This phase II trial tests the impact of biomarkers in predicting initial treatment (first-line) PD1 or PD-L1 (PD[L]-1)-based immunotherapy response and in selecting second-line treatment in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Response and survival rates in advanced stage NSCLC, unlike other cancers, rely on response to first-line therapy. Immunotherapy with PD(L)1-based therapy, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. While immunotherapy has improved survival rate, the prognosis remains poor with most patients receiving chemotherapy after immunotherapy. Many types of tumors tend to lose cells or release different types of cellular products including their deoxyribonucleic acid (DNA) which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. The first part of this trial, studying samples of blood and tissue in the laboratory from patients receiving immunotherapy may help doctors learn more about the effects PD(L)1-based therapy on cells. It may also help doctors understand how well patients respond to treatment and may help develop new individualized treatment strategies. The second part of this trial also tests the effect of second-line immunotherapy, such as tremelimumab and durvalumab or adagrasib and bevacizumab, in treating patients with NSCLC with specific genetic mutations that is growing, spreading or getting worse (progressive). Tremelimumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adagrasib, a type of targeted therapy, may stop the growth of tumor cells by blocking a protein needed for tumor cell growth and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving second-line immunotherapy, tremelimumab and durvalumab or adagrasib with bevacizumab, may be safe, tolerable, and/or effective in treating patients with stage IIIB/IV NSCLC with specific genetic mutations.

开始日期2026-09-21

申办/合作机构

City of Hope National Medical Center

[+1]

NCT07511504

/ Not yet recruiting临床2期IIT

A Phase II Study to Evaluate the Efficacy and Safety of Y-90, Durvalumab, Tremelimumab, and Zanzalintinib in Patients With Unresectable and Locally-Advanced Hepatocellular Carcinoma

This phase II trial tests how well giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib works for the treatment of hepatocellular carcinoma that cannot be removed by surgery (unresectable) and that has spread to nearby tissue or lymph nodes (locally advanced). Y-90 radioembolization is a therapy that injects radioactive particles directly into an artery that feeds liver tumors to cut off their blood supply. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Zanzalintinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib may be effective for treating unresectable and locally-advanced hepatocellular carcinoma.

开始日期2026-04-02

申办/合作机构

OHSU Knight Cancer Institute

[+2]

NCT07489976

/ Recruiting临床2期IIT

Leveraging Immunotherapy For Tumor Downstaging to Milan Criteria in Patients With Hepatocellular Carcinoma

The investigators are doing this study to learn if a combination of immunotherapy and a liver-directed tumor procedure can safely and effectively shrink or control liver cancer (hepatocellular carcinoma, HCC). The goal is to try to lower the stage of the cancer so that more patients may become eligible for a liver transplant. The investigators will also closely watch for side effects from the study treatments. Section 2 has more details.

开始日期2026-04-01

申办/合作机构

Cedars-Sinai Medical Center

100 项与曲麦利尤单抗相关的临床结果

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100 项与曲麦利尤单抗相关的转化医学

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100 项与曲麦利尤单抗相关的专利（医药）

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582

项与曲麦利尤单抗相关的文献（医药）

2026-03-01·JHEP Reports

Reproducible safety and efficacy of durvalumab with or without tremelimumab for hepatocellular carcinoma in clinical practice: Results of the DT-real study

Article

作者: Manfredi, Giulia F ; Khaled, Najib Ben ; Sparacino, Alba ; Singal, Amit G ; Ponziani, Francesca Romana ; Iavarone, Massimo ; Fortuny, Marta ; Andanamala, Haripriya ; Stefanini, Bernardo ; Di Maria, Gabriele ; Ulahannan, Susanna ; Gonzalez, Melina ; Cabibbo, Giuseppe ; Vaccaro, Marco ; Rapposelli, Ilario Giovanni ; Li, Michael ; Toyoda, Hidenori ; Kaseb, Ahmed O ; Rimassa, Lorenza ; Ricci, Angela Dalia ; Vivaldi, Caterina ; Stella, Leonardo ; Villani, Rosanna ; Carminati, Ornella ; Kudo, Masatoshi ; Kelley, Robin K ; Pinato, David James ; Fulgenzi, Claudia A M ; Nishida, Naoshi ; Cammà, Calogero ; Chamseddine, Shadi Mohamad ; Pinter, Matthias ; Celsa, Ciro ; Lombardi, Pasquale ; Orlandi, Elena ; D'Alessio, Antonio ; Casadei-Gardini, Andrea ; Reig, Maria ; Scheiner, Bernhard ; Arvind, Ashwini ; Pressiani, Tiziana

Background & Aims:

Durvalumab plus tremelimumab (STRIDE) has emerged as a first-line systemic treatment option for unresectable hepatocellular carcinoma (HCC). This international multicentre study aimed to evaluate the efficacy and tolerability of STRIDE or durvalumab monotherapy in routine clinical practice, comparing outcomes between patients within and outside key eligibility criteria for the HIMALAYA trial.

Methods:

From a database of 1,423 patients with advanced/unresectable HCC treated with immunotherapy across 35 centres, we analysed 233 patients receiving STRIDE or durvalumab monotherapy. Patients were categorized as HIMALAYA-IN or HIMALAYA-OUT based on key trial eligibility criteria (no prior systemic therapy, ECOG-PS 0-1, Child-Pugh class A, no Vp4 thrombosis). Baseline characteristics were assessed for overall survival (OS) and hepatic decompensation using a multivariable Cox model and competing-risk analysis, respectively. Objective response rates and treatment-related adverse events were recorded.

