预约演示

更新于：2025-05-24

Ipilimumab

伊匹木单抗

更新于：2025-05-24

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伴有 11q23 异常的急性髓系白血病急性早幼粒细胞白血病+ [115]

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

+ [13]

非在研机构

Jonsson Comprehensive Cancer Center

Checkmate Pharmaceuticals, Inc.

Mayo Clinic

+ [11]

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

848

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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5,689

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 ; Lawless, Aleigha R. ; Curkovic, Nina B. ; 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.

1,344

项与伊匹木单抗相关的新闻（医药）

2025-05-23

·医学新视点

无需化疗，客观缓解率达62%，无进展生存期近14个月！JCO：双免疫疗法或为胃癌一线治疗新选择

食管胃结合部腺癌（AGC）是一类特殊的胃癌，近年来发病率明显上升，属临床重点关注的癌症类型。微卫星不稳定性（MSI）是指DNA错配修复功能出现异常，微卫星复制错误得不到纠正并不断累积，使微卫星序列长度或碱基组成改变。微卫星高度不稳定（MSI-H）晚期AGC是特殊的分子亚型，约占所有AGC的5%~6%，因其独特的免疫微环境和高突变负荷对免疫治疗高度敏感。近期，美国临床肿瘤学会（ASCO）旗下《临床肿瘤学杂志》（JCO）发表了NO LIMIT（WJOG13320G）的单臂2期研究，评估了在无化疗的基础上，将纳武利尤单抗联合低剂量伊匹木单抗作为MSI-H AGC一线治疗的疗效和安全性。研究结果显示，该治疗方案展示出持久的生存获益和抗肿瘤活性，客观缓解率（ORR）为62.1%，中位无进展生存期（PFS）为13.8个月，12个月总生存（OS）率为79.5%。截图来源：JCONO LIMIT是一项在日本开展的单臂、多中心2期研究，在2020年11月至2022年8月期间，共纳入29例经组织学证实的MSI-H AGC患者，患者平均年龄为75岁，女性占比55.2%。治疗方案为纳武利尤单抗（240 mg，每2周一次）联合低剂量伊匹木单抗（1 mg/kg，每6周一次），治疗期为24个月，或直至患者发生疾病进展或出现不可接受的毒副作用。主要研究终点为盲法独立中心评审（BICR）的ORR，关键次要终点包括疾病控制率（DCR）、PFS、OS及安全性。数据截止时，中位随访时间为9.0个月。在27例可评估的患者中，有24例患者肿瘤有所缩小。研究结果显示，BICR确认的ORR为62.1%（95%CI：42.3%~79.3%），其中完全缓解率为10.3%、部分缓解率为51.7%。DCR为79.3%（95%CI：60.3%~92.0%）。中位PFS为13.8个月（95% CI：13.7个月~未达到），12个月PFS为73.3%；中位OS数据尚在积累中，12个月OS率为79.5%。▲肿瘤较基线变化（A和B）、PFS（C）和OS（D）情况（图片来源：参考文献[2]）共有21例患者停止治疗，其中12例停止治疗的原因与治疗相关不良事件（TRAEs）有关，不过在排除1例疾病进展患者后，剩余11例患者在停止治疗后展现出长期抗肿瘤疗效，缓解持续时间范围达到了0.9~15.6个月。安全性方面，93.1%的患者出现了任何级别的TRAEs，其中3级及以上TRAEs发生率为37.9%，常见TRAEs为瘙痒、肺炎等。文章表示，这是作者团队所知的首个针对MSI-H AGC群体开展的纳武利尤单抗联合低剂量伊匹木单抗联合治疗前瞻性试验。该方案在无化疗的基础上，展现出令人满意的疗效，尽管有部分患者因TRAEs停药，但大多数患者在停药后仍能维持疗效。研究结果支持进一步探索双免疫疗法方案作为MSI-H AGC一线治疗策略。点击文末“阅读原文/Read more”，即可访问JCO官网阅读完整论文。推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料[1] Kawakami H, Kadowaki S, Makiyama A, et al. Phase II Study (NO LIMIT, WJOG13320G) of First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High Advanced Gastric or Esophagogastric Junction Cancer. J Clin Oncol. 2025 May 16:JCO2402463. doi: 10.1200/JCO-24-02463. [2] New Paper Alert: NO LIMIT Trial. First-Line Nivolumab Plus Low-Dose Ipilimumab in MSI-High Advanced Gastric and GEJ Cancer. Retrieved May 19, 2025. From https://oncodaily.com/opinion/nivolumab-ipilimumab-msi-h-gc-no-limit-trial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「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com分享，点赞，在看，传递医学新知

