A Phase 1, Open-Label Window-of-Opportunity Study to Assess the Pharmacokinetics, Pharmacodynamics and Central Nervous System (CNS) Penetration of Xevinapant in Preoperative Subjects With Recurrent High-Grade Glioma (rHGG)

Researchers will investigate the ability of Xevinapant to cross the blood-brain barrier and exert anti-tumor effects on rHGG through activation of apoptosis. Researchers hypothesize that oral administration of Xevinapant has acceptable safety and tolerability in patients with recurrent HGG and demonstrate pharmacokinetic and pharmacodynamic effects in HGG tumors. To that end, Researchers will engage in a phase I "window of opportunity" translational clinical trial in patients undergoing a clinically-indicated craniotomy for resection of recurrent tumors to evaluate the impact of treatment on rHGG.

开始日期2024-07-22

申办/合作机构

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

[+1]

NCT06084845

/ Withdrawn临床2期IIT

Phase II Trial of Xevinapant and Chemoradiotherapy in Adjuvant Treatment for Patients With Head and Neck Squamous Cell Carcinoma With High Risk Pathologic Features

This phase II trial compares the effect of usual radiation therapy with cisplatin/carboplatin (chemoradiation) to the addition of xevinapant with chemoradiation in patients with head and neck cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Xevinapant is a first-in-class antagonist of inhibitor of apoptosis (programmed cell death) proteins (IAPs), which leads to tumor cell death and enhances tumor cell sensitivity to chemotherapy and radiotherapy. Giving xevinapant with chemoradiation may be more effective in preventing head and neck cancer from growing or spreading than chemoradiation alone.

开始日期2024-04-12

申办/合作机构

ECOG-ACRIN Medical Research Foundation, Inc.

[+1]

NCT06110195

/ Active, not recruiting临床1期IIT

A Phase I Study of Xevinapant With Radiation and Concurrent Carboplatin and Paclitaxel in Patients Ineligible for Cisplatin With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck

The goal of this clinical trial is to determine the best safe dose of xevinapant that can be given in combination with chemotherapy and radiation in patients with head and neck cancer. Up to 4 doses of xevinapant will be tested in the dose escalation portion of the study. After the best safe dose is found during escalation, an additional group of participants will be enrolled at that dose to learn more about the treatment combination (dose expansion).
The main question[s] it aims to answer are:
* what is the maximum safe dose that can be given
* what dose should be used in subsequent (phase 2) trials
Participants will receive xevinapant in combination with paclitaxel and carboplatin chemotherapy and radiation. Treatment will be given in 3-week cycles for 3 cycles.

开始日期2024-01-24

申办/合作机构

The University of Chicago

[+1]

100 项与 Xevinapant 相关的临床结果

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100 项与 Xevinapant 相关的转化医学

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100 项与 Xevinapant 相关的专利（医药）

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255

项与 Xevinapant 相关的文献（医药）

2025-11-01·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

IFN-γ enhances Poly(I:C)-induced necroptosis and immunogenic cell death via TLR3 upregulation in cholangiocarcinoma cells

Article

作者: Sae-Fung, Apiwit ; Lomphithak, Thanpisit ; Jitkaew, Siriporn ; Duangthim, Nattaya

Cholangiocarcinoma (CCA), a heterogeneous tumor arising in the bile ducts, is associated with unfavorable prognosis and high mortality rates due to limited effective treatment options. Though promising, immunotherapy is hindered by CCA's desmoplastic tumor microenvironment, known for its inflammatory and immunosuppressive characteristics, often termed a "cold tumor". Previously, we reported that Poly(I:C), a TLR3 agonist, synergizes with a Smac mimetic, an IAP antagonist, to trigger necroptosis when caspase activity is blocked. In this study, we aimed to evaluate rational combination strategies to advance Poly(I:C)-based necroptosis immunotherapy in preclinical models. Transcriptomic analysis of public CCA patient datasets revealed that low expression of TLR3, accompanied by low IFNG or IRF1 expression, is significantly associated with poorer prognosis. These findings highlight the clinical relevance of the IFN-γ/IRF1/TLR3 axis and support the development of therapies targeting this pathway. We further found that IFN-γ treatment increases TLR3 expression. Importantly, we demonstrated that IFN-γ could enhance Poly(I:C)-induced necroptosis and immunogenic cell death (ICD) when IAPs and caspases are inhibited by Smac mimetic and the pan-caspase inhibitor Z-VAD-FMK in human CCA cell lines. CU-CPT 4a, a highly selective TLR3 inhibitor, partially reduced this cell death. This indicates that the effect is mediated in part through TLR3. The combined effects were shown to depend on RIPK1/RIPK3/MLKL-induced necroptosis. Additionally, the dying cells released HMGB1, a marker of ICD, and their conditioned medium promoted dendritic cell maturation (CD80, CD86, HLA-DR), which is critical for antigen presentation and T-cell priming. From a personalized medicine perspective, TLR3, IFNG, and IRF1 expression levels may serve as predictive biomarkers to guide patient selection for TLR3 agonist-based therapies. These findings could advance TLR3 ligand, Poly(I:C)-based necroptosis cancer immunotherapy, alone or with immune checkpoint inhibitors, for CCA and possibly other cancers.

