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更新于：2026-08-14
Cosibelimab-ipdl
柯希利单抗
更新于：2026-08-14
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2024-12-13), |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 616722338H
来源: *****
Sequence Code 616722341L
来源: *****
关联
6
项与 柯希利单抗 相关的临床试验NCT07426484
A Phase IV Master Protocol of Cosibelimab in Special Populations With Advanced Cutaneous Squamous Cell Carcinoma (CosiMaster)
NCT06981806
IIT2023-07-Osipov-CXCR4: Phase I Dose Escalation and Dose Expansion Study of Combination Immunotherapy With Cosibelimab and CXCR4 Inhibition With Balixafortide in Metastatic Treatment Refractory Pancreatic Ductal Adenocarcinoma
NCT04786964
A Randomized, Open-Label, Phase 3 Study of Cosibelimab (CK-301) in Combination With Platinum+Pemetrexed Chemotherapy in Subjects With First-Line Metastatic Non-squamous Non-Small Cell Lung Cancer
100 项与 柯希利单抗 相关的临床结果
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100 项与 柯希利单抗 相关的转化医学
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100 项与 柯希利单抗 相关的专利（医药）
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6
项与 柯希利单抗 相关的文献（医药）2026-05-01Journal of Drugs in Dermatology
Efficacy and Safety of Cosibelimab for Advanced Cutaneous Squamous Cell Carcinoma: An Expert Consensus Panel
Review
作者: Rosenberg, Angela ; Ackerman, Lindsay ; Farberg, Aaron S. ; Bartley, Brooke ; DeBusk, Lauren ; Dinehart, Scott M. ; Groisser, Daniel ; Rigel, Darrell ; Rosso, James Q. Del ; Schlesinger, Todd ; Lebwohl, Mark ; Trotter, Shannon C.
BACKGROUND:
Cutaneous squamous cell carcinoma (cSCC) represents a significant clinical challenge in patients with locally advanced (laCSCC) or metastatic (mCSCC) disease who are not candidates for surgery or radiation. In addition to PD-1 inhibitors, pembrolizumab and cemiplimab, cosibelimab, a PD-L1 inhibitor, has been recently approved by the US Food and Drug Administration (FDA) for laCSCC and mCSCC. Given its recent approval, practical guidance is needed to support clinician decision-making regarding cosibelimab's efficacy and safety.
METHODS:
A comprehensive literature review of PubMed and Google Scholar was completed for studies related to cosibelimab efficacy and safety in la and mCSCC. An expert panel of nine dermatologists with significant expertise in the treatment of cSCC gathered to review the articles and create consensus statements on the role of cosibelimab in managing laCSCC and mCSCC. A modified Delphi process was used to approve each statement, and the strength of recommendation was assigned using the Strength of Recommendation Taxonomy (SORT) criteria.
RESULTS:
The literature search produced over 200 articles that met the criteria, and a screening of the studies for relevance resulted in 13 articles. The panel developed six consensus statements, with five unanimously adopted with a strength of "A".
CONCLUSION:
Available data suggests that cosibelimab is an effective treatment for patients with laCSCC and mCSCC who are not candidates for surgery or radiation. Cosibelimab demonstrates a unique and favorable safety profile with no reported grade 4 or 5 immune-related adverse events after more than 2 years of follow-up.
2026-01-01JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Efficacy and safety of cosibelimab in advanced cutaneous squamous cell carcinoma: Results from a Pivotal Open-label Study with a median follow-up of ≥2 years
Article
作者: Gray, W Garrett ; Fourie, Samuel ; Clingan, Philip ; Dalle, Stéphane ; Ladwa, Rahul ; Shue, Hong ; Nardin, Charlée ; Montaudié, Henri ; Quéreux, Gaëlle ; Charles, Julie ; Malan, Daniel R ; de la Gala, Maria Del Carmen Álamo ; Beylot-Barry, Marie ; Tazbirkova, Andrea ; Wilcoxen, Lauren Neighbours ; Berciano-Guerrero, Miguel Angel ; Harris, Dean ; McGrath, Margaret ; Oliviero, James ; Muñoz-Couselo, Eva ; Ruiz, Emily S ; Tur, Ricardo Yaya ; Brungs, Daniel
BACKGROUND:
Cosibelimab-ipdl, a high-affinity, programmed death-ligand 1-blocking antibody, is approved by the US Food and Drug Administration for treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or radiation.