临床结果ASCO会议临床2期免疫疗法

2025-05-22

·精准药物

2025年4月国内外抗肿瘤药物获批情况一览

据公开资料显示，2025年4月，国家药品监督管理局（NMPA）及美国食品药品监督管理局（FDA）批准了多个重要药物的新适应症，涵盖了非小细胞肺癌、乳腺癌、结直肠癌、肝细胞癌、鼻咽癌等多种恶性肿瘤，其中FDA批准新适应症4条，NMPA批准新适应症7条。详细4月获批上市药物及药物新获批适应症见下文。1Part.1新药速递（概括版）2Part.2新药速递（详细版）1. 纳武利尤单抗+伊匹木单抗/商品名：欧狄沃+逸沃通用名：纳武利尤单抗+伊匹木单抗适应症：不可切除或转移性MSI-H或dMMR CRC成人和≥12 岁儿童患者临床试验：CheckMate 8HW研发公司：百时美施贵宝获批日期：2025.04.08批准机构：FDA2025年4月8日，FDA批准纳武利尤单抗+伊匹木单抗用于治疗患有不可切除或转移性MSI-H或dMMR CRC成人和 ≥12岁儿童患者。同时，FDA还将纳武利尤单抗单药针对接受过氟尿嘧啶、奥沙利铂和伊立替康治疗后进展的MSI-H/dMMR转移性CRC成人和≥12岁儿童患者的加速批准转为常规批准。该适应症获批是基于CheckMate 8HW研究（NCT04008030）。这是一项随机、三臂、开放标签研究，入组了既往未接受免疫治疗的MSI-H/dMMR不可切除或转移性CRC患者。患者以 2:2:1的比例随机接受以下方案之一：①每三周接受 240mg纳武利尤单抗和1mg/kg伊匹木单抗治疗，最多4次，然后每四周接受480mg纳武利尤单抗维持治疗；②每两周接受240mg纳武利尤单抗，共6 次，然后每四周接受480mg纳武利尤单抗维持治疗；③研究者选择的化疗方案。主要疗效结果指标是盲法独立中央审查（BICR）确认的无进展生存期（PFS），根据RECIST v1.1标准通过对以下预先指定的集中确认MSI-H/dMMR状态的患者进行评估：①一线治疗：纳武利尤单抗+伊匹木单抗 vs. 化疗；②全线治疗：纳武利尤单抗+伊匹木单抗 vs. 纳武利尤单抗单药。CheckMate 8HW研究一线疗效数据一线治疗研究结果显示，双免组的中位PFS尚未达到（NR），而化疗组仅为5.8个月，双免方案将疾病进展或死亡风险显著降低79%（风险比（HR）：0.21；95%CI：0.14-0.32；p< 0.0001）。这是首次在III期研究中证实双免疫联合疗法对比标准化疗在MSI-H/dMMR mCRC一线治疗中可为患者带来显著临床获益，展现了双免方案巨大的临床应用潜力。CheckMate 8HW研究全线疗效数据双免方案和纳武利尤单抗单药的全线治疗对比结果显示，中位PFS分别是NR vs. 39.3 个月，双免方案将疾病进展或死亡风险降低 38%（HR：0.62，95%CI：0.48-0.81，p= 0.0003）。双免组的客观缓解率（ORR）也得到显著提升，两组分别为 71% vs. 58%（p = 0.0011）。2. 拉罗替尼/商品名：维泰凯、Vitrakvi通用名：拉罗替尼、Larotrectinib适应症：NTRK融合实体瘤临床试验：LOXO-TRK-14001/SCOUT/NAVIGATE原研公司：拜耳获批日期：2025.04.09（完全批准）批准机构：FDA2025年4月9日，FDA完全批准拉罗替尼用于治疗患有以下实体瘤的成人和儿童患者：肿瘤具有神经营养性受体酪氨酸激酶（NTRK）基因融合，且无已知的获得性耐药突变；肿瘤为转移性或手术切除可能导致严重发病；且无令人满意的替代治疗方案，或在治疗后疾病进展。本次批准基于三项多中心、开放标签、单臂临床试验的数据：LOXO-TRK-14001（NCT02122913）、SCOUT（NCT02637687）和NAVIGATE（NCT02576431）。该分析纳入了339名患有不可切除或转移性实体瘤并伴有NTRK基因融合的儿童和成人患者。所有患者都要求在全身治疗后疾病进展（如果适用），或者对于局部晚期疾病需要进行可能导致严重发病的手术治疗。主要疗效指标是由独立盲法审查委员会（BIRC）根据RECIST v1.1确定的总缓解率和缓解持续时间（DoR）。在这三项试验中，共评估了444名患者的安全性。拉罗替尼3项研究疗效汇总数据汇总的疗效结果显示，总缓解率为60%（95%CI: 55%-65%），完全缓解率（CR）为24%，部分缓解率（PR）为36%，中位DoR为43.3个月（95%CI: 32.5-NE（不可评估））。