A Multicenter Open-label, Prospective Study to Evaluate the Efficacy and Safety of SIRT Using Yttrium-90 Glass Microspheres Followed by Durvalumab and Tremelimumab for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis

Hepatocellular carcinoma (HCC) is the most common primary liver cancer, being the third leading cause of cancer-related death worldwide, with approximately 745 000 deaths reported annually.
For advanced patients, including patients with tumoral portal vein thrombosis (PVT), most treatment guidelines recommend systemic therapy, either combination immunotherapy (IO) or combination of immunotherapy and anti-angiogenic treatment for first line option.
Results for PVT patients are provided in one trial with a median overall survival of 14.2 months with IO underlying the necessity to improve treatment of PVT patients. Two recent other phase 3 trials also reported positive results for different IO regimen.
Selective internal radiation therapy (SIRT) using yttrium-90 (90Y)-loaded glass microspheres (TheraSphereTM) can be used for patients with early stage to locally advanced HCC including PVT patients without extrahepatic spread (EHS). TheraSphereTM is recognized and is reimbursed in France for PVT patients without EHS, since 2019.Several retrospective studies have shown promising results for PVT patients.
Nowadays use of SIRT in locally advanced HCC is regaining interest based on the results of the randomized DOSISPHERE-01 study including non-operable patients, about 70% with PVT. This randomized Phase II trial using 90Y-loaded microspheres sought was noted the effectiveness of 90Y-loaded microspheres using a personalized dosimetry approach versus a standard dosimetry approach.
The use of a systemic treatment as IO after a locoregional treatment with the strong local debulking effect of SIRT is logical and of interest. Indeed, the most frequent pattern of progression after SIRT is recurrence in an untreated area, including untreated liver or EHS. Patients are then usually referred to IO.
Such kind of therapeutic approach, using SIRT followed by IO has already been evaluated in a phase 2 study using nivolumab after 90Y loaded resin microspheres with promising efficacy without safety deterioration.
The aim of this study is to evaluate SIRT followed by IO used according to their current indications in advanced HCC patient with PVT patients and without EHS.

开始日期2026-01-02

申办/合作机构

Center Eugene Marquis

[+1]

NCT06824363

/ Not yet recruiting早期临床1期IIT

Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082

This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.

开始日期2025-11-01

申办/合作机构

University of California, Irvine

NCT07166406

/ Not yet recruiting临床3期IIT

Phase III Randomized Trial of IO-Based Systemic Treatment +/- Liver SBRT in Hepatocellular Cancer With Macrovascular Invasion (HELIO-RT)

This phase III trial compares the effect immunotherapy (IO) with stereotactic body radiation therapy (SBRT) to IO alone in treating patients with liver cancer (hepatocellular cancer) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). The usual approach is treatment with IO-based drug combinations, such as atezolizumab and bevacizumab, durvalumab and tremelimumab, or ipilimumab and nivolumab. Durvalumab and tremelimumab are monoclonal antibodies 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). IO with monoclonal antibodies, such as atezolizumab, nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. 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 cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Giving IO with SBRT may be more effective than IO alone in helping patients with advanced hepatocellular cancer live longer.

开始日期2025-10-02

申办/合作机构

NRG Oncology

100 项与曲美木单抗相关的临床结果

登录后查看更多信息

100 项与曲美木单抗相关的转化医学

登录后查看更多信息

100 项与曲美木单抗相关的专利（医药）

登录后查看更多信息

661

项与曲美木单抗相关的文献（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.

2025-12-01·Journal of Gastrointestinal Cancer

The Efficacy and Safety of Durvalumab and Tremelimumab with Concomitant Treatment for MSS/pMMR Metastatic Colorectal Cancer: A Single Arm Meta-Analysis

Article

作者: Zhang, Danning ; Chen, Tianyu

OBJECTIVES:

To address the issue that most microsatellite-stable (MSS) and proficient mismatch repair (pMMR) metastatic colorectal cancer (mCRC) patients have minimal response to immunotherapy, this meta-analysis evaluated the efficacy and safety of durvalumab and tremelimumab with concomitant treatment in treating MSS/pMMR metastatic colorectal cancer.

METHODS:

All included trials were prospective studies with a median patient age of 63 years, of which 94.2% were MSS/pMMR mCRC patients, with a male to female ratio of 1.5:1. Based on durvalumab and tremelimumab treatment, one study performed surgical resection on resectable cases, while the other four studies performed radiotherapy or chemotherapy on unresectable cases. Analyses include objective response rate (ORR).etc. for drug activity, overall survival (OS) and progression-free survival (PFS) for therapeutic efficacy, and adverse events (AEs) for safety. The risk of bias was assessed by sensitivity analysis.