2025-11-01·Cancer research communications

Xevinapant plus Chemoradiotherapy Negatively Sculpts the Tumor-Immune Microenvironment in Head and Neck Cancer

Article

作者: Harrington, Kevin J. ; Gifford, Valentina ; Tenev, Tencho ; Ono, Masahiro ; Chan Wah Hak, Charleen ; Kyula-Currie, Joan N. ; Foo, Shane ; Hubbard, Lisa C. ; Patin, Emmanuel C. ; Wongariyapak, Amarin ; Appleton, Elizabeth S. ; Baldock, Holly ; Nicastri, Annalisa ; Pedersen, Malin ; Patrikeev, Anton ; Rullan, Antonio ; Kozik, Zuza ; Choudhary, Jyoti S. ; Roulstone, Victoria ; Melcher, Alan A.

Abstract:

Xevinapant is an orally bioavailable antagonist of select members of the inhibitor of apoptosis protein family. Despite promising phase II data, combining xevinapant with chemoradiotherapy (CRT) failed to improve outcomes in the phase III TrilynX trial when combined with CRT for locally advanced head and neck squamous cell cancer (SCCHN). In immunocompetent mouse models of SCCHN, xevinapant plus CRT maintained or improved locoregional control but in a CD8+ T cell–independent manner. On addition of xevinapant to CRT, the numbers of tumor-infiltrating cytotoxic CD8+ T cells and NK cells were reduced, with remaining CD8+ T cells characterized by PD-1hi CD38hi expression and Nr4a3 dynamics consistent with nonresponsiveness to antigenic restimulation. Furthermore, combination treatment significantly downregulated gene expression associated with immune-related pathways, increased levels of immunodysregulatory acute-phase proteins, and decreased levels of necroptosis mediator receptor-interacting protein kinase 3. Overall, xevinapant plus CRT has an immunosuppressive effect on the tumor-immune microenvironment, which may explain its lack of clinical benefit.

Significance::

Despite hugely promising randomized phase II study data, combined CRT plus xevinapant failed in the TrilynX phase III clinical trial in locally advanced SCCHN. We show that adding xevinapant to chemoradiotherapy in vivo dysregulates antitumor lymphocyte function, acute-phase proteins, and cell death pathways, with net immunosuppressive effects on the tumor-immune microenvironment.

2025-10-10·JOURNAL OF CLINICAL ONCOLOGY

Xevinapant or Placebo Plus Platinum-Based Chemoradiotherapy in Unresected Locally Advanced Squamous Cell Carcinoma of the Head and Neck (TrilynX): A Randomized, Phase III Study

Article

作者: Tao, Yungan ; Ha, Ngoc-Thuy ; Sukari, Ammar ; Licitra, Lisa F. ; Burtness, Barbara ; Bourhis, Jean ; Tahara, Makoto ; Psyrri, Amanda ; Matitashvili, Amiran ; Tiscoski, Katsuki Arima ; Haddad, Robert ; Salas, Sebastien ; Schroeder, Andreas ; Cohen, Ezra E.W. ; Harrington, Kevin ; Schoenfeld, Jonathan D. ; Rutkowski, Tomasz ; Scheerlinck, Rudi ; Nauwelaerts, Heidi ; Rodriguez-Gutierrez, Almudena

PURPOSE:

TrilynX was a randomized, double-blind, phase III study evaluating the addition of xevinapant (an inhibitor of apoptosis proteins inhibitor) or placebo to chemoradiotherapy (CRT) in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).

