伊匹木单抗(Ipilimumab) - 药物靶点：CTLA4_在研适应症：晚期肝细胞癌，不可切除的肝细胞癌，错配修复缺陷或微高卫星不稳定性结肠癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti CTLA-4 monoclonal antibody、Anti-CTLA-4 Mab、Ipilimumab (Genetical Recombination)

+ [16]

靶点

CTLA4

作用方式

抑制剂

作用机制

CTLA4抑制剂(细胞毒性T淋巴细胞相关抗原4抑制剂)

治疗领域

肿瘤消化系统疾病呼吸系统疾病+ [12]

在研适应症

晚期肝细胞癌不可切除的肝细胞癌错配修复缺陷或微高卫星不稳定性结肠癌+ [291]

非在研适应症

复发性急性淋巴细胞白血病急性早幼粒细胞白血病转移性腺癌+ [119]

原研机构

Bristol Myers Squibb Co.

在研机构

Bristol Myers Squibb Co.

The University of Texas MD Anderson Cancer Center

National Cancer Institute

+ [15]

非在研机构

Jonsson Comprehensive Cancer Center

Checkmate Pharmaceuticals, Inc.

University of Southern California

+ [13]

权益机构

Nektar Therapeutics

Inspirna, Inc.

Gritstone bio, Inc.

+ [10]

最高研发阶段批准上市

首次获批日期

美国 (2011-03-25),

黑色素瘤

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、快速通道 (美国)、孤儿药 (美国)、优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国)、孤儿药 (韩国)、优先审评 (澳大利亚)、加速批准 (美国)、突破性疗法 (美国)

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结构/序列

Sequence Code 143797L

来源: *****

Sequence Code 9060585H

来源: *****

关联

847

项与伊匹木单抗相关的临床试验

NCT06946797

/ Not yet recruiting临床2期

A Phase 2, Open-label, Randomized Trial to Evaluate Two Dosing Regimens of Subcutaneous Formulation of Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent NSCLC

The purpose of this study is to evaluate two dosing regimens of subcutaneous Nivolumab in combination with intravenous Ipilimumab and chemotherapy in participants with previously untreated metastatic or recurrent Non-Small Cell Lung Cancer (NSCLC)

开始日期2025-08-02

申办/合作机构

Bristol Myers Squibb Co.

NCT06968988

/ Not yet recruiting临床1期IIT

Phase I Study With Expansion Cohort of Zanzalintinib in Combination With Ipilimumab and Nivolumab in Patients With Metastatic Soft Tissue Sarcoma

The investigators hypothesize that zanzalintinib in combination with ipilimumab and nivolumab will be well tolerated and serve as a potential therapeutic strategy in metastatic soft tissue sarcoma (mSTS) including myxofibrosarcoma, undifferentiated pleomorphic sarcoma, dedifferentiated liposarcoma, cutaneous angiosarcoma, and undifferentiated sarcoma histologies.

开始日期2025-07-31

申办/合作机构

Washington University School of Medicine

[+1]

NCT06712927

/ Not yet recruiting临床2期IIT

A Multicenter, Phase II Trial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases

This is a multicenter, phase II trial of relatlimab (rela), nivolumab (nivo), and ipilimumab (ipi) in patients with asymptomatic and symptomatic melanoma brain metastases.

开始日期2025-07-01

申办/合作机构

Stanford University

100 项与伊匹木单抗相关的临床结果

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100 项与伊匹木单抗相关的转化医学

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100 项与伊匹木单抗相关的专利（医药）

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5,696

项与伊匹木单抗相关的文献（医药）

2025-12-31·mAbs

Engineered ipilimumab variants that bind human and mouse CTLA-4

Article

作者: Barman, Ishita ; Lee, Peter S. ; Diong, SJ ; Bee, Christine ; Rajpal, Arvind ; Kumar, Anusha ; West, Sean M. ; Chau, Bryant ; Strop, Pavel ; Robison, Brett ; Chang, Olin ; Korman, Alan J. ; Moon, Thomas M.

Testing of candidate monoclonal antibody therapeutics in preclinical models is an essential step in drug development. Identification of antibody therapeutic candidates that bind their human targets and cross-react to mouse orthologs is often challenging, especially for targets with low sequence homology. In such cases, surrogate antibodies that bind mouse orthologs must be used. The antibody 9D9, which binds mouse CTLA-4, is a commonly used surrogate for CTLA-4 checkpoint blockade studies in mouse cancer models. In this work, we reveal that 9D9 has significant biophysical dissimilarities to therapeutic CTLA-4 antibodies. The 9D9-mCTLA4 complex crystal structure was determined and shows that the surrogate antibody binds an epitope distinct from ipilimumab and tremelimumab. In addition, while ipilimumab has pH-independent binding to hCTLA-4, 9D9 loses binding to mCTLA-4 at physiologically relevant acidic pH ranges. We used phage and yeast display to engineer ipilimumab to bind mouse CTLA-4 with single-digit nM affinity from an initial state with no apparent binding. The engineered variants showed pH-independent and cross-reactive binding to both mouse and human CTLA-4. Crystal structures of a variant in complex with both mouse and human CTLA-4 confirmed that it targets an equivalent epitope as ipilimumab. These cross-reactive ipilimumab variants may facilitate improved translatability and future mechanism-of-action studies for anti-CTLA-4 targeting in murine models.