RESULTS:

5 studies involving 228 patients were included in this meta-analysis. The pooled estimates showed a median OS of 9.26 months, median PFS of 2.53 months, partial response (PR) of 13.6%, stable disease (SD) of 32.8%, ORR of 12.5% and disease control rate (DCR) of 65.4%. AEs were generally low, with pruritus (27.5%), diarrhea (28.8%), and fatigue (53.9%) being the most common, while other AEs occurred at less frequencies.

CONCLUSIONS:

Durvalumab and tremelimumab with concomitant treatment for MSS/pMMR mCRC patients is relatively effective and safe, which is helpful in addressing the problem of mCRC with MSS/pMMR that has minimal response to immunotherapy.

2025-12-01·Journal of Gastrointestinal Cancer

Neutrophil-to-Lymphocyte Ratio (NLR) as a Predictive Biomarker in Advanced Hepatocellular Carcinoma Treated with First-Line Immunotherapy

Article

作者: Felismino, Tiago ; Martins, Luanna ; Brito, Angelo ; Maccali, Claudia ; Barroso, Matheus ; Carvalho, Daniela ; Coimbra, Felipe

PURPOSE:

Hepatocellular carcinoma (HCC) is a globally prevalent malignancy with high mortality and limited predictive biomarkers. The neutrophil-to-lymphocyte ratio (NLR), a systemic inflammation marker, has been proposed as a prognostic tool. This study aimed to evaluate the association between baseline NLR and clinical outcomes in patients with advanced HCC treated with first-line immunotherapy.

METHODS:

We conducted a retrospective analysis of 58 consecutive patients with advanced HCC treated with atezolizumab plus bevacizumab or durvalumab plus tremelimumab at a Latin American cancer center between July 2020 and March 2025. Baseline NLR was calculated from pretreatment blood counts and dichotomized using a cut-off of 4. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method and compared using the log-rank test. Univariable and multivariable Cox regression models were applied to assess prognostic and predictive factors. The association between NLR and disease control rate (DCR) was evaluated using logistic regression.

RESULTS:

Among 58 patients, 15 (28.8%) had NLR ≥ 4. Median PFS was significantly shorter in patients with NLR ≥ 4 compared to those with NLR < 4 (2.3 vs. 8.2 months; p < 0.001). In multivariable analysis, NLR ≥ 4 remained independently associated with inferior PFS (HR 3.90; 95% CI, 1.83-8.33; p < 0.001). NLR was not associated with OS. Patients with NLR ≥ 4 had markedly lower odds of achieving disease control (OR 0.04; 95% CI, 0.002-0.28; p = 0.005).

CONCLUSION:

Baseline NLR ≥ 4 is associated with inferior PFS and reduced DCR in patients with advanced HCC receiving immunotherapy. NLR may serve as a cost-effective predictive biomarker to inform immunotherapy strategy.

517

项与曲美木单抗相关的新闻（医药）

2025-09-19

·PRNewswire

Liver Cancer Therapeutics Market Size Surpasses USD 13.16 Billion by 2032, Increasing at a CAGR of 16.5% from 2025 to 2033