Results:

Of the 233 patients, 123 (53%) were HIMALAYA-IN and 110 (47%) were HIMALAYA-OUT. STRIDE was given in 95% of HIMALAYA-IN patients. After median follow-up of 6.0 months, median OS was 20.4 months (95% CI 11.7-NR) in the overall population. HIMALAYA-IN patients achieved significantly longer OS than HIMALAYA-OUT patients (23.0 vs. 12.2 months; hazard ratio 0.61; 95% CI 0.39-0.96; p = 0.03). Macrovascular invasion and hepatic decompensation were independent negative prognostic factors in the whole cohort. Hepatic decompensation occurred in 10.5% of patients within 12 months from treatment start. Objective response rate was 23.7% and 17.8% of HIMALAYA-IN and -OUT patients, respectively. Patients achieving disease control (whole cohort: 59.4%) demonstrated 24-month OS of 58.2% in HIMALAYA-IN and 44.8% in HIMALAYA-OUT groups. Grade 3-4 treatment-related adverse events occurred in 16.3% of patients.

Conclusions:

STRIDE shows reproducible effectiveness and an acceptable safety profile in real-world practice. Achieving disease control and maintaining liver function emerged as key determinants of long-term survival benefit.

Impact and implications:

The DT-real study validates the efficacy and safety of STRIDE (durvalumab plus tremelimumab) in routine clinical practice, with HIMALAYA trial-eligible patients achieving 23-month median survival, and showing a safety profile comparable to that observed in the pivotal trial. Nearly half of real-world patients received treatment despite not meeting original trial criteria, reflecting urgent clinical need in this population with limited therapeutic options. As for other immunotherapy-based combinations, hepatic decompensation is a critical determinant of survival. Patients achieving disease control demonstrated substantially improved 24-month overall survival rates compared to those with progressive disease, confirming the findings of the exploratory analyses of the HIMALAYA trial.

2026-03-01·Therapeutic Advances in Medical Oncology

Sequential or upfront triple combination with durvalumab, tremelimumab, and bevacizumab for patients with unresectable hepatocellular carcinoma: the MONTBLANC trial protocol (AIO-HEP-0325/ass)

Article

作者: Ricke, Jens ; Kubisch, Ilja ; Mayerle, Julia ; Auriemma, Alessandra ; Vivaldi, Caterina ; Daniele, Bruno ; Ondrejkova, Katarina ; Reiter, Florian P. ; Perkhofer, Lukas ; Soldà, Caterina ; Schneider, Julia S. ; Philipp, Alexander ; Schwald, Isabel ; Enssle, Stefan ; De Toni, Enrico N. ; Chater, Jack ; Basch, Marion ; Ehmer, Ursula ; Gonzalez-Carmona, Maria A. ; Felden, Johann von ; Weinmann, Arndt ; Karin, Monika ; Oehrle, Bettina ; Piseddu, Ignazio ; Zhou, Taotao ; Geier, Andreas ; Altenhofer, Julia ; Masi, Gianluca ; Hüwer, Tim ; Ettrich, Thomas J. ; Gröper, Moritz N. ; Foerster, Friedrich ; De Rosa, Antonio ; Weiss, Lena ; Schulze, Kornelius ; Antonuzzo, Lorenzo ; Bauer, Ulrike ; Seidensticker, Max ; Ben Khaled, Najib ; Beyer, Georg

Background::

Immune checkpoint inhibitor (ICI)-based combination therapy has transformed the therapeutic landscape of advanced hepatocellular carcinoma (aHCC). However, durable clinical benefit remains limited to a subset of patients, highlighting the need for approaches that enhance efficacy.

Objectives::

The MONTBLANC study presents a novel investigational strategy utilizing triple immunotherapy through the combination of the anti-programmed cell death ligand 1 antibody durvalumab, the anti-cytotoxic T-lymphocyte-associated antigen-4 tremelimumab, and the anti-vascular endothelial growth factor bevacizumab in patients with aHCC.

Methods and analysis::

This randomized, open-label, phase II clinical trial examines two distinct therapeutic regimens through parallel study arms: upfront triple-agent administration or doublet therapy with durvalumab and tremelimumab, followed by the addition of bevacizumab upon disease progression or lack of objective radiological response. The primary endpoint is the overall response rate. Secondary endpoints include overall survival, progression-free survival, safety, and patient-reported outcomes.

Ethics::

The ethics review boards of all participating sites have approved the study protocol. The trial will be performed in accordance with the Declaration of Helsinki, Good Clinical Practice Standards, and the applicable laws and regulations. All patients must provide written informed consent.

Discussion::

The MONTBLANC study aims at guiding the design of future trials in aHCC by assessing efficacy signals of upfront triple or response-adapted treatment escalation with durvalumab, tremelimumab, and bevacizumab.

Trial registration::

The MONTBLANC clinical trial is registered at the US National Institutes of Health (ClinicalTrials.gov, NCT05844046) and the European Union Drug Regulating Authorities Clinical Trials Database (clinicaltrialsregister.eu, 2022-001201-48).

2026-03-01·ANTICANCER RESEARCH

Clinical Utility of Tremelimumab/Durvalumab as First-line Treatment for Unresectable Hepatocellular Carcinoma: Serum Cytokine Profile Insights

Article

作者: Kobayashi, Kojiro ; Higai, Koji ; Igarashi, Yoshinori ; Matsui, Teppei ; Matsuda, Takahisa ; Wakui, Noritaka ; Yoshimine, Naoyuki ; Mohri, Kunihide ; Nagumo, Hideki ; Mukozu, Takanori ; Ogino, Y U ; Nagai, Hidenari ; Momiyama, Koichi

BACKGROUND/AIM:

Although immunotherapies such as atezolizumab plus bevacizumab (Ate/Bev) and tremelimumab plus durvalumab (Tre/Dur) are recommended as first-line treatments for unresectable hepatocellular carcinoma (uHCC), the clinical utility of Tre/Dur as first- or second-line therapy for uHCC remains debatable. We studied the clinical utility of first-line Tre/Dur treatment for uHCC using serum cytokine profiles.