2025-12-31·OncoImmunology

Circulating cytokine associations with clinical outcomes in melanoma patients treated with combination nivolumab plus ipilimumab

Article

作者: Baginska, Joanna ; Rodig, Scott J. ; Severgnini, Mariano ; Hodi, F. Stephen ; Chen, Jiajia ; Brennick, Ryan ; Manuszak, Claire ; Weirather, Jason L. ; Manos, Michael ; Ranasinghe, Srinika ; Liu, David ; Huang, Amy Y. ; Holovatska, Marta ; Hathaway, Emma ; Nazzaro, Matthew ; Giobbie-Hurder, Anita ; Tarantino, Giuseppe ; Russell, Janice D. ; Pfaff, Kathleen L.

Nivolumab plus ipilimumab (aCTLA-4/aPD-1) combination therapy has significantly improved clinical outcomes in patients with metastatic melanoma, with 50%-60% of patients responding to treatment, but predictors of response are poorly characterized. We hypothesized that circulating cytokines and peripheral white blood cells may predict response to therapy and evaluated 15 cytokines and complete blood counts (CBC with differentials) from 89 patients with advanced melanoma treated with combination therapy from three points in time: pre-treatment, one month and approximately three months after starting therapy. Clinical endpoints evaluated included durable clinical benefit (DCB), progression-free survival (PFS), and overall survival (OS). A parsimonious predictive model was developed to identify cytokines predictors of response to combination therapy. In this study, we found that pre-treatment, patients with DCB had higher IL-23, lower CXCL6, and lower IL-10 levels. Lower NLR one month after starting therapy predicted better PFS and OS, primarily driven by an increase in absolute lymphocytes. A multivariate model demonstrated that baseline CXCL6, IL-10, IL-23 were independent predictors of therapy response, and the combined model has reached an area under the curve (AUC) of 0.79 in prediction of response to combination therapy. Our study identified baseline CXCL6, IL-23, and IL-10 as predictors of response to aCTLA4/aPD1 combination therapy among patients with metastatic melanoma. This study also provides a framework for identifying patients who are likely to respond to combination ICB, as well as a subset of patients with high risk of developing resistance and are thus in need of alternative therapeutic options, such as clinical trials.

2025-12-31·OncoImmunology

Impact of steroid dose and timing on efficacy of combination PD-1/CTLA-4 blockade

Article

作者: Czapla, Juliane Andrade ; Burnette, Hannah R. ; Cui, Can ; Curkovic, Nina B. ; Lawless, Aleigha R. ; Irlmeier, Rebecca ; Sullivan, Ryan ; Ye, Fei ; Johnson, Douglas B. ; Bai, Xue

With the increasing use of immune checkpoint inhibitors (ICIs) in combination regimens and in earlier stages of advanced melanoma, the effective management of immune-related adverse events (irAEs) is key to balancing immunotherapy efficacy and toxicity. Conflicting evidence exists on possible detrimental effects of immunosuppression with corticosteroids for irAEs on ICI effectiveness. We conducted a multicenter, retrospective cohort study of immunotherapy-naïve advanced melanoma patients undergoing treatment with ipilimumab and nivolumab and a small cohort treated with nivolumab/relatlimab. We utilized univariate tests to assess response, PFS, and OS based on presence of irAE, receipt of steroids for irAEs, peak dose, and time-to-steroid, as well as multivariable analysis for response, OS, and PFS in patients receiving steroids for irAEs. Among 226 total ipilimumab/nivolumab patients, those without irAEs had poorer PFS and OS compared to irAE groups regardless of steroid administration. In subgroup analysis of patients receiving steroids for an irAE, increased time-to-steroid was significantly associated with improved response (aOR, 1.026 p = 0.0005), PFS (aHR, 0.986 p = 0.001), and OS (aHR, 0.983 p = 0.0008). Higher peak steroid dose was significantly associated with poorer PFS (aHR, 1.002 p = 0.005), and OS (aHR, 1.002 p = 0.003). Use of additional immunosuppressants was associated with poorer OS (aHR, 1.941 p = 0.018). Cumulative dose was not significantly associated with outcomes. Among 42 additional patients treated with nivolumab/relatlimab, irAEs were significantly associated with improved PFS/OS, which appeared to be slightly mitigated by steroid administration; dosing relationships were limited by small numbers.

