An Open Label, Single-arm, Phase 2 Study of Perioperative Sacituzumab Govitecan in Combination With Zimberelimab and Domvanalimab for Patients With Muscle Invasive Bladder Cancer Ineligible for Cisplatin-based Chemotherapy

The main objective of this trial is to evaluate the efficacy of the combo Sacituzumab govitecan (SG) + Zimberelimab (AB 122) (ZIM) + Domvanalimab (AB 154) (DOM), measured as pathologic complete response (pCR) rates, in the perioperative setting in patients with Muscle Invasive Bladder Cancer (MIBC) who are either unfit for platinum-based chemotherapy or unwilling to receive that therapy.

开始日期2024-07-01

申办/合作机构

Apices Soluciones SL

NCT06048484 / Recruiting临床2期

A Phase 2, Open-Label, Multicenter, Randomized Study Evaluating Neoadjuvant Therapy Targeting the Adenosine Immunosuppressive Pathway in Combination With Immune Checkpoint Blockade and Radiation Therapy in Patients With Advanced PANCreatic Ductal Adenocarcinoma Who Are Candidates for Surgical Resection

The purpose of this study is to combine standard radiation therapy with drugs that encourages the body's immune system against cancer cells and simultaneously adding drugs which also target the pathway that the tumor uses to evade the immune system (CD73 and A2a/b). The study hopes that these drugs will work in concert with radiation therapy to kill cancer cells.
The specific goal of this study is to ensure that treatment with zimberelimab and stereotactic body radiation therapy (SBRT) alone or in combination with quemliclustat (a drug which blocks CD73), with or without etrumadenant (a drug which blocks the A2a/b) given before surgery is safe and if it can further increase the immune response against the tumor.

开始日期2024-06-01

申办/合作机构

Columbia University

[+1]

NCT06238921 / Not yet recruiting临床1/2期IIT

Phase I/II Study of Stereotactic Radiation and Sacituzumab Govitecan With Zimberelimab in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases

This is a Phase I/II Study to determine the safety and efficacy of Sacituzumab Govitecan and Zimberelimab with stereotactic radiation (SRS) in participants with metastatic triple negative breast cancer with brain metastases, compared to treatment with Sacituzumab Govitecan alone.

开始日期2024-04-01

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+1]

100 项与赛帕利单抗相关的临床结果

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100 项与赛帕利单抗相关的转化医学

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100 项与赛帕利单抗相关的专利（医药）

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项与赛帕利单抗相关的文献（医药）

2024-01-12·Medicine

Whether specific genetic feature predicted immunotherapy efficacy: A case report

Article

作者: Chen, Jun ; Cheng, Xiaochun ; Pang, Linrong ; Li, Ting ; He, Lianxiang

Rationale::

Blockade of programmed death protein 1 (PD-1), have been observed to have quite good efficacy in recurrent and metastatic cervical cancer. Generally, we believe that the biomarkers of PD-1 inhibitors are programmed cell death-ligand 1, tumor mutational burden, high microsatellite instability, or deficient mismatch repair. However, in the case reported below, we observed that the patient with negative existing predictive biomarkers have significant benefits after zimberelimab monotherapy, indicating that there were other biomarkers that may predict immunotherapy efficacy. However, currently, no one has explored and studied the other potential biomarkers of PD-1 inhibitors.

Patient concerns::

A 51-year-old patient, diagnosed with cervical adenocarcinoma nearly 11 years ago, requested treatment.

Diagnoses::

The next-generation sequencing has shown PIK3CA E545K, SMAD4 1309-1G, and ALK E717K gene mutations, receptor tyrosine kinase 2 (ErbB-2) amplification, microsatellite stability, and low tumor mutational burden of 6.3 mutations per megabase. And immunohistochemistry revealed that the tumor was programmed cell death-ligand 1 negative.

Intervention::

Zimberelimab monotherapy was accepted as third-line treatment.

Outcomes::

The patient had received zimberelimab for nearly 10 months, the best tumor response was PR (Response Evaluation Criteria in Solid Tumours) and no noticeable adverse reactions were observed.