AUSTIN, Texas and TOKYO, Sept. 19, 2025 /PRNewswire/ -- According to DataM Intelligence, the global liver cancer therapeutics market size was valued at US$3.36 billion in 2024 and is expected to reach US$13.16 billion by 2033, growing at a CAGR of 16.5% during the forecast period 2025-2033. The liver cancer therapeutics market is entering a transformative phase, driven by the shift from traditional systemic therapies to innovative immunotherapies and targeted agents that offer improved survival outcomes. The growing adoption of combination regimens, particularly checkpoint inhibitors paired with VEGF or TKI therapies, is expected to redefine the treatment landscape and expand the eligible patient pool. At the same time, the rising prevalence of hepatocellular carcinoma worldwide, coupled with strong R&D pipelines and increasing regulatory approvals, positions this market for sustained growth. A significant advancement in liver cancer therapeutics is the approval of combination immunotherapy regimens. Notably, AstraZeneca's Imfinzi (durvalumab) plus Imjudo (tremelimumab) gained global recognition after the HIMALAYA trial demonstrated a meaningful overall survival benefit in patients with unresectable hepatocellular carcinoma. This approval provided a new first-line treatment option beyond tyrosine kinase inhibitors and VEGF-targeted therapies, offering durable survival outcomes for a subset of patients and reshaping the standard of care in advanced HCC. Another key advancement is the expansion of targeted oral therapies, which have improved safety and efficacy profiles. Drugs such as lenvatinib and cabozantinib have demonstrated substantial clinical activity as first- or second-line options, while ongoing research is investigating their use in combination with checkpoint inhibitors. The growing pipeline of next-generation TKIs and precision therapies, tailored to genetic and molecular profiles, is driving innovation, improving patient survival, and reinforcing the importance of oral targeted agents in the long-term management of HCC. Get a Sample PDF Brochure of the Report (Use Corporate Email ID for a Quick Response): The chemotherapy segment, based on therapy type, is expected to account for 39.1% of the liver cancer therapeutics market share. Chemotherapy remains a vital part of the liver cancer therapeutics market, especially for patients with intermediate-stage hepatocellular carcinoma (HCC) or those ineligible for surgical resection or transplantation. Trans-arterial chemoembolization (TACE) is a standard of care used in clinical settings and often combined with targeted therapies. Despite the rise of immunotherapies and precision drugs, chemotherapy remains vital due to its established protocols, lower costs, and widespread availability. Clinical studies are exploring the synergy of chemotherapeutic agents with immunomodulators to prolong survival and delay disease progression. The North American liver cancer therapeutics market was valued at 42.1% market share in 2024. North America is expected to dominate the liver cancer therapeutics market due to its robust healthcare infrastructure, high awareness, and significant investments in oncology research and development (R&D). For instance, in January 2025, researchers at Mount Sinai made a significant breakthrough in treating hepatocellular carcinoma (HCC), a type of liver cancer. Additionally, the rise in liver cancer incidence, driven by NAFLD, obesity, and chronic hepatitis C, has increased early diagnosis rates and demand for advanced therapeutics. The FDA's favorable regulatory pathways, including priority reviews and orphan drug designations, have accelerated drug approval, ensuring rapid market access. The liver cancer therapeutics market in the U.S. dominated the North America market with the largest revenue share in 2024, driven by the increasing investment in pharmaceuticals. The regulatory framework in the U.S. ensures only safe and effective drugs reach the market, which increases trust of patients and healthcare providers in the medicines. Furthermore, the involvement of major players and the launch of novel treatments contribute to its dominance. Regulatory approvals for innovative drugs support market expansion, making the U.S. a leader in liver cancer treatments. This environment fosters continuous innovation and growth. Get Customization in the Report as Per Your Business Requirements: Europe is the second-dominating region in the liver cancer therapeutics market, valued at 34.5% market share in 2024. The liver cancer therapeutics market in Europe is driven by the growing prevalence of hepatitis B and C infections, rising alcohol consumption, and increasing cases of non-alcoholic fatty liver disease (NAFLD). Supportive regulatory approvals for novel immunotherapies, combined with a well-established healthcare infrastructure and government-backed cancer screening programs, are driving the adoption of advanced treatment regimens. In the U.K., a high burden of liver disease linked to obesity, diabetes, and alcohol misuse is accelerating demand for effective HCC treatments. National Health Service (NHS) initiatives to expand early cancer diagnosis, along with faster access schemes for innovative oncology drugs, further drive uptake of immunotherapies and targeted therapies. The Asia-Pacific region in the Liver Cancer Therapeutics Market was valued at 23.5% market share in 2024. This region is witnessing significant growth due to the very high incidence of hepatitis B and C, particularly in China and Southeast Asia, which are leading causes of HCC. Rising investments in healthcare infrastructure, increased clinical trial activity, and expanding patient access to immuno-oncology drugs are driving market growth. In Japan, liver cancer remains a leading cause of cancer mortality, primarily associated with hepatitis virus infections and an ageing population. Strong government support for oncology research, rapid adoption of cutting-edge immunotherapies, and the presence of domestic pharmaceutical players are key factors driving therapeutic innovation and market expansion. For instance, in June 2025, Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K. received supplemental approval for their anti-PD-1 antibody, Opdivo, and BMSKK's anti-CTLA-4 antibody, Yervoy, in combination therapy in Japan to expand their use for treating unresectable hepatocellular carcinoma (HCC), a type of cancer. Purchase This Exclusive Report at Just USD 4350 Only: Key Liver Cancer Therapeutics Companies: Top companies in the liver cancer therapeutics market include AstraZeneca, Bayer AG, Eli Lilly, Bristol-Myers Squibb Company, Eisai Co., Ltd., Genentech and among others. Recent Developments in the Market In September 2025, Akeso, Inc. has dosed the first patient in its Phase II registrational trial, evaluating cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, in combination with lenvatinib for treating advanced hepatocellular carcinoma in patients previously treated with atezolizumab and bevacizumab. In July 2025, Apollo Proton Cancer Centre (APCC) has launched an 'Advanced Liver Cancers Clinic', an integrated clinic for primary liver cancers and liver metastases. Related Reports: Pediatric Oncology Drugs Market Size, Share, Industry, Forecast and Outlook (2024-2031) Cancer Immunotherapy Market Size, Trends & Forecast 2033 Hepatocellular Carcinoma Treatment Market Size, Share, Growth Trends and Forecast Report 2025-2033 About DataM Intelligence 4Market Research: DataM Intelligence 4Market Research is a comprehensive market intelligence platform offering syndicated and customized reports along with expert consulting across multiple industries, including chemicals, healthcare, agriculture, food & beverages, and more. With extensive experience and a strategy-focused approach, DataM provides businesses and individuals with reliable market insights, statistical forecasts, and personalized research solutions to help them make informed decisions and successfully bring innovations to market. To find out more, visit or follow us on Twitter, LinkedIn and Facebook. Contact: Mr. Sai Kiran DataM Intelligence 4market Research LLP Ground floor DSL Abacus IT Park, Industrial Development Area Uppal, Hyderabad, Telangana 500039 USA: +1 877-441-4866 Email: [email protected] Content Source: Visit Our Website: Logo: SOURCE DataM Intelligence 4 Market Research LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