拉罗替尼治疗不同肿瘤类型的疗效数据3. 纳武利尤单抗+伊匹木单抗/商品名：欧狄沃+逸沃通用名：纳武利尤单抗+伊匹木单抗适应症：不可切除或晚期HCC成人患者的一线治疗临床试验：CheckMate-9DW研发公司：百时美施贵宝获批日期：2025.04.11批准机构：FDA2025年4月11日，FDA批准纳武利尤单抗联合伊匹木单抗用于不可切除或转移性肝细胞癌（HCC）成人患者的一线治疗。本次批准主要基于CHECKMATE-9DW（NCT04039607）试验。CHECKMATE-9DW试验是一项随机、开放标签的多中心试验，共纳入668例不可切除或转移性HCC成人患者。患者需经组织学确诊为HCC、Child-Pugh A级、ECOG体能状态评分0或1分，且未接受过针对晚期疾病的系统性治疗。患者被随机（1:1）分配接受以下两种方案之一：纳武利尤单抗1mg/kg联合伊匹木单抗3mg/kg静脉输注（ivgtt，q3w，最多4次），随后单用纳武利尤单抗480mg（ivgtt，q4w）；或研究者选择的仑伐替尼或索拉非尼治疗。研究的主要疗效终点为所有随机患者的总生存期（OS），次要终点为BICR基于RECIST v1.1标准评估的总缓解率。CHECKMATE-9DW研究疗效数据结果显示，联合治疗组的中位OS为23.7个月，而仑伐替尼或索拉非尼组为20.6个月（HR：0.79，95%CI：0.65-0.96；p=0.018）。联合治疗组的总缓解率为36.1%（95%CI：31.0%-41.5%），显著高于对照组的13.2%（95%CI：9.8%-17.3%；p<0.0001）。CHECKMATE-9DW研究总生存期数据安全性分析显示，最常见（>20%）的不良反应包括皮疹、瘙痒、乏力和腹泻。4. 卡匹色替/商品名：荃科得、Truqap通用名：卡匹色替、Capivasertib适应症：HR+/HER2-并携带PIK3CA/AKT1/PTEN变异的乳腺癌临床试验：CAPItello-291原研公司：阿斯利康获批日期：2025.04.15获批机构：NMPA2025年04月15日，NMPA批准卡匹色替联合氟维司群用于转移性阶段至少接受过一种内分泌治疗后疾病进展，或在辅助治疗期间或完成辅助治疗后12个月内复发的HR+、HER2-且伴有一种或多种PIK3CA/AKT1/PTEN改变的局部晚期或转移性乳腺癌成人患者。该药品上市为患者提供了新的治疗选择。本次获批主要是基于CAPItello-291研究全球队列的研究结果，及其在2023欧洲肿瘤内科学会亚洲年会（ESMO Asia）上公布的中国队列的积极结果。CAPItello-291研究是一项全球多中心、双盲、随机的III期临床试验，该研究旨在评估卡匹色替联合氟维司群对比安慰剂联合氟维司群治疗局部晚期（不可手术）或转移性HR+/HER2低表达或阴性乳腺癌的安全性和有效性。研究招募了708例经组织学证实为HR+/HER2低表达或阴性乳腺癌的患者，试验的主要终点为总体人群和携带PIK3CA/AKT1/PTEN突变患者亚组的PFS。在研究中，约40%的患者有PI3K/AKT/PTEN突变。结果表明，与安慰剂联合氟维司群相比，卡匹色替联合氟维司群的PFS具有统计学意义和临床意义的改善。在总体人群中，卡匹色替组和安慰剂组的中位PFS分别为7.2个月 vs. 3.6个月，与安慰剂组相比，卡匹色替组疾病进展或死亡风险降低40%。在PI3K/AKT/PTEN突变的亚组中，中位PFS分别为7.3个月 vs. 3.1个月，同时与安慰剂组相比，卡匹色替组疾病进展或死亡风险降低50%。在是否存在肝转移或既往是否接受过CDK4/6抑制剂治疗亚组中，卡匹色替组的HR均具有优势。在次要终点方面，在总体人群中，ORR为22.9% vs. 12.2%；在PI3K/AKT/PTEN突变的人群中，ORR为26% vs. 8%。CAPItello-291研究疗效数据CAPItello-291研究中国队列研究结果显示，在中国患者总人群中，与安慰剂相比，卡匹色替联合氟维司群取得了具有统计学显著性和临床意义的PFS改善（6.9 个月 vs. 2.8 个月，HR：0.51）；PIK3CA/AKT1/PTEN变异的中国患者中，卡匹色替联合氟维司群组的PFS也具有临床意义的显著改善（5.7 个月 vs. 1.9 个月，HR：0.41）。卡匹色替联合氟维司群在中国人群中的安全性与全球人群基本一致。CAPItello-291研究亚洲人群疗效数据5. 