PATIENTS AND METHODS:

We analyzed preserved serum of adult Japanese patients with liver cirrhosis and uHCC from a previous prospective study who received Tre/Dur at our hospital. Blood samples were collected before and after four weeks of treatment. Dynamic computed tomography (CT) was performed after 8-12 weeks of treatment to assess the response.

RESULTS:

Among nine non-immunotherapy (non-IO) group patients, three, five, and one patients showed partial response (PR), stable disease (SD), and progressive disease (PD), respectively, whereas none of the 10 IO group patients showed PR; three and seven patients showed SD and PD, respectively. Serum tumor necrosis factor (TNF)-alpha and soluble IL-2 receptor (IL-2R) increased significantly in both groups, with no significant changes in interleukin (IL)-6 levels in both groups. No significant difference was noted in serum MHC class I levels before and after treatment in either group, whereas soluble programmed cell death ligand 1 (sPD-L1) level increased in both groups. However, serum soluble MHC class I and sPD-L1 levels before treatment were higher in the IO group than in the non-IO group.

CONCLUSION:

A history of Ate/Bev therapy increased soluble MHC class I and sPD-L1 serum levels. Tre/Dur therapy may be useful as a first-line treatment for uHCC, and elevated sPD-L1 levels may attenuate Dur efficacy. This increase may impair tumor recognition and potentially reduce Tre/Dur therapy effectiveness despite activated cytotoxic T cells.

