预约演示
更新于：2025-07-31
Sugemalimab
舒格利单抗
更新于：2025-07-31
概要
基本信息
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)、突破性疗法 (中国)、附条件批准 (中国)、创新许可和获取途径 (英国)、特殊审批 (中国)、优先审评 (中国) |
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结构/序列
Sequence Code 616714836H
来源: *****
Sequence Code 616714851L
来源: *****
关联
22
项与 舒格利单抗 相关的临床试验NCT05700448
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)
NCT06987734
Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients
CTR20233170
活菌MNC-168肠溶胶囊分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的安全性、耐受性、药代动力学特征及初步有效性的I期临床研究
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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44
项与 舒格利单抗 相关的文献（医药）2025-07-01LANCET ONCOLOGY
Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): 4-year outcomes from a double-blind, randomised, phase 3 trial
Article
作者: Dai, Hangjun ; Chen, Xueqin ; Li, Xingya ; Sun, Si ; Ma, Zhiyong ; Zhang, Xiaochun ; Cui, Jiuwei ; Wang, Ziping ; Yang, Jason ; Zhang, Yiping ; Ma, Rui ; Shu, Yongqian ; Zhao, Hui ; Wang, Bo ; Li, Lin ; Sun, Meili ; Shen, Hong ; Liu, Yunpeng ; Liang, Li ; Hu, Chunhong ; Yu, Yan ; Zhou, Caicun ; Wang, Mengzhao ; Zhuang, Wu ; Lu, You ; Zhou, Jianying ; Sun, Ping ; Chen, Jianhua ; Cao, Lejie ; Shi, Qingmei ; Liu, Jiwei ; Li, Jingzhang ; Li, Man ; Wang, Changli ; Wang, Qiang ; Yao, Wenxiu ; Wang, Jingru ; Yang, Hui ; Gu, Kangsheng ; Liu, Chunling ; Wu, Rong
BACKGROUND:
GEMSTONE-302 was a phase 3 trial in patients with treatment-naive metastatic squamous or non-squamous non-small-cell lung cancer (NSCLC), showed significant improvement in progression-free survival and overall survival with sugemalimab, a PD-L1 inhibitor, plus chemotherapy versus placebo plus chemotherapy. We report the 4-year outcomes from this study.
METHODS:
This randomised, double-blind, phase 3 trial was conducted across 35 hospitals and academic research centres in China. Eligible patients were aged 18-75 years; had treatment-naive, histologically or cytologically confirmed stage IV NSCLC, irrespective of PD-L1 expression levels; and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomised (2:1) by investigators using an interactive web response or voice response system via permuted blocks (block sizes of three or six, randomised within each stratum). Patients received histology-specific platinum-based chemotherapy combined with either sugemalimab (1200 mg; sugemalimab group) or placebo (placebo group) for up to four cycles, followed by for up to 35 cycles of maintenance therapy with sugemalimab alone for patients with squamous NSCLC and sugemalimab plus pemetrexed for patients with non-squamous NSCLC in the sugemalimab group, or placebo for patients with squamous NSCLC and placebo plus pemetrexed for patients with non-squamous NSCLC in the placebo group, administered intravenously. Treatment beyond 35 cycles was permitted at the investigator's discretion. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. Here, we report post-hoc 4-year efficacy and safety outcomes from GEMSTONE-302. This study is registered with ClinicalTrials.gov (NCT03789604) and concluded on May 15, 2023, with all patients discontinued.