1,354

项与伊匹木单抗相关的新闻（医药）

12 小时之前

·PRNewswire

John Theurer Cancer Center Presents Innovative Cancer Research at Major Annual Cancer Meeting, Offering New Hope for Patients

Presentations and publications address novel therapeutics, molecular biology studies, and global trends for blood cancers and solid tumors HACKENSACK, N.J., May 29, 2025 /PRNewswire/ -- Investigators from Hackensack Meridian John Theurer Cancer Center (JTCC)—part of the National Cancer Institute-designated Lombardi Comprehensive Cancer Center at Georgetown University—and Hackensack University Medical Center are reporting research findings from 32 studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting is the premier event for cancer professionals and takes place in Chicago from May 30 to June 3. "The future of cancer treatment begins with the pioneering exploration being carried out today," notes Andre Goy, MD, chair, vice president, physician-in-chief of oncology, at Hackensack Meridian John Theurer Cancer Center. "We are fortunate to be in a time where many cancers will respond to standard treatments. But for those cancers that don't, it's critical that patients have access to a world-class research program that will yield innovative therapies. At John Theurer Cancer Center, our globally recognized investigators continue to drive the latest oncology advances in cellular therapy, immunotherapy and other areas, enabling improved outcomes for patients across the Hackensack Meridian Health network and beyond." Several studies address novel drug combinations for multiple myeloma, as well as racial disparities in treatment outcomes and the expression of key biomarkers. Investigators are also presenting data on emerging immunotherapies for leukemia and lymphoma, molecular markers predicting disease relapse, and innovative treatment regimens such as all-oral therapies for acute myeloid leukemia. Solid tumor studies focus on disparities in gastric cancer, machine learning applications for breast cancer metastasis, and promising antibody-drug conjugates for lung cancer. Investigations related to melanoma and skin cancer examine circulating tumor DNA as a marker for disease progression, comparative survival analyses based on biomarkers, and the identification of targetable mutations across different skin cancer types. These findings underscore the breadth of ongoing efforts at John Theurer Cancer Center—New Jersey's largest cancer center—to refine therapeutic strategies, enhance precision oncology, and improve patient outcomes. Multiple Myeloma Research Carfilzomib, iberdomide, and dexamethasone in patients with transplant-eligible newly diagnosed multiple myeloma: Updated results from phase 1/2 study Updated results from phase 2b study of selinexor in combination with carfilzomib, daratumumab, or pomalidomide in patients with multiple myeloma relapsing on current therapy Real-world outcomes of patients with multiple myeloma treated with T-cell engagers compared to those treated on clinical trials Impact of racial disparities on efficacy and safety outcomes for patients with relapsing/refractory multiple myeloma receiving T-cell engagers Heterogeneity in the expression of GPRC5D between patients with multiple myeloma Evaluation of immune checkpoint inhibitors and concurrent radiation therapy for the treatment of extramedullary multiple myeloma Global burden of multiple myeloma: Analysis from 1980 to 2021 Efficacy and safety of less frequent dosing with elranatamab in patients with relapsed or refractory multiple myeloma: A US subgroup analysis from MagnetisMM-3 Leukemia and Lymphoma Peripheral blood cell-free DNA testing as a predictor for relapse post-allogeneic stem cell transplant for acute myeloid leukemia An all-oral regimen of decitabine-cedazuridine plus venetoclax in patients with newly diagnosed acute myeloid leukemia ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 pts Employing novel pan-cancer targets for immunotherapy in leukemias and solid tumors MRD negativity after end of induction in the phase 3 PhALLCON trial: A post hoc analysis Results from the completed dose-finding part of phase 2 study of the innate cell engager acimtamig (AFM13) in combination with AlloNK (AB-101) in relapsed or refractory classical Hodgkin lymphoma (LuminICE-203) Novel analysis of 3-y results from the pivotal EPCORE NHL-1 study: Outcomes in patients with relapsed/refractory large B-cell lymphoma and complete response at 2 years with epcoritamab monotherapy TITANium: An open-label, global multicenter phase 1/2 study of AZD5492, a first-in-class subcutaneous CD8-guided tri-specific T-cell engager, in patients with relapsed or refractory B-cell malignancies Solid Tumor Research Limited changes in the central nervous system immune microenvironment in patients with breast cancer metastasis and capturing these changes using machine learning Relationship between FOLR1 expression and pan-cancer subgroup of tumors with specific transcriptomic profile Disparities and trends in gastric cancer: Incidence, mortality, and stage-specific trends Prevalence of the HPV, EBV, and TTV viral RNA in the plasma of patients with solid and hematologic neoplasms and the detection of a specific immune signature Global trends in soft tissue and extraosseous sarcomas (1980–2021): Regional and economic disparities ZL-1310, a DLL3 antibody-drug conjugate, in patients with extensive stage small cell lung cancer: Phase 1 trial update Ongoing phase 1/2 trial of the hematopoietic progenitor kinase 1 (HPK1) inhibitor NDI-101150 as monotherapy or in combination with pembrolizumab: Clinical safety and efficacy update in clear cell renal cell carcinoma Ipilimumab and nivolumab in patients with metastatic clear cell renal cell carcinoma treated on the phase 3 PDIGREE (Alliance A031704) trial: Results from Step 1 analysis Initial safety and efficacy results from a first-in-human, phase 1/2 study of SAR445877, an anti-PD-1/IL-15 fusion protein, for patients with advanced solid tumors An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors A phase 1 dose escalation and dose expansion study for LNCB74, a B7-H4 targeted antibody drug conjugate, as monotherapy in participants with advanced solid tumors A phase 1, open-label, multi-center study of the safety, tolerability, and efficacy of IPH4502 as a single agent in advanced solid tumors A phase 2 safety and efficacy study of PRT3789 in combination with pembrolizumab in patients with advanced or metastatic solid tumors and a SMARCA4 mutation Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer Melanoma and Other Skin Cancers Comparison of ctDNA and hematologic ratios as markers of disease progression in early versus late-stage melanoma: A single-center retrospective study Survival analysis based on markers of progression in melanoma: A single-center comparison of survival in patients with high vs low biomarkers Targetable mutations in cutaneous skin cancers: A comparative study across melanoma, squamous cell carcinoma, basal cell carcinoma, and Merkel cell carcinoma SOURCE Hackensack Meridian John Theurer Cancer Center WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 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ASCO会议临床结果免疫疗法临床1期临床2期