642

项与曲麦利尤单抗相关的新闻（医药）

2026-04-10

·阿斯利康中国

英卓凡®联合英飞凡®和化疗在华获批用于晚期非小细胞肺癌一线治疗

POSEIDON III期临床研究显示：与单独化疗相比，英卓凡®联合英飞凡®和化疗为患者带来显著的生存获益重磅发布 2026年4月7日，上海——阿斯利康宣布，中国国家药品监督管理局已正式批准英卓凡®（英文商品名：Imjudo®，中文通用名：曲麦利尤单抗）联合英飞凡®（英文商品名：Imfinzi®，中文通用名：度伐利尤单抗）和含铂化疗用于表皮生长因子受体（EGFR）敏感突变阴性和间变性淋巴瘤激酶（ALK）阴性的转移性非小细胞肺癌（NSCLC）的一线治疗。这是阿斯利康“双免疫治疗”在中国获批的首个适应症，也标志着阿斯利康第二款免疫治疗药物曲麦利尤单抗在中国正式获批。曲麦利尤单抗是一种人源抗细胞毒性T淋巴细胞相关蛋白 4（CTLA-4）的单克隆抗体，通过阻断 CTLA-4 介导的抑制信号，促进 T 细胞活化并增强机体的抗肿瘤免疫应答，促进癌细胞死亡。度伐利尤单抗是一种人源PD-L1单克隆抗体，自2019年在中国上市以来，已获批8项适应症，覆盖肺癌、胆道癌和妇科肿瘤。二者联合应用可通过协同阻断PD-L1和CTLA-4两个免疫检查点通路，在肿瘤免疫应答的不同阶段发挥互补作用：曲麦利尤单抗有助于诱导并维持记忆T细胞反应，支持机体建立更持久的抗肿瘤免疫效应；与度伐利尤单抗联合后，有望进一步强化免疫应答的持续性。本次国家药品监督管理局（NMPA）的批准是基于III期临床研究POSEIDON结果：与单独化疗相比，接受短疗程的曲麦利尤单抗（5个周期）联合度伐利尤单抗以及含铂化疗（4个周期）治疗的患者，其死亡风险降低了23% (风险比 [HR] 0.77；95% CI 0.65-0.92；p=0.00304），该联合治疗方案的中位总生存期（OS）为 14.0 个月，2年OS率约33%，而单独化疗的中位OS为 11.7 个月, 2年OS率仅22%；此外，该联合治疗方案将疾病进展或死亡风险显著降低28%（HR 0.72；95% CI 0.60-0.86；p=0.00031），且联合方案与两种药物的已知特征一致，未发现新的安全信号,说明该短疗程联合治疗模式能有效增强机体抗肿瘤免疫应答，并兼顾安全性与耐受性。此外，该联合治疗方案还展现出显著的“生存长拖尾效应”：在2023年欧洲肿瘤内科学会免疫肿瘤学大会（ESMO IO）上公布的POSEIDON III期临床试验逾5年随访的更新数据显示，曲麦利尤单抗联合度伐利尤单抗和化疗组显示出持久的OS获益（HR 0.76；95% CI 0.64-0.89），5年OS率为15.7%，而单独化疗组仅为6.8%1。肺癌是位居我国发病率和死亡率第一的恶性肿瘤2。中国2022年最新肺癌发病例数为106.06万、死亡例数达73.3万3。肺癌分为非小细胞肺癌（NSCLC）和小细胞肺癌（SCLC），其中非小细胞肺癌约占所有肺癌患者的80-85%4。大部分（约75%）非小细胞肺癌患者在确诊时已是晚期5。晚期肺癌通常指转移性疾病3，转移性非小细胞肺癌患者治疗耐受度普遍较低，预后尤其差，只有约5%的患者能在诊断后存活满五年6，亟需更多创新治疗方案延长生命。POSEIDON III期临床研究中国大陆扩展队列的结果显示：曲麦利尤单抗联合度伐利尤单抗和化疗一线治疗转移性NSCLC的疗效和安全性，与全球队列的结果一致7。王洁教授中国医学科学院肿瘤医院 POSEIDON中国牵头研究者转移性非小细胞肺癌患者面临严峻的治疗挑战，尤其是对标准治疗应答不佳的患者，亟需更有效的创新方案。曲麦利尤单抗联合度伐利尤单抗和化疗的治疗方案兼具疗效与耐受性，在为患者带来显著生存获益的同时，也保证了生活质量，无疑为晚期转移性非小细胞肺癌的一线治疗提供了具有重要临床价值的创新选择。何静博士阿斯利康全球高级副总裁全球研发中国负责人此次获批是阿斯利康深耕研发、满足中国晚期肺癌患者治疗需求的又一重磅成果。曲麦利尤单抗作为阿斯利康第二个免疫检查点抑制剂，与度伐利尤单抗联合的治疗方案，标志着我们在免疫治疗领域又取得了关键创新突破。未来，我们还将继续“以患者为中心”，发挥强大的研发优势，推进更多创新成果的转化，为中国肺癌患者带来突破性的治疗选择。关冬梅女士阿斯利康中国肿瘤业务总经理曲麦利尤单抗联合度伐利尤单抗和化疗的获批，是我们在肺癌领域纵深布局的又一重要进展，为晚期非小细胞肺癌患者带来了长生存的可能。阿斯利康自率先开启中国肺癌靶向治疗时代以来，始终围绕以患者未被满足的临床治疗需求为核心，逐步拓展并完善涵盖免疫治疗、抗体偶联药物（ADC）、双免疫联合治疗以及晚期耐药等创新解决方案，不断丰富治疗选择，助力更多中国肺癌患者实现更长生存、更高质量的生活。未来，我们还将加速引进前沿药物，携手多方合作伙伴推动肺癌规范化诊疗，切实改善中国肺癌患者的治疗结局，为“健康中国2030”癌症防治目标贡献力量。关于POSEIDON研究 POSEIDON 研究是一项随机、开放标签、多中心的全球III期临床研究，旨在评估度伐利尤单抗联合曲麦利尤单抗及含铂化疗或度伐利尤单抗联合含铂化疗，对比单纯化疗，一线治疗 1013例转移性非小细胞肺癌（NSCLC）患者的疗效与安全性。研究人群涵盖非鳞癌和鳞癌患者，且覆盖所有PD-L1表达水平；排除了携带特定表皮生长因子受体（EGFR）突变或间变性淋巴瘤激酶（ALK）融合的患者。该研究在全球18个国家和地区的150多个研究中心开展，包括美国、欧洲、南美洲、亚洲及南非。在试验组中，患者每三周接受一次1500mg固定剂量的度伐利尤单抗联合最多四个周期化疗，或接受度伐利尤单抗联合75mg固定剂量的曲麦利尤单抗及最多四个周期化疗，后续均采用度伐利尤单抗单药每四周一次维持治疗；其中，度伐利尤单抗联合曲麦利尤单抗和化疗组患者在第16周时额外接受一剂75mg曲麦利尤单抗治疗。相比之下，对照组患者可接受最多六个周期化疗。另外，对于所有组别的非鳞癌患者，若初始治疗阶段使用了培美曲塞，则可继续接受培美曲塞维持治疗。几乎所有非鳞癌患者（95.5%）均接受了培美曲塞联合铂类药物治疗，而大多数鳞癌患者（88.3%）则采用吉西他滨联合铂类药物治疗。该研究的主要终点为度伐利尤单抗联合化疗组与单纯化疗组对比的PFS和OS；关键次要终点为度伐利尤单抗联合曲麦利尤单抗和化疗组与单纯化疗组对比的PFS和OS。由于度伐利尤单抗联合化疗组、度伐利尤单抗联合曲麦利尤单抗和化疗组均达到预设的PFS终点，根据预先制定的统计分析计划，对度伐利尤单抗联合曲麦利尤单抗和化疗组开展OS分析，度伐利尤单抗联合化疗组中观察到有OS获益趋势，但未达到统计学显著性。关于曲麦利尤单抗曲麦利尤单抗是一种人源单克隆抗体，可与细胞毒性T淋巴细胞相关蛋白4 （CTLA-4）结合，，阻断CTLA-4的活性，有助于T细胞的活化并增强对肿瘤的免疫应答，促进癌细胞死亡。除POSEIDON研究外，曲麦利尤单抗与度伐利尤单抗的联合治疗方案，已在国内提交不可切除的肝细胞癌（HCC）成人患者的适应症申请（HIMALAYA研究），并且正在国内外局灶性HCC（EMERALD-3研究）、SCLC（ADRIATIC研究）和膀胱癌（VOLGA 研究和 NILE研究）等多种肿瘤类型当中验证曲麦利尤单抗与度伐利尤单抗联合用药的疗效。关于度伐利尤单抗度伐利尤单抗是一种人源PD-L1单克隆抗体，可与PD-L1蛋白结合，能够阻断PD-L1与PD-1和CD80蛋白的结合，从而阻断肿瘤免疫逃逸并恢复被抑制的免疫反应。