Clear-Me is a biomarker-driven phase II study that tests whether the combination anti- lymphocyte-activation gene-3 (LAG3)/anti-programmed cell death protein 1(PD-1) inhibition Bristol-Myers Squibb (BMS986213) is superior to anti-PD-1 inhibition in patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) following definitive surgery for high risk melanoma. Patients will be allocated to either Arm A or Arm B via the process of randomization. The randomization process will be stratified according to stage (Stage 2A/2B/3A/3B/3C/3D or 4), to ensure absolute balance between stage groups. The investigators are choosing only 1 stratification factor, disease stage, as the investigators consider stage being the most significant prognosticating variable. Each stage represents a biologically distinct entity with varying recurrence rate outcomes. Block randomization will be performed to ensure equal sample sizes in the combination and monotherapy arms. At least 54 patients will be included in the randomized part of the study. The investigators are expecting approximately 20% of the patients to have detectable ctDNA after definite surgery. Therefore, approximately 270 patients are expected to be enrolled and tested for ctDNA in the entire study.

开始日期2026-02-27

申办/合作机构

University Health Network

NCT07223411

/ RecruitingN/AIIT

Dose-response Analysis of Nivolumab/Relatlimab in the Fixed-dosed Combination 'Opdualag' vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood for Participants With Unresectable or Metastatic Melanoma: A Corollary Study of HCC 24-056 (NCT06246916)

This translational study will examine the immune effector responses of patients who received a two-drug combination for first line therapy by examining tumor and peripheral blood of participants with unresectable locally advanced or metastatic melanoma.

开始日期2025-11-19

申办/合作机构

University of Pittsburgh

[+1]

NCT06624475

/ Recruiting临床2期IIT

Randomized Phase II Trial Neoadjuvant Opdualag Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma

This is a Phase 2 clinical trial with a 2:1 randomization comparing neoadjuvant Nivolumab + Relatlimab (Opdualag) vs neoadjuvant Nivolumab in patients with resectable high risk BCC (HR BCC)

开始日期2025-08-21

申办/合作机构

University of California San Diego

[+1]

100 项与纳武利尤单抗/瑞拉利单抗相关的临床结果

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100 项与纳武利尤单抗/瑞拉利单抗相关的转化医学

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100 项与纳武利尤单抗/瑞拉利单抗相关的专利（医药）

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项与纳武利尤单抗/瑞拉利单抗相关的文献（医药）

2025-10-01·EUROPEAN JOURNAL OF PHARMACOLOGY

Safety profile of nivolumab-relatlimab in cancer patients: a living pharmacovigilance study of clinical trials and postmarketing data (version 1.0)

Review

作者: Wu, Chengmi ; Zhou, Jingyi ; Wu, Qian ; Jiang, Jie ; Yang, Ziwen ; Zhu, Jianhong ; Li, Sha ; Wu, Junyan

In 2022, the FDA approved nivolumab-relatlimab for the treatment of unresectable or metastatic melanoma. In the present study, we conducted a living pharmacovigilance study, integrating data from clinical trials and the FDA Adverse Event Reporting System (FAERS) database, to assess the safety profile of nivolumab-relatlimab. Treatment related adverse events (TRAEs) in trials of nivolumab-relatlimab available in electronic databases were systematically searched. The outcomes included were all-grade (grades 1-5) and high-grade (grades 3-5) TRAEs, considering both overall and individual aspects. Meta-analysis was conducted to calculate the incidence and risk ratio of TRAEs associated with nivolumab-relatlimab. Certainty of evidence was assessed using the GRADE system. Adverse events reports were extracted from the FAERS database, and a disproportionality analysis was carried out to estimate the safety signals of AEs associated with nivolumab-relatlimab. A total of 12 trials were included, the incidence of all-grade and high-grade TRAEs for nivolumab-relatlimab was 74.11 % and 38.05 %, respectively. Compared with nivolumab monotherapy, therapy with nivolumab-relatlimab was associated with a significantly increased risk of high-grade TRAEs, and some individual specified all-grade TRAEs, including hypothyroidism/thyroiditis, rash, diarrhea/colitis, hepatitis, adrenal insufficiency, hypophysitis, arthralgia and myalgia. Disproportionality analyses of FAERS pharmacovigilance data identified 39 positive signals, with 18 AEs not mentioned in the drug label. Nivolumab-relatlimab showed significantly higher reporting frequencies for 15 AEs than nivolumab monotherapy. Our study provides valuable insights into the potential safety profile of nivolumab-relatlimab, the results of this living study will be updated to incorporate new, robust evidence as it becomes available.

