柯希利单抗(Cosibelimab-ipdl) - 药物靶点：PDL1_在研适应症：皮肤鳞状细胞癌，晚期癌症，B细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Cosibelimab、Cosibelimab (USAN/INN)、CK-301

+ [2]

靶点

PDL1

作用方式

抑制剂、刺激剂

作用机制

PDL1抑制剂(程序性死亡配体1抑制剂)、ADCC(抗体依赖的细胞毒作用)、T淋巴细胞刺激剂

治疗领域

肿瘤免疫系统疾病感染+ [6]

在研适应症

皮肤鳞状细胞癌晚期癌症B细胞淋巴瘤+ [13]

非在研适应症

难治性B细胞淋巴瘤EGFR阳性非小细胞肺癌转移性非鳞状非小细胞肺癌

原研机构

Dana-Farber Cancer Institute, Inc.

在研机构

Checkpoint Therapeutics, Inc.

非在研机构

TG Therapeutics, Inc.

权益机构

GC Cell Corp.

Sun Pharmaceutical Industries Ltd.

TG Therapeutics, Inc.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2024-12-13),

皮肤鳞状细胞癌

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

结构/序列

Sequence Code 616722338H

来源: *****

Sequence Code 616722341L

来源: *****

关联

5

项与柯希利单抗相关的临床试验

NCT06981806

/ Not yet recruiting临床1期

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

This is a single-center, open-label, phase 1 dose escalation and dose expansion (safety confirmation) trial to evaluate the safety and tolerability of balixafortide and cosibelimab in patients with metastatic PDAC who progressed after SOC chemotherapy.

开始日期2026-01-01

申办/合作机构

Cedars-Sinai Medical Center

NCT04786964

/ Terminated临床3期

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

This is an efficacy and safety study of cosibelimab (CK-301) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned in a 2:1 ratio to receive cosibelimab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin).
The primary hypothesis is that cosibelimab in combination with pemetrexed/platinum chemotherapy prolongs Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.

开始日期2021-12-08

申办/合作机构

Checkpoint Therapeutics, Inc.

NCT03778073

/ Terminated临床1期

A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma

Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory B-cell Non Hodgkin's Lymphoma.

开始日期2019-04-17

申办/合作机构

TG Therapeutics, Inc.

100 项与柯希利单抗相关的临床结果

登录后查看更多信息

100 项与柯希利单抗相关的转化医学

登录后查看更多信息

100 项与柯希利单抗相关的专利（医药）

登录后查看更多信息

4

项与柯希利单抗相关的文献（医药）

2025-11-01·The 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.

2025-09-01·JOURNAL 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.

2025-05-01·DRUGS

Cosibelimab: First Approval

Review

作者: Lee, Arnold

Cosibelimab (UNLOXCYT; cosibelimab-ipdl) is an anti-PD-L1 antibody developed by Checkpoint Therapeutics for the treatment of advanced cancers, including metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC). Cosibelimab is the first approved anti-PD-L1 therapy in the USA for the treatment of adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation. In contrast to other anti-PD-L1 antibodies, cosibelimab can induce antibody-dependent cell mediated cytotoxicity as it includes a functional F_c domain. This article summarizes the milestones in the development of cosibelimab leading to this first approval for this indication.

161

项与柯希利单抗相关的新闻（医药）

2025-12-03

·drugs

FDA Approves Updated Label for Unloxcyt

WEDNESDAY, Dec. 3, 2025 -- The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation. The updated label incorporates long-term follow-up data from the pivotal CK-301-101 trial, which included 109 patients (31 with locally advanced and 78 with metastatic CSCC). Results showed patients receiving Unloxcyt experienced durable clinical responses, including for the primary end point of objective response rate, in which at least 50 percent of patients achieved an objective response. In addition, 14 percent of patients with metastatic CSCC and 32 percent of patient with locally advanced CSCC achieved stable disease. The median duration of response had not been reached in either group at the time of analysis. A rapid response was seen, with a median time to response of 1.9 months (range, 1.6 to 16.9) and 3.6 months (range, 1.7 to 10.1) in metastatic and locally advanced disease, respectively. There were no changes to the safety profile of Unloxcyt in this label update, including immune-mediated adverse reactions, which occurred in 24 percent of participants. The most common adverse reactions (≥10 percent) included fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection. "This label update reinforces the importance of therapeutic diversity in advanced CSCC," David Miller, M.D., Ph.D., from the Mass General Brigham Cancer Institute, said in a statement. "Having access to a treatment option that works in a different way than other checkpoint inhibitors can only benefit patients who are fighting this disease and demand an efficacious treatment with acceptable tolerability." This approval was granted to Sun Pharma. More Information