孤儿药临床2期上市批准免疫疗法

2025-09-11

·Abiosciences

肝癌患者福音！联合免疫疗法响应机制被揭示，为临床治疗提供重要依据！

点击蓝字关注我们 Abiosciences 发表期刊：Gut 影响因子：23.1 发表时间：2025年2月18日研究疾病：肝细胞癌（HCC）样本类型：血液样本（用于分析外周血单核细胞和细胞因子）和肿瘤组织样本（用于全外显子测序、单细胞RNA测序、CODEX技术分析等）样本分组：根据无进展生存期（PFS）大于6个月的标准，将患者分为应答者（13人）和非应答者（15人）；此外，还有部分患者接受了局部区域治疗（14人）应用技术： CODEX（16例患者的20个FFPE样本），bulk RNA-seq（23例患者的36个样本），scRNA-seq（17例患者的23个样本），WES（19例患者）研究背景。肝细胞癌（HCC）是癌症相关死亡的主要原因之一，通常在慢性肝炎（包括病毒性和脂肪性肝炎）的背景下发生，许多患者因高复发率而进展到晚期临床阶段。近年来，两种联合免疫疗法已成为晚期HCC的一线治疗选择，但免疫疗法的疗效仍然有限。目前尚缺乏综合研究来深入理解肿瘤免疫微环境（TiME）的空间背景下的免疫反应，以及治疗后的外周免疫反应。本研究旨在通过高维多组学分析，包括全外显子测序、单细胞RNA测序、CODEX、流式细胞术和多因子细胞因子/趋化因子分析，结合临床数据，深入研究接受tremelimumab（anti-CTLA4）和durvalumab（anti-PD-L1）联合治疗的HCC患者的免疫反应，揭示治疗反应机制，并寻找潜在的生物标志物。研究思路研究结论本研究通过对28名接受tremelimumab联合durvalumab治疗的肝细胞癌（HCC）患者的多组学分析，揭示了免疫治疗反应与肿瘤免疫微环境（TiME）中调节性T细胞（Treg）分布的密切关系。研究发现，治疗后响应者的肿瘤组织中干扰素反应增强，且抗原呈递基因集富集，而非响应者的肿瘤组织中Treg细胞数量增加，且这些Treg细胞富集在免疫细胞密集的区域，表达高水平的ICOS和PD-1。空间分析显示，非响应者肿瘤中PD1+CD8+T细胞与Treg细胞的相互作用增强，而响应者肿瘤中则未观察到这种现象。此外，外周血分析显示，响应者的经典单核细胞增加，而非响应者的Treg细胞增加。单患者计算分析从860个特征中识别出包括Treg特征在内的多组学特征集。这些结果强调了Treg细胞在HCC免疫治疗反应中的重要性，并为未来的生物标志物研究和免疫治疗试验提供了新的方向。研究意义本研究通过对肝细胞癌（HCC）患者接受tremelimumab和durvalumab联合治疗的多组学分析，揭示了肿瘤免疫微环境（TiME）中调节性T细胞（Tregs）与CD8+ T细胞的相互作用对治疗反应的重要性。研究发现非应答者肿瘤组织中Tregs的富集可能削弱CD8+ T细胞的抗肿瘤效应，而应答者则表现出更强的炎症反应和抗原呈递特征。此外，研究还通过整合临床数据和多组学特征，开发了一种预测治疗反应的计算流程。这些发现不仅增进了对HCC免疫治疗反应机制的理解，还为未来的生物标志物分析和免疫治疗试验提供了蓝图，可能显著影响HCC患者的临床治疗策略和预后。此外，该研究的方法和发现还可能促进其他癌症类型免疫治疗的研究和应用。百奥锐评 1. 患者队列规模较小：研究中纳入的患者数量有限（n=28），这可能影响结果的统计功效和普遍适用性，使得某些发现可能存在偶然性，难以代表更广泛的患者群体。而且其中一半的患者（n=14）接受了局部区域治疗，这可能引入了额外的变量，影响对治疗反应的准确评估，使得难以区分局部区域治疗与免疫检查点抑制剂治疗的独立效果。 2. 生物标志物结果未在验证队列中验证：由于样本量较小且存在治疗方案的差异，研究中发现的潜在生物标志物结果未能在独立的验证队列中进行验证，限制了这些生物标志物在临床实践中的应用前景和可靠性。原文链接： https://doi.org/10.1136/gutjnl-2024-334026 END 百奥智汇媒体矩阵