Lessons::

PIK3CA-E542K, ErbB2 amplification, and SMAD4 mutations could be potential biomarkers for PD-1 inhibitors, but a single instance is insufficient to validate the hypotheses. A larger number of patients or more clinical data will be necessary to determine whether these gene mutations are appropriate biomarkers for patients when treatment with PD-1 inhibitors.

2023-12-01·International Journal of Gynecologic Cancer

Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study

Article

作者: Wei, Zhixia ; Liu, Haiyan ; Song, Lijie ; Zhu, Yanling ; Wang, Ke ; Li, Li ; Cheng, Huijun ; Liu, Zheng ; Xiao, Zemin ; Zhu, Jiman ; Wang, Jing ; Zhu, Jianqing ; Chen, Jie ; Yin, Yongmei ; Luo, Xiaoyong ; Wu, Xiaohua ; Xia, Lingfang ; Lou, Ge ; Wang, Chunyan ; Li, Yunxia ; Zhou, Qi ; Zheng, Hong ; Ai, Xiaohong ; Ye, Yijing ; Zhang, Qingming ; Gulina, Kurban ; Rao, Qunxian ; Tong, Jiandong ; Chang, Baoping ; Wang, Xia

Objective:

There is an unmet need to improve clinical outcomes for patients with recurrent/metastatic cervical cancer. Checkpoint inhibitors represent a promising treatment strategy. We evaluated the safety and anti-tumor activity of zimberelimab, an anti-programmed cell death protein-1 antibody, in patients with previously treated, recurrent, metastatic cervical cancer.

Methods:

This phase II, single-arm, open-label study used a Simon two-stage minimax design. Eligible patients were women aged 18–75 years with programmed death ligand-1-positive recurrent or metastatic cervical cancer that had progressed after first- or subsequent-line chemotherapy (Eastern Cooperative Oncology Group (ECOG) performance status 0–1). Patients received intravenous zimberelimab (240 mg every 2 weeks) for 2 years until disease progression, intolerable adverse effects, or withdrawal from the study. The primary endpoint was objective response rate assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, by an independent review committee.

Results:

A total of 105 patients were enrolled. Median age was 51 (range, 31–75) years; 63.8% had an ECOG performance status of 1. The median number of previous treatment lines was 1 (range, 1–4). Median follow-up was 16.9 (range, 16.3–18.4) months. The objective response rate was 27.6%, and the disease control rate was 55.2%. Median duration of response was not reached. Median overall survival was 16.8 months, and median progression-free survival was 3.7 months. The incidence of treatment-related adverse events of any grade was 78.1%, of which the most common were hypothyroidism (26.7%) and anemia (19.0%).

Conclusion:

Zimberelimab monotherapy demonstrated durable anti-tumor activity and an acceptable safety profile in patients with cervical cancer.

Clinical trial registration:

NCT03972722.

2023-08-01·Oncology letters

Combination therapy with antibody‑drug conjugate RC48 (disitamab vedotin) and zimberelimab (PD‑1 inhibitor) successfully controlled recurrent HER2‑positive breast cancer resistant to trastuzumab emtansine: A case report.

作者: Sang, Die ; He, Lianxiang ; Fan, Shanmin

Options for later-line therapy are limited for patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have exhibited resistance to several systemic treatments. Antibody drug conjugates (ADCs) and immune checkpoint inhibitors are novel approaches for HER2-positive breast cancer, but few reports have been published regarding the efficacy of their combinations, particularly in patients with prior ADC failure. The present report describes a case of recurrent metastatic HER2-positive breast cancer, which responded poorly to several perioperative systemic therapies, including chemotherapies, HER2-targeted antibodies, small molecule inhibitors and trastuzumab emtansine (an ADC), along with post-surgical radiotherapy. Following failure of front-line therapies for recurrent cancer located in the chest wall, combination treatment with another HER2-targeted ADC, disitamab vedotin (120 mg), and zimberelimab (240 mg), a fully humanized anti-programmed cell death protein-1 (PD-1) antibody, administered intravenously every 2 weeks, was initiated. The tumor lesions improved slightly after two cycles of treatment and shrunk markedly, and almost disappeared at the end of the sixth cycle of therapy. The patient is still in remission at present. The present findings suggest the potential efficacy of HER2-targeted ADCs combined with PD-1 inhibitors for patients with HER2-positive breast cancer, including those resistant to prior HER2-targeted ADCs.