纳武利尤单抗/商品名：欧狄沃通用名：纳武利尤单抗适应症：联合化疗作为新辅助治疗，术后作为单药辅助治疗，用于治疗可手术切除且无已知EGFR突变或ALK重排的NSCLC临床试验：CheckMate-77T研发公司：百时美施贵宝获批日期：2025.04.22批准机构：NMPA2025年4月22日，NMPA批准纳武利尤单抗联合含铂化疗作为新辅助治疗，术后继续以纳武利尤单抗作为单药辅助治疗，用于治疗可手术切除的II、IIIA和IIIB期且无已知EGFR突变或ALK重排的成人NSCLC患者。该获批是基于一项全球III期随机对照研究（CheckMate-77T，NCT04025879），旨在评估纳武利尤单抗联合含铂双药化疗作为新辅助治疗、序贯手术和纳武利尤单抗单药辅助治疗，对比新辅助化疗联合安慰剂，序贯手术和安慰剂辅助治疗，用于可切除NSCLC患者的疗效。CheckMate-77T研究疗效数据研究主要终点结果显示，对比围术期化疗及安慰剂组，纳武利尤单抗组可显著降低42%疾病复发、进展或死亡风险（无事件生存期（EFS）HR：0.58，p=0.00025）。次要终点方面，纳武利尤单抗方案组25.3%的患者实现了病理完全缓解（pCR，即手术切除的原发灶和淋巴结标本中均未发现存活肿瘤细胞），而化疗组仅为4.7%。研究中，纳武利尤单抗方案的安全性可控，未发现新的不良反应信号。CheckMate-77T研究中国患者亚组疗效数据此外，针对中国患者的亚组分析显示，纳武利尤单抗方案在中国患者中具有一致的获益和安全性，可降低60%疾病复发、进展或死亡风险（EFS HR：0.40），pCR率为35.1%（化疗组为3.2%）。此次获批后，纳武利尤单抗已在中国获批4项早期肿瘤适应症，包括围术期、新辅助和辅助治疗，覆盖肺癌、食管癌、尿路上皮癌，位居所有PD-1抑制剂首位。纳武利尤单抗也是目前唯一在中国获批两项可切除NSCLC适应症的免疫治疗药物，覆盖围术期与单纯新辅助治疗。6. 派安普利单抗/商品名：安尼可通用名：派安普利单抗、Penpulimab适应症：联合化疗用于NPC一线治疗；单药用于NPC后线治疗临床试验：AK105-304（一线）/AK105-202（后线）原研公司：康方生物/正大天晴获批日期：2025.04.24获批机构：FDA2025年4月24日，FDA宣布批准派安普利单抗两项适应症，分别为：联合顺铂或卡铂和吉西他滨用于复发或转移性非角化性鼻咽癌（NPC）成人患者的一线治疗；单药治疗成人转移性非角化性NPC，这些患者在铂基化疗和至少一种其他先前治疗期间或之后出现疾病进展。AK105-304（NCT04974398）研究评估了派安普利单抗联合顺铂或卡铂和吉西他滨的疗效，这是一项随机、双盲、多中心III期临床试验，在291例复发或转移性鼻咽癌患者中进行，这些患者之前没有接受过复发或转移性疾病的全身化疗。主要疗效指标是PFS，由盲法独立审查委员会根据RECIST v1.1进行评估。派安普利单抗组的中位PFS为9.6个月，安慰剂组的中位PFS为7.0个月。OS结果尚未成熟。AK105-304研究疗效数据AK105-202研究评估了单药派安普利单抗的疗效，这是一项开放标签、多中心、单组试验。该试验共纳入125例不可切除或转移性非角化性鼻咽癌患者，这些患者在铂类化疗和至少一种其他治疗后出现疾病进展。主要疗效指标是ORR和DoR，根据独立放射学审查委员会评估的RECIST v1.1。ORR为28%，中位DoR未达到。AK105-202研究疗效数据此前，派安普利单抗已在中国获批4项适应症，分别为联合化疗一线治疗局部晚期或转移鳞状NSCLC，至少经过二线系统化疗复发或难治性经典型霍奇金淋巴瘤，以及接受过二线及以上系统治疗失败的复发/转移性NPC、联合化疗一线治疗复发或转移NPC。7. 利厄替尼/商品名：奥壹新通用名：利厄替尼、Limertinib适应症：一线治疗EGFR 19del或L858R突变的NSCLC临床试验：ASK-LC-120067-F-III原研公司：信达生物、奥赛康药业获批日期：2025.04.22获批机构：NMPA2025年04月22日，NMPA批准利厄替尼片用于具有EGFR 19del或L858R的局部晚期或转移性NSCLC成人患者的一线治疗。利厄替尼（limertinib，ASK120067）是一款具有全新分子实体、活性显著的口服的第三代EGFR-TKI。利厄替尼于 2025年1月首次在国内获批上市，用于既往经EGFR-TKI 治疗时或治疗后出现疾病进展，并且经检测确认存在 EGFR T790M突变阳性的局部晚期或转移性NSCLC成人患者的治疗。