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更新于：2025-10-15

Ipilimumab

伊匹木单抗

更新于：2025-10-15

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)

+ [17]

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

MSI-H 直肠癌PD-L1阳性非小细胞肺癌转移性肝细胞癌+ [304]

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+ [121]

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

+ [16]

非在研机构

Checkmate Pharmaceuticals, Inc.

University of Southern CaliforniaNational Institutes of Health Clinical Center

+ [11]

权益机构

Nektar Therapeutics

Inspirna, Inc.

Gritstone bio, Inc.

+ [8]

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

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结构/序列

Sequence Code 143797L

来源: *****

Sequence Code 9060585H

来源: *****

关联

873

项与伊匹木单抗相关的临床试验

NCT07128680

/ Not yet recruiting临床1期IIT

A Randomized Study of Nivolumab and Ipilimumab With and Without EXL01 in First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC)

This phase I trial tests the safety and effectiveness of nivolumab and ipilimumab with and without EXL01 for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. EXL01 is a live biotherapeutic product containing a strain of bacteria called Faecalibacterium prausnitzii. It may enhance a patient's response to treatment with immune checkpoint inhibitors like nivolumab and ipilimumab by altering the composition of the bacteria in the gut. Adding EXL01 to treatment with nivolumab and ipilimumab may be safe and more effective than giving nivolumab and ipilimumab alone.

开始日期2025-12-05

申办/合作机构

City of Hope National Medical Center

[+1]

NCT07188896

/ Not yet recruiting临床2期IIT

A Randomized Phase 2 Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)

This three-arm randomized phase 2 trial will enroll advanced clear cell RCC patients (all IMDC risk groups). Patients will be randomized 2:2:1 to either Arm A (fianlimab/ cemiplimab/ ipilimumab), Arm B (fianlimab/ cemiplimab), or Arm C (standard ipilimumab/ nivolumab), respectively.

开始日期2025-11-01

申办/合作机构

Hoosier Cancer Research Network

[+2]

NCT07155317

/ Not yet recruiting临床2期IIT

The TIME Trial - Phase II Randomized Controlled Trial of Time-of-Day Specified Immunotherapy for Advanced Melanoma

This phase II trial tests the safety and effectiveness of giving ipilimumab and nivolumab in the morning compared to other times of day in treating patients with melanoma that is stage IV or that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. While some patients have impressive outcomes with both of these drugs, over 40% of patients do not experience any clinical benefit. Studies have shown that the time of day that vaccines and other therapies are given have had an impact on response and survival. It is not known, however, whether time of day has an impact on response to immune checkpoint inhibitors, such as ipilimumab and nivolumab. Giving ipilimumab and nivolumab earlier in the day compared to later in the day may improve response to treatment and survival in patients with stage IV or unresectable melanoma.

开始日期2025-10-29

申办/合作机构

Emory University

[+1]

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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5,622

项与伊匹木单抗相关的文献（医药）

2025-12-31·OncoImmunology

Immune-related hepatitis and hypophysitis are associated with superior survival in melanoma patients treated with combined ipilimumab and nivolumab

Article

作者: Bjursten, Sara ; Ny, Lars ; Lindén, Maria ; Levin, Max ; Zhao, Zhiyuan ; Pandita, Ankur ; Al Remawi, Hifaa ; Rudin, Anna

Combination CTLA-4 (ipilimumab) and PD-1 (nivolumab) checkpoint inhibition (dual-ICI) improves survival in patients with advanced melanoma. However, many patients also experience immune-related adverse events (irAE) that require systemic treatment with corticosteroids. Corticosteroids dampen the anti-tumoral response and may impair survival. Here, we investigated the association between irAE and overall survival as well as exposure to corticosteroids and second line immunosuppressants in dual ICI-treated patients with advanced melanoma (n = 205). Patients with irAE (n = 113) had superior OS compared to patients with no irAE (n = 92). The survival benefit persisted after adjusting for immortal time bias. Regarding specific irAE, patients with colitis, hepatitis, rheumatic irAE, hypophysitis, and skin-related irAE had improved OS after adjusting for negative baseline factors. A survival benefit persisted for hypophysitis (p = 0.03) and hepatitis (p = 0.04) after adjusting for immortal time bias, whereas rheumatic (p = 0.05) and skin-related irAE (p = 0.06) where borderline significant. Hepatitis and colitis required higher doses of corticosteroids for longer times and more often second-line immunosuppression compared to other irAE. In conclusion, irAE are associated with superior OS in patients with advanced melanoma treated with dual ICI. Hepatitis and hypophysitis were most strongly associated with better survival outcomes. Studies investigating the mechanisms underlying hepatitis and hypophysitis may identify important response mechanisms.

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. ; Hodi, F. Stephen ; Severgnini, Mariano ; 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·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 ; Moon, Thomas M. ; Korman, Alan J.

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.