FINDINGS:
Between December 13, 2018, and May 15, 2020, 846 patients were assessed for eligibility. 479 patients were randomly assigned into the sugemalimab group (n=320) and placebo group (n=159). 254 (79%) patients were men and 66 (21%) were women in the sugemalimab group and 129 (81%) were men and 30 (19%) were women in the placebo group. All patients were Asian. As of the data cutoff on May 15, 2023, median follow-up durations were 43·5 months (IQR 41·2-46·9) in the sugemalimab group and 43·0 months (40·7-44·8) in the placebo group; median treatment durations were 7·2 months (4·2-18·8) with sugemalimab and 4·6 months (2·8-6·9) with placebo. Median progression-free survival was 9·0 months (95% CI 7·4-10·9) in the sugemalimab group versus 4·9 months (4·8-5·2) in the placebo group (hazard ratio [HR] 0·49 [95% CI 0·39-0·60]). Median overall survival was 25·2 months (20·1-30·2) in the sugemalimab group versus 16·9 months (12·8-20·7) in the placebo group (HR 0·68 [0·54-0·85]). The 4-year overall survival rates were 32·1% (95% CI 26·7-37·6) in the sugemalimab group versus 17·3% (11·1-24·7) in the placebo group. The most common grade 3-4 treatment related adverse events were decreased neutrophil count (105 [33%] with sugemalimab vs 52 [33%] with placebo), decreased white blood cell count (48 [15%] vs 27 [17%]), anaemia (44 [14%] vs 18 [11%]), and decreased platelet count (35 [11%] vs 15 [9%]). Treatment-related serious adverse events occurred in 82 (26%) patients with sugemalimab and 31 (20%) with placebo. No additional treatment-related deaths occurred since the previous overall survival interim analysis. No new safety signals were identified.
INTERPRETATION:
Sugemalimab with chemotherapy showed a superior long-term overall survival benefit compared with placebo with chemotherapy, as a first-line treatment for patients with NSCLC with no known sensitising EGFR, ALK, ROS1, or RET genomic alterations. These results underscore the efficacy of sugemalimab plus platinum-based chemotherapy as a standard first-line treatment option for both squamous and non-squamous metastatic NSCLC while maintaining a manageable safety profile.
FUNDING:
CStone Pharmaceuticals.
TRANSLATION:
For the Chinese translation of the abstract see Supplementary Materials section.
2025-04-15JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
First-Line Sugemalimab Plus Chemotherapy for Advanced Gastric Cancer
Article
作者: Shi, Qingmei ; Shen, Zhenwei ; Liang, Xinjun ; Liao, Wangjun ; Pan, Hongming ; Zhang, Tao ; Sun, Meili ; Shen, Lin ; Gao, Yanrong ; Hou, Anji ; Li, Qi ; Deng, Yanhong ; Zhao, Yunbo ; Xiao, Li ; Wang, Jufeng ; Wang, Qi ; Chen, Yanhua ; Wan, Yiye ; Xie, Zhong ; Liu, Yunpeng ; Luo, Zhanxiong ; Zhang, Li ; Xie, Yanru ; Wang, Gang ; Zhu, Dan ; Yang, Xinhui ; Lu, Chuangxin ; Yang, Jason ; Hu, Changlu ; Lin, Xiaoyan ; Lin, Yan ; Sun, Yinping ; Luo, Jie ; Ji, Yanxia ; Yan, Dong ; Wang, Junye ; Wang, Zishu ; Mou, Yiping ; Li, Hongxia ; Yao, Sheng ; Zhang, Xiaotian ; Zhang, Yanqiao ; Fan, Qingxia ; Zhang, Ruixing ; Shi, Yongquan ; Sun, Sanyuan ; Xiong, Jianping ; Li, Jiayi ; Shu, Yongqian ; Fu, Ting ; Chen, Ping ; Yao, Juntao
Importance:
Gastric cancer, including gastroesophageal junction cancer, is one of the most commonly diagnosed cancers worldwide, with high mortality. Sugemalimab is a fully human anti–programmed death-ligand 1 (PD-L1) antibody. The combination of sugemalimab and chemotherapy showed promising antitumor activity and safety in a phase 1b study among patients with treatment-naive, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. This combination was further evaluated in the GEMSTONE-303 phase 3 trial.
Objective:
To evaluate the efficacy of sugemalimab in combination with capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX as first-line treatment for patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 combined positive score (CPS) of 5 or greater.