2025-01-11·Gastroenterology Report

Single-cell transcriptomic landscape indicates the potential role of immunotherapy in metastatic pancreatic angiosarcoma

Article

作者: Yang, Yizhen ; Chen, Luohai ; Zeng, Zhirong ; Peng, Sui ; Xie, Yubin ; Liu, Man ; Lin, Xiaoxuan ; Chen, Minhu ; Zhang, Ning

Abstract:

Background:

Pancreatic angiosarcoma is a rare and highly aggressive tumor originating from lymphatic or vascular endothelial cells, with poor prognosis and few effective treatments. In this study, we aimed to characterize the tumor ecosystem of metastatic pancreatic angiosarcoma, along with its potential treatment strategies.

Methods:

Single-cell RNA-sequencing and bioinformatics analysis were performed on samples obtained from one patient, including at total of 16,841 cells from pancreatic angiosarcoma liver metastasis and adjacent normal liver tissue.

Results:

Pancreatic angiosarcoma cells exhibited marked upregulation of nuclear factor kappa-B (NF-κB), hypoxia-inducible factor 1 (HIF-1), and myelocytomatosis oncogene (MYC) proto-oncogene signaling pathways, while presenting limited upregulation of actionable therapeutic targets except for cyclin-dependent kinase 4 (CDK4) and epidermal growth factor receptor. Several immune checkpoint genes, including cytotoxic T-lymphocyte-associated protein 4 (CTLA4), lymphocyte-activation gene 3 (LAG3), programmed cell death protein 1 (PDCD1), and cluster of differentiation 86 (CD86), were upregulated in tumor-infiltrating T cells, natural killer (NK) cells, and myeloid cells. Furthermore, intercellular interaction profiling demonstrated enhanced activity of the programmed death-ligand 1 (PD-L1) and CD86 signaling pathways within the tumor microenvironment. The gene-set scores of T/NK-cell exhaustion, regulatory T cell, and macrophage angiogenesis were significantly higher in tumor tissues compared with adjacent normal tissues. However, the phagocytosis scores of macrophages within the tumor-infiltrating region were significantly lower than those in the adjacent normal tissues.

Conclusions:

Our findings outlined an immunosuppressive and angiogenic tumor ecosystem in pancreatic angiosarcoma liver metastasis, suggesting that pancreatic angiosarcoma may be insensitive to most targeted therapies. Conversely, immunotherapies targeting LAG3, PD-L1, and CD86 (e.g. isatuximab, Opdualag, and abatacept) and anti-angiogenic agents may be therapeutically effective and worthy of subsequent exploration.

2024-08-01·Melanoma research

Pseudoprogression in a patient with metastatic melanoma treated with PD-1 and LAG-3 inhibition

Article

作者: Tao, Jacqueline J. ; McDonnell, Diana ; Wu, Lawrence W. ; Izar, Benjamin

Pseudoprogression encapsulates a process of temporary radiographic growth followed by subsequent regression of metastatic melanoma lesions in response to immune checkpoint blockade (ICB), such as the combination of anti-programmed cell death protein 1 (PD-1) and anticytotoxic T-lymphocyte-associated antigen 4 therapy. This occurs in approximately 5–10% of ICB-treated patients, but has not yet been described in the context of novel combination therapies. Here, we report a case of an 89-year-old patient with metastatic melanoma to the liver, lung and lymph nodes, who underwent treatment with Opdualag (combining anti-PD-1 nivolumab and anti-lymphocyte-activation gene 3 relatlimab ICBs), and developed pseudoprogression after two cycles of therapy. The patient experienced a radiographic increase in liver metastatic lesion size, but was found to have a subsequent reduction in these lesions. The patient has been on therapy for 18 months without evidence of disease progression and continues to be clinically well-appearing.