1,488

项与伊匹木单抗相关的新闻（医药）

2025-10-15

·Biotech前瞻

CPS 1–9晚期胃癌还能从免疫治疗获益吗？Meta分析给出答案

点击蓝字关注我们本期看点随着免疫检查点抑制剂（ICI）成为胃食管腺癌（GEAC）一线治疗的重要组成部分，PD-L1表达水平逐渐成为疗效预测的关键指标。PD-L1高表达（CPS≥10）的胃食管腺癌免疫疗效毫无疑问是确定的。然而，当CPS＜10的“灰色地带”患者进入临床视野后，关于免疫治疗是否真正带来生存获益，学界一直存在分歧。截图：文章截图一项发表于 ESMO Open 的国际多中心患者层面Meta分析，首次整合KEYNOTE-859、CHECKMATE-649、RATIONALE-305等重磅研究的个体数据（IPD），深入评估了PD-L1低表达（CPS 1–9）人群的真实获益。本文也将结合最新FDA的政策进行内容的及时校正，以飨读者。本期内容 01 引言 02 材料与方法 03 研究结果 04 总结与展望【01 引言】在晚期 HER2 阴性胃癌或胃食管交界腺癌（GEAC）的一线治疗中，抗PD-1单抗联合双药化疗已成为国际主流方案。然而，各国在免疫联合化疗的监管标准和适应症范围上存在显著差异。 2024年 FDA ODAC投票结果（延伸阅读： 2024年9月26日，FDA召开肿瘤药物咨询委员会（ODAC）会议讨论：免疫检查点抑制剂（ICIs）联合化疗一线治疗不同PD-L1 蛋白表达水平的晚期G/GEJ腺癌，晚期食管鳞癌的风险获益评估。会议上，ODAC以10篇赞成，2票反对，1票弃权的结果，认为ICIs作为PD-L1＜1的晚期HER2阴性，MSS的G/GEJ腺癌一线治疗，风险大于收益。）在美国，纳武利尤单抗（nivolumab）联合化疗最初（CheckMate-649研究）获批时不受PD-L1限制，但2025年FDA已收紧适应症，要求实际使用限于PD-L1阳性（CPS≥1）患者。同样，帕博利珠单抗（pembrolizumab）联合化疗（KEYNOTE-859研究）最初可用于所有人群，但FDA在2025年再次修订标签，将适应症限制为PD-L1阳性（CPS≥1）。这一政策变化使得美国在免疫联合治疗的临床应用上与欧洲趋于一致。欧洲药品管理局（EMA）自始维持严格标准：Opdivo + 化疗仅批准用于CPS≥5患者，而Keytruda + 化疗批准用于CPS≥1人群。在中国，替雷利珠单抗（tislelizumab）联合化疗于2024年获批，用于PD-L1肿瘤区阳性≥5%患者；而舒格利单抗（sugemalimab）在GEMSTONE-303研究中显示，CPS≥5人群显著获益，但CPS 5–9亚组未见明确生存优势。对于 HER2 阳性 GEAC，KEYNOTE-811研究的初步结果支持帕博利珠单抗联合曲妥珠单抗与化疗用于所有患者，但FDA在2023年11月7日发布修订，将适应症限制为PD-L1 CPS≥1，并在2025年3月再次确认该限定标准，与EMA保持一致。总体来看，全球监管趋向一致：PD-L1阴性（CPS<1）患者不再推荐常规免疫联合化疗。研究与真实世界数据均显示：免疫获益与PD-L1水平呈正相关——CPS 1–4患者存在有限但显著的生存获益，而CPS 5–9患者疗效边缘、CPS<1人群几无收益。这一系列调整意味着，今后在美国及多数地区，GEAC一线免疫化疗基本需PD-L1阳性（CPS≥1）方可使用，而在中国、欧洲等地也逐步收紧标签标准，推动精准免疫分层的进一步落地。 02 材料与方法检索与研究筛选本研究遵循 PRISMA 系统综述与Meta分析指南，在 PubMed、EMBASE、Web of Science 和 Cochrane CENTRAL 四个数据库中检索至 2024年6月30日。纳入所有报道晚期HER2阴性或HER2阳性GEAC一线ICI疗效的Ⅲ期随机对照试验，包括正式发表论文和会议摘要（如ASCO、ESMO）。检索不限语言，三位研究者独立筛选文献并进行全文复核，分歧由高级作者裁定。数据提取与质量评估使用统一模板提取研究信息。采用 Cochrane RoB2 工具评估偏倚风险，涵盖随机化、干预偏离、缺失数据、结果测量及报告选择等五个领域。两位研究者独立评估，争议经讨论解决。生存数据重建利用图形重建算法从已发表的 KEYNOTE-859、KEYNOTE-811 和 RATIONALE-305 研究的 Kaplan–Meier（KM）曲线中提取总生存期（OS）、无进展生存期（PFS）和缓解持续时间（DOR）数据，并通过 Cox 比例风险模型计算风险比（HR）。重建曲线与原图在HR、log-rank值及中位生存期等指标上进行比对以验证准确性。 KMSubtraction算法与亚组推导通过 KMSubtraction 算法结合 Hungarian 匹配法，在已知整体及部分亚组曲线基础上重建未公开亚组数据。匹配精度经马尔可夫链蒙特卡洛（MCMC）模拟（1000次迭代）及 Bland–Altman 图验证。生成的KM曲线用于计算各亚组HR。 Meta分析利用上述重建的个体数据进行一阶段Meta分析，评估以下亚组的OS结果： PD-L1 CPS 1–9亚组（KEYNOTE-859、KEYNOTE-062、RATIONALE-305）； PD-L1 CPS 1–4亚组（KEYNOTE-859、CHECKMATE-649、RATIONALE-305）； PD-L1 CPS 5–9亚组（KEYNOTE-859、RATIONALE-305）。分析采用 Cox比例风险模型，并以研究为分层变量以控制异质性；若比例风险假设不成立，则改用受限平均生存时间（RMST）进行敏感性分析。所有统计分析在 R 4.3.1 中完成，双侧P<0.05 为显著性标准。【03 研究结果】研究亮点：创新方法深挖未报告数据与传统的文献综述不同，本研究采用了先进的KMSubtraction算法，从已发表的KEYNOTE-859、CHECKMATE-649、RATIONALE-305等关键III期临床试验的生存曲线中，重建并提取了单个患者的数据（IPD）。