临床结果上市批准放射疗法

2025-11-27

·药明康德

突破性抗癌小分子向FDA滚动递交上市申请；一线治疗胃癌，FDA批准创新抗癌单抗标签更新

突破性抗癌小分子向FDA滚动递交上市申请大鹏药品工业株式会社（Taiho Pharmaceutical）、Taiho Oncology和Cullinan Therapeutics日前宣布已向美国FDA滚动递交新药申请（NDA），寻求其在研小分子zipalertinib的加速批准，用于治疗既往接受过含铂全身化疗、携带EGFR第20外显子插入（ex20ins）突变的局部晚期或转移性非小细胞肺癌（NSCLC）患者。此次NDA递交主要基于REZILIENT1试验的积极数据。这是一项针对既往接受过治疗、携带EGFR ex20ins突变NSCLC患者开展的zipalertinib单药1/2期临床试验。之前公布的结果显示，在中位随访9.3个月时，在总疗效人群（n=176）中，确认的客观缓解率（ORR）为35%，中位缓解持续时间（mDOR）为8.8个月。在之前仅接受过铂类化疗的患者中（n=125），ORR为40%，mDOR为8.8个月。而在接受过化疗和EGFR/MET靶向抗体amivantamab治疗（未添加其他ex20ins靶向治疗）的患者（n=30）中，ORR为30%，mDOR为14.7个月。在接受过化疗和amivantamab治疗（联合或不联合其他ex20ins靶向治疗）的患者（n=51）中，ORR为24%，mDOR为8.5个月。在脑转移患者（n=68）中，ORR则为31%，mDOR为8.3个月。 Zipalertinib是一款靶向EGFR激活性突变体的口服小分子抑制剂。它能够抑制携带外显子20插入突变的EGFR变体，同时避免对野生型EGFR的抑制。Zipalertinib旨在作为下一代不可逆EGFR抑制剂，用于治疗特定基因亚型的NSCLC患者。它曾获得FDA授予的突破性疗法认定。 FDA批准创新抗癌单抗标签更新 Sun Pharmaceutical日前宣布，美国FDA已批准更新Unloxcyt（cosibelimab）的标签，用于治疗不适合根治性手术或放疗的转移性皮肤鳞状细胞癌（mCSCC）或局部晚期皮肤鳞状细胞癌（laCSCC）患者。本次标签更新纳入了关键性CK-301-101试验的长期随访数据。该试验为多中心、多队列、开放性研究，共纳入109例患者（其中31例为laCSCC，78例为mCSCC），结果显示接受Unloxcyt治疗的患者可获得持久的临床缓解。研究结果显示，至少50%的受试者达到客观缓解这一主要终点。此外，14%的mCSCC患者和32%的laCSCC患者病情达到稳定。在随访分析时，两组患者的缓解中位持续时间均尚未达到，提示疗效具有持续性。许多受试者获得了较为迅速的缓解：mCSCC患者的缓解中位应答起始时间为1.9个月（范围：1.6–16.9个月），laCSCC患者为3.6个月（范围：1.7–10.1个月）。长期随访分析进一步表明，在mCSCC和laCSCC两组中，客观缓解率相较初始分析有所提升，包括完全缓解病例增加在内，整体有≥50%的患者产生客观缓解。 Unloxcyt是一种完全人源化、具有高亲和力的单克隆抗体，可直接与PD-L1结合，从而阻断其与PD-1以及B7.1受体的相互作用，进而除去PD-L1对CD8阳性T细胞的抑制效果，恢复其毒杀性T细胞反应。之前的新闻稿指出，Unloxcyt与目前上市的PD-1和PD-L1抗体的潜在差异在于它具有持续的、超过99%的目标肿瘤占位率（tumor occupancy），可以重新激活抗肿瘤免疫反应，此外它还具有能够诱导抗体依赖性细胞介导的细胞毒性（ADCC）的功能性Fc结构域，从而在某些肿瘤类型中发挥更为强大的疗效。参考资料： [1] Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics Initiate Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Zipalertinib for Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. Retrieved November 27, 2025 from https://www.prnewswire.com/news-releases/taiho-oncology-taiho-pharmaceutical-and-cullinan-therapeutics-initiate-rolling-submission-of-new-drug-application-to-us-food-and-drug-administration-for-zipalertinib-for-treatment-of-locally-advanced-or-metastatic-non-small-cel-302621302.html [2] FDA approves label update for UNLOXCYT™ (cosibelimab-ipdl) based on longer-term data that demonstrated improved clinical outcomes in advanced cutaneous squamous cell carcinoma (aCSCC). Retrieved November 27, 2025 from https://www.prnewswire.com/news-releases/fda-approves-label-update-for-unloxcyt-cosibelimab-ipdl-based-on-longer-term-data-that-demonstrated-improved-clinical-outcomes-in-advanced-cutaneous-squamous-cell-carcinoma-acscc-302626366.html 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