241

项与纳武利尤单抗/瑞拉利单抗相关的新闻（医药）

2025-12-11

·生物制药小编

下一个要申报LAG-3

近日，Dr. Reddy’s Laboratories与Immutep达成合作协议，共同开发和商业化Immutep的 LAG-3 融合蛋白Eftilagimod Alfa（Efti）。据协议，Dr. Reddy’s将获得efti除北美、欧洲、日本和大中华区以外所有国家开发和商业化的独家权利，Immutep仍保有在全球范围内对efti的生产权利。为此，Immutep将获得Dr. Reddy’s支付的2000万美元预付款，以及有资格获得3.495亿美元的监管和商业里程碑付款，以及两位数的销售分成。下一个申报LAG-3吗？ Efti（IMP321）是一种可溶性二聚体重组蛋白，是首个进入临床试验的LAG-3融合蛋白，Efti可以与MHC class II 结合，介导APC活化。更早之前（2013年），该公司已将Efti在大中华区的开发和商业化权利授权给了亿腾医药。围绕Efti，Immutep开发了非小细胞肺癌、头颈癌、乳腺癌、软组织肉瘤等多个适应症。对于头颈癌，公司已经有上市计划。今年5月，公布的针对复发或转移性头颈部鳞状细胞癌（PD-L1 CPS<1）一线治疗的Ⅱb期临床TACTI-003显示，Efti+Keytruda在这一患者群体中取得了17.6个月中位总生存期，显著优于历史数据（已批准药物），公司已计划与FDA讨论针对该适应症的监管路径。目前，Efti针对非小细胞肺癌已经进入了Ⅲ期（TACTI-004）阶段，与Keytruda+化疗联用，作为晚期或转移性非小细胞肺癌的一线治疗方案，其疗效数据预计将在2026年第一季度公布。 LAG-3布局管线最多的公司 Immutep可以说是LAG-3 靶点“管线布局最多的公司，既开发了LAG-3的阻断剂，也开发了激动剂，适应症覆盖了肿瘤以及自身免疫病。包括Efti在内，Immutep曾经开发了四条LAG-3管线：IMP761、IMP701、IMP731。 IMP761是一种针对自身免疫病的LAG-3激动剂抗体，是除了Efti外，Immutep唯一还在自主推进的LAG-3管线。IMP761 IMP761主要是通过靶向活化T细胞表面LAG-3受体，促使更强的抑制信号传递到T细胞，进而阻止其继续在患者自身组织中增殖以及反应。目前，IMP761处于临床Ⅰ期阶段。今年6月，Immutep公布的Ⅰ期临床显示，最高剂量（0.9 mg/kg）组中，IMP761的安全性和耐受性良好，未出现治疗相关不良反应，10天的T细胞浸润抑制达80%。目前，公司正推进其剂量递增试验，更多数据预计2025年年底前公布。 MP701是一种针对肿瘤的LAG-3阻断性抗体，旨在用以阻断肿瘤浸润T细胞中LAG-3介导的抑制信号，以使CD8 T细胞更好的产生针对肿瘤细胞的细胞毒性反应。2012年，Immutep将其独家授权给了CoStim公司（CoStim2014年被诺华收购），现在由诺华全权负责其临床开发，目前已进展到临床II期。 IMP731也是一种LAG-3阻断性抗体，但是针对针对自身免疫性病，旨在杀死少量浸入自身免疫疾病部位的LAG-3活化的T细胞。2010年，Immutep将其全球独家权益授权给了GSK。不过这个项目在GSK手中进展并不顺利，近两年再未出现临床试验更新，且已经不在Immutep的管线当中了，基本处于搁置状态。总结 LAG-3是继CTLA-4、PD-1/L1后，第三个获批使用的免疫检查点抑制剂，目前唯一获批LAG-3靶向药仍是来自百时美施贵宝的Opdualag（LAG-3+PD-1联用组合）。 Eftilagimod是继Opdualag之外少有在临床中取得积极数据的LAG-3候选管线，如果能在黑色素瘤外的其他实体瘤中取得III期阳性结果，将进一步验证LAG-3作为PD-1强搭档的临床价值。参考出处： https://www.fiercebiotech.com/biotech/dr-reddys-pens-370m-pact-rights-immuteps-phase-3-stage-immunotherapy-certain-markets https://www.globenewswire.com/news-release/2025/12/08/3201497/0/en/Immutep-and-Dr-Reddy-s-enters-into-Strategic-Collaboration-for-Commercialisation-of-an-Innovative-Oncology-Drug-Eftilagimod-Alfa.html https://www.immutep.com/immutep-quarterly-activities-report-q4-fy25/