这种方法使得研究者能够“还原”出那些在原始论文中未曾详细公布的亚组数据，特别是PD-L1低表达（CPS 1-9）的细分群体，从而进行更强大的汇总分析。最终共纳入八项随机对照研究（RCT）：KEYNOTE-062、CHECKMATE-649、KEYNOTE-590、KEYNOTE-811、KEYNOTE-859、ORIENT-16、RATIONALE-305 以及 ATTRACTION-4（见图1）。其中三项研究（KEYNOTE-590、ORIENT-16、ATTRACTION-4）未报告PD-L1低表达亚组的Kaplan–Meier（KM）生存曲线。所有纳入研究的偏倚风险均为低水平。试验特征、PD-L1检测方法及表达分布见表1。 Figure 1. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowchart diagram. 主要研究结果 PD-L1低表达与阴性亚组分析结果 KEYNOTE-811（HER2阳性，CPS<1亚组）：帕博利珠单抗 + 曲妥珠单抗 + 化疗组与对照组在PFS上无显著差异（HR 1.011, 95%CI 0.635–1.612, P=0.962），且OS有恶化趋势（HR 1.585, 95%CI 0.967–2.596, P=0.065），提示PD-L1阴性人群无获益甚至可能有害。 RATIONALE-305（HER2阴性，CPS 1–9亚组）：免疫联合化疗组与化疗组相比，OS差异未达统计学显著（HR 0.844, 95%CI 0.701–1.016, P=0.073）。在CPS 1–4（HR 0.843, P=0.148）及CPS 5–9（HR 0.796, P=0.131）亚组中，同样未观察到显著生存获益。 KEYNOTE-859： CPS<1亚组：OS（HR 0.933, P=0.565）与PFS（HR 0.876, P=0.292）均无显著差异。 CPS 1–9亚组：免疫联合组OS（HR 0.827, P=0.023）与PFS（HR 0.829, P=0.032）均显著改善，DOR亦延长（HR 0.751, P=0.040）。 CPS 1–4亚组：显示显著的OS与PFS获益（OS HR 0.785, P=0.017；PFS HR 0.780, P=0.018），但3年OS仅为11.4% vs 7.6%，获益幅度有限。 CPS 5–9亚组：未见显著差异（OS HR 0.934, P=0.636；PFS HR 0.908, P=0.525），尽管3年OS有15.1% vs 3.2%的差距。 HER2阴性人群中PD-L1低表达亚组汇总分析为提高统计效能，研究者将 KEYNOTE-859、KEYNOTE-062、RATIONALE-305 的 CPS 1–9亚组数据合并进行一阶段Meta分析，结果显示免疫联合治疗可带来显著但轻度的生存获益（OS HR 0.840, 95%CI 0.753–0.937, P=0.002）。进一步分层分析： CPS 1–4亚组（整合KEYNOTE-859、CHECKMATE-649、RATIONALE-305）同样显示显著OS获益（HR 0.868, 95%CI 0.772–0.976, P=0.018）； CPS 5–9亚组（KEYNOTE-859、RATIONALE-305）则无统计学显著性（HR 0.867, 95%CI 0.702–1.069, P=0.181）。整体趋势表明：免疫治疗获益主要集中在CPS 1–4群体，CPS<1及CPS 5–9亚组疗效有限。不同化疗方案的影响分析为探讨化疗方案差异的影响，研究者按顺铂方案与奥沙利铂方案分别汇总分析。结果显示：两种化疗方案联合PD-1治疗均改善OS与PFS（顺铂方案OS HR 0.82，奥沙利铂方案OS HR 0.81），异质性检验无显著差异（P>0.05）。惟独CHECKMATE-649中nivolumab + ipilimumab双免组表现为显著较差的PFS，因此在敏感性分析中被排除。临床启示与策略 CPS<10治疗困境：目前对CPS<10患者尚无公认最佳策略。标准免疫联合化疗的优势微弱，患者仍然面临较差预后。需要警惕过度使用免疫治疗可能带来的成本及毒副作用。对CPS5–9群体尤其需谨慎决策。其他靶向或免疫策略：对于具有其他可驱动靶点的患者，或考虑替代治疗。例如Claudin 18.2阳性的GEAC可使用zolbetuximab。研究（如SPOTLIGHT、GLOW）显示zolbetuximab加化疗能显著提高CLDN18.2阳性患者的PFS和OSmdpi.com；该疗法已获美日欧批准用于一线CLDN18.2阳性HER2阴性胃癌mdpi.com。对于CPS<10且CLDN18.2阳性的患者，可考虑将zolbetuximab纳入治疗方案。精准免疫分型：需进一步挖掘PD-L1以外的生物标志物（如TMB、微卫星状态、特定免疫细胞浸润等），进行更精细的免疫分型，以预测低表达患者谁能获益。未来研究应在CPS<10群体中设计亚组分析或探讨组合疗法（例如免疫+靶向、免疫+放疗/化疗优化方案）。真实世界数据积累：倡导基于真实世界的疗效与安全性研究，观察不同PD-L1水平患者在临床实践中的表现。大数据研究能为CPS<10群体提供更多证据，指导临床决策。 04 总结与展望本研究也指出了当前生物标志物的局限性。PD-L1表达本身存在异质性和检测判读的变异，尤其是在低表达范围。要真正实现精准医疗，我们需要：开发复合生物标志物：结合微卫星不稳定性（MSI）、肿瘤突变负荷（TMB）等指标，构建更精准的预测模型。推动数据共享：作者呼吁未来所有的临床试验都应完整公布各亚组的生存数据，以促进更深入的研究，最终惠及患者。这项深入的Meta分析如同一位严谨的“病理学家”，在PD-L1表达的显微镜下，对胃癌的免疫治疗疗效进行了更精细的“细胞分型”。它告诉我们，“低表达”背后是复杂的疾病图谱，临床决策需要从粗放走向精准。在为明确获益人群感到欣喜的同时，我们也必须正视那些尚未被满足需求的广大患者群体，这既是挑战，也是未来研究的方向。参考文献 https://doi-org.libproxy1.nus.edu.sg/10.1016/j.esmoop.2024.103962 ★