METHODS:

Patients with unresected LA SCCHN (oropharynx [p16-negative only], hypopharynx, or larynx) were randomly assigned 1:1 to six cycles of oral xevinapant 200 mg/day or matched placebo (once daily on Days 1-14 of a 21-day cycle) plus CRT for the first three cycles (cisplatin [100 mg/m 2 once on Day 2 of every cycle] plus intensity-modulated radiotherapy [70 Gy; 35 fractions of 2 Gy/day, 5 days/week]). The primary end point was event-free survival (EFS) assessed by the blinded independent review committee. Progression-free survival, overall survival (OS), and safety were secondary end points.

RESULTS:

Between September 20, 2020, and February 27, 2023, 730 patients were randomly assigned to xevinapant plus CRT (n = 364) or placebo plus CRT (n = 366). The median (95% CI) EFS was 19.4 months (14.5 to not estimable) with xevinapant and 33.1 months (21.0 to not estimable) with placebo (hazard ratio [HR], 1.33 [95% CI, 1.05 to 1.67]; P = .9919). OS was worse in the xevinapant arm (HR, 1.39 [95% CI, 1.04 to 1.86]). Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 320 (87.9%; xevinapant) and 286 (80.3%; placebo) patients; anemia (78 [21.4%] v 51 [14.3%]) and neutropenia (71 [19.5%] v 69 [19.4%]) were the most common. Serious TEAEs occurred in 194 (53.3%; xevinapant) and 129 (36.2%; placebo) patients. TEAEs leading to death occurred in 22 (6.0%; xevinapant) and 13 (3.7%; placebo) patients.

CONCLUSION:

Xevinapant plus CRT did not improve EFS (EFS was shorter with xevinapant v placebo) and demonstrated an unfavorable safety profile versus placebo plus CRT in patients with unresected LA SCCHN.