临床2期引进/卖出并购临床3期临床1期

2025-12-09

·证券之星

新股前瞻|布局TCE肿瘤疗法千亿蓝海，时迈药业能否博得市场青睐？

（原标题：新股前瞻|布局TCE肿瘤疗法千亿蓝海，时迈药业能否博得市场青睐？）近日，又一创新药企正式向港交所提交上市申请。根据港交所披露，浙江时迈药业股份有限公司-B(简称：时迈药业)已递交主板上市招股书，由华泰国际担任独家保荐人。在此之前，时迈药业已于2022年成功完成3.3亿元C轮融资，投后估值达到22.3亿元，吸引了包括贝达药业、贝加投资、温氏股份、杭州高新金投、浙商证券及迈百瑞等多家知名机构的参与。公开信息显示，时迈药业成立于2017年，作为下一代T细胞衔接器(TCE)疗法的先驱及全球领军企业，旨在利用并引导人体免疫系统对抗癌症的下一代免疫疗法，公司已开发下一代先锋疗法遮蔽型TCE，可在肿瘤中被选择性激活，用于治疗实体瘤。时迈药业此番冲刺资本市场，正值全球TCE赛道进入高速发展期。自2024年下半年以来，该领域交易热度持续攀升，国际巨头争相加码TCE赛道。在此背景下，作为一家专注于实体瘤TCE疗法、且具备多款全球前列临床管线的企业，时迈药业的上市进程亦自然备受瞩目。布局TCE疗法四款创新药物处于临床阶段智通财经APP了解到，时迈药业目前仍处于临床研发阶段，并无产品商业化。财务数据显示，2023年、2024年及2025年上半年，公司其他收入及收益分别为1464.9万元、661.8万元及227.8万元(人民币，下同)。招股书指出，时迈药业产生收益的金融资产为理财及结构性存款，各期末分别为2.16亿元、1.64亿元及6663.7万元，其中主要是结构性存款。同期，公司亏损及全面亏损总额分别为7494.3万元、5989.9万元、2542万元，，呈现逐年收窄趋势。相应期间，公司研发费用分别为7610.9万元、5338.2万元、2238.9万元，其中员工成本是研发开支的第二大构成，2025年上半年达到259.5万元。期末，时迈药业拥有研发人员31人，上半年人均月薪约1.4万元。在产品管线方面，时迈药业目前拥有四款自主研发的临床阶段创新候选药物，另外还有两款处于临床前阶段的下一代多功能�逻辑门控TCE候选药物CMDE101及CMDE102，它们分别是靶向FOLR1×PD-L1×CD3及PSMA×PD-L1×CD3的三特异性遮蔽型TCE。其中，DNV3是一款靶向LAG3的潜在同类最佳T细胞调节器(TCM)，也是时迈药业进展最快的药物，其对标的是百时美施贵宝已获批的LAG-3抗体疗法Opdualag。Opdualag于2022年获FDA批准，成为近十年来针对全新免疫检查点的首款肿瘤免疫疗法，2024年销售额达9.28亿美元，同比增长48%，显示出LAG-3靶点可观的商业化潜力。招股书显示，临床前及临床数据表明，DNV3具有逆转对PD-1/PD-L1抑制剂耐药性的潜力。在小鼠研究中，DNV3对T细胞及B细胞的结合能力明显高于现有可比疗法(对T细胞高出20%，对B细胞高出十倍以上)。