214

项与赛帕利单抗相关的新闻（医药）

2024-05-03

·佰傲谷BioValley

2024Q1：大药厂砍掉的管线

为降低运营成本，将资金将用于更有价值资产的开发，精简管线仍是大药企2024年的重要目标之一。近期，多家全球知名药企纷纷披露了2024Q1财报，除了各项财务数据外，其缩减研发项目也成了每家大药企的标配动作。吉利德吉利德这次砍掉了十个研发项目，其中备受关注的就是其斥资49亿美元收购Forty Seven得来的CD47抗体Magrolimab，其所有6项临床试验全部移出研发管线，被彻底放弃继续开发。还有一个值得关注的就是TIGIT项目domvanalimab，此次吉利德停止了zimberelimab+domvanalimab联合/不联合化疗用于一线非小细胞肺癌的2个临床。在此之前，吉利德对TIGIT单抗Domvanalimab都是信心十足的态度。今年1月，吉利德还与Arcus再度修订了合作协议，以3.2亿美元入股Arcus，除了重点推进Domvanalima的STAR-121和STAR-221两项Ⅲ期临床外，还将启动一项新的Ⅲ期临床STAR-131。如今看来，对是否要继续Domvanalimab推进，吉利德并没有之前表露出来的那么坚定。此外，吉利德还终止了2个细胞疗法项目，分别为自体CD19 CAR-T疗法ZUMA-25治疗罕见B细胞恶性肿瘤的Ⅱ期临床、以及自体CLL-1-CAR-T疗法KITE-222治疗复发难治性急性髓系白血病的Ⅰ期临床。罗氏去年以来，罗氏的大幅瘦身行动就已经开始了。在2024年2月1日的公司2023年业绩报告会上，便提到将剔除8款处于临床管线。这次的2024年一季度财报业绩公布会上，移除了5条研发管线，RG6185、RG6526、RG6286、RG6163、 RG6319。RG6526是一种口服ATR抑制剂，用于治疗具有特定合成致死基因组改变的肿瘤。RG6185是一种选择性泛RAF激酶抑制剂，推进到了Ⅱ期项临床阶段，但现已停止患者招募。RG6286是一款LY6G6D/CD3双抗，处于临床Ⅰ期阶段，用于治疗结直肠癌。RG6163是一款精神疾病药物，没有披露靶标。RG6319是一款LepB抑制剂，用于尿路感染。赛诺菲赛诺菲放弃了3个研发项目，涉及三条管线。Frexalimab是一种CD40L单抗，为赛诺菲于2017年从ImmuNext公司引进。开发了干燥综合征、系统性红斑狼疮、多发性硬化症(MS)等适应症，且都已经推进到临床Ⅱ期阶段。此次是放弃了对干燥综合征这个适应症，原因是Frexalimab在Ⅱ期临床中疗效未达到预期，其他正在开展的临床适应症不受影响。Oditrasertib是一种RIPK1抑制剂，与Denali合作开发，适应症主要涉及自免和神经退行性疾病两大方向。此次放弃的是肌萎缩性侧索硬化症(ALS)。今年2月，Denali报告，Oditrasertib在ALS的II期HIMALAYA未达到ALS功能评定量表修订版 (ALSFRS-R) 的主要终点。Venglustat是一种CGS抑制剂，终止开发的适应症是一种罕见遗传性疾病--GM2神经节脂质沉积症，因为其在临床终点“缺乏积极趋势”。赛诺菲曾在2021年终止了一项Venglustat治疗常染色体显性多囊肾病的Ⅱ/Ⅲ期临床试验。几个月前，Venglustat治疗帕金森病的一项Ⅱ期临床也未能达到终点目标。阿斯利康2024Q1季度报显示，阿斯利康将放弃几款早期管线，包括MEDI6570、AZD7503、AZD5055。MEDI6570是一款LOX-1靶向单抗，被开发用于治疗心肌梗死，已经推进Ⅱ期临床阶段。此次被移除是由于战略调整。AZD7503是一种配体偶联反义寡核苷酸药物，于2018年从Ionis引进而来，用于治疗非酒精性脂肪性肝炎。AZD5055是一款口服Porcupine抑制剂，用于治疗进行特发性肺纤维化(IPF)以及其他进行性纤维化的间质性肺疾病(ILDs)。阿斯利康于2020年Redx公司引进。BMS百时美施贵宝（BMS）在公司2024Q1财报的同时，宣布了在2025年前削减15亿美元成本计划，其中包括裁员6%以及削减12条研发管线。包括CTLA-4抗体、SIRPα拮抗剂和BET抑制剂。公司将在今年剩余时间内继续审查其产品线，做出调整。诺华相较而言，诺华的2024Q1给管线调整幅度不大，对比2023Q4财报披露的管线发现，2024Q1移除了2个项目，CD73单抗NZV930和CSF-1R抑制剂sotuletinib。NZV930是一种CD73抑制剂，为诺华从Surface Oncology引进，临床开发涉及了单药、联合PD-1、联合A2aR拮抗剂、联合PD-1+与A2aR拮抗剂等用药方案。在此之前，已经有多个临床被终止。参考出处：https://www.bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2024/BMY-2024-Q1-Results-Investor-Presentation.pdf········