15 小时之前

·GBIHealth

欧盟唯一！百时美施贵宝欧狄沃皮下注射制剂在欧盟获批

药械追踪No.1 / 拜耳抗肺癌新药Sevabertinib获美FDA优先审评2025年5月28日，拜耳公司宣布，其在研口服小分子酪氨酸激酶抑制剂Sevabertinib（BAY 2927088）获得美国FDA授予的优先审评资格，用于治疗接受过系统性治疗的HER2突变晚期非小细胞肺癌（NSCLC）成人患者。若最终获批，Sevabertinib有望成为全球首个商业化的HER2靶向小分子激酶抑制剂。该药物已于2024年获得FDA与中国国家药监局突破性疗法资格认定。该申请基于I/II期SOHO-01研究的最新临床数据。在HER2突变NSCLC患者中，Sevabertinib在未接受过HER2靶向治疗的患者队列中显示出70.5%的客观缓解率和中位缓解持续时间8.7个月；在既往接受过HER2靶向抗体-药物偶联物治疗治疗的患者中，客观缓解率为35.3%，中位缓解持续时间为9.5个月，且整体安全性良好。Sevabertinib是一款在研药物，尚未获得任何国家卫生部门批准用于任何适应证。目前，该药物正被评估为携带人表皮生长因子受体2 (HER2) 激活突变的非小细胞肺癌（NSCLC）患者的潜在新型靶向治疗选择。该药物可有效抑制突变型HER2，包括HER2外显子20插入和HER2点突变，以及表皮生长因子受体（EGFR），对突变型 EGFR 和野生型EGFR具有高选择性。HER2突变约占2%~4%的NSCLC患者群体，临床治疗手段有限，具有显著未满足的需求。->点击文末阅读原文，解锁完整双语新闻No.2 / 药明巨诺倍诺达新适应证上市申请获国家药监局受理2025年5月28日，药明巨诺（2126.HK）宣布，其自主研发的CAR-T细胞免疫治疗产品倍诺达（瑞基奥仑赛注射液）针对“二线不适合自体造血干细胞移植成人复发或难治性大B细胞淋巴瘤（r/r LBCL）”的新适应证上市许可申请，已获国家药品监督管理局正式受理。这是该产品递交的第四项上市申请，早在2025年1月，倍诺达已获该适应证的突破性治疗药物认定。本次申请基于一项在中国开展的II期关键临床研究，纳入一线治疗失败且不适合进行自体造血干细胞移植的r/r LBCL成年患者。研究数据显示，48例可评估患者中，倍诺达的最佳客观缓解率为81.3%，完全缓解率为54.2%，严重细胞因子释放综合征（≥3级）发生率仅为4.1%，未观察到严重神经毒性。倍诺达为中国首个获批为1类生物制品的CAR-T治疗产品，已获批治疗大B细胞淋巴瘤、滤泡性淋巴瘤及套细胞淋巴瘤三项适应证。此次新增适应证申请，旨在为更多复发/难治患者提供新的治疗选择，填补临床空白。->点击文末阅读原文，解锁完整双语新闻No.3 / 诺华伊普可泮在华获批新适应证，用于PNH成人患者2025年5月29日，诺华中国宣布其口服单药疗法飞赫达（盐酸伊普可泮胶囊）获得国家药监局（NMPA）批准新增适应证，用于治疗阵发性睡眠性血红蛋白尿症（PNH）成人患者。本次适应证的拓展覆盖了已经接受过补体抑制剂治疗的PNH患者，为这一群体提供了新的治疗选择。作为全球同类首创的特异性补体B因子口服抑制剂，飞赫达在中国获批的适应证增至三项，包括既往未接受过补体抑制剂治疗的PNH成人患者和成人C3肾小球病（C3G）。除PNH和C3G之外，伊普可泮正在研发用于一系列补体介导的疾病，包括非典型溶血性尿毒症综合征（aHUS）、免疫复合物膜增生性肾小球肾炎（IC-MPGN）和狼疮性肾炎（LN）。->点击文末阅读原文，解锁完整双语新闻企业动态No.1 / 欧盟唯一！百时美施贵宝欧狄沃皮下注射制剂在欧盟获批2025年5月28日，百时美施贵宝（NYSE：BMY）宣布，欧洲委员会（EC）已批准欧狄沃（纳武利尤单抗）皮下注射制剂上市，用于治疗多种成人实体瘤，包括单药治疗、在完成静脉注射欧狄沃联合逸沃（伊匹木单抗）联合治疗后的单药维持治疗，或与化疗或卡博替尼联合使用。欧洲委员会的积极决定基于CheckMate-67T临床试验的结果以及额外数据，这些数据表明欧狄沃SC与静脉注射欧狄沃在药代动力学（PK）和安全性方面具有可比性。CheckMate-67T临床试验显示，在接受不超过两种先前系统治疗但未接受过免疫肿瘤治疗的成人晚期或转移性透明细胞肾细胞癌（ccRCC）患者中，欧狄沃SC与静脉注射欧狄沃相比，在药代动力学主要终点Cavgd28（28天平均稳态浓度）和Cminss（稳态谷浓度）方面具有非劣效性。作为欧盟唯一获批的皮下注射PD-1抑制剂，皮下注射纳武利尤单抗为适合的患者提供了一种新的给药方式。2024年12月27日，皮下注射纳武利尤单抗和透明质酸酶-nvhy（商品名Opdivo Qvantig）获得美国食品药品监督管理局（FDA）批准。->点击文末阅读原文，解锁完整双语新闻全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I”自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作▶ olivia.xu@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