2025-11-27

·ETPharma

Sun Pharma gets FDA nod for Unloxcyt label expansion

Mumbai: Indian pharma major Sun Pharmaceuticals announced that US Food and Drug Administration (FDA) has approved an updated label for its onco-derma therapy Unloxcyt label ( cosibelimab-ipdl ). The approval Unloxcyt indication to adults with metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation Label expansion has been granted based on the results of long-term follow-up data from the CK-301-101 trial, involving 109 patients (31 with laCSCC; 78 with mCSCC). Under the clinical program Unloxcyt demonstrated rapid response and, 14 per cent of mCSCC patients and 32 per cent of laCSCC patients reported progression-free survival. At the time of the follow-up analysis, the median duration of response had not been reached in either group and median time to response was 1.9 months and 3.6 months, respectively. “The longer-term results confirm that Unloxcyt represents an advancement in the available treatment options for people living with aCSCC and we support, these pivotal data highlight that more patients responded and maintained their responses to UNLOXCYT for longer than observed in the primary analysis” said Richard Ascroft, CEO, Sun Pharma North America. Sun Pharma had onboarded Unloxcyt under its acquisition of Checkpoint Therapeutics in March this year. By Online Bureau ,

临床结果上市批准放射疗法并购

100 项与柯希利单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11946	-	-	DB15770

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

适应症	国家/地区	公司	日期
皮肤鳞状细胞癌	美国	Checkpoint Therapeutics, Inc.	2024-12-13

未上市

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
转移性非鳞状非小细胞肺癌	临床3期	巴西	Checkpoint Therapeutics, Inc.	2021-12-08
转移性非鳞状非小细胞肺癌	临床3期	格鲁吉亚	Checkpoint Therapeutics, Inc.	2021-12-08
转移性非鳞状非小细胞肺癌	临床3期	马来西亚	Checkpoint Therapeutics, Inc.	2021-12-08
转移性非鳞状非小细胞肺癌	临床3期	新西兰	Checkpoint Therapeutics, Inc.	2021-12-08
转移性非鳞状非小细胞肺癌	临床3期	秘鲁	Checkpoint Therapeutics, Inc.	2021-12-08
转移性非鳞状非小细胞肺癌	临床3期	俄罗斯	Checkpoint Therapeutics, Inc.	2021-12-08
转移性非鳞状非小细胞肺癌	临床3期	南非	Checkpoint Therapeutics, Inc.	2021-12-08
转移性非鳞状非小细胞肺癌	临床3期	泰国	Checkpoint Therapeutics, Inc.	2021-12-08
EGFR阳性非小细胞肺癌	临床1期	美国	Checkpoint Therapeutics, Inc.	2020-08-02
难治性B细胞淋巴瘤	临床1期	美国	TG Therapeutics, Inc.	2019-04-17