免疫疗法临床结果

2025-10-14

·PRNewswire

Lunit AI Predicts Immunotherapy Outcome in Colorectal, Kidney, and Lung Cancer at ESMO 2025

AI-powered histopathology demonstrates predictive value for immunotherapy outcomes in pMMR mCRC, advanced ccRCC, and NSCLC with data featured in both oral and poster presentations SEOUL, South Korea, Oct. 14, 2025 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeutics, today announced the presentation of three studies at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17–21 in Berlin, Germany. All three studies highlight how Lunit's AI pathology solution, Lunit SCOPE IO®, can identify biomarkers that predict response to immune checkpoint inhibitors (ICIs), offering new potential to guide more effective and personalized cancer treatment. Among these, the first study, selected for oral presentation, was conducted in collaboration with Chiara Cremolini, MD, PhD, Professor of Medical Oncology at the University of Pisa, Italy. Researchers applied Lunit SCOPE IO to pre-treatment H&E slides from patients with proficient mismatch repair (pMMR) metastatic colorectal cancer (mCRC) enrolled in the AtezoTRIBE and AVETRIC trials. The AI quantified multiple cell types within the tumor microenvironment, generating a biomarker that stratified patients into "biomarker-high" and "biomarker-low" groups. In the AtezoTRIBE trial, biomarker-high patients treated with atezolizumab plus FOLFOXIRI/bevacizumab showed significantly improved progression-free survival (PFS) and overall survival (OS) compared to biomarker-low patients, while no such benefit was observed in the control arm. Validation in the AVETRIC cohort confirmed improved survival outcomes for biomarker-high patients receiving ICI-based therapy, with better PFS and OS compared to biomarker-low patients. These results suggest that an AI-derived tumor microenvironment biomarker could help identify patients with pMMR mCRC who are most likely to benefit from immunotherapy combinations—an urgent unmet need in this population. A collaborative study with Yonsei University College of Medicine, Korea, evaluated whether AI-defined immune phenotypes (IP) could predict outcomes in patients with advanced clear cell renal cell carcinoma (ccRCC) treated with either nivolumab plus ipilimumab (NIVO+IPI) or sunitinib (SUN). Using Lunit SCOPE IO, tumors were classified as inflamed or non-inflamed, based on the density and spatial distribution of tumor-infiltrating lymphocytes. Patients with inflamed tumors treated with NIVO+IPI demonstrated significantly longer PFS, OS, and higher response rates (60.5% vs. 23.2%) compared to those with non-inflamed tumors. No such benefit was observed in the SUN arm. Findings were validated in an independent ccRCC cohort and aligned with inflamed gene expression signatures from The Cancer Genome Atlas, supporting AI-based immune phenotyping as a promising biomarker to guide treatment selection between immunotherapy combinations and targeted therapies in first-line treatment for ccRCC. The third study, conducted in collaboration with the National Cancer Center Hospital East (NCCHE) Japan, further validated the predictive power of Lunit SCOPE IO for ICI treatment response in non-small cell lung cancer (NSCLC) patients. In this multicenter prospective study, tumors classified as inflamed showed significantly better responses and longer survival with ICI therapy compared to non-inflamed tumors, a difference not observed among patients treated with cytotoxic chemotherapy. This result strengthens the evidence supporting Lunit SCOPE IO as a predictive biomarker for immunotherapy benefit in NSCLC. "At ESMO 2025, we are demonstrating how AI can unlock predictive biomarkers directly from routine pathology slides," said Brandon Suh, CEO of Lunit. "These findings show the potential of Lunit SCOPE IO to help identify patients who will truly benefit from immunotherapy—whether in colorectal or kidney cancer—and to guide treatment strategies that can make cancer care more precise and effective." Lunit's Featured Presentations at ESMO 2025 Oral Presentation [#725O/Berlin Auditorium - Hub 27, Oct.20, 09:10-20 AM]: Leveraging Artificial Intelligence to predict immune checkpoint inhibitor (ICI) efficacy in proficient MMR mCRC: translational analyses of AtezoTRIBE and AVETRIC trials — Chiara Cremolini, University of Pisa, Italy Poster Presentation [#1912P]: Inflamed immune phenotype as a novel predictive marker of immune checkpoint inhibitors for non-small cell lung cancer — Yoshitaka Zenke, National Cancer Center Hospital East, Japan Poster Presentation [#2624P]: Artificial intelligence (AI)-powered immune phenotype predicts differential benefit from nivolumab plus ipilimumab versus sunitinib in advanced clear cell renal cell carcinoma — Chang Gon Kim, Yonsei University College of Medicine, Korea Visit Lunit at booth #3017 to learn more about its latest AI-powered cancer research and innovations in digital pathology. ### About Lunit Founded in 2013, Lunit (KRX:328130.KQ) is a global leader in AI for cancer diagnostics and therapeutics. With a mission to conquer cancer through AI, Lunit develops AI-powered solutions for medical imaging and biomarker analysis to enable precise diagnosis and personalized treatment. Lunit's FDA-cleared Lunit INSIGHT suite supports cancer screening at over 7,000 medical institutions in more than 65 countries, while Lunit SCOPE is used in research partnerships with global pharma giants focused on biomarker development and companion diagnostics. Lunit clinical studies have been featured in top-tier journals—including The Lancet Digital Health and Journal of Clinical Oncology—and presented at major conferences such as ASCO and RSNA. Headquartered in Seoul with global offices, Lunit is driving the worldwide fight against cancer. Learn more at lunit.io. SOURCE Lunit WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床研究