财报免疫疗法临床2期临床1期细胞疗法

2024-04-29

·生物制品圈

2024一季度：6家跨国药企，砍掉30＋管线

随着2024年第一季度财报的公布，多家跨国药企披露了其产品管线的变化，包括终止的在研管线情况。通过砍掉冗余管线，可以节约成本并集中资源，聚焦更有前景的资产，有力推动企业的重组转型。本文统计了诺华、罗氏、BMS、赛诺菲、阿斯利康及吉利德6家MNC的管线变化情况，这些药企合计砍掉了超30条管线项目。诺华4月23日，诺华发布2024Q1业绩：营收34亿美元，同比增长39%；净销售额达118亿美元，同比增长11%。在研发管线上，通过对比诺华2024Q1与2023Q4财报中披露的管线发现，其进行了管线调整，移除了2个项目，包括CD73单抗NZV930项目和CSF-1R抑制剂sotuletinib。其中，NZV930是诺华从Surface Oncology引进，此前已经有多个临床被终止。罗氏4月24日，罗氏发布2024Q1业绩：总收入143.99亿瑞士法郎（156.95亿美元；1瑞士法郎=1.09 美元），按固定汇率（CER）计算，增长2%。除去COVID-19相关的产品，销售额增长了7%。据第一季报显示，公司在今年第一季度削减了六个项目，包括用于实体肿瘤的camonsertib和belvarafenib、用于结直肠癌的双特异性抗体RG6286、用于精神疾病的RG6163以及用于尿路感染的LepB抑制剂RG6319、camonsertib和治疗重症肌无力的 Enspryng。Camonsertib：这是一款潜在的BIC口服ATR抑制剂，用于治疗具有特定合成致死基因组改变的肿瘤，包括ATM基因改变。今年1月份，2期TAPISTRY研究中第1名患者接受了Camonsertib治疗，由此触发了一个4000万美元的里程碑付款。但情况突然急转而下，半个月后罗氏突然宣布将终止协议，理由是“出于对罗氏的管线和不断变化的外部因素进行审查后的结果”。Belvarafenib：一种选择性泛RAF激酶抑制剂，目前处于2项临床，但已停止患者招募，即使已从管线移除此项目，但公司将继续提供研究治疗并监测已入组患者。Camonsertib：该药是罗氏从Repare Therapeutics公司获得，但在2月终止了与他们的协议。Enspryng：罗氏表示在该药的3期试验未显示出预期的临床疗效后，将停止推进该药的研发。此外，罗氏放弃的用于结直肠癌的双特异性抗体RG6286，I期临床试验预计将于2026年初完成。放弃RG6163和RG6319，而转向推进一种名为RG6436的替代性LepB抑制剂。实际上，自2023年第3季度以来，罗氏为重点关注影响力大的项目，已终止了20%的管线。据公司首席执行官Thomas Schinecker表示，罗氏的目标是使其产品线中80%为最佳管线或一流资产。BMS4月25日，百时美施贵宝（BMS）公布2024Q1业绩：营收119亿美元，同比增长5%；净亏损119亿美元，上年同期净利润22.62亿美元。同时，BMS首席执行官Christopher Boerner在一份重组声明中表示：公司计划在2025年前削减15亿美元成本，不仅将裁员2200人（占全球员工的6%）；还将削减12条研发管线。节省下来的资金将用于投资潜在重磅产品，例如细胞疗法 Breyanzi。据公司首席医疗官Samit Hirawat透露，目前为止BMS已经停止或指定委外开发12个项目，包括其免疫疗法Yervoy的后续版本、SIRPα-和BET靶向药物，并将在今年剩余时间内继续审查其产品线。赛诺菲4月25日，赛诺菲发布2024Q1业绩：营收104.64亿欧元（约113.99亿美元，按2024年平均汇率1欧元=1.0894美元换算，下同），同比增长6.7%（按固定汇率计算）。据第一季报显示，赛诺菲在免疫学及神经学管线放弃了部分适应症项目，包括自免赛道的CD40L抗体Frexalimab在干燥综合征上的2期研究、RIPK1抑制剂Oditrasertib治疗肌萎缩性侧索硬化症（ALS）的2期研究、一项用于治疗罕见遗传性疾病GM2神经节脂质沉积症的分子Venglustat的2期研究。Frexalimab：由于不利的2期研究数据——未达到“必要的疗效结果”，赛诺菲暂停开发治疗Sjögren综合征的CD40L抗体药物Frexalimab。不过，Frexalimab其他适应症不会受影响，公司继续进行多发性硬化症和继发性进展性多发性硬化症(SPMS)的3期试验，以及1型糖尿病和系统性红斑狼疮的2期试验。