此外，现有临床试验结果表明，DNV3与抗PD-1抗体及化疗的联合治疗于既往接受PD-(L)1抑制剂治疗的18名黏膜黑色素瘤患者中取得44.4%的客观缓解率(ORR)，根据公开可得数据，高于现有可比疗法约三倍;于皮肤黑色素瘤中，IIT及II期试验数据显示，采用相同联合疗法的12名皮肤黑色素瘤患者的客观缓解率为66.7%，根据公开可得数据，高于现有可比疗法5倍以上。公司已于2022年3月完成DNV3单药靶向治疗晚期�转移性实体瘤及淋巴瘤的I期临床试验，目前正开展DNV3联合抗PD-1抗体及化疗的靶向治疗局部晚期不可切除或转移性黑色素瘤的II期临床试验。根据弗若斯特沙利文的资料，截至最后实际可行日期，在治疗黑色素瘤的抗LAG-3抗体候选药物中，DNV3按临床开发阶段计在全球及中国均排名第二。目前中国尚未有抗LAG-3抗体药物获批，DNV3在此领域具备明显的先发优势。时迈药业的另一款候选药物SMET12是一款潜在同类首创静脉注射用EGFR×CD3TCE，适应症为表皮生长因子受体(EGFR)阳性晚期实体瘤，研发进度同样领先，在全球与中国同类候选药物中临床进展排名第一。SMET12已获得美国FDA的IND批准，目前处于IIa期临床试验阶段。此外，CMD011是一款潜在同类最佳的GPC3×CD3TCE，CMDE005是一款潜在同类首创EGFR×CD3下一代遮蔽型TCE，二者均已获得FDA的IND批准，并进入I期临床。CMD011在同类药物中排名全球前二，CMDE005则是中国首个且全球前二进入临床的采用遮蔽肽技术的TCE药物。招股书显示，公司的每一款候选药物均通过专门的研发平台开发，包括多通道抗体发现平台、H型双特异性TCE平台(H-BiTE平台)、蛋白酶激活型双特异性TCE平台(Pro-BiTE平台)以及多功能�逻辑门控TCE平台，共同构成了公司在TCE赛道中的核心竞争壁垒。千亿美元蓝海，TCE领域升温作为一种通过同时结合肿瘤细胞表面抗原与T细胞表面CD3分子、从而精准激活T细胞杀伤肿瘤的创新疗法，TCE兼具特异性强、可及性高、安全性好等多重优势。相比个性化、定制化的CAR-T疗法，TCE摆脱了个体化制备的高成本与复杂性;相对于抗体偶联药物(ADC)，TCE则避免了化疗载荷带来的细胞毒性风险，有望成为下一代肿瘤免疫治疗的重要方向。(TCE双抗原理示意图，图源招商证券)智通财经APP了解到，近年来全球生物医药领域对T细胞衔接器(Tcell-engager，TCE)的关注度显著提升，相关交易与合作持续升温。2024年以来，全球相关交易总额已突破85亿美元，安进、强生、艾伯维、默沙东、罗氏等国际巨头纷纷入局。其中，安进的CD19×CD3双抗Blincyto(贝林妥欧单抗)成为首个年销售额突破10亿美元的TCE药物，2024年销售额超过12亿美元，验证了该赛道的商业价值。