根据信达生物官微显示，此次新适应症获批是基于一项随机、双盲、阳性对照III期临床研究（NCT04143607，ASK-LC-120067-F-III）的积极结果。该研究共纳入337例未经系统性治疗的EGFR敏感突变阳性局部晚期或转移性NSCLC患者，按1:1比例随机接受利厄替尼或吉非替尼治疗。主要研究终点是独立审评委员会（IRC）评估的PFS。结果显示，与吉非替尼相比，利厄替尼显著延长了初治EGFR敏感突变阳性局部晚期或转移性NSCLC患者的中位PFS（20.7个月vs. 9.7个月），疾病进展或死亡风险显著降低56%（HR：0.44；95%CI: 0.34-0.58；p＜0.0001）。在中枢神经系统（CNS）存在可测量病灶患者中，与吉非替尼相比，利厄替尼显著延长了中位CNS PFS（20.7个月vs. 7.1个月），疾病进展或死亡风险降低高达72%(HR：0.28；95%CI：0.10-0.82；p=0.0136)，显示对于脑转移患者具有突出的疗效。利厄替尼主要不良反应为EGFR靶点常见不良反应，患者耐受性较好，试验未观察到新的安全性信号。8. 依沃西单抗/商品名：依达方通用名：依沃西单抗、Ivonescimab适应症：一线治疗PD-L1表达阳性的EGFR基因突变阴性和ALK阴性NSCLC临床试验：HARMONi-2原研公司：康方生物获批日期：2025.04.22获批机构：NMPA2025年04月22日，NMPA批准依沃西单抗单药用于PD-L1 表达阳性（PD-L1 TPS≥1%）的EGFR基因突变阴性和ALK阴性的局部晚期或转移性NSCLC的一线治疗。这是继其EGFR-TKI耐药适应症获批后，依沃西单抗在中国斩获的第二个重要适应症。依沃西单抗是一款PD-1/VEGF双特异性抗体。2024年5 月，依沃西单抗首次在国内获批上市，适应症为联合培美曲塞和卡铂用于经EGFR-TKI治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞状NSCLC患者的二线治疗。本次批准主要基于HARMONi-2研究（NCT05499390）。HARMONi-2研究是一项随机、双盲、对照III期临床试验，对比了依沃西单抗与帕博利珠单抗在PD-L1 TPS ≥1%（E1L3N抗体）的驱动基因阴性NSCLC患者中的疗效和安全性。HARMONi-2研究疗效数据研究数据显示，与帕博利珠单抗单药治疗相比，依沃西单抗显著延长了患者的无进展生存期（mPFS: 11.1个月 vs. 5.8个月；HR：0.51；95%CI: 0.38-0.69；p<0.0001），降低了49%疾病进展或死亡风险，提高了患者的客观缓解率（ORR：50.0% vs. 39%）和疾病控制率（DCR：90% vs. 71%）。HARMONi-2研究PFS数据亚组分析进一步显示，无论患者的PD-L1表达高（≥50%）或低（1%-49%），依沃西单抗在鳞状和非鳞状肺癌患者中均表现出较优的疗效，HR分别为0.48和0.54。此外，依沃西单抗分别在鳞癌、非鳞癌患者中，以及存在肝转移、脑转移的患者中均展现了较优的疗效。在安全性方面，依沃西单抗组的总体安全性良好，未出现新的安全性信号。9. 特瑞普利单抗/商品名：拓益、Loqtorzi通用名：特瑞普利单抗、Toripalimab适应症：一线治疗不可切除或转移性黑色素瘤临床试验：MELATORCH原研公司：君实生物获批日期：2025.04.22获批机构：NMPA2025年04月22日，NMPA批准特瑞普利单抗用于不可切除或转移性黑色素瘤一线治疗。本次适应症获批使其成为首个覆盖晚期黑色素瘤一线免疫治疗的国产PD-1单抗。本次新适应证获批主要基于2024年CSCO大会上首发的MELATORCH研究（NCT03430297）数据。结果显示，相较于达卡巴嗪组（N=128），特瑞普利单抗组（N=127）基于盲态独立中心阅片（BICR）评估的PFS显著延长，两组中位PFS分别为2.3个月和2.1个月，疾病进展或死亡风险降低29.2%（HR：0.708，95%CI: 0.526-0.954；p=0.0209）；研究者评估的PFS也显示出一致的获益，中位PFS分别为2.4 vs. 2.1个月，HR：0.673（95%CI：0.508-0.891）。无论基于BICR还是研究者的评估结果，特瑞普利单抗组的ORR均高于达卡巴嗪组，且DoR较达卡巴嗪组显示出明显的延长趋势。与达卡巴嗪相比，特瑞普利单抗治疗组显示出明显的生存获益趋势。