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04786964 (CONTERNO, CTgov)	临床3期	转移性非鳞状非小细胞肺癌	25	Vitamin B12 1000 μg+Carboplatin+Pemetrexed+Cosibelimab+Dexamethasone 4mg+cisplatin (Cosibelimab)	範範鬱願淵膚鑰糧鬱淵 = 膚鏇觸範艱齋繭齋鹽觸簾糧膚觸觸夢觸簾製鏇 (繭蓋艱觸獵艱壓窪簾鏇, 蓋網衊憲範鬱構鬱範淵 ~ 齋餘齋願憲餘鬱醖醖獵) 更多	-	2025-04-02
				Vitamin B12 1000 μg+Carboplatin+Pemetrexed+Dexamethasone 4mg+cisplatin (Control)	範範鬱願淵膚鑰糧鬱淵 = 衊糧獵蓋願鹽積簾製網簾糧膚觸觸夢觸簾製鏇 (繭蓋艱觸獵艱壓窪簾鏇, 鬱窪廠鬱膚餘觸糧網壓 ~ 選夢醖壓齋鏇製獵遞遞) 更多
NCT03212404 (CK-301-101, FDA_CDER) 人工标引	临床1期	皮肤鳞状细胞癌	109	UNLOXCYT (mCSCC)	選壓鑰齋廠觸網艱夢艱(築膚積繭醖鹽鹹網觸遞) = 鏇鏇積選範襯醖憲願網艱襯鏇顧鹹範積鏇簾糧 (顧憲壓選製衊積襯構鏇, 36 ~ 59) 更多	积极	2024-12-13
				UNLOXCYT (laCSCC)	選壓鑰齋廠觸網艱夢艱(築膚積繭醖鹽鹹網觸遞) = 衊鏇繭鏇構範鹹鹽鹽衊艱襯鏇顧鹹範積鏇簾糧 (顧憲壓選製衊積襯構鏇, 30 ~ 67) 更多
NCT03212404 (ESMO2024) 人工标引	临床1期	晚期皮肤鳞状细胞癌	109	Cosibelimab 800 mg Q2W	鏇範繭窪鏇壓壓遞襯齋(蓋網衊鬱膚觸齋築選鏇) = 齋築積壓襯選積窪願齋餘顧膚簾夢築遞蓋餘鹹 (夢遞餘鹽窪觸構鏇鏇餘, 38.5 ~ 61.5) 更多	积极	2024-09-14
				Cosibelimab 1200 mg Q3W	鏇範繭窪鏇壓壓遞襯齋(蓋網衊鬱膚觸齋築選鏇) = 築淵積鹽夢餘窪積築選餘顧膚簾夢築遞蓋餘鹹 (夢遞餘鹽窪觸構鏇鏇餘, 36.0 ~ 72.7) 更多
NCT03212404 (pivotal study of patients with metastatic CSCC, Pubmed \| J Immunother Cancer)	临床1期	鳞状细胞癌，转移	78	Cosibelimab 800 mg	壓蓋夢糧艱選鑰觸憲醖(選廠網簾餘鑰顧艱蓋膚) = 衊鑰餘淵鹹網膚構醖壓積範製艱鏇鏇顧窪遞糧 (齋鏇糧築壓淵膚壓製遞, 36.0 ~ 59.1)	积极	2023-10-01
GlobeNewswire 人工标引	N/A	皮肤鳞状细胞癌	109	Cosibelimab (Locally Advanced cutaneous squamous cell carcinoma)	衊鑰鑰夢觸觸鏇築餘繭(遞夢繭齋壓鏇淵簾鑰夢) = 衊選願構壓窪鑰構鬱憲廠積襯淵顧廠鏇廠範網 (膚鬱餘積鑰鹹願鬱鹹遞, 36 ~ 73) 更多	积极	2023-07-27
				Cosibelimab (Metastatic cutaneous squamous cell carcinoma)	衊鑰鑰夢觸觸鏇築餘繭(遞夢繭齋壓鏇淵簾鑰夢) = 醖積觸鹽廠廠願糧鏇蓋廠積襯淵顧廠鏇廠範網 (膚鬱餘積鑰鹹願鬱鹹遞, 39 ~ 62) 更多
NCT03212404 (CK-301-101, ASCO2022) 人工标引	临床1期	皮肤鳞状细胞癌	78	Cosibelimab 800 mg Q2WCosibelimab 800 mg Q2W	鏇鹽醖夢廠網衊鬱選遞(遞鬱選網願鏇積鏇顧構) = 膚艱鑰獵鏇壓艱製構齋積鑰淵願襯鹹願憲糧憲 (膚齋遞願簾網襯衊願網, 36.0 ~ 59.1) 更多	积极	2022-06-02
NCT03212404 (CK-301-101, Corporate Publications) 人工标引	临床1期	皮肤鳞状细胞癌	41	Cosibelimab	鹽鏇蓋齋壓選鹹蓋獵觸(願繭構選淵顧壓壓鹽憲) = 鑰遞製餘淵鏇範繭顧選鬱蓋壓觸廠築繭糧獵憲 (廠顧淵膚憲夢醖積襯艱, 34.4 ~ 68.1) 更多	积极	2020-09-17
NCT03212404 (ESMO2019)	临床1期	晚期癌症	65	Cosibelimab	齋衊築觸繭醖顧繭餘繭(醖顧衊顧網選壓糧窪選) = anemia, asthenia, hypertension, hyponatremia, and high blood pressure (n = 1 [2%] each) 淵願網遞鏇選獵餘膚觸 (衊獵簾範壓構壓網襯糧 ) 更多	积极	2019-09-28