度伐利尤单抗是III期不可切除NSCLC根治性治疗放化疗后未出现疾病进展患者的全球标准治疗方案，此外还被批准用于治疗铂类同步放化疗后未出现疾病进展的局限期小细胞肺癌；与新辅助含铂化疗联合作为可切除NSCLC患者围手术期治疗；联合化疗（依托泊苷和卡铂或顺铂）用于治疗广泛期SCLC；与短疗程的曲麦利尤单抗以及含铂化疗联合用于治疗转移性NSCLC。除了用于治疗肺癌以外，度伐利尤单抗还被批准与化疗（吉西他滨加顺铂）联合用于治疗局部晚期或转移性胆道癌，以及与曲麦利尤单抗联合用于治疗不可切除的肝细胞癌（HCC）。度伐利尤单抗还在日本和欧盟获批作为不可切除性肝细胞癌的单药疗法。2025年3月，在可切除胃癌和胃食管结合部癌患者中开展的MATTERHORN III期临床试验显示，在标准治疗化疗基础上联合围手术期度伐利尤单抗治疗，达到了无进展生存期（EFS）这一主要终点。在美国，度伐利尤单抗还获批与化疗（卡铂加紫杉醇）联合使用后序贯度伐利尤单抗单药，治疗错配修复缺陷的原发性晚期或复发性子宫内膜癌。在欧盟，联合化疗后序贯度伐利尤单抗联合奥拉帕利治疗，用于错配修复正常型（pMMR）的晚期原发性或复发性子宫内膜癌；联合化疗后序贯度伐利尤单抗单药治疗，用于错配修复缺陷型（dMMR）的晚期原发性或复发性子宫内膜癌。在日本，联合化疗后序贯度伐利尤单抗单药治疗，用于晚期原发性或复发性子宫内膜癌的一线治疗；联合化疗后序贯度伐利尤单抗联合奥拉帕利治疗，用于错配修复正常型（pMMR）的晚期原发性或复发性子宫内膜癌。自2017年5月首次获批至今，已有超过 41.4 万名患者接受了度伐利尤单抗的治疗。作为整体研发计划的一部分，度伐利尤单抗正以单药或者联合其它抗肿瘤药物的形式，探索小细胞肺癌、非小细胞肺癌、乳腺癌、膀胱癌、多种消化道肿瘤和妇科肿瘤以及其他实体肿瘤患者的治疗。关于阿斯利康在肿瘤免疫治疗（IO）的研究阿斯利康是将免疫疗法引入高度未被满足的临床医疗需求的先驱，拥有全面和多样化的免疫产品组合和管线，以免疫疗法为基础，旨在克服抗肿瘤免疫逃逸，并刺激人体免疫系统攻击肿瘤。阿斯利康旨在通过度伐利尤单抗单药治疗以及与曲麦利尤单抗或其它创新免疫疗法和机制联合用药的方式重构癌症治疗，帮助患者改变治疗结局。公司也正在探索如双特异性抗体等下一代免疫疗法，利用免疫的不同特质来靶向癌症治疗，包括细胞疗法和T细胞结合剂。阿斯利康正在大胆追求创新的临床策略，将基于IO的疗法引入各种类型的肿瘤治疗中，以期带来长期生存获益。公司专注于探索新型联合疗法，来帮助预防耐药问题并促进更长时间的免疫应答。凭借丰富的临床研究项目，公司还倡导疾病早期使用免疫治疗，因为在这个阶段有极大的潜力达到治愈。关于阿斯利康在肺癌领域的研究阿斯利康正在努力通过早期疾病的检测和治疗使肺癌患者更接近治愈，并不断突破科学边界，改善耐药和晚期肺癌患者的预后。公司旨在通过定义新的治疗人群、研究创新的疗法，将药物带给能从中受到最大获益的患者。公司全面的产品组合涵盖领先的肺癌药物和新一代创新疗法，包括泰瑞沙（通用名：奥希替尼）和易瑞沙（通用名：吉非替尼）；英飞凡（通用名：度伐利尤单抗）和英卓凡（通用名：曲麦利尤单抗）；与第一三共合作开发的优赫得（通用名：德曲妥珠单抗）和达卓优（通用名：德达博妥单抗）；与和黄医药合作开发的沃瑞沙（通用名：赛沃替尼）以及横跨各种作用机制的新药及其组合的产品管线。阿斯利康是全球Lung Ambition Alliance的创始成员，该联盟致力于加速创新并为肺癌患者带来治疗及治疗以外有意义的改善。关于阿斯利康在肿瘤领域的研究阿斯利康正引领着肿瘤领域的一场革命，致力于提供多元化的肿瘤治疗方案，以科学探索肿瘤领域的复杂性，发现、研发并向患者提供改变生命的药物。阿斯利康专注于最具挑战性的肿瘤疾病，通过持续不断的创新，阿斯利康已经建立了行业领先的多元化的产品组合和管线，持续推动医疗实践变革，改变患者体验。阿斯利康以期重新定义癌症治疗并在未来攻克癌症。关于阿斯利康阿斯利康（LSE/STO/NYSE: AZN）是一家科学至上的全球生物制药企业，专注于研发、生产及营销处方类药品，重点关注肿瘤、罕见病以及包括心血管肾脏及代谢、呼吸及免疫在内的生物制药等领域。阿斯利康全球总部位于英国剑桥，业务遍布超过125个国家，创新药物惠及全球数百万患者。更多信息，请访问www.astrazeneca.com。声明： *本文涉及未在中国获批的产品或适应症，阿斯利康不推荐任何未被批准的药品使用。内容来源：新闻稿 (内部审批号：CN-182103）参考文献（滑动查看更多） 1. Solange Peters, et al. Durvalumab (D) ± tremelimumab (T) + chemotherapy (CT) in first-line metastatic (m) NSCLC: 5-year overall survival (OS) update from the POSEIDON study. 2023 ESMO IO, Abs LBA3 2. Zheng R, Zhang S, Zeng H, et al.. Cancer incidence and mortality in China, 2016. J Natl Cancer Cent, 2022, 2(1): 1-9. doi: 10.1016/j.jncc.2022.02.002 3. Han B, Zheng R, Zeng H, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024;4(1):47-53. DOI: 10.1016/j.jncc.2024.01.006 4. American Cancer Society. What is Lung Cancer? Available at: https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed November 2022.3.Knight SB, et al. Progress and prospects of early detection in lung cancer. Open Biol. 2017;7(9): 170070. 5. Quint LE. Lung cancer: assessing resectability. Cancer Imaging. 2003;4(1):15-8. 6. World Health Organization. World Cancer Fact Sheet. Available 7. Wang J, Fang J, Shou T, Yang N, Wang Q, Shi J, et al. Durvalumab with or without tremelimumab plus chemotherapy as first-line treatment for metastatic NSCLC: Results from the phase 3 POSEIDON extended China cohort[C]. European Lung Cancer Congress (ELCC) 2025, Paris, France: 2025, Poster 25P.