125

项与 Xevinapant 相关的新闻（医药）

2025-11-21

·药化猩球

十问十答DrugHunter月度分子：成功与挑战并存

首先，向 @drughunter 的精心整理和人在药途公众号的无私分享表示最诚挚的感谢与崇高的敬意。正是基于这些高质量、专业化的资料，我们得以构建一个深入的分析框架。深度解析：2025年10月小分子药物的机遇与挑战本次分析将借助 Gemini Pro 3.0 的强大能力，对2025年10月在小分子药物领域涌现的创新研究和临床数据进行一次全面而深刻的解读。 Q1：Lanifibranor和Xevinapant，它们分别是做什么的？ A1：Lanifibranor (泛-PPAR激动剂) 是一种 Pan-PPAR激动剂，意味着它能同时激活PPARα、PPARδ和PPARγ这三种过氧化物酶体增殖物激活受体。这使得它在代谢性疾病，尤其是MASH（非酒精性脂肪性肝炎）的治疗中具有多靶点优势。Xevinapant (IAP抑制剂) 是一种 IAP（凋亡抑制蛋白）抑制剂。IAP家族蛋白参与细胞凋亡的调控，抑制它们可以促进癌细胞凋亡，从而发挥抗肿瘤作用。它主要被开发用于肿瘤治疗。 Q2：为什么说Lanifibranor是“同类最佳”策略的精准优化？ A2：从图2中可以看到，Lanifibranor的开发路径被描述为“同类最佳策略的精准优化”。这主要是因为：多靶点优势：它作为泛-PPAR激动剂，结合了PPARα/δ激动剂Elafibranor（已失败的RESOLVE-IT试验）和PPARγ激动剂的优势，全面调控代谢、炎症和纤维化。吸取教训： Lanifibranor在开发过程中，吸取了Elabrifanor失败的教训（图1中提到Elabrifanor因MASH缓解未达显著性、安慰剂反应率高而失败），通过优化结构和作用机制，力求实现更好的疗效。成功进展：它已顺利完成NATIV3试验的主要入组（N=1009），并观察到体重增加稳定在24-36周后趋于平稳的关键发现（图1）。未来可期：预计2026年上半年初将公布结果，并且拥有2043年前的专利保护，市场前景广阔（图2）。 Q3：Lanifibranor目前的临床试验进展如何？有何亮点？ A3： Lanifibranor目前正在进行 NATIV3 (Phase III) 试验，主要用于治疗MASH（代谢功能障碍相关脂肪性肝炎）和F2/F3纤维化患者。主要亮点包括：已完成主要队列入组，总人数达到1009人（图1）。在24-36周后体重增加趋于平稳，这是一个非常积极的信号，表明其可能具有良好的安全性（图1）。结果预计在2026年上半年初公布（图1），业界充满期待。 Q4：Xevinapant的开发路径为何被描述为“首创策略”的高风险博弈？ A4： Xevinapant的开发路径被称为“首创策略”的高风险博弈，这暗示了其机制的创新性及随之而来的不确定性：创新机制： IAP抑制剂是相对较新的抗肿瘤策略，缺乏成熟的成功案例，这意味着其药效和安全性需要大量探索（图2）。高风险与回报： “首创”往往意味着更高的研发投入、更长的研发周期以及更大的失败风险。但一旦成功，也可能带来巨大的市场回报。 Q5：Xevinapant主要用于治疗什么疾病？临床试验结果如何？ A5： Xevinapant主要用于治疗局部晚期头颈部鳞状细胞癌 (LA-SCCHN)。根据图1，它与CRT（联合放化疗）进行III期临床试验 (NCT04459715)。然而，关键试验结果显示：未能改善无事件生存期 (EFS)。安全性/疗效结果不佳 (unfavorable safety profile)。 Q6：Xevinapant的安全性数据令人担忧吗？ A6：是的，从图2的“II/III期试验安全性对比 (TrilynX)”中可以看出，Xevinapant的安全性数据不容乐观：严重不良事件 (Serious TEAEs)：在Xevinapant + CRT组中，有53.3%的患者出现严重不良事件，显著高于单纯CRT组的36.2%。导致死亡的不良事件 (TEAEs leading to Death)：在Xevinapant + CRT组中，有6.0%的患者因不良事件死亡，也高于单纯CRT组的3.7%。这些数据表明Xevinapant可能具有较高的毒性，这也是导致其开发中止的关键因素。 Q7：Xevinapant最终的开发命运如何？ A7：非常遗憾，鉴于不佳的临床试验结果和安全性数据，默克集团 (Merck KGaA) 已决定停止开发 (cancellation of multiple trials) Xevinapant（图1）。这标志着这款“首创策略”的分子在商业化道路上遭遇了重大挫折。 Q8：Elafibranor在MASH治疗中扮演了什么角色？它的失败对Lanifibranor有何启示？ A8： Elafibranor (GFT505, PPAR-α/δ激动剂) 在MASH领域进行过开发，但其RESOLVE-IT (Phase III) 试验最终失败。失败原因主要归结于MASH缓解未达显著性，以及安慰剂反应率较高（15%）（图1）。 Elafibranor的失败对Lanifibranor有着重要的启示，促使后者在分子设计和临床策略上进行优化，比如通过泛-PPAR激动机制，寻求更全面的疗效，并可能在入组患者选择、剂量等方面吸取经验，以避免重蹈覆辙（图2）。 Q9：从这两个分子的命运，我们可以学到哪些药物开发经验？ A9：这两个分子的案例为我们提供了宝贵的药物开发经验：精准靶点与多靶点策略： Lanifibranor的成功进展表明，多靶点、协同作用的药物（如泛-PPAR激动剂）可能在复杂疾病（如MASH）中展现出优势。安全性是基石： Xevinapant的失败再次强调了药物安全性在临床开发中的决定性作用。即使疗效潜力巨大，但安全性问题足以导致项目中止。 “首创”与“同类最佳”： “首创”策略（Xevinapant）虽然充满创新潜力，但也伴随着更高的风险；而“同类最佳”策略（Lanifibranor）则是在现有认知基础上进行优化，风险相对较低，成功率更高。从失败中学习： Elafibranor的失败为Lanifibranor的开发提供了宝贵经验，避免了同样的错误。药物研发是一个不断试错、学习和改进的过程。 Q10：展望未来，MASH和肿瘤领域未来的药物开发趋势会是怎样？ A10： MASH领域：随着Lanifibranor的积极进展，MASH治疗有望迎来突破。未来可能会出现更多靶向多种通路（如代谢、炎症、纤维化）的联合疗法或多靶点药物。同时，精准诊断和患者分层也将变得更加重要，以提高临床试验的成功率和药物疗效。肿瘤领域：尽管Xevinapant失败，但肿瘤治疗仍是创新热点。未来趋势将继续集中在：免疫疗法：更多的免疫检查点抑制剂、细胞疗法等。靶向疗法：基于基因组学和分子特征的精准治疗。抗体偶联药物 (ADCs)：将抗体特异性和化疗药物毒性结合。小分子抑制剂：不断探索新的靶点和克服耐药性。联合治疗：不同机制药物的联合应用以提高疗效和克服耐药。总而言之，药物开发之路充满挑战与机遇。Lanifibranor和Xevinapant的故事，再次提醒我们科学的严谨性、创新的重要性以及对患者安全的责任。期待未来能有更多突破性的药物问世，造福人类健康！

