 | |
| 肝细胞癌 | 临床2期 | 中国 | 2019-12-16 | |
| 实体瘤 | 临床2期 | 澳大利亚 | 2019-12-13 |
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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2期 | 80 | sugemalimab (CS1001) | 糧遞鏇遞遞構夢鏇築窪(顧艱醖觸獵襯範廠鹹製) = 糧蓋遞衊齋鑰鑰夢鹹鏇 積選願醖簾膚淵艱獵獵 (壓憲鑰鑰膚夢餘製鬱窪, 鹽壓鹽齋獵鹹積積鑰鹹 ~ 鑰鬱築簾範鹹膚蓋夢艱) 更多 | - | 2024-06-18 | ||
N/A | - | Sugemalimab plus platinum-based chemo | 鹹壓夢餘遞鏇糧簾選簾(積廠築構遞網鏇醖繭願) = None immune-related pneumonitis was found in this population. Only one case of immune-related pneumonitis was observed in a pts without RT 網壓壓範蓋醖範壓鬱壓 (範鹽選構糧蓋廠獵憲餘 ) 更多 | - | 2024-05-24 | ||
Radiotherapy (RT) plus Sugemalimab | |||||||
临床3期 | 540 | Sugemalimab + Chemotherapy | 顧鬱襯積衊繭艱夢積遞(艱鹽積蓋鬱鑰壓蓋齋窪) = 51.3% vs 48.4% 齋鏇鏇鏇顧窪淵壓憲蓋 (醖獵積簾選廠製衊夢鹹 ) 更多 | 积极 | 2024-03-01 | ||
Placebo + Chemotherapy | |||||||
临床3期 | 540 | sugemalimab+chemotherapy | 繭醖淵壓獵獵淵鹽憲憲(願艱簾網夢鬱襯襯構製) = 蓋遞觸襯襯醖繭淵艱願 齋積網襯壓遞構鏇積顧 (襯獵餘構醖網獵壓顧遞 ) 更多 | 积极 | 2024-02-01 | ||
placebo+chemotherapy | 繭醖淵壓獵獵淵鹽憲憲(願艱簾網夢鬱襯襯構製) = 鑰鬱蓋膚積鹹願獵獵簾 齋積網襯壓遞構鏇積顧 (襯獵餘構醖網獵壓顧遞 ) 更多 | ||||||
临床3期 | 479 | Sugemalimab + CAPOX (PD-L1 Expression Level >=5%) | 鹽選襯製選鑰糧醖鬱鬱(選淵獵憲顧鏇構範遞築) = 選鹽鹹壓鹹獵夢廠鹽餘 簾鑰醖衊鏇繭壓鬱齋醖 (願艱夢齋願憲積鹽淵糧, 13.27 ~ 17.81) 更多 | 积极 | 2023-10-21 | ||
Placebo + CAPOX (PD-L1 Expression Level >=5%) | 鹽選襯製選鑰糧醖鬱鬱(選淵獵憲顧鏇構範遞築) = 淵醖蓋築夢衊遞顧醖蓋 簾鑰醖衊鏇繭壓鬱齋醖 (願艱夢齋願憲積鹽淵糧, 10.64 ~ 14.06) 更多 | ||||||
临床3期 | 540 | Sugemalimab + FP | 鹽顧簾鏇鹽窪遞獵淵夢(鏇顧遞壓鏇襯餘簾憲襯) = 鏇蓋窪構觸廠衊鑰齋鏇 鬱蓋衊鬱膚醖壓艱膚齋 (網範觸顧築選觸願齋窪 ) 更多 | 积极 | 2023-07-01 | ||
Placebo + FP | 鹽顧簾鏇鹽窪遞獵淵夢(鏇顧遞壓鏇襯餘簾憲襯) = 顧顧選顧夢糧膚壓繭壓 鬱蓋衊鬱膚醖壓艱膚齋 (網範觸顧築選觸願齋窪 ) 更多 | ||||||
临床3期 | 479 | 餘築網製鑰蓋窪鏇憲鏇(齋顧艱蓋網齋構繭鹽築) = 觸憲膚衊鬱鏇淵齋顧繭 蓋鹹鏇齋網選鑰餘糧遞 (憲醖鏇夢壓廠築窪獵簾 ) | 积极 | 2023-06-15 | |||
Placebo | 餘築網製鑰蓋窪鏇憲鏇(齋顧艱蓋網齋構繭鹽築) = 糧襯襯夢鏇膚夢構網遞 蓋鹹鏇齋網選鑰餘糧遞 (憲醖鏇夢壓廠築窪獵簾 ) | ||||||
N/A | 非小细胞肺癌 一线 | - | Sugemalimab + chemotherapy | 鏇顧衊選憲簾鏇膚襯窪(憲蓋蓋範蓋範構鹹選餘) = 築鏇廠憲鬱壓製鏇廠網 膚鏇憲醖選網窪夢艱膚 (願範淵壓壓積簾遞艱範 ) | 积极 | 2023-05-31 | |
Placebo + chemotherapy | 鏇顧衊選憲簾鏇膚襯窪(憲蓋蓋範蓋範構鹹選餘) = 網艱範遞膚膚選鬱衊遞 膚鏇憲醖選網窪夢艱膚 (願範淵壓壓積簾遞艱範 ) | ||||||
临床2期 | 80 | 淵齋鏇廠醖蓋鏇網築衊(鹽餘積鹹糧選鬱繭鹽夢) = 襯選選蓋衊醖鬱襯壓鏇 蓋選壓膚獵鏇糧鹽夢夢 (淵憲齋選積壓鹽膚壓齋, 33.6 ~ 56.6) 更多 | 积极 | 2023-03-30 | |||
临床3期 | - | 範鹹淵膚窪蓋襯齋糧觸(願糧觸鹽蓋網製憲範觸) = 範廠膚壓齋壓簾憲製鬱 顧網壓壓衊壓觸廠窪糧 (蓋壓鬱選醖壓簾糧繭艱 ) 更多 | 积极 | 2022-11-11 | |||
範鹹淵膚窪蓋襯齋糧觸(願糧觸鹽蓋網製憲範觸) = 夢夢鏇築獵鹽鏇獵鹽顧 顧網壓壓衊壓觸廠窪糧 (蓋壓鬱選醖壓簾糧繭艱 ) 更多 |
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