2026-04-10

·丁香园 Insight 数据库

一线治疗！阿斯利康双免疫疗法国内获批上市

4 月 10 日，NMPA 官网显示，阿斯利康度伐利尤单抗（PD-L1）和曲麦利尤单抗（CTLA4）联合疗法在国内获批上市。根据该药物此前国外获批适应症和临床研究，Insight 数据库推测该适应症是两药联合用于一线治疗驱动基因阴性的非小细胞肺癌（受理号：JXSS2400096/7/8/9）。截图来源：NMPA 官网度伐利尤单抗（Imfinzi）是一款人源化 PD-L1 单克隆抗体，通过阻断 PD-L1 与 PD-1 和 CD80 的结合，从而阻断肿瘤免疫逃逸策略并恢复被抑制的免疫反应。自 2017 年 5 月在美国获批以来，该药已经成为全球药品销售额 TOP100 榜单的常驻选手，2025 年全球销售额达 60.63 亿美元，同比增长 28.54%，同时也是阿斯利康产品管线中收入前三的当家产品。截图来源：Insight 数据库此前，度伐利尤单抗已在国内获批 7 项适应症，包括胆道癌、小细胞肺癌、非小细胞肺癌、子宫内膜癌。本次是度伐利尤单抗获批的第 8 项适应症，同时也是曲麦利尤单抗首次在国内获批。截图来源：Insight 数据库本次适应症的获批是基于 III 期临床试验 POSEIDON 的积极结果（登记号：NCT03164616/CTR20180636）。POSEIDON 研究登记于 2017 年，在全球招募 1186 例患者，其中境内招募 175 例。这是一项随机、多中心、阳性对照、开放标签研究，研究对象为未接受过系统治疗的转移性 NSCLC 患者，旨在评估度伐利尤单抗和曲麦利尤单抗联合治疗+SoC 化疗与单独 SoC 化疗相比在所有患者 PFS 方面的疗效。患者被随机分配到以下三个治疗组之一：(1) 曲麦利尤单抗、度伐利尤单抗和铂类化疗 (2) 度伐利尤单抗加铂类化疗或 (3) 铂类化疗。结果显示，与铂类化疗相比，曲麦利尤单抗加度伐利尤单抗和铂类化疗在 OS 方面获益显著，降低疾病死亡风险 23%（HR 为 0.77 [95% CI：0.65, 0.92]，p = 0.00304）；治疗组 1 和 3 的 mOS 分别为 14 个月和 11.7 个月，mPFS 分别为 6.2 个月和 4.8 个月。 2024 年 9 月，《Journal of thoracic oncology》上公布的 III 期 POSEIDON 结果显示，曲麦利尤单抗联合度伐利尤单抗加化疗的 5 年长期随访结果显示，与单独化疗相比，联合疗法具有持续的 OS 优势（HR = 0.76，95% CI：0.64-0.89），5 年 OS 率分别为 15.7% vs 6.8%。 2025 年 ELCC 大会上，阿斯利康公布了 POSEIDON 试验中国扩展队列数据。结果显示，共 175 例患者被随机分配。截至 2024 年 4 月 30 日（中位随访时间 24.1 个月），曲麦利尤单抗+度伐利尤单抗+铂类化疗组和度伐利尤单抗+铂类化疗组相较于铂类化疗组在 PFS 和 OS 方面均显示出数值上的改善。治疗相关不良事件（TRAEs）中，曲麦利尤单抗+度伐利尤单抗+铂类化疗组、度伐利尤单抗+铂类化疗组、铂类化疗组中 3/4 级不良事件的发生率分别为 65.5%、62.3% 和 49.1%，导致的死亡率分别为 5.2%、0% 和 0%，因 TRAEs 导致停止治疗的患者比例分别为 22.4%、11.3% 和 12.3%。截图来源：ELCC 2025 Insight 视角 Insight 数据库显示，目前 CTLA4 和 PD-1(L1) 的双免联合疗法只有纳武利尤单抗和伊匹木单抗的联用方案在国内获批。但就 CTLA4 单抗而言，BMS/小野制药的伊匹木单抗以及信达生物的伊匹木单抗 N01 均已获得 NMPA 批准上市，曲麦利尤单抗本次获批，成为在国内第 3 款获批上市的 CTLA4 单抗。值得注意的是，CTLA4 和 PD-1(L1) 的双抗已经崛起，康方生物的卡度尼利单抗，已在国内获批宫颈癌（二线、三线）疗法和胃癌一线疗法；齐鲁制药靶向 CTLA4 和 PD-1 的混合抗体艾帕洛利单抗/托沃瑞利单抗也在国内获批用于宫颈癌二线疗法。扫描二维码添加「小音」，回复口令新药获批，即可获得 Insight 整理的 2026 年全球新药获批上市资源大礼包👇（每月初更新一次，目前更新至 3 月）。封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：ccai PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn

临床3期免疫疗法上市批准临床结果

2026-04-06

·今日头条

阿斯利康肝癌四联疗法3期阳性：PFS显著获益，或改写中晚期肝癌治疗标准

> 2026年4月3日，阿斯利康公司宣布其EMERALD-3临床3期试验取得积极结果，为可接受栓塞治疗的不可切除肝细胞癌患者带来了压低复发风险的新希望。这一突破直面了肝癌治疗中肿瘤易复发进展的核心难题，可能重塑中晚期患者的治疗路径。 ![](blockview://markdown-image-tos-cn-i-tt/600b8f53799341c19fc39c37e217c2a1) ## 试验突破：PFS显著改善，OS呈现积极趋势 EMERALD-3试验是一项随机、多中心的全球性研究，直接比较了四联疗法与单独使用**经动脉化疗栓塞（TACE）**的疗效。四联方案结合了阿斯利康的免疫疗法**Imfinzi（durvalumab）**和**Imjudo（tremelimumab）**、靶向药物**lenvatinib**以及局部治疗TACE。 - 核心结果显示，与单独TACE相比，四联疗法在主要终点**无进展生存期（PFS）**上取得了**具有统计学显著性和临床意义的改善**。这意味着患者的疾病无进展生存时间显著延长，复发或进展风险得到有效控制。 - 在对关键次要终点**总生存期（OS）**的期中分析中，该联合治疗方案也显示出改善OS的积极趋势。虽然OS数据尚未完全成熟，但这一趋势为长期生存获益提供了早期信号。 - 安全性方面，联合治疗的安全性总体与各药物既往已知的特征一致，**未观察到新的安全性信号**。这为临床应用的耐受性提供了保障。 ## 机制解析：免疫、靶向与局部治疗的协同围剿该四联疗法旨在通过多角度攻击肿瘤，形成协同效应： > Imfinzi是一款抗PD-L1单克隆抗体，通过阻断PD-L1与PD-1和CD80蛋白的结合，解除肿瘤细胞对免疫反应的抑制。Imjudo则为抗CTLA-4单抗，可阻断CTLA-4的活性，从而促进T细胞激活，激发免疫系统对癌症的免疫反应。 - **免疫疗法**（Imfinzi和Imjudo）负责激活和“松绑”人体免疫系统，使其能够识别并攻击癌细胞。 - **靶向药物**（lenvatinib）则通过抑制肿瘤血管生成等多种途径，直接抑制肿瘤生长并切断其营养供应。 - **局部治疗**（TACE）作为中晚期肝细胞癌的标准治疗之一，通过栓塞肿瘤供血动脉并局部注入化疗药物，实现对可见肿瘤的精准打击。这种组合策略不仅针对原发肿瘤，也旨在清除潜在的微转移灶，从根源上压低复发风险。 ## 临床意义：或改写不可切除肝癌治疗标准肝细胞癌是全球常见的恶性肿瘤，尤其在中国，发病率和死亡率居高不下。对于不可切除但适合TACE的患者，单纯TACE治疗后肿瘤进展或复发的风险依然很高，患者预后改善有限。 EMERALD-3试验的成功，首次在3期临床试验中证实了“免疫+靶向+TACE”这一强效联合方案能为这类患者带来确切的PFS获益和OS改善趋势。这为不可切除肝细胞癌提供了一个潜在的新标准治疗选择，帮助患者打破“治疗-复发”的循环，有望获得更长久、更有质量的生存。 ## 行业背景：阿斯利康加码中国，加速创新疗法可及阿斯利康近年来持续深化在华布局，其中国研发战略与全球高度协同。公司已宣布在华投资**超1000亿元人民币**，用于研发、生产等全价值链能力建设。 ![](blockview://markdown-image-tos-cn-i-tt/6f850e9e79f64f149f581bebc696aa9e) - **阿斯利康中国研发管线项目与全球同步率为100%**，目前正在全国与近500家医院开展近200个临床项目。 ![](blockview://markdown-image-tos-cn-i-tt/00c35637b9e14508a7affaf21290ad6d) - 这种“在中国，为全球”的战略意味着，像EMERALD-3这样的全球关键试验成果，未来一旦获得监管批准，中国患者有望同步或快速用上创新疗法。 ![](blockview://markdown-image-tos-cn-i-tt/6aa238f2d30d4b85bf49824ba3ebb09b) 随着阳性结果的公布，阿斯利康正在与全球监管机构沟通，以推进该四联疗法的上市进程。这一进展不仅体现了肿瘤联合治疗策略的演进，也凸显了中国市场在全球医药创新版图中的重要性。

100 项与曲麦利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06657	曲麦利尤单抗	-	DB11771

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
肝细胞癌	加拿大	AstraZeneca Canada, Inc.	2023-08-31
晚期肝细胞癌	欧盟	AstraZeneca AB	2023-02-20
晚期肝细胞癌	冰岛	AstraZeneca AB	2023-02-20
晚期肝细胞癌	列支敦士登	AstraZeneca AB	2023-02-20
晚期肝细胞癌	挪威	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	欧盟	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	冰岛	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	列支敦士登	AstraZeneca AB	2023-02-20
转移性非小细胞肺癌	挪威	AstraZeneca AB	2023-02-20
晚期非小细胞肺癌	日本	AstraZeneca KK	2022-12-23
非小细胞肺癌	美国	AstraZeneca AB	2022-11-10
不可切除的肝细胞癌	美国	AstraZeneca AB	2022-10-21

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
非肌层浸润性膀胱肿瘤	临床3期	美国	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	日本	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	阿根廷	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	奥地利	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	巴西	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	加拿大	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	智利	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	法国	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	德国	AstraZeneca PLC	2021-08-05
非肌层浸润性膀胱肿瘤	临床3期	希腊	AstraZeneca PLC	2021-08-05

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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