市场规模方面，全球TCE药物市场已从2020年的4亿美元快速增长至2024年的30亿美元，年复合增长率达67.6%。据预测，到2030年市场规模有望升至475亿美元，2035年进一步突破1,200亿美元，市场增长动力强劲。然而，TCE赛道内部呈现明显的分化格局，各适应症领域“冷热不均”。与CAR-T类似，TCE的发展遵循从血液瘤向实体瘤、再向自免疾病延伸的路径。长期以来，TCE的应用主要局限于血液瘤领域，而血液瘤仅占癌症病例的不足10%，临床与市场空间相对有限;真正占据癌症90%以上的实体瘤，因存在实体瘤TAA靶向安全性、实体瘤淋巴细胞数量较少等诸多挑战，TCE研发进展缓慢。2024年5月，安进的塔拉妥单抗被FDA加速批准用于治疗三线小细胞肺癌，也成为首款治疗实体瘤的TCE药物，一时之间风头无两，使得市场对TCE实体瘤疗法的关注度大增。根据时迈药业招股书披露，当前仅有两款用于实体瘤的TCE药物获得全球批准，市场存在大量空白，这为具备相关布局能力的创新药企提供了结构性机遇。以时迈药业为例，其四款临床阶段药物中，除DNV3为T细胞调节器外，SMET12、CMD011及CMDE005三款均为针对实体瘤的TCE药物，展现出明确的差异化定位。在国内，TCE赛道参与者众多，据不完全统计，截至2025年11月，国内在研管线已超150条，但多数仍聚焦于血液瘤且处于研发早期阶段。实体瘤领域竞争相对稀少，已有泽�制药、康诺亚、维立志博等企业进行布局。其中，泽�制药的三抗疗法ZG006在早期临床中展现出优于同类国际疗法的缓解率，康诺亚通过多款TCE双抗产品的对外授权实现了资产价值提前变现，维立志博则采用“血液瘤打底、实体瘤突破、自免领域卡位”的三维策略，公司的LBL-033(MUC16xCD3)是全球第二款进入临床阶段的MUC16靶向TCE双抗，聚焦卵巢癌、宫颈癌等妇科实体瘤，填补了实体瘤MUC16靶点治疗的空白。值得关注的是，自身免疫疾病正成为TCE疗法下一个潜在的爆发点。与CAR-T相比，TCE可通过剂量调节更好控制细胞因子风暴(CRS)风险，且多数可开发为皮下给药，在长期用药安全性、便捷性与患者依从性方面具备明显优势。数据显示，全球已有20余款TCE药物开展自免相关临床研究，靶点组合类型主要集中在CD3×CD19、CD3×CD20、CD3×BCMA等。2024年8月，默沙东以13亿美元收购同润生物的CD3×CD19双抗CN201，体现出大药企对TCE在自免领域应用前景的认可。整体来看，在TCE赛道潜力逐渐显现的当下，时迈药业作为一家专注于实体瘤TCE疗法的创新药企，多款核心药物具备“同类最佳”潜力，且研发进度处于全球前列，市场同类竞争者较少，具备可观的长期商业化前景。与此同时，值得注意的是，公司产品管线均处于临床早中期，疗效与安全性有待大规模临床验证;作为一家高成长、高投入的生物医药企业，未来数年仍需持续高强度研发投入，未来现金流及融资能力或成为挑战。考虑到TCE赛道早期入场机遇，时迈药业不失为一家值得关注的投资标的。