突破性疗法优先审批免疫疗法细胞疗法ASH会议

2025-05-29

·药明康德

超90%患者肿瘤缩小！潜在“best-in-class”小分子达3期主要终点；潜在首款！GSK小分子有望今年递交上市申请……

潜在首款！GSK小分子疗法关键3期试验达主要终点，今年递交上市申请GSK与Spero Therapeutics今日宣布，其所开发的抗生素tebipenem HBr在关键3期PIVOT-PO临床试验中取得积极结果。基于该疗法用于治疗复杂性尿路感染（cUTI，包括肾盂肾炎）患者的中期分析疗效数据，独立数据监查委员会（IDMC）建议提前终止试验。GSK预计将在2025年下半年将试验结果递交给美国FDA，作为上市申请的一部分。根据新闻稿，如果获得批准，tebipenem HBr将成为治疗cUTI的首个美国FDA批准的口服碳青霉烯类抗菌药物。此次试验结果包含入组的1690例患者的数据。分析显示，试验达到主要终点：在住院cUTI（包括肾盂肾炎）成人患者中，tebipenem HBr在治愈评估访视（test-of-cure visit）时的总缓解率（包括临床治愈和微生物清除的复合指标）不劣于静脉注射的亚胺培南-西司他丁。IDMC在审查过程中未发现该药物新的安全问题，最常见的不良事件为腹泻和头痛。Tebipenem HBr（原名SPR994）是Spero所开发的一种碳青霉烯类口服抗生素。该抗生素自2009年起以商品名Orapenem在日本用于治疗肺炎、中耳炎和鼻窦炎的儿科感染。碳青霉烯类是抗生素的一个重要子类，已观察到它们在治疗耐药革兰氏阴性细菌感染方面是安全有效的。GSK在2022年9月取得该疗法的独家许可，使其可在除日本和某些其他亚洲国家和地区以外的所有地区对tebipenem HBr进行商业化。首款！百时美施贵宝单抗皮下制剂获欧盟委员会批准百时美施贵宝（Bristol Myers Squibb）今日宣布，欧盟委员会（EC）已批准Opdivo（nivolumab，纳武利尤单抗）皮下注射剂（600 mg/瓶），用于多种成人实体瘤的治疗，包括单药治疗、静脉注射Opdivo联合Yervoy（伊匹单抗）治疗后的单药维持治疗，或与化疗或卡博替尼联合使用。根据新闻稿，Opdivo是在欧盟首个获批可皮下注射使用的PD-1抑制剂。这次欧盟委员会的批准主要基于CheckMate-67T的临床试验结果，显示Opdivo皮下注射剂（n=248）与静脉注射剂（n=247）在药代动力学（PK）和安全性方面的结果一致。分析显示，在既往接受不超过两种系统性治疗、但未接受过免疫治疗的晚期或转移性透明细胞肾细胞癌（ccRCC）成人患者中，Opdivo皮下注射剂与静脉注射剂相比，在PK主要终点上达非劣性。28天平均血药浓度的几何均数比（GMR）为2.10（90% CI：2.00–2.20），稳态谷浓度的GMR为1.77（90% CI：1.63–1.93）。此外，在关键次要终点客观缓解率（ORR）上，Opdivo皮下注射剂组为24%（95% CI：19–30），而静脉注射剂组为18%（95% CI：14–24），显示Opdivo两种剂型在疗效方面具有相似性。超90%患者肿瘤缩小！潜在“best-in-class”小分子3期试验达主要终点德国默克（Merck KGaA）今日公布了MANEUVER临床3期试验第一部分的详细积极结果。该试验评估了由与和誉医药（Abbisko Therapeutics）联合开发的集落刺激因子-1受体（CSF-1R）抑制剂pimicotinib用于治疗腱鞘巨细胞瘤（TGCT）患者的疗效。分析显示，每日一次口服的pimicotinib在试验第25周达到主要终点——由盲法独立评审委员会（BIRC）评估的客观缓解率显著优于安慰剂，分别为54.0%与3.2%（p<0.0001）。研究还在所有与TGCT相关的关键患者报告结局的次要终点上显示出具有统计学意义且临床显著的改善。Pimicotinib起效迅速，在13周时已有41.3%的患者（63人中的26人）达成客观缓解。在主要分析数据截止时，BIRC根据RECIST v1.1标准评估发现，几乎所有pimicotinib组患者（63人中的58人，92.1%）的肿瘤体积出现缩小，其中1人获得完全缓解，33人获得部分缓解。而针对TGCT专门设定的终点指标——肿瘤体积评分（TVS）显示，近三分之二接受pimicotinib治疗患者的肿瘤体积减少至少50%（pimicotinib组61.9% vs安慰剂组3.2%，p<0.0001）。Pimicotinib（ABSK021）是和誉医药研发的一款口服、高选择性与活性、潜在“best-in-class”的CSF-1R小分子抑制剂，用于治疗不可手术的腱鞘巨细胞瘤。参考资料：[1] PIVOT-PO phase III study for tebipenem HBr stopped early for efficacy following review by Independent Data Monitoring Committee. Retrieved May 28, 2025 from https://www.gsk.com/en-gb/media/press-releases/pivot-po-phase-iii-study-for-tebipenem-hbr-stopped-early-for-efficacy-following-review-by-independent-data-monitoring-committee/[2] Bristol Myers Squibb Receives European Commission Approval for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications. Retrieved May 28, 2025 from https://investors.bms.com/iframes/press-releases/press-release-details/2025/Bristol-Myers-Squibb-Receives-European-Commission-Approval-for-the-Subcutaneous-Formulation-of-Opdivo-nivolumab-Across-Multiple-Solid-Tumor-Indications/default.aspx[3] Pimicotinib Demonstrates Best-in-Class Potential with Significant Efficacy and Clinically Meaningful Improvements in Patients with Tenosynovial Giant Cell Tumor. Retrieved May 28, 2025 from https://www.businesswire.com/news/home/20250527338086/en/Pimicotinib-Demonstrates-Best-in-Class-Potential-with-Significant-Efficacy-and-Clinically-Meaningful-Improvements-in-Patients-with-Tenosynovial-Giant-Cell-Tumor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

临床3期临床结果上市批准免疫疗法

100 项与伊匹木单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04603	伊匹木单抗	L01XC11	DB06186