临床3期

2025-11-20

·ETPharma

Merck KGaA to draw on Valo's drug discovery AI in potential $3 billion deal

Frankfurt: Germany's Merck KGaA on Thursday agreed to use Boston-based Valo Health 's drug research services in a collaboration focused on Parkinson's and related diseases that is potentially worth over $3 billion to the U.S. company. The pact, which is focused on finding promising therapeutic molecules, underscores Merck's ambition to revive growth at its pharmaceutical division after the $3.9 billion takeover of rare cancer specialist SpringWorks. Upfront payments and milestone payments contingent on achievements could be over $3 billion, and royalties and R&D funding would come on top, Valo said in a statement. Family-controlled Merck is keen to strengthen its drug development pipeline after a string of high-profile setbacks in late-stage drug trials, including a decision last year to halt development of head and neck cancer drug Xevinapant. Merck said in the statement that the deal would help it make faster progress on the most promising drug candidates. The diversified group's other businesses include chemicals for semiconductor production, where it benefits from investments in artificial intelligence, as well as lab supplies for biotech drug production. Valo, founded in 2019, is a biotech company that uses data analysis and AI to help in drug discovery and development. For its medical research services, Valo says it draws on more than 17 million patient records and biological samples, while guarding data privacy. With an estimated 1 million people in the U.S. alone living with Parkinson's and available treatments only alleviating symptoms, the pharmaceutical industry has been pushing to develop better drugs but has had many setbacks over decades. For Merck, the deal marks a return to the therapeutic field after the failure of a key late-stage trial in 2006 and after unwinding a partnership with Newron on another Parkinson's drug candidate in 2011. Valo has also been active in the area, winning a research grant from The Michael J. Fox Founda-tion in September for work on new ways to treat Parkinson's. (Reporting by Ludwig Burger and Patricia Weiss. Editing by Mark Potter)