61.2%的达卡巴嗪组患者接受了特瑞普利单抗交叉治疗，两阶段法矫正交叉治疗后结果显示特瑞普利单抗组的OS较达卡巴嗪组明显获益，中位OS分别为15.1 vs. 9.4个月（HR：0.680；95%CI：0.486-0.951）。特瑞普利单抗的安全性良好，与既往研究一致，未发现新的安全信号。MELATORCH研究PFS数据特瑞普利单抗作为我国批准上市的首个国产PD-1单抗，已在国内获批12项适应症，包括黑色素瘤、鼻咽癌、尿路上皮癌/膀胱癌、食管鳞癌、非鳞状NSCLC、NSCLC、肾细胞癌、小细胞肺癌、三阴性乳腺癌、肝癌等适应症。10. 阿昔替尼+特瑞普利单抗/商品名：英立达+拓益通用名：阿昔替尼+特瑞普利单抗适应症：一线治疗中高危的不可切除或转移性RCC临床试验：RENOTORCH原研公司：辉瑞制药/君实生物获批日期：2025.04.22获批机构：NMPA2025年04月22日，NMPA批准阿昔替尼联合特瑞普利单抗用于中高危的不可切除或转移性肾细胞癌（RCC）患者的一线治疗。本次获批是基于一项多中心、随机、开放、阳性药对照的III期临床研究RENOTORCH（NCT04394975）。该研究共纳入421例中高危、不可切除或转移性RCC患者，按照1：1比例随机分配至特瑞普利单抗联合阿昔替尼组（n=210）或舒尼替尼组（n=211）接受治疗。主要研究终点为IRC评估的PFS。IRC评估的研究结果显示，与舒尼替尼单药治疗相比，接受特瑞普利单抗联合阿昔替尼治疗可显著延长患者的PFS（IRC评估：18.0个月 vs. 9.8个月），疾病进展或死亡风险降低35%（HR=0.65）。此外，特瑞普利单抗联合组的ORR更优（56.7% vs. 30.8%），DoR更长（未达到 vs. 16.7个月），具有明显的OS获益趋势（未达到 vs. 26.8个月）。安全性方面，特瑞普利单抗联合阿昔替尼的安全性和耐受性良好，未发现新的安全性信号。RENOTORCH研究经IRC评估的PFS数据RENOTORCH研究经IRC评估的疗效数据11.埃万妥单抗/商品名：锐珂、RYBREVANT通用名：埃万妥单抗、Amivantamab适应症：联合化疗用于EGFR 19del/L858R突变且经EGFR-TKI治疗进展的非鳞状NSCLC临床试验：MARIPOSA-2原研公司：强生获批日期：2025.04.22获批机构：NMPA2025年04月22日，NMPA批准埃万妥单抗与卡铂和培美曲塞联合用于治疗携带EGFR19del/L858R突变且在EGFR-TKI治疗期间或之后疾病进展的局部晚期或转移性非鳞状NSCLC成人患者。埃万妥单抗是一款全人源双特异性抗体，同时针对EGFR和MET两个靶点。这是埃万妥单抗今年在中国获批的第二个肺癌适应症，此前，埃万妥单抗已于今年2月获批用于治疗携带EGFR 20号外显子插入突变的局部晚期或转移性NSCLC成人患者的一线治疗。本次获批是基于MARIPOSA-2研究。MARIPOSA-2研究是一项随机、开放标签、多中心试验，旨在评估埃万妥单抗联合策略治疗奥希替尼耐药后NSCLC的疗效及安全性。结果显示，与单独化疗组相比，埃万妥单抗联合化疗可将疾病进展或死亡风险降低52%，中位PFS为6.3个月，而单独化疗组为4.2个月（HR：0.48；95%CI：0.36-0.64；p<0.001）。MARIPOSA-2研究PFS数据针对亚洲亚组人群的分析结果显示，中位随访9.5个月时，埃万妥单抗联合化疗组患者的疾病进展或死亡风险降低了46%（HR：0.54；95%CI：0.37-0.81；p=0.002），埃万妥单抗联合化疗组和化疗组的中位PFS为6.8 vs. 4.2个月，与总体人群相当。埃万妥单抗联合化疗组的ORR为66%（95%CI：53-78），化疗组为32%（95%CI：24-41）（比值比，4.04；95%CI：2.13-7.67；p<0.001）。埃万妥单抗联合化疗组的中位颅内PFS为12.45个月，化疗组为8.5个月（HR：0.58；95%CI：0.34-1.00；p=0.049）。MARIPOSA-2研究亚洲人群疗效数据在安全性方面，亚洲患者的AE发生率与MARIPOSA-2总体人群的相似。埃万妥单抗联合化疗组中最常见的TEAE是中性粒细胞减少和血小板减少，但持续时间短暂、严重程度较轻，主要发生在第1周期，与中性粒细胞减少性发热和出血并发症的发生率有关。声明：发表/转载本文仅仅是出于传播信息的需要，并不意味着代表本公众号观点或证实其内容的真实性。据此内容作出的任何判断，后果自负。若有侵权，告知必删！长按关注本公众号粉丝群/投稿/授权/广告等请联系公众号助手觉得本文好看，请点这里↓