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期肝细胞癌	欧盟	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	冰岛	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	列支敦士登	Bristol Myers Squibb Co.	2025-03-08
晚期肝细胞癌	挪威	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	欧盟	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	冰岛	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	列支敦士登	Bristol Myers Squibb Co.	2025-03-08
不可切除的肝细胞癌	挪威	Bristol Myers Squibb Co.	2025-03-08
错配修复缺陷或微高卫星不稳定性结肠癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2025-01-13
错配修复缺陷或微高卫星不稳定性结肠癌	冰岛	Bristol-Myers Squibb Pharma EEIG	2025-01-13
错配修复缺陷或微高卫星不稳定性结肠癌	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2025-01-13
错配修复缺陷或微高卫星不稳定性结肠癌	挪威	Bristol-Myers Squibb Pharma EEIG	2025-01-13
不能切除的食管鳞状细胞癌	美国	Bristol Myers Squibb Co.	2022-05-27
食管癌	日本	Bristol-Myers Squibb KK	2022-05-26
间皮瘤	日本	Ono Pharmaceutical Co., Ltd.	2021-05-27
间皮瘤	日本	Bristol-Myers Squibb KK	2021-05-27
肝细胞癌	美国	Bristol Myers Squibb Co.	2020-03-10
皮肤黑色素瘤	美国	Bristol Myers Squibb Co.	2018-07-10
结直肠癌	美国	Bristol Myers Squibb Co.	2018-04-16
晚期肾细胞癌	欧盟	Bristol-Myers Squibb Pharma EEIG	2011-07-13

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
膀胱癌	临床3期	美国	Ono Pharmaceutical Co., Ltd.	2022-01-30
膀胱癌	临床3期	美国	中美上海施贵宝制药有限公司	2022-01-30
HER2阴性胃癌	临床3期	日本	Ono Pharmaceutical Co., Ltd.	2021-11-05
HER2阴性胃癌	临床3期	韩国	Ono Pharmaceutical Co., Ltd.	2021-11-05
HER2阴性胃癌	临床3期	中国台湾	Ono Pharmaceutical Co., Ltd.	2021-11-05
胶质母细胞瘤	临床3期	美国	National Cancer Institute	2020-09-01
神经胶质肉瘤	临床3期	美国	National Cancer Institute	2020-09-01
局部晚期非小细胞肺癌	临床3期	美国	Bristol Myers Squibb Co.	2019-10-08
局部晚期非小细胞肺癌	临床3期	中国	Bristol Myers Squibb Co.	2019-10-08
局部晚期非小细胞肺癌	临床3期	日本	Bristol Myers Squibb Co.	2019-10-08

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临床结果

适应症

分期

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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