免疫疗法临床结果

2025-09-08

·美通社

泰瑞沙联合化疗方案显示出近四年的中位总生存期（OS），这是EGFR敏感突变阳性晚期非小细胞肺癌全球III期临床研究中报道的最长*生存获益

FLAURA2 最终总生存期分析进一步证实了该联合方案有利的获益 - 风险特征以上结果巩固了奥希替尼无论分期，都是 EGFR 突变阳性非小细胞肺癌基石疗法的地位上海 2025年9月8日 /美通社/ -- FLAURA2 III期临床研究最终总生存期（OS）分析的阳性结果显示，阿斯利康泰瑞沙 ® （英文商品名：TAGRISSO ® ，通用名：甲磺酸奥希替尼片，以下简称"奥希替尼"）联合培美曲塞和铂类化疗药物用于具有表皮生长因子受体（EGFR）外显子19缺失或外显子21（L858R）置换突变的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线治疗中，与奥希替尼单药相比，在关键次要研究终点OS上显示出具有统计学意义以及临床意义显著的改善。该结果已于9月7日在西班牙巴塞罗那举行的国际肺癌研究协会（IASLC）2025年世界肺癌大会（WCLC）全体大会上公布（摘要编号#PL02.06）。最终OS分析结果显示，奥希替尼联合化疗组的中位OS接近四年（47.5个月），奥希替尼单药治疗组约为三年（37.6个月）。在57%数据成熟度下，结果显示奥希替尼联合化疗与奥希替尼单药治疗相比，死亡风险降低了23%（基于风险比[HR]为0.77；95%置信区间[CI]为0.61-0.96；p=0.0202）。据估计，联合治疗组中有63.1%的患者在三年时存活，49.1%的患者在四年时存活，而单药治疗组分别为50.9%和40.8%。值得注意的是，奥希替尼联合化疗相较于奥希替尼单药治疗的OS获益在所有预设亚组中均保持一致。对照组患者在疾病进展后接受了包括化疗在内的标准治疗（交叉治疗率72%），进一步支持了OS结果的临床意义。法国古斯塔夫鲁西研究所肿瘤研究所，胸部肿瘤组主任、FLAURA2试验首席研究员，医学博士David Planchard表示："肺癌治疗的根本目标是延长患者的生存时间，同时保障患者的生活质量。这项令人信服的研究结果展示了前所未有的中位总生存期，表明该联合方案能够同时实现这两个目标，并支持奥希替尼，无论是否联合化疗，作为晚期一线EGFR敏感突变阳性非小细胞肺癌患者的标准治疗方案。对于这些患者，现在有两种基于奥希替尼的高效治疗方案，医生可以更好地根据病人的个体需求定制治疗方案，从而确保每位患者获得最佳的治疗效果。" 阿斯利康全球执行副总裁、肿瘤研发负责人高书璨博士（Dr. Susan Galbraith）表示："FLAURA2的最新研究结果表明，奥希替尼联合化疗方案在晚期EGFR敏感突变阳性非小细胞肺癌一线治疗中展现出接近四年的中位总生存期，超越了FLAURA临床研究在此前设立的三年基准线，为肺癌患者带来了新的生存希望。过去十年来，奥希替尼在非小细胞肺癌所有分期的治疗中，持续带来的显著生存获益和可耐受的安全性，巩固了奥希替尼作为EGFR敏感突变阳性非小细胞肺癌基石疗法的地位。" OS 结果总结： FLAURA2 奥希替尼联合化疗 (n=279) 奥希替尼单药 (n=278) 中位OS i, ii, iii ，单位：月 47.5 (41.0-NC iv ) 37.6 (33.2 ,43.2) 风险比(95% CI) 0.77 (0.61-0.96) 分层log-rank检验P值 v 0.0202 死亡病例数n（%） 144 (51.6) 171 (61.5) 数据成熟度 57 % 24个月OS率（%） 79.7 (74.5-84.0) 71.5 (65.8-76.5) 36个月OS率（%） 63.1 (57.1-68.5) 50.9 (44.8-56.6) 48个月OS率（%） 49.1 (43.0-55.0) 40.8 (34.9-46.6) i. OS数据截止日期为 2025 年6 月 12日 ii. 在数据截止时，接受奥希替尼联合化疗治疗的患者中位随访时间为51.2个月（范围0.2-60.4个月），而接受奥希替尼单药治疗的患者中位随访时间为51.3个月（范围0.1-60.1个月） iii. 使用Kaplan–Meier法计算 iv. 无法计算 v. 根据O'Brien和Fleming的消耗规则，统计显著性要求双侧p值小于0.04953。随着随访时间延长，奥希替尼联合化疗的安全性仍可管理，且与各单独药物已知的安全性一致。在所有原因导致的3级或更高级别不良事件（AEs）中，奥希替尼联合化疗组的发生率为70%，主要由特征明确的化疗相关AEs驱动，而奥希替尼单药组为34%，与2023年IASLC WCLC大会上首次公布的主要分析结果（64% vs 27%）相似‌。两组因AEs导致的靶向药物停药率均较低（12% vs 7%）‌。关于非小细胞肺癌（ NSCLC ）肺癌是癌症死亡的主要原因，约占所有癌症死亡病人数的五分之一 ‌1 。肺癌通常分为小细胞肺癌（SCLC）和非小细胞肺癌（NSCLC），其中非小细胞肺癌约占所有肺癌患者的80-85% 2‌ 。大部分（约75%）非小细胞肺癌患者在确诊时已是晚期。 3 美国和欧洲的非小细胞肺癌患者中约有10-25％存在EGFR突变，而亚洲患者中该比例则高达30-40% 4-6 。尽管EGFR酪氨酸激酶抑制剂（TKI）显著改善了一线治疗的疗效，但耐药机制和疾病进展极为常见，在后续治疗方案中对有效且耐受性良好的治疗选择上仍存在着重大的未满足需求 7-10 。关于 FLAURA2 研究 FLAURA2是一项随机对照、开放标签、全球多中心的III期试验，对局部晚期(IIIB-IIIC期)或转移性(IV期)EGFR突变（19del/21L858R）的非小细胞肺癌患者进行一线治疗。试验组患者接受奥希替尼80mg每日一次口服片剂联合化疗（培美曲塞（500mg/m2）加顺铂（75mg/m2）或卡铂（AUC5）），每三周一次，持续四个周期，随后每三周接受一次泰瑞沙联合培美曲塞维持治疗，对照组患者接受奥希替尼80mg每日一次口服。该研究共入组557例患者，在全球包括美国、欧洲、南美和亚洲在内的150多个研究中心开展。主要终点为无进展生存期（PFS），总生存期（OS）为关键次要终点。关于奥希替尼奥希替尼是一种不可逆的第三代EGFR-TKI，在治疗非小细胞肺癌（包括伴中枢神经系统转移）患者中有确证的临床活性。奥希替尼（40mg和80mg每日一次口服片剂）在全球获批的各种适应症已治疗了超过100万名患者。