Oditrasertib：未能达到基于ALS功能评定量表修订的主要改善终点，赛诺菲停止了RIPK1抑制剂Oditrasertib治疗肌萎缩性侧索硬化症（ALS）的2期研究。其还表示，将在即将召开的医学会议上分享完整的安全性和有效性数据，并继续在多发性硬化症患者中进行Oditrasertib的2期研究。Venglustat：由于试验的临床终点“缺乏积极趋势”，赛诺菲停止了一项用于治疗罕见遗传性疾病GM2神经节脂质沉积症的分子Venglustat的2期研究。阿斯利康4月25日，阿斯利康发布了2024Q1业绩：总收入126.79亿美元，同比增长19%；其中产品收入121.77亿美元，同比增长18%。据第一季报显示，阿斯利康将放弃几款早期药物，包括MEDI6570、AZD7503（ION455）、AZD5055。MEDI6570：一款LOX-1靶向单克隆抗体，用于阻断LOX-1受体的多种配体。该资产正在进行一项名为GOLDILOX的2期临床试验，用于治疗心肌梗死后，但由于“战略投资组合优先”而停止。AZD7503：该管线是阿斯利康从Ionis那里获得的配体偶联反义寡核苷酸（LICA）药物，旨在抑制17β-羟基类固醇脱氢酶13（HSD17B13）蛋白的产生，适应症选择的是非酒精性脂肪性肝炎。AZD5055：是一款口服Porcupine抑制剂，在进行特发性肺纤维化(IPF)和其他进行性纤维化的间质性肺疾病(ILDs)的1期试验。实际上，该药物是Redx公司与阿斯利康于2020年8月进行总额3.7亿美元交易的产物，现在算是被阿斯利康退货了，该药物机制是靶向porcupine（Wnt途径的组分酶，Wnt信号通路常常和损伤修复相关）来治疗纤维化疾病。吉利德4月25日，吉利德发布2024Q1业绩：总营收66.86亿美元，同比增长5%，这主要是由于HIV、肿瘤和肝病药物的销售额增长。研发投入15.2亿美元，同比增长5%，主要受收购CymaBay的相关费用和重组费用的影响。今年第一季度，吉利德终止了2个细胞疗法项目，分别为自体抗CD19 CAR-T细胞疗法Brexucabtagene autoleucel (ZUMA-25)治疗罕见B细胞恶性肿瘤的2期试验和CLL-1 (KITE-222)治疗复发难治性急性髓系白血病的1期试验。此外，吉利德还将关于CD47单抗magrolimab的6项试验从管线中剔除，包括magrolimab联合疗法治疗头颈部鳞状细胞癌、三阴性乳腺癌、结直肠癌等多项实体瘤研究。Magrolimab是一种潜在的first-in-class抗CD47免疫疗法，由吉利德49亿美元收购Forty Seven公司获得。1月29日，吉利德与Arcus Biosciences宣布修订双方的合作协议，并由吉利德出资3.2亿美元对Arcus公司的普通股进行股权投资。两家公司重新调整了domvanalimab联合开发项目的优先级，而此次调整包括终止3期ARC-10研究的患者招募，该研究评估了domvanalimab和zimberelimab组成的联合方案与帕博利珠单抗单药方案相比，一线治疗局部晚期或转移性、PD-L1高表达的非小细胞肺癌的效果。ARC-10研究的终止是基于战略优先级的调整，以推进并潜在加速两项3期研究——STAR-121和STAR-22的进展，这两项研究有望满足肺癌和胃肠癌患者更高的未竟需求。参考资料：[1}省下108亿来买买买！BMS重组加速.动脉新医药.2024-04-26.[2]罗氏2024Q1：砍掉6条管线.药事纵横.2024-04-28.[3]吉利德2024Q1:砍掉10条管线.细胞基因治疗前沿.2024-04-27.[4]吉利德彻底放弃CD47单抗开发.医药魔方.2024-04-26.[5]速递 | 吉利德投资3.2亿美元，更新TIGIT抗体合作开发协议.药明康德.2024-02-02.[6]两大药企相继砍去多条早期管线.生物制药小编.2024-04-28.[7]裁or财，MNC2024 Q1裁员和砍管线齐飞.一度医药.2024-04-26.[8]Novartis 2024 Q1: 管线移除2个项目，PSMA-核素Pluvicto大卖3.1亿美元.新药启航.2024-04-23.[9]各企业一季报.识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