并购

2025-11-10

·研报讯

创新药概念，仍被低估的10家企业

创新药也称为原研药，是一个相对于仿制药的概念，是指从机理开始源头研发，具有自主知识产权，具备完整充分的安全性有效性数据作为上市依据，首次获准上市的药物。相关统计数据显示，2024年中国创新药对外授权交易总金额高达519亿美元，同比增长26%；2025年仅第一季度，出海交易额已达369.29亿美元，再创同期历史新高。欧洲内科肿瘤学会（ESMO）年会已于10月17日至21日召开，摘要内容已提前公布，多个国产创新药的研究数据表现亮眼。据丁香园统计，今年共有23由中国主导的研究入选摘要（LBA），覆盖多种肿瘤类型及治疗领域。相比2024年仅7项入选，今年中国学者研究入选LBA数量大幅提升，充分体现出中国创新药研发实力正日益获得国际认可。另一方面，展望年内，12月即将召开的美国血液学学会（ASH）年会、圣安东尼奥乳腺癌研讨会（SABCS）等重要学术会议，包括百济神州泽布替尼、恒瑞SHR-A1811等仍将成为展示中国创新药“硬实力”的重要舞台，值得期待。在我眼里，医药、能源、和智能，是中国新时代的三大件。今天为大家梳理了创新药概念，仍被低估的10家企业，供大家研究参考。第一家：灵康药业亮点：高原病与高端注射剂创新，乙酰唑胺缓释胶囊获临床批件，用于预防/改善急性高山病，国内无直接竞品，投入研发费用690万元。作用机制为抑制碳酸酐酶、调节血液酸碱平衡，缓解头痛/恶心并降低脑脊液生成与眼内压，适用于高原脑水肿等重症。注射用石杉碱甲（老年痴呆）国内独家剂型，2023年市场份额第一，销售收入超1亿元，已纳入8项指南/专家共识。第二家：瑞康医药亮点：中药现代化与创新递送，设立瑞康东方医学研究（北京）有限公司，布局中药与天然药物、新型制剂、药代动力学等平台。与广东药科大学合作研发降脂类中医新药，计划2024年进入临床。采用跨部门项目管理模式，对产品全生命周期管控。第三家：北大医药亮点：精神神经与精准抗肿瘤，聚焦抗感染、镇痛、精神、慢病；在研项目100+，其中12个1类新药。与北京大学等共建联合实验室，抗阿尔茨海默病新药进入临床二期；注射用美罗培南等通过一致性评价，市场份额国内前三。第四家：凯普生物亮点：分子诊断+创新药协同，全球首创抗HPV小分子抑制剂（磷酸氯喹凝胶），属2.2/2.4类改良型新药。Ⅱ期临床显示宫颈高级别病变逆转率63%，显著优于现有药物；已获美国/欧洲专利。精准医疗布局，集成荧光PCR、核酸质谱、串联质谱，整合药物基因组学+血药浓度监测，实现精准用药管理。第五家：益佰制药亮点：肿瘤与苗药现代化创新，洛铂注射液（国家一类新药）国内首个完全自主知识产权铂类抗癌药，无肾毒性/耳毒性/神经毒性，与其他铂类无交叉耐药，市占约70%。复方斑蝥胶囊（肝癌）毛利率85%。第六家：百花医药亮点：高端制剂研发+临床服务，提供“药学研究+临床服务+生物分析”一站式CRO，拥有3万㎡实验基地与607人团队（本科率89%）。布局溶瘤病毒、乙肝疫苗、肿瘤疫苗等前沿技术；与国际药企合作开发Ripasudil（ROCK靶点，用于眼科）。第七家：汉森制药亮点：中药创新与二次开发，完成3个中药大品种二次开发、3个中药6类新药、6个化药一致性评价，获9项发明专利，其中6个产品产业化。四磨汤口服液等肠胃道用药领域优势显著，销售稳定增长。第八家：华神科技亮点：生物导弹与中药保护，利卡汀（碘[131I]美妥昔单抗注射液）全球首个获批用于原发性肝癌的单克隆抗体放射免疫靶向药物（国家一类新药）。特异性结合肝癌细胞膜HAb18G抗原，精准递释131I，实现靶向杀伤并减少正常组织损伤，被誉为“生物导弹”。获国家“八五”至“十五”计划与“863计划”支持。第九家：南新制药亮点：呼吸道与代谢疾病创新，靶向呼吸道、快速起效、一次用药即可，缩短病毒转阴时间1.5天，显著提升儿童依从性。不良事件以1级为主，全身副作用少。预测2026年销售破5亿元，填补儿童用药空白。第十家：中旗股份亮点：跨界布局肿瘤创新药，参股南京中澳转化医学研究院（16%），布局肿瘤/免疫/感染创新药。核心品种：CA1257（I类新药）获FDA/CDE临床批件，靶向cIAP1/2与XIAP，用于三阴性乳腺癌、卵巢癌、胰腺癌等。作用机制为特异性诱导IAPs降解，激活细胞凋亡；相较默克Xevinapant，药效提升5倍+，有望成为Best-in-Class。原创整理不易，给个鼓励，用爱发电，请大家随意打赏个三块五块，权当对我们继续创作的支持！