阿斯利康正继续探索奥希替尼用于治疗不同疾病分期的EGFR突变非小细胞肺癌患者。奥希替尼已在包括美国、欧盟、中国和日本在内的120多个国家获批作为单药疗法使用。获批适应症包括：一线治疗局部晚期或转移性EGFR突变（19del/21L858R）阳性非小细胞肺癌患者；局部晚期或转移性既往EGFR-TKI治疗失败伴EGFR T790M突变阳性NSCLC患者的治疗；早期EGFRm（19del/21L858R）NSCLC患者的辅助治疗；以及局部晚期、不可切除EGFRm（19del/21L858R） NSCLC患者在接受含铂化疗放疗（CRT）后的治疗。泰瑞沙联合化疗方案已在包括美国、欧盟、中国和日本在内的80多个国家获批，用于一线治疗局部晚期或转移性EGFRm NSCLC患者‌。有大量证据支持奥希替尼作为 EGFR突变非小细胞肺癌的推荐治疗，它是目前唯一*一个证实可改善各个分期非小细胞肺癌患者临床结局的靶向疗法。在晚期患者中，奥希替尼在FLAURA III期研究中作为单药疗法，以及在FLAURA2 III期研究中联合化疗，均显示出临床结局改善。在晚期患者中，奥希替尼与赛沃替尼联合疗法的SAFFRON III期研究，以及与DATROWAY®（达托泊单抗或Dato-DXd）联合疗法的TROPION-Lung14和TROPION-Lung15 III期研究正在进行中。奥希替尼在针对早期患者的NeoADAURA和ADAURA III期研究以及针对局部晚期患者的LAURA III期研究中，均改善了患者的临床结局。作为阿斯利康持续承诺治疗早期肺癌的重要组成部分，ADAURA2 III期研究正在进行中，评估奥希替尼用于早期可切除辅助治疗。关于阿斯利康在肺癌领域的研究阿斯利康正致力于通过早诊早治提高肺癌患者的治愈率，同时推动相关技术不断向前发展，以改善耐药患者和晚期患者的治疗结局。通过定义新的治疗靶点和评价创新疗法，阿斯利康致力于实现将最合适的药物用于能最大化获益的患者。公司丰富的产品组合包括领先的肺癌药物以及下一阶段的创新药物，包括奥希替尼和吉非替尼；度伐利尤单抗和tremelimumab；与第一三共合作开发的德曲妥珠单抗和德达博妥单抗；与和黄医药合作开发的赛沃替尼；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，该全球性联盟致力于加快创新步伐，并为肺癌患者提供包括治疗和治疗以外的具有意义的改善措施。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。阿斯利康的肿瘤业务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领先全行业的多元化产品组合和渠道，持续推动医疗实践变革，改变患者体验。阿斯利康的愿景旨在重新定义癌症治疗，以期未来终结癌症这一致死之因。关于阿斯利康阿斯利康(LSE/STO/Nasdaq: 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 。关于阿斯利康中国阿斯利康自1993年进入中国以来，专注中国患者需求最迫切的治疗领域，包括肿瘤、心血管、肾脏、代谢、呼吸、消化、罕见病、疫苗抗体及自体免疫等，已将40多款创新药物带到中国。阿斯利康中国总部位于上海，并在上海和北京设立全球战略研发中心，在北京、广州、杭州、成都、青岛设立区域总部，在无锡、泰州、青岛建立全球生产供应基地，向全球70多个市场输送优质创新药品。 * 截至 2025.09.08 ，用 EGFR-TKI 和 OS 作为关键词在 PubMed 和 MEDLINE 数据库中检索全部时间范围内的 RCT 研究声明：本文涉及未在中国获批的产品或者适应症，阿斯利康不推荐任何未被批准的药物使用。参考文献 1. World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed August 2025. 2. American Cancer Society. What Is Lung Cancer?. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2025. 3. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine . 2021;100(6):e24688. 4. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol . 2011:29;2121-27. 5. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol . 2013;6:2800-2812. 6. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol . 2013;66:79-89. 7. Chen R, et al. Emerging therapeutic agents for advanced non-small cell lung cancer. J Hematol Oncol . 2020;13(1):58. 8. Majeed U, et al. Targeted therapy in advanced non-small cell lung cancer: current advances and future trends. J Hematol Oncol . 2021;14(1):108. 9. Morgillo F, et al. Mechanisms of resistance to EGFR-targeted drugs: lung cancer. ESMO Open . 2016;1(3):e000060. 10. Han B, et al. Efficacy of pemetrexed-based regimens in advanced non-small cell lung cancer patients with activating epidermal growth factor receptor mutations after tyrosine kinase inhibitor failure: a systematic review. Onco Targets Ther . 2018;11:2121-2129.