2025-10-14

·医学新视点

致敬时代 | 近60%患者肿瘤缩小或几乎“全消失”！多款抗癌“新救星”为这类患者点亮生命之光

编者按：2025年，药明康德迎来创立25周年的重要里程碑。值此契机，我们向所有与我们共同书写产业变革篇章的科学家、医药人和投资者致以衷心感谢与诚挚敬意，也特别推出“致敬时代”系列，回顾全球同仁如何借助科学与合作的力量，不断拓展治疗边界、改善患者命运。四分之一个世纪的坚守，只为加速每一款新药的诞生。下一个25年，我们将继续心怀感恩与敬畏，依托独特的CRDMO模式，与全球伙伴携手同行，共赴健康未来。如今随着防晒的普及，越来越多人知道了一类与紫外线暴露有关的癌症——皮肤癌。在各种皮肤癌中，黑色素瘤约占1%，却是皮肤癌患者死亡的主要原因，被称为“皮肤癌之王”。黑色素瘤是由黑色素细胞基因突变与环境因素交互作用引起的一种恶性肿瘤，紫外线是主要风险因素，其他影响因素包括创伤和慢性炎症等。它可以发生于人的皮肤、眼睛、内耳、头颈和足底等多个部位。国际癌症研究机构（IARC）统计显示，每一天约有909人会被诊断为皮肤黑色素瘤，并有约161人会死于这种恶疾。这相当于，每2分钟就约有1人会被诊断为皮肤黑色素瘤，每10分钟约有1人会死于这种癌症。图片来源：123RF 从1787年有文献记载开始，到20世纪60年代，手术一直承担着早期黑色素瘤治疗的重任，但对于转移性黑色素瘤疗效有限。直到1975年，转移性黑色素瘤患者才迎来首款有效的化疗药物——达卡巴嗪（dacarbazine），它能让13.4%的患者获得缓解（偶有完全缓解案例），27%的人能活过1年、中位生存期5-11个月。此后，人们也探索过联合化疗或白细胞介素疗法的可能性，但结果都不尽理想。因此在长达三十多年的时间里，达卡巴嗪一直担任着转移性黑色素瘤治疗金标准的角色。为了让患者获得更好的生活质量，科学家们一直在努力寻找新的治疗方案。进入21世纪，黑色素瘤的治疗有了非常大的突破，从传统化疗走向了靶向治疗和免疫治疗交相辉映的新时代。作为全球医药及生命科学行业值得信赖的合作伙伴和重要贡献者，药明康德在25年发展历程中，很荣幸见证了多款黑色素瘤新疗法从实验室到临床的突破历程，更通过提供一体化、端到端的新药研发和生产服务，助力全球合作伙伴加速多款黑色素瘤创新疗法的研发进程、造福病患。今天这篇文章将回望近25年来黑色素瘤新疗法的发展历程，向那些为广大患者点亮生命之光的人们致敬。靶向疗法：半数患者的希望说到近十几年黑色素瘤靶向疗法的发展，就不得不提BRAF抑制剂。其中维莫非尼（vemurafenib）的问世更是一大里程碑，成为首个针对黑色素瘤特异性突变的靶向治疗药物。 20世纪80年代末，科学家在人类尤文氏肉瘤中发现并克隆了一个名为BRAF的基因。21世纪初，随着分子生物学和遗传学研究的深入，研究人员发现在大多数黑色素瘤中存在激活的BRAF基因突变，而且超过85%的突变是由BRAF V600E突变导致的。这一重大发现引发了科学家们开发黑色素瘤靶向药物的浪潮。起初，科学家们尝试用低效抑制剂来对付这种突变蛋白，但收效甚微。后来，在高通量筛选技术的帮助下，维莫非尼被挑选出来，它是一种对黑色素瘤中BRAF V600突变具有高度选择性和特异性的激酶抑制剂。图片来源：123RF 后续的研究中，维莫非尼也没让大家失望。在针对携带BRAF V600E基因突变的黑色素瘤患者的早期临床试验中，维莫非尼展现出惊人的缓解率，患者的肿瘤很快缩小。随后一项包含675名患者的3期临床试验再次取得令人瞩目的结果：维莫非尼的总体有效率高达48%，远远超过标准化疗的5%，并相比化疗将患者死亡风险降低了63%。基于振奋人心的疗效结果，维莫非尼在2011年8月获美国FDA批准用于携带BRAF V600E基因突变的晚期（转移性）或不可手术切除的黑色素瘤患者（商品名：Zelboraf），至此黑色素瘤终于迎来了首款靶向疗法，改变了过去三十多年来依赖化疗的局面。现在人们已经知道，BRAF基因编码一种丝氨酸/苏氨酸蛋白激酶，这个激酶就像一个“生长开关”，可调控细胞生长。正常的BRAF蛋白激酶只有在细胞需要生长的时候才激活，而突变的BRAF蛋白激酶一直处于激活状态，进而导致细胞野蛮生长。BRAF抑制剂就是通过关闭这个“开关”，从而遏制肿瘤生长。维莫非尼之后，科学家还开发出了针对MAPK信号通路中BRAF下游MEK的抑制剂，以及BRAF抑制剂和MEK抑制剂构成的组合疗法。2014-2015年，两组联合疗法先后获FDA批准用于BRAF突变的晚期黑色素瘤患者，它们分别是达拉非尼（dabrafenib，商品名：Tafinlar，BRAF抑制剂）/曲美替尼（trametinib，商品名：Mekinist，MEK抑制剂）联合疗法，以及考比替尼（cobimetinib，商品名：Cotellic，MEK抑制剂）/维莫非尼联合疗法。研究证明，“双剑合璧”的确达到了更好的疗效。于2018年获FDA批准的恩考芬尼（encorafenib，商品名：Braftovi，BRAF抑制剂）/比美替尼（binimetinib，商品名：Mektovi，MEK抑制剂）联合疗法，将携带BRAF V600突变的晚期黑色素瘤患者的中位无进展生存期和中位总生存期分别提高到了14.9个月和33.6个月。以维莫非尼为代表的这些靶向药的问世，在晚期黑色素瘤的治疗史上是个巨大进步。携带BRAF V600突变的患者在黑色素瘤中约占50%，这意味着，它们为半数患者带来了新的治疗选择，无需再依赖化疗。免疫疗法：诺奖级成果，改变更多患者命运对于另一半没有BRAF突变的患者，也有新的疗法正在加速到来。21世纪初，以免疫检查点抑制剂为代表的免疫疗法已经开始萌芽。与靶向药直接作用于癌细胞不同，免疫检查点抑制剂是通过人体自身的免疫系统来杀死癌细胞。在人体免疫系统中，有一种扮演着“警卫”角色的T细胞，当它们在巡逻中发现异常细胞时，就会复制出很多同胞兄弟来一起“干掉”这些“坏人”。不过“警卫”并非越多越好，T细胞过度活跃也可能“误伤”正常细胞、导致自身免疫疾病，所以正常情况下，人体会通过一个类似“刹车”系统的机制让T细胞及时收手，CTLA-4、PD-1就是这个“刹车”系统中的成员。但是狡猾的癌细胞也进化出了超强的“踩刹车”能力，以逃脱免疫细胞的攻击。CTLA-4抑制剂和PD-1抑制剂就是为了解除原本会被癌细胞“踩下的刹车”，从而让免疫细胞去消灭它们。其中，CTLA-4抑制剂的临床研究开展更早。2011年3月，首个CTLA-4抑制剂伊匹木单抗（ipilimumab，商品名：Yervoy）获FDA批准上市，为没有BRAF基因突变的晚期黑色素瘤患者带来了新的治疗选择。相比单纯化疗，伊匹木单抗与化疗药物的联合疗法让疗效获得了改善，1年和3年生存率分别为47.3%和20.8%（单纯化疗组为36.3%和12.2%），缓解率为15.2%（单纯化疗组为10.3%）。此后，PD-1/PD-L1抑制剂、LAG-3抑制剂等多款免疫疗法凭借亮眼的疗效接连问世。自2014年以来，帕博利珠单抗（pembrolizumab，商品名：Keytruda）、纳武利尤单抗（nivolumab，商品名：Opdivo）等免疫检查点疗法都已获批用于黑色素瘤，无论患者是否携带BRAF突变，都可以从中受益。同样地，免疫疗法的“双剑合璧”，如伊匹木单抗/纳武利尤单抗组合疗法、纳武利尤单抗/瑞拉利单抗（relatlimab，LAG-3抑制剂）组合疗法等，也相比单药获得了更惊艳的疗效。比如，在代号为CheckMate-067的3期临床试验中，科学家对945名不可切除晚期黑色素瘤初治患者经过长达5年随访的结果显示，纳武利尤单抗/伊匹木单抗联合治疗组的中位总生存期已超过60个月、5年总生存率为52%，近六成（58%）患者获得缓解（即肿瘤明显缩小或消失）、超两成（22%）患者达到完全缓解（即肿瘤几乎“全消失”），明显高于这两款药单药治疗的相应数据。值得一提的是，在联合治疗组中，携带BRAF突变患者的生存情况比无突变的患者更好，5年生存率已达60%（后者为48%）。