免疫疗法细胞疗法财报临床研究

2025-12-03

·FierceBiotech

With site \'irregularities,\' Bristol Myers delays key Cobenfy readout in Alzheimer\'s psychosis

With a newly announced delay, Bristol Myers Squibb looks to finish 2025 without a much-needed comeback story for Cobenfy after another clinical setback this spring.\n The phase 3 comeback story Bristol Myers Squibb investors were eagerly anticipating is not to be—at least not this year.The highly anticipated Adept-2 study will not read out by year-end as previously planned after BMS identified “irregularities due to clinical trial execution at a small number of study sites,” the company said Wednesday.Adept-2 is one of three phase 3 trials in which BMS is testing its blockbuster hopeful Cobenfy in psychosis associated with Alzheimer’s disease.With the delay, BMS looks to finish 2025 without a much-needed comeback story for Cobenfy after another trial flop this spring for the drug as an adjunctive treatment for schizophrenia. More broadly, out of the six pivotal trials BMS has read out this year, only one success was booked on one of the dual primary endpoints in a multiple myeloma trial of iberdomide.Alzheimer’s psychosis is a large market, as BMS estimates about half of the 6 million U.S. patients with Alzheimer’s suffer from hallucinations and delusions.Investors have high expectations for Adept-2 “given the size of the market opportunity, need for momentum in the Cobenfy clinical trial launch, and recent setbacks with other late-stage programs at Bristol Myers,” William Blair analysts pointed out in a Dec. 3 note. Investors first got anxious about Adept-2 after executive comments made during BMS’ second-quarter earnings call in July. At that time, BMS’ then-chief medical officer Samit Hirawat, M.D., said the New Jersey pharma was conducting trial site reviews of Adept-2 as part of an effort to improve success for all BMS clinical programs.Now, with the reviews having identified “irregularities,” BMS has decided to exclude patient data from those sites. Following agreement with the FDA, an independent party conducted an interim data analysis of both efficacy and safety while BMS remained blinded to study data. At the recommendation of the data monitoring committee, BMS will start enrolling new patients into Adept-2, which is now expected to read out by the end of 2026. The company’s Adept-1 and Adept-4 trials are expected to read out by the end of next year as originally planned, the company said.Because BMS has said that at least two positive trials are required for a filing for approval, the Adept-2 delay alone does not impact the company’s original regulatory plan.While site irregularities and a delay might raise concerns, the William Blair team deemed the data monitoring committee’s recommendation to continue the trial as a positive sign, because, they wrote, “if there was no signal, why bother increasing enrollment?”The affected sites are located in the U.S., according to William Blair analysts who spoke with BMS’ investor relations team. The company is not disclosing the number of patients affected nor the exact nature of the irregularities, other than explaining that the situation involved a multitude of issues, according to William Blair. The study previously closed enrollment after reaching 400 patients, according to ClinicalTrials.gov.Those sites’ data will also be excluded from Adept-1 and -4 if they participated in those parallel Cobenfy studies, according to the analysts.“Our decision to exclude patient data from sites where irregularities were observed reflects our unwavering commitment to safeguarding the integrity of our studies,” Laura Gault, M.D, Ph.D., who heads up neuroscience drug development at BMS, said in a Dec. 3 statement. “Psychosis related to Alzheimer’s Disease remains an area of tremendous unmet medical need, and maintaining rigorous standards is essential as we work to identify innovative treatment options for patients and families affected by this devastating condition.” BMS needs several wins to instill confidence in its growth potential for 2030 and beyond. Besides Cobenfy’s flop as an adjunctive schizophrenia treatment, the company also recorded phase 3 failures this year for Opdualag, Camzyos, Reblozyl and, most recently, Johnson & Johnson-partnered factor XIa inhibitor milvexian.Hirawat stepped down amid the string of trial setbacks and was recently succeeded by AstraZeneca veteran Cristian Massacesi, M.D.

$With site \'irregularities,\' Bristol Myers delays key Cobenfy readout in Alzheimer\'s psychosis$

临床3期临床2期临床失败临床终止

100 项与纳武利尤单抗/瑞拉利单抗相关的药物交易

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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
转移性黑色素瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2022-09-15
转移性黑色素瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2022-09-15
转移性黑色素瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2022-09-15
转移性黑色素瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2022-09-15
不可切除的黑色素瘤	欧盟	Bristol-Myers Squibb Pharma EEIG	2022-09-15
不可切除的黑色素瘤	冰岛	Bristol-Myers Squibb Pharma EEIG	2022-09-15
不可切除的黑色素瘤	列支敦士登	Bristol-Myers Squibb Pharma EEIG	2022-09-15
不可切除的黑色素瘤	挪威	Bristol-Myers Squibb Pharma EEIG	2022-09-15
黑色素瘤	美国	Bristol Myers Squibb Co.	2022-03-18