临床3期临床结果临床成功

100 项与曲美木单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D06657	曲美木单抗	-	DB11771

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

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,

后查看更多信息

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

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03298451 (HIMALAYA, Pubmed \| J Hepatol)	临床3期	不可切除的肝细胞癌	-	STRIDE (Tremelimumab plus Durvalumab)	積憲遞遞鹹簾繭餘鹽鹹(糧構製鹹觸觸糧憲艱齋) = 製憲餘廠選淵製廠膚築範製選餘壓願淵構壓觸 (鬱蓋憲顧壓齋製鑰顧製 )	积极	2025-10-01
				Sorafenib	積憲遞遞鹹簾繭餘鹽鹹(糧構製鹹觸觸糧憲艱齋) = 鬱夢鏇製膚鑰構壓鏇壓範製選餘壓願淵構壓觸 (鬱蓋憲顧壓齋製鑰顧製 )
NCT03518606 (MOVIE, Pubmed \| Breast)	临床2期	晚期乳腺癌 ER Negative \| PR Negative \| HER2 Negative	30	Tremelimumab plus Durvalumab combined to metronomic oral Vinorelbine	鹽廠襯淵餘艱鹹憲襯膚(願淵製獵襯窪築鏇壓衊) = 鑰築製網淵願糧膚構積構遞齋夢製鹹製窪選簾 (製鑰遞淵鹹遞願鏇簾選, 5.5 ~ 29.8) 更多	不佳	2025-10-01
NCT03638141 (CTgov)	临床2期	肝细胞癌	21	Tremelimumab+Durvalumab	窪鹽簾鏇鹽蓋窪簾鬱願 = 築鬱衊窪齋願齋襯遞夢齋糧簾齋憲簾製艱鏇鹹 (範壓膚構獵遞鏇鏇顧築, 齋齋鏇襯構夢網願齋齋 ~ 繭衊鏇蓋廠窪壓夢鹽簾) 更多	-	2025-08-17
NCT03703297 (ADRIATIC, CTgov)	临床3期	局限期小细胞肺癌	730	Durvalumab (Durvalumab)	壓鹹餘夢夢醖選鹽願淵(糧廠簾艱製憲觸夢蓋鬱) = 簾蓋構夢選夢鏇構繭選製淵衊積簾壓構鑰鬱憲 (簾選艱願築醖襯積構憲, 簾鬱鏇鬱遞顧製淵簾鑰 ~ 鬱製襯鹽構襯遞鏇醖衊) 更多	-	2025-08-01
				placebo (Placebo)	壓鹹餘夢夢醖選鹽願淵(糧廠簾艱製憲觸夢蓋鬱) = 鹽淵鬱顧築夢餘鬱繭選製淵衊積簾壓構鑰鬱憲 (簾選艱願築醖襯積構憲, 觸範願簾壓範選鑰艱獵 ~ 製壓夢願膚餘襯衊壓鏇) 更多
HIMALAYA Trial (ESMO_GI2025)	N/A	-	233	Durvalumab+Tremelimumab	顧願衊襯艱鑰繭簾淵憲(鑰廠醖網範膚構鏇淵選) = 鏇網壓獵願憲願積襯憲獵範鬱淵獵廠憲壓醖窪 (簾膚窪膚製廠選網廠遞, 43.2 ~ 73.9) 更多	积极	2025-07-03
				Durvalumab	膚餘遞願遞醖積醖鏇選(憲窪夢遞餘簾獵壓醖鹽) = 夢繭遞壓獵製窪襯顧鹽醖衊鏇醖餘糧鹽淵構鏇 (網觸醖鬱衊鏇鹽襯鏇鬱, 8.0 ~ NR) 更多
NCT02815995 (CTgov)	临床2期	卡波西肉瘤 \| 晚期肉瘤	57	Tremelimumab+Durvalumab (Adipocytic Tumors Group)	鑰糧淵壓艱襯構製淵艱 = 願簾淵鹹壓鹽蓋簾蓋淵夢壓醖鑰壓壓壓遞壓鏇 (夢積製餘願觸顧膚鏇願, 願餘醖衊鹹淵淵繭鹽構 ~ 選鬱築齋鑰鹽網襯衊艱) 更多	-	2025-06-12