另外科学家发现，免疫疗法还可以成为靶向药的“助攻”，多管齐下治疗BRAF V600突变阳性的黑色素瘤。比如此前已斩获其他多个癌种适应症的PD-L1抑制剂阿替利珠单抗（atezolizumab，商品名：Tecentriq），其与考比替尼/维莫非尼的联合疗法已于2020年获FDA批准上市，用于治疗BRAF V600突变阳性晚期黑色素瘤患者。目前，免疫疗法已成为晚期黑色素瘤的标准一线治疗。除了黑色素瘤，肺癌、头颈癌、淋巴瘤等至少二十种恶性肿瘤患者也已从这些疗法中获益，人类抗击癌症的历史已因它们的到来而改变。免疫检查点的两个经典靶点的发现者也因其突破性贡献斩获了诺贝尔奖——2018年，诺贝尔生理学或医学奖颁给了CTLA-4的发现者詹姆斯·艾利森（James P. Allison）教授和PD-1的发现者本庶佑（Tasuku Honjo）教授，以表彰他们在癌症治疗方面所做的贡献。这些新疗法接连的问世，让晚期黑色素瘤患者的生存率发生了翻天覆地的变化。就在十多年前，单纯化疗患者的3年生存率还只有10%左右；而当年勇敢参加纳武利尤单抗1期临床试验的患者，5年生存率就达到了34.2%，更有超过30%的患者在随访96个月（8年）时依然存活；纳武利尤单抗/伊匹木单抗联合疗法更是将晚期黑色素瘤患者的5年生存率提高到了52%。 ▲纳武利尤单抗在1期临床试验中单药治疗3种癌症的十年随访数据，MEL代表晚期黑色素瘤患者（图片来源：参考资料[9]）然而，免疫检查点抑制剂并非“万能神药”。针对免疫疗法难治性患者，产业界也在不断探索新药研发。2024年，肿瘤浸润淋巴细胞（TIL）疗法lifileucel（商品名：Amtagvi）获FDA加速批准，用于先前接受过PD-1抑制剂治疗的不可切除或转移性黑色素瘤成年患者，如果患者呈BRAF V600突变阳性，还可使用BRAF抑制剂，并且选择联合或不联合MEK抑制剂。针对这类问题的新药还有妥拉美替尼，这是一款MEK抑制剂，于2024年在中国获批上市（商品名：科露平），适合于接受抗PD-1/PD-L1治疗失败，携带NRAS突变的晚期黑色素瘤患者。向治愈出发，更多新疗法蓄势待发过去25年间，美国FDA共批准了至少14款治疗黑色素瘤的新疗法，除上述药物之外，还有2015年获批的溶瘤病毒局部疗法talimogene laherparepvec（商品名：Imlygic），以及2022年获批用于晚期葡萄膜黑色素瘤的T细胞受体（TCR）疗法tebentafusp（商品名：Kimmtrak）。此外，近25年在中国获批用于黑色素瘤适应症的还有化疗药物表柔比星、重组人白细胞介素2，以及PD-1抑制剂普特利单抗（商品名：普佑恒）和特瑞普利单抗（商品名：拓益）。药明康德很高兴能为其中多款疗法提供赋能、助力合作伙伴的这些创新疗法来到全球患者身边。为帮助患者达到更高的生存目标，产业圈仍在探索之路上继续前行。当下还有500多款针对黑色素瘤的新疗法正处于积极的临床研究中，有望在未来造福更多患者。其中近百款药物已进入3期临床阶段，涵盖小分子靶向药、T细胞受体工程T细胞（TCR-T）疗法和癌症疫苗（包括多肽疫苗、mRNA疫苗）等多种类型。比如在研癌症疫苗Cylembio（imsapepimut与etimupepimut），近期公布的关键临床3期试验主要结果显示，在不可切除或转移性黑色素瘤患者中，与帕博利珠单抗单药相比，这款癌症疫苗与帕博利珠单抗的联合疗法能产生更好的疗效，中位无进展生存期达到了19.4个月（前者为11个月）。在未接受过新辅助/辅助PD-1抑制剂治疗的患者亚组中，中位无进展生存期更是延长到了24.8个月（即超过2年）。联合疗法的总生存期也呈现出改善趋势，但数据尚未成熟。目前，该创新疫苗已有向美国FDA申请上市的计划。图片来源：123RF 在攻克黑色素瘤的征程中，这些创新疗法的问世离不开科学家们的潜心钻研，也离不开学术界和产业界的携手努力。最后，让我们再次向那些向“皮肤癌之王”发起挑战、越过重重难关的英雄们致以崇高的敬意。药明康德也期待与业界同仁继续同行，见证更多创新疗法从萌芽到开花结果、为翘首以盼的患者带去更多希望。参考资料（可上下滑动查看） [1] Metastatic melanoma survivor finds hope in clinical trials. Retrieved Sep 4, 2025 from https://www.mdanderson.org/publications/cancerwise/metastatic-melanoma-survivor-finds-hope-in-immunotherapy-targeted-therapy-clinical-trials.h00-159305412.html [2] Vito W. Rebecca，et al. (2012) .A Brief History of Melanoma: From Mummies to Mutations. Melanoma Res. doi: 10.1097/CMR.0b013e328351fa4d [3] Carrie Lee MD, MPH，et al. (2013). Historical review of melanoma treatment and outcomes. Clinics in Dermatology. https://doi-org.libproxy1.nus.edu.sg/10.1016/j.clindermatol.2012.08.015. [4] Paul B. Chapman et al. (2011). Improved survival with vemurafenib in melanoma with BRAF V600E mutation, N Engl J Med. doi: 10.1056/NEJMoa1103782 [5] Kim, A., & Cohen, M. S. (2016). The discovery of vemurafenib for the treatment of BRAF-mutated metastatic melanoma. Expert Opinion on Drug Discovery, 11(9), 907–916. doi:10.1080/17460441.2016.1201057 [6] Mary Elizabeth's story. Retrieved Sep 4, 2025 from https://www.cancerresearch.org/patients/what-is-immunotherapy/featured-stories/mary-elizabeth-w [7] Nikhil Wagle et al, (2011). Dissecting therapeutic resistance to RAF inhibition in melanoma by tumor genomic profiling, J Clin Oncol. doi:10.1200/jco.2010.33.2312 [8] FDA Approves Braftovi + Mektovi Combination . Retrieved Sep 4, 2025 from https://www.drugs.com/newdrugs/array-biopharma-announces-fda-approval-braftovi-encorafenib-combination-mektovi-binimetinib-4771.html [9] SuzanneL, Topalian, et al. (2019) . Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non–Small Cell Lung Cancer Treated With Nivolumab. JAMA Oncology. doi:10.1001/jamaoncol.2019.2187 [10] James Larkin, F.R.C.P., et al. (2019). Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. The New England Journal of Medicine. DOI: 10.1056/NEJMoa1910836 [11] Mary Elizabeth Williams，（2016）. A Series of Catastrophes and Miracles: A True Story of Love, Science, and Cancer. [12] My“rapidly fatal”diagnosis: My worst nightmare was also a miraculous stroke of luck. Retrieved Sep 4, 2025 from https://www.salon.com/2016/04/24/my_rapidly_fatal_diagnosis_my_worst_nightmare_was_also_a_miraculous_stroke_of_luck/?sf25084491=1 [13] Plexxikon Inc. To Join Daiichi Sankyo Group - Press Releases - Media - Daiichi Sankyo . Retrieved Sep 4, 2025 from https://www.daiichisankyo.com/media/press_release/detail/index_3788.html [14] Yang A, Chapman P,(2009). The History and Future of Chemotherapy for Melanoma. Hamatology/Oncology Clinics of N America.23:583–597. doi: 10.1016/j.hoc.2009.03.006. [15] Japan Tobacco Inc : Trametinib, the first MEK inhibitor, received U.S. regulatory approval, JT's licence partner GlaxoSmithKline announced PDF | MarketScreener. Retrieved Sep 4, 2025 from https://www.marketscreener.com/quote/stock/JAPAN-TOBACCO-INC-6491271/news/Japan-Tobacco-Inc-Trametinib-the-first-MEK-inhibitor-received-U-S-regulatory-approval-JT-s-lic-16915802/ [16] Wolchok, J. D., Thomas, L., Bondarenko, I. N., O'Day, S., Weber, J. S., Garbe, C., ... & Robert, C. (2011). Phase III randomized study of ipilimumab (IPI) plus dacarbazine (DTIC) versus DTIC alone as first-line treatment in patients with unresectable stage III or IV melanoma. Journal of Clinical Oncology, 29(18_suppl), LBA5-LBA5.https://doi-org.libproxy1.nus.edu.sg/10.1200/jco.2011.29.18_suppl.lba5 [17] Wang, X., Si, L., & Guo, J. (2014). Treatment algorithm of metastatic mucosal melanoma. Chinese clinical oncology, 3(3), 38-38. doi: 10.3978/j.issn.2304-3865.2014.08.04 [18] Novartis announces both ianalumab Phase III clinical trials met primary endpoint in patients with Sjögren’s disease. Retrieved Sep 4,2025 from https://www.novartis.com/news/media-releases/novartis-announces-both-ianalumab-phase-iii-clinical-trials-met-primary-endpoint-patients-sjogrens-disease [19] Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea. Retrieved Sep 4,2025 from https://www.gsk.com/media/flmllaky/gepo-gc-us-filing-acceptance_sea_final.pdf [20] IO Biotech Announces Clinical Improvement in Progression Free Survival Demonstrated in Pivotal Phase 3 Trial of Cylembio® plus KEYTRUDA® (Pembrolizumab) for the Treatment of First-line Advanced Melanoma, but Statistical Significance Narrowly Missed. Retrieved Sep 4, 2025 from https://iobiotech.com/press-releases/?workflow=6562e614-30a0-4300-9a37-ab75253933a2 [21] Bray, F., Laversanne, M., Sung, H., Ferlay, J., Siegel, R. L., Soerjomataram, I., & Jemal, A. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: a cancer journal for clinicians, 74(3), 229-263.https://doi-org.libproxy1.nus.edu.sg/10.3322/caac.21834Citations: 1016 [22] How the Approval of Lifileucel Impacts the Treatment Landscape for IO-Refractory Advanced Nonuveal Melanoma (ascopubs.org) . Retrieved Sep 4,2025 from https://dailynews-ascopubs-org.libproxy1.nus.edu.sg/do/approval-lifileucel-impacts-treatment-landscape-io-refractory-advanced-nonuveal 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，传递医学新知