NCT04039607 (CheckMate 9DW, Pubmed) 人工标引	临床3期	不可切除的肝细胞癌一线	668	Nivolumab plus ipilimumab	選繭壓鬱獵遞膚齋夢衊(築夢夢製襯遞淵糧遞繭) = 廠蓋願選鹽衊築窪選鹽範膚鬱顧艱艱窪憲網餘 (鹽餘願鑰糧夢選顧鬱壓, 18.8 ~ 29.4) 更多	积极	2025-05-01
				Lenvatinib or sorafenib	選繭壓鬱獵遞膚齋夢衊(築夢夢製襯遞淵糧遞繭) = 選顧願願餘艱獵願夢選範膚鬱顧艱艱窪憲網餘 (鹽餘願鑰糧夢選顧鬱壓, 17.5 ~ 22.5) 更多
NCT04938232 (CTgov)	临床2期	复发性经典霍奇金淋巴瘤 \| 难治性霍奇金淋巴瘤	13	ipilimumab+Nivolumab	襯遞餘積網齋壓繭夢襯 = 淵願願觸簾餘艱憲鬱齋繭選廠蓋製鹽窪選網齋 (艱膚淵構膚鑰繭夢鏇製, 襯蓋範積淵鏇願網顧齋 ~ 鏇窪築糧觸窪繭鏇膚範) 更多	-	2025-04-03
ESMO_ELCC2025	N/A	恶性间皮瘤一线	399	Ipilimumab plus Nivolumab	築鹹簾簾壓構醖糧鹹積(壓憲願繭願顧淵淵蓋網) = required in over half (53%) of TRAEs 構獵窪齋願膚糧願願衊 (淵鑰醖廠製淵糧構網繭 ) 更多	积极	2025-03-26
RW-9LA (ESMO_ELCC2025)	N/A	晚期非小细胞肺癌 programmed death-ligand (PD-L1) negative	40	Ipilimumab/Nivolumab + Chemotherapy	憲淵遞壓膚簾鑰糧襯鑰(齋積築憲鏇製繭顧網簾) = 簾獵製鏇鹽衊鬱願窪鏇鬱蓋衊衊餘糧醖遞淵繭 (鏇積鹽淵鏇夢廠簾製觸 ) 更多	积极	2025-03-26
NCT03377023 (CTgov)	临床1/2期	转移性非小细胞肺癌	66	Nivolumab+Ipilimumab+Nintedanib (Phase 1-Dose Escalation)	鏇網艱繭遞遞淵繭壓糧 = 膚醖繭簾積襯糧壓遞範鏇艱積廠選鬱膚構繭遞 (糧鹹壓築鏇築觸簾憲願, 鏇顧壓製鹽鬱鬱構糧淵 ~ 醖鏇網選網鹽築簾壓網)	-	2025-03-25
				Nivolumab+ipilimumab+Nintedanib (Phase 2 - Arm A)	範願鹽艱鏇網憲窪獵鹹 = 鏇網簾選廠襯積簾壓遞襯鑰齋衊製鹽鹹範醖鬱 (醖網鹹選窪淵壓窪窪餘, 鏇醖夢觸齋廠窪築選憲 ~ 顧獵顧鏇鬱鹽遞憲鏇憲) 更多
NCT02488759 (CheckMate 358, Pubmed \| J Clin Oncol)	临床1/2期	转移性Merkel细胞癌	-	Nivolumab	鹽製繭構蓋蓋齋鏇壓蓋(鏇簾壓製選蓋願蓋獵遞) = 觸夢選壓壓積淵構遞選齋鏇觸膚遞顧顧獵鬱淵 (築構夢糧積鑰窪築鬱遞, 38.7 ~ 78.9) 更多	不佳	2025-03-20