临床结果临床3期免疫疗法上市批准

2025-05-22

·GlobeNewswire-Health Care

Replimune Reports Fiscal Fourth Quarter and Year End 2025 Financial Results and Provides Corporate Update

• BLA priority review of RP1 plus nivolumab in advanced melanoma proceeding on schedule; manufacturing inspections and late cycle review meeting complete • Full commercial infrastructure for launch in place ahead of July 22nd PDUFA date • Conference call today at 8:00 AM ET WOBURN, Mass., May 22, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal fourth quarter and year ended March 31, 2025 and provided a business update. “As we near our PDUFA date, our commercial organization is now fully hired and ready to execute our first launch in advanced melanoma,” said Sushil Patel, Ph.D., CEO of Replimune. “We have a deep understanding of the market landscape, prescriber adoption and referral patterns, and a launch plan optimized for intra-tumoral delivery across all customer segments. We believe the opportunity for RP1 to help improve the lives of patients with advanced melanoma is significant. We estimate approximately 13,000 patients progress on or after PD-1 treatment annually in the U.S. with approximately 80% of these patients eligible for treatment with RP1. Importantly, these treatments will take place in the outpatient setting and not require hospitalization. We look forward to further discussing our commercial plans for RP1 and pipeline development for RP1 and RP2 at an investor day on June 24th.” Program Highlights & Milestones RP1 (vusolimogene oderparepvec) RP1 combined with Opdivo® (nivolumab) in anti-PD1 failed melanoma The FDA recently completed their late-cycle review and manufacturing inspections for the biologics license application, which remains on schedule ahead of a July 22, 2025 PDUFA date.The FDA has indicated no advisory committee is planned.The Company completed the build out of its commercial infrastructure, including the hiring and training of customer-facing teams. Distribution channels have been established and are ready to receive product, pending approval, and key state licensing is in place.Enrollment is ongoing in the confirmatory Phase 3 trial, IGNYTE-3, with over 100 sites planned globally. This trial is expected to enroll 400 patients and is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The primary endpoint of this trial is overall survival and key secondary endpoints are progression free survival and overall response rate. RP2 RP2 in uveal melanoma The registration-directed REVEAL trial of RP2 in metastatic uveal melanoma is currently enrolling. The clinical trial is expected to enroll approximately 280 patients with metastatic uveal melanoma who are immune checkpoint inhibitor-naïve and evaluate RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. RP2 in hepatocellular carcinoma (HCC) The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD1/PD-L1 progressed HCC is currently enrolling. The clinical trial will evaluate RP2 combined with the second-line therapy of atezolizumab and bevacizumab and is expected to enroll 30 patients. The trial is being conducted under a collaboration and supply agreement with Roche. Upcoming Events American Society of Clinical Oncology (ASCO) 2025 Annual Meeting being held May 30-June 3, 2025: Poster: Response analysis for injected and non-injected lesions and the safety and efficacy of superficial and deep/visceral RP1 injection in the registrational cohort of anti-PD-1 failed melanoma patients of the IGNYTE trialPoster: Biosafety analysis from the skin cancer cohorts in the IGNYTE clinical trial of RP1Poster: A randomized, controlled, multicenter, phase 3 study of vusolimogene oderparepvec combined with nivolumab vs. treatment of physician’s choice in patients with advanced melanoma that has progressed on anti-PD-1 and anti-CTLA-4 therapy (IGNYTE-3)Poster: A randomized, phase 2/3 clinical trial investigating RP2 plus nivolumab vs. ipilimumab plus nivolumab in immune checkpoint inhibitor-naïve patients with metastatic uveal melanomaAdditional poster from an investigator sponsored trial: A phase 1/2 study of vusolimogene oderparepvec (RP1) in primary melanoma (mel) to reduce the risk of sentinel lymph node (SLN) metastasis. Fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 5, 2025 at 4:20 PM ETReplimune to host an Investor Day on Tuesday, June 24, 2025 at 10:00 AM ET Financial Highlights Cash Position: As of March 31, 2025, cash, cash equivalents and short-term investments were $483.8 million, as compared to $420.7 million as of fiscal year ended March 31, 2024. The increase in cash balance was a result of the public offering in November 2024, somewhat offset by cash utilized in operating activities in advancing the Company’s clinical development plans.Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of March 31, 2025 will enable the Company to fund operations into the fourth quarter of 2026 which includes scale up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue. R&D Expenses: Research and development expenses were $54.0 million for the fiscal fourth quarter and $189.4 million for the fiscal year ended March 31, 2025, as compared to $42.6 million for the fiscal fourth quarter and $175.0 million for the fiscal year ended March 31, 2024. This increase was primarily due to an increase in personnel-related costs as we scaled operations in preparation for commercial launch of RP1, as well as consulting and facility-related costs. Research and development expenses included $4.5 million in stock-based compensation expenses for the fiscal fourth quarter and $18.4 million for the fiscal year ended March 31, 2025.S,G&A Expenses: Selling, general and administrative expenses were $25.4 million for the fiscal fourth quarter and $72.2 million for the fiscal year ended March 31, 2025, as compared to $16.2 million for the fiscal fourth quarter and $59.8 million for the fiscal year ended March 31, 2024. Selling, general and administrative expenses included $3.8 million in stock-based compensation expenses for the fiscal fourth quarter and $16.6 million for the fiscal year ended March 31, 2025. Net Loss: Net loss was $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025, as compared to a net loss of $55.1 million for the fiscal fourth quarter and $215.8 million for the fiscal ended March 31, 2024. Conference Call In connection with this announcement, Replimune will host a conference call and webcast at 8:00 AM ET today. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the Company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time. About RP1 RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response. About RP2 RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity. About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. Forward Looking StatementsThis press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about our cash runway, the status of the FDA review in advance of our scheduled PDUFA date, the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the regulatory review process and timing of potential product approval, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues and the Russian-Ukrainian and Israel-Hamas political and military conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor InquiriesChris BrinzeyICR Healthcare339.970.2843chris.brinzey@icrhealthcare.com Media InquiriesArleen GoldenbergReplimune917.548.1582 media@replimune.com Replimune Group, Inc.Condensed Consolidated Statements of Operations(Amounts in thousands, except share and per share amounts)(Audited) March 31, 2025 2024 Operating expenses: Research and development$189,447 $174,963 General and administrative$72,180 $59,810 Total operating expenses 261,627 234,773 Loss from operations (261,627) (234,773)Other income (expense): Research and development incentives 1,773 1,920 Investment income 21,120 23,356 Interest expense on finance lease liability (2,118) (2,163)Interest expense on debt obligations (5,775) (4,497)Other (expense) income (202) 771 Total other income (expense), net 14,798 19,387 Loss before income taxes$(246,829) $(215,386)Income tax provision$468 $408 Net loss$(247,297) $(215,794)Net loss per common share, basic and diluted$(3.07) $(3.24)Weighted average common shares outstanding, basic and diluted 80,564,147 66,569,894 Replimune Group, Inc.Condensed Consolidated Balance Sheets(Amounts In thousands, except share and per share amounts)(Audited) March 31,2025 March 31,2024 (in thousands)Consolidated Balance Sheet Data: Cash, cash equivalents and short-term investments$483,804 $420,668 Working capital 433,518 393,229 Total assets 551,328 487,722 Total stockholders' equity 415,843 374,508

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D04603	伊匹木单抗	L01XC11	DB06186

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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