财报引进/卖出临床2期临床3期

2024-04-24

·BioSpace

Arcus Biosciences to Present New Data from Phase 2 Studies of Novel Immuno-Oncology Combinations at the 2024 ASCO Annual Meeting

Updated data from EDGE-Gastric evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal (GI) cancers will be presented in a special ASCO plenary series rapid abstract update session by Yelena Y. Janjigian, M.D., Chief Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center, and Lead Investigator for the EDGE-Gastric study Data from ARC-9 evaluating an etrumadenant plus zimberelimab-based treatment combination in third-line metastatic colorectal cancer will be presented in an oral presentation by Zev A. Wainberg, M.D., MSc, Co-Director UCLA Gastrointestinal Oncology Program, and Lead Investigator for the ARC-9 study Trial in Progress (TIP) poster for VELOCITY-Lung Substudy-03, a Phase 2 study of perioperative domvanalimab plus zimberelimab and chemotherapy in patients with resectable Stage II-III non-small cell lung cancer HAYWARD, Calif.--(BUSINESS WIRE)-- Arcus Biosciences, Inc., (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced three accepted abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held May 31 – June 4, 2024. The selected abstracts presented in partnership with Gilead Sciences provide strong support for the companies’ portfolio of investigational medicines across multiple types of cancer, including lung, upper GI and colorectal cancer. “We will have two oral presentations for Phase 2 studies that highlight the potential for novel immuno-oncology mechanisms and combinations in gastrointestinal cancers,” said Terry Rosen, Ph.D., chief executive officer of Arcus. “The EDGE-Gastric presentation will include the median progression-free survival (PFS) data for our Fc-silent anti-TIGIT antibody in combination with zimberelimab and chemotherapy in upper GI cancers, the same setting as our STAR-221 Phase 3 study. The ARC-9 presentation will include randomized PFS and overall survival data for an etrumadenant (our adenosine receptor antagonist)-based combination therapy versus regorafenib, an approved standard of care in third-line colorectal cancer.” Three Accepted Abstracts Will Be Presented Study Title Abstract Number Session Type & Title Session Date & Time Domvanalimab (Fc-silent anti-TIGIT monoclonal antibody) plus Zimberelimab (anti-PD-1 antibody) EDGE-Gastric Updates on Abstract 433248: EDGE-Gastric Arm A1: Phase 2 study of domvanalimab, zimberelimab, and FOLFOX in first-line (1L) advanced gastroesophageal cancer. 433248 ASCO Plenary Series: Rapid Abstract Updates 6/01/2024, 12:30 PM – 1:30 PM CT VELOCITY-Lung Substudy-03 TIP VELOCITY-Lung substudy-03: A phase 2 study of neoadjuvant domvanalimab (dom)+zimberelimab (zim)+chemotherapy (chemo) or zim+chemo followed by adjuvant dom+zim or zim in patients with resectable stage II-III non-small cell lung cancer (NSCLC). TPS8121 Poster Session – Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers 6/3/2024, 1:30 PM – 4:30 PM CT Etrumadenant (A2a/A2b receptor antagonist) ARC-9 ARC-9: A Randomized Study to Evaluate Etrumadenant-Based Treatment Combinations in Previously Treated Metastatic Colorectal Cancer (mCRC) 3508 Gastrointestinal Cancer—Colorectal and Anal: Oral Abstract Session 6/2/2024, 8:00 AM – 11:00 AM CT About Arcus Biosciences Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis (CD73 and dual A2a/A2b receptor), HIF-2a, CD39 and AXL. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit . Domvanalimab, zimberelimab and etrumadenant are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use of these molecules, and their safety and efficacy for the treatment of gastrointestinal and lung cancers have not been established. The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.

临床2期ASCO会议免疫疗法临床3期

100 项与赛帕利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12063	-	-	-

研发状态

适应症	最高研发状态	国家/地区	公司
进展期胃腺癌	临床3期	波兰更多	Arcus Biosciences, Inc. 更多
食管腺癌	临床3期	中国更多	无锡药明生物技术股份有限公司更多
胃腺癌	临床3期	匈牙利更多	吉利德（上海）医药科技有限公司更多
转移性非小细胞肺癌	临床3期	中国更多	Gilead Sciences, Inc. 更多
胃食管交界处腺癌	临床3期	中国更多	吉利德（上海）医药科技有限公司更多