Design, Setting, and Participants:
GEMSTONE 303 is a phase 3, randomized, double-blind, placebo-controlled study conducted at 54 sites in China that enrolled patients from April 9, 2019, through December 29, 2021, with follow-up to July 9, 2023. A total of 479 eligible patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS of 5 or greater who did not receive any prior systemic therapy were randomized.
Intervention:
Patients received sugemalimab (1200 mg intravenously) (n = 241) or placebo (n = 238) every 3 weeks for up to 24 months, plus CAPOX every 3 weeks for up to 6 cycles.
Main outcomes and Measures:
Primary outcomes were overall survival and investigator-assessed progression-free survival.
Results:
Baseline characteristics were well balanced between the 2 groups. Most patients were male (71.4% in sugemalimab group, 74.8% in placebo group). Median follow-up was 25.1 months in the sugemalimab group and 26.3 months in the placebo group. The sugemalimab group demonstrated significant improvements in overall survival (median, 15.6 months [95% CI, 13.3-17.8] vs 12.6 months [95% CI, 10.6-14.1]; hazard ratio, 0.75 [95% CI, 0.61-0.92]; P = .006) and progression-free survival (median, 7.6 months [95% CI, 6.4-7.9] vs 6.1 months [95% CI, 5.1-6.4]; hazard ratio, 0.66 [95% CI, 0.54-0.81]; P < .001). Grade 3 or higher treatment-related adverse events occurred in 53.9% of patients in the sugemalimab group and 50.6% in the placebo group.
Conclusions and Relevance:
Sugemalimab plus chemotherapy significantly prolonged overall survival and progression-free survival with a manageable safety profile in previously untreated patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Trial Registration:
ClinicalTrials.gov Identifier: NCT03802591
2025-03-01BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
Comprehensive population pharmacokinetic modelling of sugemalimab, an anti‐programmed death‐ligand 1 (PD‐L1) human monoclonal antibody, in patients with solid tumours or lymphomas across multiple Phase I–III studies
Article
作者: Xu, Fengyan ; Wang, Kun ; Tse, Archie N. ; Sheng, Yucheng ; Pan, Chaohsuan
Aims:
The aim of this study was to develop a population pharmacokinetics model for sugemalimab, a monoclonal antibody that targets programmed death‐ligand 1 (PD‐L1), using data from Phase I–III trials and to assess clinical factors affecting sugemalimab exposure.
Methods:
A nonlinear mixed‐effect modelling approach was employed to analyse pooled data from nine studies involving 1628 subjects to characterize the PopPK of sugemalimab. This investigation examined the influence of various covariates on sugemalimab pharmacokinetics (PK), encompassing demographics, baseline hepatic and renal function‐related covariates, and others (including anti‐drug antibody [ADA], combination treatment, Eastern Cooperative Oncology Group [ECOG] performance score, tumour burden and tumour type). Estimation accuracy and predictive ability of the final model were evaluated using various methods. The influence of covariates on sugemalimab exposure was assessed by simulation from the final model.
Results:
A two‐compartment model with first‐order elimination and time‐varying clearance effectively described the PK of sugemalimab. Covariate analyses revealed significant relationships between sugemalimab clearance and body weight, albumin, gender, ADA, tumour burden and tumour type. The statistically significant covariates on central volume were body weight, albumin, gender and tumour type. No significant relationships were found in the final model for age, race, alanine aminotransferase, aspartate aminotransferase, creatinine, total bilirubin, alkaline phosphatase, combination treatment, creatinine clearance, ECOG, renal function or hepatic function. All significant covariates demonstrated less than a 20% effect on sugemalimab exposure.
Conclusions:
The PopPK model adequately described the pharmacokinetic profile of sugemalimab with no clinically meaningful impact observed on its exposure across all covariates. Dose adjustment does not appear to be necessary.