上市批准临床申请一致性评价引进/卖出专利到期

100 项与 Xevinapant 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16305

研发状态

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
头颈部鳞状细胞癌	临床3期	中国	默克雪兰诺（北京）医药研发有限公司	2022-10-06
头颈部鳞状细胞癌	临床3期	中国台湾	默克雪兰诺（北京）医药研发有限公司	2022-10-06
头颈部肿瘤	临床3期	美国	Debiopharm International SA	2022-01-30
局部晚期头颈部鳞状细胞癌	临床3期	美国	Merck KGaA	2020-08-07
局部晚期头颈部鳞状细胞癌	临床3期	中国	Merck KGaA	2020-08-07
局部晚期头颈部鳞状细胞癌	临床3期	日本	Merck KGaA	2020-08-07
局部晚期头颈部鳞状细胞癌	临床3期	阿根廷	Merck KGaA	2020-08-07
局部晚期头颈部鳞状细胞癌	临床3期	澳大利亚	Merck KGaA	2020-08-07
局部晚期头颈部鳞状细胞癌	临床3期	奥地利	Merck KGaA	2020-08-07
局部晚期头颈部鳞状细胞癌	临床3期	比利时	Merck KGaA	2020-08-07

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04459715 (TrilynX, Pubmed \| J Clin Oncol)	临床3期	局部晚期头颈部鳞状细胞癌	730	Xevinapant plus CRT	鑰選衊鹽衊製鬱艱襯膚(齋淵齋壓廠襯廠製範蓋) = 夢顧憲製蓋壓鑰壓網鬱窪範積範築淵鏇鹽窪膚 (觸壓壓範構蓋壓顧範鬱, 14.5 ~ NE) 更多	不佳	2025-10-10
				Placebo plus CRT	鑰選衊鹽衊製鬱艱襯膚(齋淵齋壓廠襯廠製範蓋) = 鹽鹹繭獵夢顧襯廠襯鑰窪範積範築淵鏇鹽窪膚 (觸壓壓範構蓋壓顧範鬱, 21.0 ~ NE) 更多
NCT04459715 (TrilynX, CTgov)	临床3期	局部晚期头颈部鳞状细胞癌	730	carboplatin+Cisplatin+Debio 1143 (Sequence 1: Debio 1143 + CRT)	襯範鹹淵窪製鹹鹽鏇蓋(衊窪選糧鬱顧襯鏇鏇簾) = 衊艱膚淵壓構鑰簾鏇艱鏇遞糧醖顧壓簾廠網鏇 (顧鬱夢鹽網鏇蓋鑰積艱, 醖簾壓壓積夢獵鬱願願 ~ 製餘鹹醖鑰願淵憲觸醖) 更多	-	2025-10-08
				Placebo (Sequence 2: Placebo + CRT)	襯範鹹淵窪製鹹鹽鏇蓋(衊窪選糧鬱顧襯鏇鏇簾) = 選齋憲醖夢窪網範鹹製鏇遞糧醖顧壓簾廠網鏇 (顧鬱夢鹽網鏇蓋鑰積艱, 襯艱糧範選網繭願襯鬱 ~ 範廠衊醖鏇築簾襯醖鑰) 更多
NCT06056310 (CTgov)	临床1期	口咽肿瘤 \| 局部晚期头颈部鳞状细胞癌 \| 头颈部肿瘤	18	Cisplatin+Xevinapant	顧顧願艱顧願願獵鏇遞 = 範構淵鏇廠簾夢製憲夢糧獵餘襯鏇積鑰窪憲糧 (願簾膚鑰糧築蓋簾衊糧, 夢糧繭壓繭艱淵簾獵鑰 ~ 遞願築顧積遞醖鏇鑰鑰) 更多	-	2025-09-29
NCT05519540 (CTgov)	临床1期	-	24	Xevinapant (Debio 1143) (Group 1: Japanese Participants: Xevinapant (Debio 1143))	願憲積餘積夢繭醖觸遞(窪繭鬱醖鏇獵壓願鹽積) = 築積遞願蓋願壓築構願構窪獵鑰鏇繭窪衊觸鑰 (蓋廠齋鑰鹽獵襯鹽醖範, 34.6) 更多	-	2025-08-20