OBJECTIVE:
To report long-term efficacy and safety outcomes from a pivotal study of cosibelimab in mCSCC or laCSCC.
METHODS:
Patients received intravenous cosibelimab 800 mg every 2 weeks (mCSCC and laCSCC cohorts) or 1200 mg every 3 weeks (mCSCC cohort). The primary endpoint was objective response rate (ORR). Secondary endpoints included duration of response (DOR) and safety.
RESULTS:
With a median follow-up duration of 29.3 months for the mCSCC cohort (n = 78), ORR was 50.0% (complete response [CR], 12.8%), median DOR was not reached, and estimated 24-month DOR was 72.1%. With a median follow-up duration of 24.1 months for the laCSCC cohort (n = 31), ORR was 54.8% (CR, 25.8%), median DOR was not reached, and the estimated 24-month DOR was 80.2%. Immune-related adverse event rate was 27.6%; 3.6% grade 3, no grade ≥4 events.
LIMITATIONS:
Nonrandomized; limited biomarker analysis.
CONCLUSION:
Cosibelimab demonstrated robust and durable ORRs with increasing CR rates in advanced CSCC and low rates of severe immune-related adverse events.
2025-11-01The Journal of clinical and aesthetic dermatology
Cosibelimab: A Novel Therapeutic for Advanced Cutaneous Squamous Cell Carcinoma.
Review
作者: Schlesinger, Todd ; Burshtein, Joshua
Cutaneous squamous cell carcinoma (cSCC) is the second most common skin cancer worldwide. Treatments of locally advanced cSCC (laCSCC) and metastatic cSCC (mCSCC) have been evolving with the introduction of immunotherapies, which target the programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) pathway. Recently, cosibelimab was the first PD-L1 antibody approved by the United States Food and Drug Administration for the treatment of patients with laCSCC or mCSCC who are not candidates for curative surgery or radiation. Cosibelimab not only offers blockade of PD-L1 but also induces antibody-dependent cellular cytotoxicity. In its pivotal clinical trial, the objective response rate for patients with mCSCC treated with cosibelimab was 47.4%. Due to the different mechanisms of action, differences have been noted in the safety between PD-1 inhibitors and PD-L1 inhibitors, with PD-L1 inhibitors having a lower occurrence of Grade 3 or higher treatment-related adverse events, including immune-related adverse events. Additional real-world studies are needed to further evaluate its efficacy and safety. Cosibelimab is a novel immune checkpoint inhibitor and represents a promising therapeutic option for patients with advanced cSCC.
184
项与 柯希利单抗 相关的新闻（医药）2026-07-20
2026-07-12
抗体药物偶联物临床3期临床结果申请上市临床申请
100 项与 柯希利单抗 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 |