未上市

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤	临床3期	美国	Bristol Myers Squibb Co.	2024-10-07
肿瘤	临床3期	日本	Bristol Myers Squibb Co.	2024-10-07
肿瘤	临床3期	阿根廷	Bristol Myers Squibb Co.	2024-10-07
肿瘤	临床3期	澳大利亚	Bristol Myers Squibb Co.	2024-10-07
肿瘤	临床3期	奥地利	Bristol Myers Squibb Co.	2024-10-07
肿瘤	临床3期	比利时	Bristol Myers Squibb Co.	2024-10-07
肿瘤	临床3期	巴西	Bristol Myers Squibb Co.	2024-10-07
肿瘤	临床3期	智利	Bristol Myers Squibb Co.	2024-10-07
肿瘤	临床3期	哥伦比亚	Bristol Myers Squibb Co.	2024-10-07
肿瘤	临床3期	丹麦	Bristol Myers Squibb Co.	2024-10-07

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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


NCT05002569 (RELATIVITY-098, Company_Website) 人工标引	临床3期	黑色素瘤辅助	-	Opdualag	顧願願製獵觸願網製鬱(衊鏇築淵簾繭膚鏇糧壓) = did not meet its primary endpoint. 製築繭糧願膚蓋築鏇鹽 (鹽構膚窪遞繭壓觸壓齋 ) 未达到	不佳	2025-02-13
				Opdivo
ESMO2024 人工标引	N/A	黑色素瘤二线 \| 一线 \| 新辅助	205	Nivolumab/Relatlimab	糧積齋顧醖齋選鑰構壓(襯窪壓膚鹹膚願襯廠範) = 積憲憲衊遞遞壓鏇鏇築壓觸繭繭構醖夢淵築艱 (鹽醖壓範淵膚醖鏇遞築 ) 更多	积极	2024-09-14
				Nivolumab/Relatlimab (subsequent line(C2))	糧積齋顧醖齋選鑰構壓(襯窪壓膚鹹膚願襯廠範) = 鬱獵壓憲廠製鑰夢鹹齋壓觸繭繭構醖夢淵築艱 (鹽醖壓範淵膚醖鏇遞築 ) 更多
NEWS 人工标引	临床2/3期	黑色素瘤	714	Opdualag	衊鹹憲鏇淵淵繭醖鹽膚(鬱顧獵襯鹹願繭窪淵繭) = 鹽餘簾積夢選憲獵鏇範膚構鏇糧膚鹽艱齋艱範 (壓選範餘鏇醖衊願顧齋 )	积极	2024-01-03
				nivolumab	衊鹹憲鏇淵淵繭醖鹽膚(鬱顧獵襯鹹願繭窪淵繭) = 艱夢襯構顧衊醖淵構衊膚構鏇糧膚鹽艱齋艱範 (壓選範餘鏇醖衊願顧齋 )
NCT03662659 (RELATIVITY-060, CTgov)	临床2期	胃食管交界处癌 \| 胃食管交界处腺癌	274	BMS986213 (BMS986213 + Chemotherapy)	壓繭選廠齋觸壓鏇餘夢 = 齋鹽繭膚憲網願鏇築壓鬱鹽廠蓋簾範觸糧窪廠 (膚願夢衊壓壓窪範鬱糧, 顧製鹽鏇網鹽顧製鏇餘 ~ 艱餘糧糧醖觸鹽積醖淵) 更多	-	2022-05-09
				Nivolumab (Nivolumab + Chemotherapy)	壓繭選廠齋觸壓鏇餘夢 = 構淵製範蓋壓鏇範憲壓鬱鹽廠蓋簾範觸糧窪廠 (膚願夢衊壓壓窪範鬱糧, 繭鏇憲鹽築簾廠膚齋積 ~ 顧繭鹹憲鹹觸糧膚膚醖) 更多