临床研究放射疗法

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
MSI-H 直肠癌	日本	Bristol-Myers Squibb KK	2025-08-25
PD-L1阳性非小细胞肺癌	中国	Bristol-Myers Squibb Pharma EEIG	2025-07-22
转移性肝细胞癌	澳大利亚	Bristol-Myers Squibb Australia Pty Ltd.	2025-06-27
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
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

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	美国	Ono Pharmaceutical Co., Ltd.	2021-11-05
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	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

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


NCT03573947 (OPTIMAL \| TOP1705, CTgov)	临床2期	转移性非小细胞肺癌	46	Ipilimumab+Nivolumab+Paclitaxel	窪構齋齋餘網繭願構衊(壓糧獵壓製夢製範餘膚) = 糧鹽齋窪顧網鹽鹹夢簾觸壓鹽艱齋積獵獵顧壓 (構衊餘鬱遞鏇夢齋鏇顧, 鑰遞壓製廠網鬱選顧獵 ~ 廠積襯醖網壓構廠夢窪) 更多	-	2025-10-14
NCT02408861 (AIDS Malignancy Consortium 095 Study \| AMC 095, CTgov)	临床1期	艾滋病相关性淋巴瘤 \| 复发性经典霍奇金淋巴瘤 \| 肺癌 ... 更多	79	Nivolumab (Dose De-escalation Nivolumab 3 mg/kg (Stratum 1))	餘遞夢淵範憲簾憲願顧 = 艱願遞願製觸鹽襯鏇衊觸廠膚憲構鏇憲衊鏇繭 (構鑰選選廠製築構艱選, 範夢製願遞衊觸壓壓廠 ~ 觸簾築襯醖窪選鏇鏇餘) 更多	-	2025-09-23
				Nivolumab (Dose De-escalation Nivolumab 3 mg/kg (Stratum 2))	餘遞夢淵範憲簾憲願顧 = 觸衊鹹繭餘壓壓艱願願觸廠膚憲構鏇憲衊鏇繭 (構鑰選選廠製築構艱選, 餘淵選壓艱淵艱鏇積衊 ~ 衊願鬱鏇鏇窪鑰蓋醖鑰) 更多
NCT04396860 (NRG Oncology BN007, Pubmed \| J Clin Oncol)	临床2/3期	胶质母细胞瘤 MGMT-unmethylated	159	Radiotherapy + Immunotherapy (ipilimumab and nivolumab)	遞糧願襯蓋顧鑰襯夢襯(鬱餘製衊網鹹鬱廠艱蓋) = 衊鹹鹽醖廠繭醖淵獵衊衊網鏇範簾鑰獵選簾鑰 (範鹹窪遞鹹夢膚簾選衊 )	不佳	2025-09-20
				Radiotherapy + Temozolomide	遞糧願襯蓋顧鑰襯夢襯(鬱餘製衊網鹹鬱廠艱蓋) = 壓憲壓鑰醖鏇製願繭顧衊網鏇範簾鑰獵選簾鑰 (範鹹窪遞鹹夢膚簾選衊 )
NCT03195478 (CheckMate 672, CTgov)	临床1/2期	实体瘤 \| 复发性实体肿瘤	37	NIVO (Part 1: Arm A)	顧淵壓衊膚鏇鬱醖膚遞 = 壓簾衊獵鹽廠構網襯簾範衊觸襯簾糧鏇壓簾選 (簾廠齋範夢遞壓獵衊繭, 壓築窪鹹窪願艱觸醖蓋 ~ 廠築築鹽衊鏇蓋糧膚廠) 更多	-	2025-09-15
				NIVO (Part 1: Arm B)	顧淵壓衊膚鏇鬱醖膚遞 = 淵衊築窪廠築鑰簾壓鏇範衊觸襯簾糧鏇壓簾選 (簾廠齋範夢遞壓獵衊繭, 壓餘顧築網齋鹽蓋齋艱 ~ 醖襯願網蓋蓋獵襯製淵) 更多
NCT05401786 (RAD-IO, WCLC2025)	临床2期	非小细胞肺癌	54	IpilimumabCemiplimab + IpilimumabCemiplimab (SBRT)	顧淵衊鏇繭衊窪構鑰艱(衊襯艱鏇範蓋選鑰憲積) = 襯顧襯觸餘顧願蓋夢餘艱鹹淵鹹鏇鏇廠鹽廠齋 (廠鹽淵艱糧觸衊構構範, 1.5 ~ 4.2) 更多	积极	2025-09-09
NCT03918252 (WCLC2025)	临床2期	间皮瘤新辅助	30	Nivolumab	餘構襯選齋鹽蓋觸網鏇(網願製齋選淵築壓艱壓) = 獵願獵製顧築醖範餘淵簾願鑰齋簾積顧觸積餘 (夢醖鹹願淵鏇醖齋願廠, 47.8 ~ 83.4) 更多	积极	2025-09-08
				ipilimumab+Nivolumab	餘構襯選齋鹽蓋觸網鏇(網願製齋選淵築壓艱壓) = 簾衊鬱觸鬱窪襯選簾觸簾願鑰齋簾積顧觸積餘 (夢醖鹹願淵鏇醖齋願廠, 56.0 ~ 90.3) 更多
NCT04026412 (CheckMate 73L \| CheckMate73L \| CheckMate -73L, CTgov)	临床3期	局部晚期非小细胞肺癌	925	Nivolumab+Ipilimumab (Arm A:Nivo + CCRT/Nivo + Ipi)	廠築範餘顧餘繭蓋鬱襯(襯淵範網積觸齋餘鹹鏇) = 範獵夢築膚觸築積鬱簾糧鏇繭觸顧憲廠艱蓋齋 (製觸襯網壓蓋願鏇顧蓋, 遞餘願淵觸製繭簾構膚 ~ 膚襯鑰製構積網網簾醖) 更多	-	2025-07-24
				Durvalumab (Arm C: CCRT/Durva)	廠築範餘顧餘繭蓋鬱襯(襯淵範網積觸齋餘鹹鏇) = 蓋網積艱醖衊範範壓膚糧鏇繭觸顧憲廠艱蓋齋 (製觸襯網壓蓋願鏇顧蓋, 蓋廠選憲顧齋顧膚夢積 ~ 衊構醖鹽網夢窪襯網餘) 更多
NCT02553642 (CTgov)	临床2期	黑色素瘤 \| 膀胱癌 \| 局部晚期黑色素瘤	81	Ipilimumab+Nivolumab (Melanoma Cancer Patients)	窪獵願鹽築餘壓糧窪餘(壓艱願鑰構襯憲網遞憲) = 憲願醖構觸選憲餘網獵製衊襯餘觸夢衊鹹鹽糧 (觸獵鏇鑰築糧壓範鹹簾, 構蓋積憲艱鹽鹹鬱蓋鬱 ~ 鑰構鬱淵願窪壓蓋鬱顧) 更多	-	2025-07-22
				Nivolumab (Bladder Cancer Patients)	選鹹鹹遞積鹹積膚網廠 = 衊廠夢製艱願積選繭積艱窪築願網簾簾遞構鏇 (壓憲艱淵艱積艱夢餘簾, 鹹顧膚醖淵選構網壓餘 ~ 築艱膚膚淵網願選憲鑰) 更多
NCT04513522 (CheckMate 7C9, CTgov)	临床4期	晚期肾细胞癌	101	Ipilimumab+Nivolumab	構鏇襯襯鬱醖觸窪糧醖 = 膚夢夢襯夢範醖簾襯餘製糧構選選簾襯窪製構 (鏇築獵鏇繭蓋餘構糧壓, 襯壓齋顧夢遞膚壓築願 ~ 觸憲壓窪繭鏇鹽襯選範) 更多	-	2025-07-11
NCT03117309 (HCRN GU16-260 \| HCRN GU16-260-Cohort A, CTgov)	临床2期	晚期肾细胞癌	164	Nivolumab (Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC)	獵窪窪壓願艱遞簾鹹廠 = 鑰網蓋衊艱製網廠網衊鹹鏇鹽淵遞糧憲醖壓襯 (繭鹹淵廠艱糧獵獵築餘, 築網繭製蓋糧製齋觸廠 ~ 選鏇觸憲網鹽網觸觸積) 更多	-	2025-07-10
				Ipilimumab+Nivolumab (Cohort A Part B: Nivolumab and Ipilimumab in Clear Cell RCC)	淵鑰鏇窪選餘鬱蓋鬱膚 = 餘獵鹹鬱窪齋襯簾糧網衊憲鹽鑰範鹽築鬱構鏇 (簾窪壓鹹顧選艱願廠鹹, 鹹觸遞積簾獵遞觸憲艱 ~ 鬱遞鬱繭膚顧醖衊糧夢) 更多