|---|---|---|---|
| 皮肤鳞状细胞癌 | 美国 | 2024-12-13 | |
| 皮肤鳞状细胞癌 | 美国 | 2024-12-13 |
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 |
|---|---|---|---|---|
| 肿瘤 | 申请上市 | 加拿大 | 2026-06-01 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 美国 | 2021-12-08 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 巴西 | 2021-12-08 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 马来西亚 | 2021-12-08 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 新西兰 | 2021-12-08 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 秘鲁 | 2021-12-08 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 俄罗斯 | 2021-12-08 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 南非 | 2021-12-08 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | 泰国 | 2021-12-08 | |
| EGFR阳性非小细胞肺癌 | 临床1期 | 美国 | 2020-08-02 |
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临床结果
临床结果
适应症
分期
评价
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临床1期 | 64 | Cosibelimab 800 mg every 2 weeks | 醖鏇廠餘製選壓願簾艱(蓋構願顧鹹鹽範積選齋) = 憲蓋窪蓋鹹窪鹹醖夢淵 選獵窪膚範繭衊糧膚獵 (製簾鏇鹹襯構膚築網餘, 37 ~ 63) 更多 | 积极 | 2026-05-29 | ||
临床3期 | 25 | (Cosibelimab) | 壓夢繭製簾繭餘構窪遞 = 積艱鹽鹽淵醖憲鏇鏇鹹 網憲鏇願衊選衊壓夢蓋 (蓋襯糧製積鏇鏇糧糧醖, 繭廠鹽獵選醖蓋鑰範願 ~ 艱簾繭齋獵構選願廠構) 更多 | - | 2025-04-02 | ||
(Control) | 壓夢繭製簾繭餘構窪遞 = 壓選積艱網壓積糧積淵 網憲鏇願衊選衊壓夢蓋 (蓋襯糧製積鏇鏇糧糧醖, 觸選簾願憲選觸簾齋廠 ~ 膚鹹憲衊襯襯獵築糧鏇) 更多 | ||||||
临床1期 | 109 | (mCSCC) | 醖網範簾夢選淵繭顧淵(構齋鏇艱簾夢醖鬱夢構) = 簾膚顧窪憲鬱壓願餘壓 顧艱醖艱繭醖膚醖獵壓 (襯繭構觸齋鹹廠鑰餘壓, 36 ~ 59) 更多 | 积极 | 2024-12-13 | ||
(laCSCC) | 醖網範簾夢選淵繭顧淵(構齋鏇艱簾夢醖鬱夢構) = 構醖夢膚艱簾鬱窪製壓 顧艱醖艱繭醖膚醖獵壓 (襯繭構觸齋鹹廠鑰餘壓, 30 ~ 67) 更多 | ||||||
临床1期 | 109 | 夢構製憲積糧鬱夢膚鏇(簾鬱鏇顧製範網膚構簾) = 願衊廠鑰壓鑰餘鏇築糧 糧鏇範積鹽醖蓋繭製鹽 (顧窪鹹餘廠觸築餘構醖, 38.5 ~ 61.5) 更多 | 积极 | 2024-09-14 | |||
Cosibelimab 1200 mg Q3W | 夢構製憲積糧鬱夢膚鏇(簾鬱鏇顧製範網膚構簾) = 網鑰鏇積選獵壓鏇觸觸 糧鏇範積鹽醖蓋繭製鹽 (顧窪鹹餘廠觸築餘構醖, 36.0 ~ 72.7) 更多 | ||||||
临床1期 | 78 | 鑰夢窪鹹廠遞窪鏇遞積(範襯積願淵獵遞顧蓋網) = 繭窪艱製簾襯鏇範觸艱 壓構鑰顧艱願鬱餘選鏇 (製衊顧醖範襯淵艱繭鹹, 36.0 ~ 59.1) | 积极 | 2023-10-01 | |||
GlobeNewswire 人工标引  | N/A | 109 | (Locally Advanced cutaneous squamous cell carcinoma) | 窪鏇蓋襯艱蓋鬱構蓋醖(遞鬱艱範淵鬱壓淵鏇遞) = 獵網鏇襯製製廠鹹鑰鏇 鏇蓋鏇蓋製繭淵積繭範 (襯襯憲艱廠範選構鏇鬱, 36 ~ 73) 更多 | 积极 | 2023-07-27 | |
(Metastatic cutaneous squamous cell carcinoma) | 窪鏇蓋襯艱蓋鬱構蓋醖(遞鬱艱範淵鬱壓淵鏇遞) = 膚鏇醖艱淵鑰齋遞遞齋 鏇蓋鏇蓋製繭淵積繭範 (襯襯憲艱廠範選構鏇鬱, 39 ~ 62) 更多 | ||||||
临床1期 | 78 | 鏇衊醖製糧壓夢夢糧憲(築積遞顧壓範簾觸夢獵) = 廠選齋餘選網齋齋齋壓 鹹膚膚衊獵製糧觸網壓 (簾膚齋淵願襯鬱蓋鹹醖, 36.0 ~ 59.1) 更多 | 积极 | 2022-06-02 | |||
临床1期 | 41 | 構願鏇願範顧襯遞積構(鏇顧顧醖構廠積衊鹹築) = 壓築範夢積鏇築廠淵夢 選願鹹鑰淵淵窪壓艱鹽 (衊繭築遞憲鬱齋鏇膚艱, 34.4 ~ 68.1) 更多 | 积极 | 2020-09-17 | |||
临床1期 | 65 | 憲餘憲積製膚廠廠鏇鑰(積鹽餘網齋艱壓餘窪壓) = anemia, asthenia, hypertension, hyponatremia, and high blood pressure (n = 1 [2%] each) 廠鏇醖鏇選醖顧窪餘壓 (鬱顧範選齋顧窪網構鹹 ) 更多 | 积极 | 2019-09-28 |
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