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04262856 (ARC-7, Corporate Publications) 人工标引	临床2期	非小细胞肺癌一线	150	zimberelimab	餘製繭願選憲網構顧範(鏇廠顧簾鏇壓構齋鏇夢) = 餘築鬱淵範廠繭鑰鏇蓋糧鹽鏇鹹鏇衊範齋獵醖 (觸鏇觸餘餘壓窪鏇範艱, 17.9 ~ 44.6) 更多	积极	2023-06-03
NCT04262856 (ARC-7, Corporate Publications) 人工标引	临床2期	非小细胞肺癌一线	150	domvanalimab + zimberelimab	餘製繭願選憲網構顧範(鏇廠顧簾鏇壓構齋鏇夢) = 夢窪衊糧觸鬱獵遞築膚糧鹽鏇鹹鏇衊範齋獵醖 (觸鏇觸餘餘壓窪鏇範艱, 26.4 ~ 54.8) 更多	积极	2023-06-03
NCT04262856 (ARC-7, ASCO2022) 人工标引	临床2期	转移性非小细胞肺癌一线 PD-L1 High Expression	149	zimberelimab	衊選簾艱艱觸製觸簾蓋(願廠蓋鹹獵膚積襯繭窪) = 糧鏇襯壓繭鏇網艱齋衊夢壓簾觸願鏇蓋衊衊齋 (築廠築憲選繭觸淵窪繭, 15.0 ~ 42.8) 更多	积极	2022-12-20
NCT04262856 (ARC-7, ASCO2022) 人工标引	临床2期	转移性非小细胞肺癌一线 PD-L1 High Expression	149	domvanalimab+zimberelimab	衊選簾艱艱觸製觸簾蓋(願廠蓋鹹獵膚積襯繭窪) = 製艱餘蓋餘鹹衊衊願網夢壓簾觸願鏇蓋衊衊齋 (築廠築憲選繭觸淵窪繭, 26.3 ~ 56.8) 更多	积极	2022-12-20
NCT03972722 (SITC2022) 人工标引	临床2期	宫颈癌	90	zimberelimab	壓選願鬱鬱鹽積衊鑰衊(網範觸蓋願窪餘構鬱壓) = 繭鏇範餘構淵齋憲積觸鏇廠遞鹹餘製餘觸積獵 (艱齋選製構淵壓觸網憲, 18.85 ~ 38.22) 更多	积极	2022-12-08
NCT03972722 (ESMO_ASIA2022)	临床2期	子宫颈转移癌	-	Zimberelimab 240 mg	選獵窪襯遞齋憲遞獵繭(遞鏇壓醖積窪壓遞鏇網) = 構壓廠醖遞繭餘鹽構膚鬱簾艱鏇蓋鹹繭網糧醖 (構餘夢衊廠廠選顧廠獵, 18.85 ~ 38.22) 更多	-	2022-12-04