				Tremelimumab+Durvalumab (Vascular Tumors Group)	鑰糧淵壓艱襯構製淵艱 = 醖積製願齋窪範遞遞簾夢壓醖鑰壓壓壓遞壓鏇 (夢積製餘願觸顧膚鏇願, 齋觸簾襯艱糧範鏇積簾 ~ 網遞襯顧顧顧襯膚醖繭) 更多
NCT02821754 (2019-002767-98, Pubmed \| Gut)	临床2期	肝细胞癌 interferon responses \| antigen presentation \| ICOS ... 更多	28	Tremelimumab plus Durvalumab	選繭夢製構遞艱製艱淵(繭鹹餘廠網膚遞鏇築積) = 鏇膚製鬱夢製範鹹鏇餘網積製範鏇醖醖淵餘衊 (積憲鏇餘憲膚鏇構構鑰 )	-	2025-06-01
NCT05844046 (AIO-MONTBLANC, ASCO2025)	临床2期	不可切除的肝细胞癌一线 Child-Pugh A \| AFP ≥400 ng/mL	70	Durvalumab + Tremelimumab	壓膚積鹹積廠選鏇膚積(壓壓齋糧構鏇鏇遞繭網) = 鹽壓鬱構鏇製窪廠廠鹹遞夢積鹹製淵鏇糧鬱壓 (繭願醖鹽醖簾觸製構衊 ) 更多	积极	2025-05-30
ACTRN12617001325392 (BCT1703 DIAmOND, ESMO_BC 12025 \| ESMO_BC 22025) 人工标引	临床2期	晚期 HER2 阳性乳腺癌	68	Total	襯鏇夢艱膚餘鹽鹽顧憲(繭顧選淵醖齋構鑰膚膚) = 簾鬱衊獵範繭選艱鬱積願膚鹹鏇遞願夢壓選齋 (網觸獵範壓鏇夢衊獵獵 ) 更多	积极	2025-05-16
				tremelimumabtremelimumab 75mg with durvalumab 1500mg Q4Wdurvalumab 1500mg Q4W and Trastuzumab 2mg/kg Q1W for 12 weeks with ongoing Q3W durvalumab 1120mgTrastuzumab 2mg/kg Q1W for 12 weeks with ongoing Q3W durvalumab 1120mg and Trastuzumab 6mg/kg (C1, estrogen receptor (ER)-positive (≥1%))	襯鏇夢艱膚餘鹽鹽顧憲(繭顧選淵醖齋構鑰膚膚) = 構觸襯窪廠築積憲願蓋願膚鹹鏇遞願夢壓選齋 (網觸獵範壓鏇夢衊獵獵 ) 更多
NCT03164616 (POSEIDON, ESMO_ELCC2025)	临床3期	转移性非小细胞肺癌一线 EGFR/ALK wild-type	175	Durvalumab + Tremelimumab + Chemotherapy	願製膚餘製壓艱範觸窪(積鹽餘餘鬱夢網獵鬱簾) = D+T+CT demonstrated statistically significant improvements in both progression-free survival (PFS; HR 0.72; 95% CI 0.60-0.86; p = 0.0003) and overall survival (OS; HR 0.77; 95% CI 0.65-0.92; p = 0.0030) vs CT alone, leading to approvals for this regimen. D+CT significantly improved PFS vs CT (0.74; 95% CI 0.62-0.89; p = 0.0009), with a positive trend for OS improvement (HR 0.86; 95% CI 0.72-1.02; p = 0.0758) 糧觸憲簾築夢製蓋襯窪 (網蓋鏇壓醖範衊餘憲憲 ) 更多	积极	2025-03-26
				Durvalumab + Chemotherapy