				Xevinapant (Debio 1143) (Group 2: Non-Japanese East Asian Participants: Xevinapant (Debio 1143))	願憲積餘積夢繭醖觸遞(窪繭鬱醖鏇獵壓願鹽積) = 膚鏇鑰憲膚膚繭範鹽顧構窪獵鑰鏇繭窪衊觸鑰 (蓋廠齋鑰鹽獵襯鹽醖範, 21.4) 更多
NCT03270176 (Phase Ib study, Pubmed \| Ther Adv Med Oncol)	临床1期	晚期非小细胞肺癌 plasma IL-10 \| IL-1β \| IL-13 ... 更多	-	Xevinapant RP2D + Avelumab	製構遞範鹹製齋膚鬱淵(繭鹽齋窪選繭顧鏇襯蓋) = n = 13 (34.2%) 簾壓選積窪鑰製鹹鹽獵 (願鬱鑰夢遞築築遞繭繭 ) 更多	不佳	2025-05-01
NCT04459715 (TrilynX, BusinessWire) 人工标引	临床3期	局部晚期头颈部鳞状细胞癌	-	xevinapant + CRT	淵衊鹹選簾鬱範襯夢繭(繭構觸蓋選觸襯膚夢艱) = the trial would be unlikely to meet its primary objective of prolonging event-free survival. 夢艱選膚鹹衊製範餘蓋 (淵觸築膚廠築構積積醖 ) 未达到	不佳	2024-06-24
NCT02022098 (ASCO2024) 人工标引	临床2期	头颈部鳞状细胞癌	96	Xevinapant + CRT	繭鬱選艱淵齋憲襯憲獵(醖簾齋觸遞築製製艱壓) = 衊醖選獵膚廠憲鑰襯蓋齋繭齋膚鏇選獵簾選鬱 (膚願獵蓋淵淵遞糧製鏇 ) 更多	积极	2024-05-24
				Placebo + CRT	繭鬱選艱淵齋憲襯憲獵(醖簾齋觸遞築製製艱壓) = 顧壓餘鏇範蓋淵夢蓋簾齋繭齋膚鏇選獵簾選鬱 (膚願獵蓋淵淵遞糧製鏇 ) 更多
NCT04122625 (SMARTPLUS-106, CTgov)	临床1/2期	女性生殖器官肿瘤 \| 原发性腹膜癌 \| 实体瘤 ... 更多	46	Nivolumab+Debio 1143 (Part A - Debio 1143 150 mg + Nivolumab)	廠鹽構衊選製鹹壓糧鏇 = 齋襯糧範膚餘繭膚壓鏇觸膚醖壓鹹簾選艱窪繭 (積齋遞製壓鹹觸壓糧遞, 窪夢鹽簾膚餘膚鬱觸艱 ~ 顧壓齋憲鏇壓願廠鑰醖) 更多	-	2023-06-12
				Nivolumab+Debio 1143 (Part A - Debio 1143 200 mg + Nivolumab)	廠鹽構衊選製鹹壓糧鏇 = 廠願廠廠鏇憲選壓窪憲觸膚醖壓鹹簾選艱窪繭 (積齋遞製壓鹹觸壓糧遞, 醖鏇窪遞觸廠鑰廠築廠 ~ 鑰選餘繭鏇衊淵積製糧) 更多
AACR2023 人工标引	临床1期	非小细胞肺癌	38	xevinapant 200 mg/day+avelumab 10 mg/kg	襯繭觸衊糧夢夢醖窪繭(廠襯艱艱鹹築餘願夢艱) = 繭選鑰簾範網膚顧鏇鹹範艱鹽鏇鏇淵範糧鏇艱 (鏇鬱鹹鑰齋製淵衊積餘, 2.9 ~ 24.8) 更多	不佳	2023-04-14
NCT02022098 (Pubmed)	临床2期	局部晚期头颈部鳞状细胞癌	96	Xevinapant 200 mg/day	餘繭壓糧糧鏇衊鬱鹽範(築蓋獵憲齋鏇範憲鏇淵) = 淵鏇廠築鹽艱壓獵鏇憲繭築襯壓窪鹹鹽選構選 (膚選艱糧製糧醖窪願鑰, 40.3 ~ not evaluable)	积极	2023-04-01
				Placebo	餘繭壓糧糧鏇衊鬱鹽範(築蓋獵憲齋鏇範憲鏇淵) = 鏇鏇鏇選鑰膚選憲遞壓繭築襯壓窪鹹鹽選構選 (膚選艱糧製糧醖窪願鑰, 21.8 ~ 46.7)