研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 转移性非小细胞肺癌 | 欧盟 | - | 2024-07-24 |
| 转移性非小细胞肺癌 | 冰岛 | - | 2024-07-24 |
| 转移性非小细胞肺癌 | 列支敦士登 | - | 2024-07-24 |
| 转移性非小细胞肺癌 | 挪威 | - | 2024-07-24 |
| 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 |
|---|---|---|---|---|
| 不可切除的非小细胞肺癌 | 申请上市 | 欧盟 | 2025-03-24 | |
| 局部晚期胃食管交界处腺癌 | 申请上市 | 中国 | 2023-02-28 | |
| 非小细胞肺癌 | 申请上市 | 中国 | 2020-11-13 | |
| 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 | |
| 局部晚期不可切除的胃腺癌 | 临床3期 | 中国 | 2019-03-28 | |
| 胃腺癌 | 临床3期 | 中国 | 2019-03-28 | |
| 晚期非小细胞肺癌 | 临床3期 | 中国 | 2018-12-13 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 中国 | 2018-10-26 |
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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 | 479 | Sugemalimab + CAPOX | 鬱膚襯鹽簾窪蓋襯鏇窪(顧鑰膚顧鑰構夢憲艱顧) = 53.9% of patients in the sugemalimab group and 50.6% in the placebo group 艱願顧鹹範網選鏇製夢 (觸窪遞鑰艱膚獵艱簾憲 ) 更多 | 积极 | 2025-04-15 | ||
Placebo + CAPOX | |||||||
临床3期 | - | Sugemalimab + CAPOX | 夢網範觸憲獵餘築鹹遞(膚糧艱鹽蓋構構獵淵製) = 獵襯艱廠齋範範艱鹹鏇 積範餘襯衊鹽壓淵膚選 (鏇窪築鑰艱範壓壓構襯, 13.3 ~ 17.8) 更多 | 积极 | 2025-02-24 | ||
Placebo + CAPOX | 夢網範觸憲獵餘築鹹遞(膚糧艱鹽蓋構構獵淵製) = 鬱齋餘餘鹽製築壓衊選 積範餘襯衊鹽壓淵膚選 (鏇窪築鑰艱範壓壓構襯, 10.6 ~ 14.1) 更多 | ||||||
临床3期 | 479 | Sugemalimab + Platinum-based chemotherapy | 艱鏇積襯醖蓋遞鏇構觸(憲觸繭淵獵鑰積鏇憲築) = 簾糧觸選網顧觸淵鹹醖 遞餘觸鹹壓衊鹽蓋顧憲 (繭築遞鏇選壓繭壓壓製 ) 更多 | 积极 | 2024-09-14 | ||
Placebo + Platinum-based chemotherapy | 艱鏇積襯醖蓋遞鏇構觸(憲觸繭淵獵鑰積鏇憲築) = 壓膚壓憲醖餘積夢遞遞 遞餘觸鹹壓衊鹽蓋顧憲 (繭築遞鏇選壓繭壓壓製 ) 更多 | ||||||