NCT06526104 (STRIDE in CP-B, AACR2026)	临床2期	肝细胞癌一线	30	Tremelimumab 300 mg + Durvalumab 1500 mg (Hepatocellular Carcinoma + Child-Pugh B cirrhosis)	選構範觸艱獵蓋築鬱鏇(齋獵衊鬱鑰膚膚廠製膚) = 繭襯鹹範願醖淵廠夢餘獵顧鑰觸鹹壓鏇願獵鑰 (餘壓憲窪憲襯夢餘遞齋 ) 更多	积极	2026-04-21
AACR2026	临床2/3期	膀胱癌一线	200	ICI-only regimen(Durvalumab, Durvalumab+Tremelimumab, Pembrolizumab)	艱憲淵艱獵餘壓鏇醖憲(襯簾願糧廠蓋願築廠簾): HR = 1.92 (95.0% CI, 1.63 ~ 2.25) 更多	不佳	2026-04-21
				chemotherapy
NCT05844046 (MONTBLANC, Pubmed \| Ther Adv Med Oncol)	临床2期	不可切除的肝细胞癌 programmed cell death ligand 1 \| cytotoxic T-lymphocyte-associated antigen-4 \| vascular endothelial growth factor	168	Durvalumab + Tremelimumab + Bevacizumab	選鹽壓繭願鑰廠憲衊醖(窪選淵蓋糧顧淵築淵網) = 壓醖窪鏇蓋觸願選鹽夢鏇夢構鏇廠顧選獵製餘 (夢觸憲憲鹹襯艱淵鏇夢 )	积极	2026-03-01
				Durvalumab + Tremelimumab	範構製願壓餘襯憲顧鹽(糧蓋艱蓋膚遞膚壓鏇遞) = 遞遞廠獵鹹鏇簾憲網齋壓願壓製鹹襯窪衊構憲 (鬱築觸選鑰艱鬱衊獵襯 ) 更多
IMbrave150 (ASCO_GI2026)	临床2/3期	晚期肝细胞癌一线	1,064	Tremelimumab + Durvalumab	鹽艱獵蓋顧齋齋淵範廠(遞範鑰顧憲鹽製鑰願齋) = 餘憲簾鬱範艱觸簾窪壓築鏇築糧簾鑰襯觸築簾 (製醖夢遞願膚夢艱積積 ) 更多	积极	2026-01-08
				Atezolizumab + Bevacizumab	鹽艱獵蓋顧齋齋淵範廠(遞範鑰顧憲鹽製鑰願齋) = 鬱範夢繭顧衊簾觸鬱製築鏇築糧簾鑰襯觸築簾 (製醖夢遞願膚夢艱積積 ) 更多
NCT02962063 (ASCO_GI2026)	临床2期	食管腺癌	20	Durvalumab + Tremelimumab + PET-directed chemoradiation	醖鏇網艱製襯餘範衊淵(衊簾鹹齋製鹽網網願餘) = 廠壓壓醖繭願醖壓遞醖觸網膚鏇餘憲餘顧鬱襯 (製構簾餘淵鹽襯簾醖鏇 ) 更多	积极	2026-01-08
				Durvalumab + Tremelimumab + PET-directed chemoradiation (resected Pts)	醖鏇網艱製襯餘範衊淵(衊簾鹹齋製鹽網網願餘) = 遞鬱顧獵廠夢壓蓋繭網觸網膚鏇餘憲餘顧鬱襯 (製構簾餘淵鹽襯簾醖鏇 )
ASCO_GI2026	N/A	晚期肝细胞癌一线	3,306	Bevacizumab-atezolizumab	願選鬱淵築鹽蓋繭觸夢(廠遞遞繭簾觸壓窪醖醖): HR = 0.873 (95.0% CI, 0.75 ~ 0.935), P-Value = 0.0016	积极	2026-01-08
				Lenvatinib
NCT03298451 (HIMALAYA, ESMO_ASIA2025)	临床3期	不可切除的肝细胞癌	321	Tremelimumab + Durvalumab	製製衊獵窪廠築觸築壓(範窪齋醖餘鏇憲鬱壓齋) = 簾廠觸選糧繭壓衊鹹淵鹹遞繭範遞窪醖蓋顧齋 (憲夢淵積憲簾蓋鑰積選, 14.46 ~ 33.35) 更多	积极	2025-12-05
				Durvalumab	製製衊獵窪廠築觸築壓(範窪齋醖餘鏇憲鬱壓齋) = 膚醖構廠夢網築淵膚蓋鹹遞繭範遞窪醖蓋顧齋 (憲夢淵積憲簾蓋鑰積選, 15.84 ~ 23.85) 更多
NCT07081633 (TREMENDOUS-2, ESMO_ASIA2025)	临床2期	不可切除的肝细胞癌一线	114	Lenvatinib+durvalumab+tremelimumab	衊鏇廠衊醖餘襯窪築願(醖觸鬱築顧獵糧鹽網獵) = 觸夢觸艱鹹築築構壓願衊艱窪遞繭製蓋選蓋齋 (製顧鏇範糧鹹鹽繭鑰窪 ) 更多	积极	2025-12-05
NCT02879318 (CCTG PA.7, ESMO2025)	临床2期	转移性胰腺导管腺癌 MTA \| SAM	173	gemcitabine/nab-paclitaxel+durvalumab+tremelimumab	膚蓋鏇獵簾醖襯襯鹹窪(鹽膚壓醖構顧醖糧糧膚) = 鹹鑰夢鹽積選夢製餘顧鹹繭糧艱鹹糧餘艱鏇齋 (憲觸簾膚鬱積顧膚願鏇 ) 更多	积极	2025-10-17
				gemcitabine/nab-paclitaxel	膚蓋鏇獵簾醖襯襯鹹窪(鹽膚壓醖構顧醖糧糧膚) = 鬱齋糧齋鏇鏇構顧鏇鏇鹹繭糧艱鹹糧餘艱鏇齋 (憲觸簾膚鬱積顧膚願鏇 ) 更多
NCT03288532 (RAMPART, ESMO2025)	临床3期	肾细胞癌辅助	23	durvalumab	獵蓋蓋簾獵鏇製範衊遞(淵膚鬱鹽願鹹夢壓壓鏇) = 鹹遞壓糧製鹽鬱餘製醖鏇構簾鹹網鹽鹽製鹹憲 (膚鬱衊夢襯齋鹹夢膚鹹 ) 更多	积极	2025-10-17