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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	選網網餘壓鹹願鹽艱鑰(網蓋鏇醖鹹網觸糧衊顧) = 鹽網積憲簾夢積醖夢遞範遞艱鑰鏇醖顧獵築顧 (繭艱齋構獵餘製網壓願, 18.8 ~ 29.4) 更多	积极	2025-05-01
				Lenvatinib or sorafenib	選網網餘壓鹹願鹽艱鑰(網蓋鏇醖鹹網觸糧衊顧) = 網願齋築夢觸衊積構鏇範遞艱鑰鏇醖顧獵築顧 (繭艱齋構獵餘製網壓願, 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	範簾觸膚廠壓繭積鏇窪 = 醖憲鑰艱齋鬱夢醖鏇網廠窪築窪艱窪夢窪鏇夢 (夢選醖窪鏇憲鬱鬱壓糧, 觸構遞憲蓋願艱繭遞夢 ~ 積製壓積蓋夢蓋壓淵夢) 更多	-	2025-04-03
ESMO_ELCC2025	N/A	恶性间皮瘤一线	399	Ipilimumab plus Nivolumab	鹽鹽鏇襯願遞艱鹽觸鬱(齋齋廠繭膚蓋糧網築壓) = required in over half (53%) of TRAEs 繭憲獵選醖獵觸顧膚製 (鹽網壓製遞窪齋襯鏇醖 ) 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	範餘窪製顧觸鬱壓襯築(艱憲醖築鏇襯蓋糧積醖) = 窪築繭簾選膚遞鑰遞餘襯鑰遞醖膚顧鹽築糧選 (壓糧糧廠襯鏇範鬱鑰製 ) 更多	积极	2025-03-26
NCT03377023 (CTgov)	临床1/2期	转移性非小细胞肺癌	66	Ipilimumab+Nivolumab+Nintedanib (Phase 1-Dose Escalation)	選憲壓齋獵餘膚鏇選遞 = 艱網繭願齋廠齋夢鑰鏇襯廠鹽衊夢鏇築齋網構 (鏇鹹積鏇簾顧選餘願壓, 鹹鹹簾鬱憲製糧願膚簾 ~ 範淵鑰廠糧窪簾製壓鏇)	-	2025-03-25
				ipilimumab+Nivolumab+Nintedanib (Phase 2 - Arm A)	鏇壓醖鹹夢鑰築鬱繭壓 = 糧顧鏇壓餘蓋範築膚範淵網築網醖膚網鏇餘製 (築構構選鬱餘鬱築範齋, 製選網製遞淵構鹽鏇選 ~ 積選鹹築醖遞鏇遞構鏇) 更多
NCT02488759 (CheckMate 358, Pubmed \| J Clin Oncol)	临床1/2期	转移性Merkel细胞癌	-	Nivolumab	廠鬱獵憲構夢糧鹽鏇顧(遞憲鬱願廠鹽鏇淵範構) = 觸憲願構願鏇鹹餘鹹顧膚餘齋醖鑰範積淵獵顧 (鹹襯醖觸網壓淵鹽衊製, 38.7 ~ 78.9) 更多	不佳	2025-03-20
				Nivolumab + Ipilimumab	廠鬱獵憲構夢糧鹽鏇顧(遞憲鬱願廠鹽鏇淵範構) = 窪鏇壓廠蓋膚襯淵齋憲膚餘齋醖鑰範積淵獵顧 (鹹襯醖觸網壓淵鹽衊製, 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)	蓋選範醖憲淵膚齋築蓋 = 窪餘艱鹽選壓鬱壓窪蓋製糧顧築醖積餘糧顧鏇 (簾糧範糧簾繭獵窪醖觸, 淵憲網餘糧齋窪鑰鏇簾 ~ 網齋積範襯鹽鑰網膚艱) 更多	-	2025-03-11
				Ipilimumab+Nivolumab (Arm 2: Nivolumab Plus Ipilimumab)	蓋選範醖憲淵膚齋築蓋 = 壓膚蓋蓋艱衊簾網觸積製糧顧築醖積餘糧顧鏇 (簾糧範糧簾繭獵窪醖觸, 廠憲構窪齋壓夢蓋獵壓 ~ 繭鏇製餘窪繭繭窪艱簾) 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)	衊鏇構襯糧蓋網獵膚淵 = 鏇繭衊獵鹹構選壓顧憲鑰遞糧鑰鬱製範襯憲範 (衊廠糧膚構鏇壓艱鏇獵, 簾衊構餘壓簾構衊蓋窪 ~ 鏇鹽糧構壓範範鬱顧觸) 更多	-	2025-03-05
				Ipilimumab+Nivolumab (Arm B - Nivolumab + Ipilimumab)	衊鏇構襯糧蓋網獵膚淵 = 醖觸憲憲淵窪網積膚餘鑰遞糧鑰鬱製範襯憲範 (衊廠糧膚構鏇壓艱鏇獵, 鹹醖鹹網齋築獵夢鹽選 ~ 醖網鏇淵齋夢鑰窪衊襯) 更多
NCT04134182 (ASCO_GU2025) 人工标引	临床2期	肾细胞癌	8	Nivolumab + Ipilimumab	壓構夢窪選襯築鹹鑰繭(廠廠積鹹觸窪鬱鬱鹽齋) = 鹽鏇構築製鑰糧鏇膚憲築衊獵夢獵鹹繭膚觸蓋 (鬱夢衊壓構積簾範築夢 ) 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	齋糧顧襯鏇鹽願簾窪鑰(膚襯壓壓餘鏇憲築壓構) = 鏇憲製鏇鹽膚壓簾齋艱鹹鏇餘鏇鑰繭淵鑰齋選 (壓壓醖廠製繭鬱醖鹹壓, 82 ~ 93) 更多	积极	2025-02-13
				Fewer Than Four Doses of IPI + NIVO	齋糧顧襯鏇鹽願簾窪鑰(膚襯壓壓餘鏇憲築壓構) = 餘鏇構膚鑰餘繭簾夢膚鹹鏇餘鏇鑰繭淵鑰齋選 (壓壓醖廠製繭鬱醖鹹壓, 72 ~ 94) 更多