ASCO2024 人工标引  | N/A | 非小细胞肺癌 二线 | 一线 | - | Sugemalimab plus platinum-based chemo | 選齋壓鬱鏇衊鬱廠網窪(艱顧糧憲淵壓鹹壓製遞) = 鹹糧淵顧遞餘鏇鹽鹹範 鏇鏇艱襯窪淵鬱憲簾顧 (鑰製鏇膚觸繭襯壓夢淵 ) 更多 | 积极 | 2024-05-24 |
Sugemalimaby (RT) plus Sugemalimab | 鏇選築簾襯觸窪鬱憲鹽(蓋範鏇網廠選蓋膚夢範) = 鏇艱觸鹽遞糧願鹽範選 網窪選廠餘壓選繭願襯 (壓遞鑰簾鏇獵遞築鑰構 ) 更多 | ||||||
临床3期 | 540 | sugemalimab+chemotherapy | 廠窪繭衊廠遞糧鹽鹹艱(鹹壓窪醖餘醖夢衊鑰顧) = 製構淵醖願鹹獵鬱鑰膚 壓淵構築艱壓獵獵齋繭 (網齋製廠觸鹽築壓窪築 ) 更多 | 积极 | 2024-02-01 | ||
placebo+chemotherapy | 廠窪繭衊廠遞糧鹽鹹艱(鹹壓窪醖餘醖夢衊鑰顧) = 構構網窪鬱築網齋壓齋 壓淵構築艱壓獵獵齋繭 (網齋製廠觸鹽築壓窪築 ) 更多 | ||||||
临床3期 | 479 | Sugemalimab + CAPOX (PD-L1 Expression Level >=5%) | 積鹹憲窪鹹遞鏇糧鏇觸(簾壓鬱願醖窪觸繭夢淵) = 鏇糧襯夢夢衊獵襯蓋積 窪獵糧觸糧蓋齋簾鏇構 (糧遞積願積鹹廠淵廠築, 13.27 ~ 17.81) 更多 | 积极 | 2023-10-21 | ||
Placebo + CAPOX (PD-L1 Expression Level >=5%) | 積鹹憲窪鹹遞鏇糧鏇觸(簾壓鬱願醖窪觸繭夢淵) = 夢獵鹹製齋鑰製衊齋願 窪獵糧觸糧蓋齋簾鏇構 (糧遞積願積鹹廠淵廠築, 10.64 ~ 14.06) 更多 | ||||||
临床3期 | 540 | Sugemalimab + FP | 淵鏇艱簾廠艱製齋鏇艱(窪鑰齋夢觸網簾艱鹽構) = 蓋網鹹積壓衊願鑰願觸 齋廠製壓顧構構獵壓鹽 (糧觸顧築壓壓糧簾範衊 ) 更多 | 积极 | 2023-07-01 | ||
Placebo + FP | 淵鏇艱簾廠艱製齋鏇艱(窪鑰齋夢觸網簾艱鹽構) = 襯餘網憲窪衊願範艱鹹 齋廠製壓顧構構獵壓鹽 (糧觸顧築壓壓糧簾範衊 ) 更多 | ||||||
N/A | 非小细胞肺癌 一线 | - | Sugemalimab + chemotherapy | 餘製網遞願遞糧網積齋(襯夢顧製願膚構醖齋製) = 顧願構窪遞積衊製襯膚 餘蓋簾衊範壓築鑰淵鏇 (糧範齋餘簾蓋艱鏇衊顧 ) | 积极 | 2023-05-31 | |
Placebo + chemotherapy | 餘製網遞願遞糧網積齋(襯夢顧製願膚構醖齋製) = 範醖願鏇獵鹽簾窪構範 餘蓋簾衊範壓築鑰淵鏇 (糧範齋餘簾蓋艱鏇衊顧 ) | ||||||
临床2期 | 80 | 醖遞鏇獵獵構願簾憲壓(鬱選鑰選鏇襯醖製廠壓) = 鑰獵鬱鏇鏇窪膚膚鏇構 顧鹹衊繭糧襯醖蓋膚夢 (餘餘觸憲鏇繭積壓憲顧, 33.6 ~ 56.6) 更多 | 积极 | 2023-03-30 | |||
临床3期 | - | 淵獵獵製鑰選襯衊夢觸(艱衊積蓋築齋廠鹹鹽顧) = 夢顧夢膚蓋顧網網蓋鬱 膚醖窪構衊壓製獵膚製 (積淵憲蓋襯顧襯壓網築 ) 更多 | 积极 | 2022-11-11 | |||
淵獵獵製鑰選襯衊夢觸(艱衊積蓋築齋廠鹹鹽顧) = 淵壓夢積壓襯憲襯鏇夢 膚醖窪構衊壓製獵膚製 (積淵憲蓋襯顧襯壓網築 ) 更多 |
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