				Nivolumab + Ipilimumab	鹽製繭構蓋蓋齋鏇壓蓋(鏇簾壓製選蓋願蓋獵遞) = 窪艱醖壓窪襯醖壓鹹顧齋鏇觸膚遞顧顧獵鬱淵 (築構夢糧積鑰窪築鬱遞, 42.1 ~ 73) 更多
NCT03285321 (BTCRC-LUN16-081 \| BTCRC LUN 16-081, CTgov)	临床2期	不可切除的非小细胞肺癌	105	Nivolumab (Arm 1: Nivolumab)	膚觸網觸鏇顧範選鏇淵 = 網繭衊齋糧鬱艱築鹽衊積鏇觸夢糧製繭積憲窪 (鬱襯壓選選積選積鏇糧, 艱膚壓鹹淵壓簾蓋網壓 ~ 蓋築鏇繭積膚窪遞顧淵) 更多	-	2025-03-11
				Ipilimumab+Nivolumab (Arm 2: Nivolumab Plus Ipilimumab)	膚觸網觸鏇顧範選鏇淵 = 選襯願鑰廠鹹糧窪廠膚積鏇觸夢糧製繭積憲窪 (鬱襯壓選選積選積鏇糧, 築製餘積廠鏇艱選艱積 ~ 鑰壓積醖襯獵壓鏇獵鹽) 更多
NCT03158129 (NEOSTAR, CTgov)	临床2期	非小细胞肺癌Ⅰ期 \| 非小细胞肺癌IIIA期 \| 非小细胞肺癌 II期	101	Nivolumab (Arm A - Nivolumab)	壓築醖願憲遞簾艱積簾 = 鹹鬱襯餘願顧願窪獵膚鹽憲窪範積鑰選餘鹹窪 (築鑰壓淵衊觸廠衊壓醖, 餘顧積膚遞遞簾構構顧 ~ 鹽構網餘範構鑰顧構積) 更多	-	2025-03-05
				Ipilimumab+Nivolumab (Arm B - Nivolumab + Ipilimumab)	壓築醖願憲遞簾艱積簾 = 獵襯鹽選鑰淵糧醖鹽膚鹽憲窪範積鑰選餘鹹窪 (築鑰壓淵衊觸廠衊壓醖, 構獵艱積構獵齋襯衊襯 ~ 鹹糧遞範簾醖網築糧壓) 更多
NCT04134182 (ASCO_GU2025) 人工标引	临床2期	肾细胞癌	8	Nivolumab + Ipilimumab	鏇選鏇鹽繭壓廠夢憲網(遞齋齋網餘鏇構簾醖範) = 壓網遞衊廠膚簾鏇艱鹹構簾構壓齋衊築醖窪鹹 (範構觸糧淵艱淵蓋鑰顧 ) 更多	积极	2025-02-13
ASCO_GU2025 人工标引	N/A	转移性肾细胞癌维持 \| 一线	222	Four Doses of IPI + NIVO	製憲範網鬱網鹽醖積壓(獵壓構範鹽顧窪廠膚簾) = 壓廠艱築鬱醖網鹹廠鬱糧範簾艱窪鹽鏇艱範簾 (願憲蓋簾獵範製顧膚齋, 82 ~ 93) 更多	积极	2025-02-13
				Fewer Than Four Doses of IPI + NIVO	製憲範網鬱網鹽醖積壓(獵壓構範鹽顧窪廠膚簾) = 廠廠網鏇衊襯製艱願窪糧範簾艱窪鹽鏇艱範簾 (願憲蓋簾獵範製顧膚齋, 72 ~ 94) 更多