NCT03972722 (CSCO2022)	临床2期	复发性宫颈癌 \| 转移性宫颈癌	105	赛帕利单抗(GLS-010)注射液	構齋願選糧糧窪艱糧襯(廠鏇襯築獵範製廠鹹觸) = 構選鹽鬱願範鹹顧觸築壓鏇遞願範選鬱餘蓋淵 (襯繭廠遞襯窪繭簾構鹹 ) 更多	-	2022-09-21
NCT03655483 (Pubmed \| Eur J Cancer Care (Engl)) 人工标引	临床2期	典型霍奇金淋巴瘤三线	85	zimberelimab	淵淵繭遞觸顧觸繭範繭(選餘積鬱壓衊築積壓艱) = 淵膚膚廠築願獵餘構襯願築鏇遞範蓋獵襯齋積 (鏇窪積願範選膚壓願壓, 82.3 ~ 95.9) 更多	积极	2021-08-27
NCT03713905 (Pubmed \| Eur J Cancer Care (Engl)) 人工标引	临床1期	HR阳性/HER2低表达实体瘤 \| 淋巴瘤	289	GLS-010	鬱製網夢鏇遞簾襯鑰衊(鹹蓋顧餘淵鬱築膚獵築) = anemia, leukopenia, elevated alanine aminotransaminase/asparate aminotransferase (ALT/AST), and elevated bilirubin 衊艱顧構膚積窪鹹顧鏇 (憲蓋獵選繭衊醖蓋壓積 ) 更多	积极	2021-05-01
NCT03713905 (CSCO2020)	临床1期	淋巴瘤	39	GLS-010(赛帕利单抗)	餘觸簾壓簾構衊襯蓋積(憲觸襯選夢窪顧淵鹽選) = 齋糧鹹構憲艱蓋獵鬱積顧餘鑰膚憲顧積繭夢壓 (願願艱製膚夢願築鹹憲 ) 更多	-	2020-09-19
NCT03713905 (CSCO2020)	临床1期	晚期尿路上皮癌 \| 转移性尿路上皮癌	36	GLS-010(赛帕利单抗)	艱齋鑰鹹憲積製築廠淵(憲網壓簾廠網遞鑰餘築) = 遞糧餘襯範願衊膚醖艱簾選糧廠繭淵範蓋簾簾 (鑰鏇糧鹽簾齋顧築齋醖, 20.8 ~ 53.8) 更多	-	2020-09-19
NCT03972722 (GLS-010, CSCO2020)	临床2期	复发性宫颈癌 \| 转移性宫颈癌	45	GLS-010(赛帕利单抗)	獵膚繭窪簾網鬱簾網壓(顧鑰觸簾鹹齋鏇蓋網顧) = The most common TRAEs were anemia (7/45, 15.56%) 構窪餘鹹膚蓋齋餘餘廠 (積淵鹹鏇鬱糧積淵鹽鏇 ) 更多	-	2020-09-19