预约演示

更新于：2025-05-07

Durvalumab

度伐利尤单抗

更新于：2025-05-07

概要

基本信息

药物类型

单克隆抗体

别名

Durvalumab (Genetical Recombination)、Durvalumab (genetical recombination) (JAN)、Durvalumab (USAN/INN)

+ [10]

靶点

PDL1

作用方式

抑制剂

作用机制

PDL1抑制剂(程序性死亡配体1抑制剂)

治疗领域

肿瘤消化系统疾病呼吸系统疾病+ [11]

在研适应症

肌层浸润性膀胱癌子宫癌晚期子宫内膜癌+ [195]

非在研适应症

急性髓性白血病晚期头颈癌侵袭性 B 细胞非霍奇金淋巴瘤+ [59]

原研机构

在研机构

+ [17]

非在研机构

Circio Holding ASA

Plexxikon, Inc.

Fred Hutchinson Cancer Research Center

+ [5]

权益机构

MedImmune Pharma BV

Ultimovacs ASAVall d'Hebron Institut d'Oncologia

+ [15]

最高研发阶段批准上市

首次获批日期

美国 (2017-05-01),

尿路上皮癌

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、孤儿药 (美国)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、加速批准 (美国)、突破性疗法 (美国)

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结构/序列

Sequence Code 10069506H

来源: *****

Sequence Code 13384675L

来源: *****

关联

862

项与度伐利尤单抗相关的临床试验

NCT05403723

/ Suspended临床1期IIT

A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination with Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).

开始日期2025-12-31

申办/合作机构

University of Maryland Baltimore

[+1]

NCT06769126

/ Not yet recruiting临床2期IIT

PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab With or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)

This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests look for certain features in cancer cells that may give doctors more information about what is driving cancer and how to treat it. Based on the biomarker test results, study doctors can determine the subtype of ES-SCLC that study treatments can target. This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.

开始日期2025-09-08

申办/合作机构

SWOG

[+1]

NCT06904170

/ Not yet recruiting临床2/3期IIT

An Integrated Phase II/III Randomized Study Comparing Durvalumab and Tremelimumab +/- Hepatic ArteriaL Infusion Chemotherapy With GEMOX in Hepatocellular Carcinoma With High Tumor burdEn

Liver cancer is a highly lethal malignancy and has become increasingly important in western countries. The management of liver cancer is complex. In advanced disease, two combinations of immunotherapies are recommanded as first line (atezolizumab-bevacizumab or durvalumab-tremelimumab). Results in patients with high tumor burden (Portal vein thrombosis Vp3 or Vp4, or tumoral liver involvement >50%) are less impressive. Innovative combinations are necessary to improve the outcome of patients.
Recently, control trials conducted in Asia highlighted the benefit of hepatic arterial infusion chemotherapy, especially in patients with high tumor burden. Studies including a limited number of patients shown that the combination seems feasible.
ALICE is a randomized multicentric Phase II/Phase III trial conducted in French medical centers, evaluating the efficacy and safety of durvalumab+tremelimumab with or without Hepatic Arterial Infusion Chemotherapy of the GEMOX regimen (gemcitabine + oxaliplatin), in patients with high tumor burden.
Oxaliplatin induce immunogenic cell death, and gemcitabin deplete regulatory immune cells. The GEMOX regimen thus has the potential for a synergic effect with immunotherapy in HCC.
The trial will provide an innovative treatment to patients with no alternative for locoregional treatment, and with limited results with actual systemic treatments. It will also be the first trial of Hepatic Arterial infusion for such patients in the western population.

开始日期2025-09-01

申办/合作机构

UNICANCER

[+1]

100 项与度伐利尤单抗相关的临床结果

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100 项与度伐利尤单抗相关的转化医学

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100 项与度伐利尤单抗相关的专利（医药）

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4,897

项与度伐利尤单抗相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

From PD-1/PD-L1 to tertiary lymphoid structures: Paving the way for precision immunotherapy in cholangiocarcinoma treatment

Review

作者: Fang, Ye-Ying ; Chen, Gang ; Huang, Fang-Ju ; He, Rong-Quan ; Su, Qin-Yan ; Wen, Jia-Ying ; Li, Jian-Jun ; Qin, Di-Yuan ; Chi, Bang-Teng ; Chen, Yi-Yang ; Zeng, Jian-Jia ; Wang, Lei ; Yang, Li-Hua ; Lin, Qian

Cholangiocarcinoma (CCA) is a highly malignant hepatobiliary tumor characterized by limited treatment options and poor prognosis. The recent rise of immunotherapy has significantly influenced research in this field. This study presents a bibliometric analysis of 416 articles retrieved from the WOSCC, Wan fang Data, CNKI and VIP databases, spanning contributions from 32 countries, 589 institutions and 3,200 authors. The analysis identified "PD-L1," "PD-1" and "pembrolizumab" as central research foci, while "immune checkpoint inhibitors," "tumor immune microenvironment," "tertiary lymphoid structures" and "durvalumab" emerged as key areas of interest. These findings emphasize the pivotal role of immunotherapy in improving survival outcomes for CCA, and they highlight the significance of tertiary lymphoid structures within the tumor microenvironment as a promising target for future research. This study offers a strategic overview of the evolving landscape of CCA immunotherapy, providing valuable insights to guide future scientific endeavors in this domain.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of perioperative nivolumab + neoadjuvant platinum doublet chemotherapy as treatment for resectable non-small cell lung cancer in the United States

Article

作者: Milev, Sandra ; White, Benjamin ; Harris, Mack ; Sun, Ariel ; Lucherini, Stefano ; Villacorta, Reginald

AIMS:

CheckMate-77T demonstrated the clinical benefit of perioperative nivolumab plus neoadjuvant platinum-doublet chemotherapy (periNivo + neoCT). This study assessed the cost-effectiveness of periNivo + neoCT as treatment for non-metastatic (Stage IIA-IIIB), resectable non-small cell lung cancer (NSCLC) vs. relevant comparators in the US.

MATERIALS AND METHODS:

Following the natural history of non-metastatic NSCLC, a four-state Markov model was developed. Modeled health states were event-free survival, locoregional recurrence, distant metastasis, and death. CheckMate-77T informed time to progression estimates for periNivo + neoCT and neoCT; mortality estimates leveraged longer-term follow-up available from CheckMate-816. Indirect treatment comparison informed efficacy of comparator treatments not considered in CheckMate-77T. Comparators were neoadjuvant treatment strategies (neoadjuvant nivolumab + chemotherapy [neoNivo + CT], neoadjuvant chemotherapy [neoCT], and neoadjuvant chemoradiotherapy [neoCRT]), adjuvant chemotherapy (adjCT), and perioperative immuno-therapy (IO) strategies (perioperative durvalumab + neoadjuvant chemotherapy [periDurva + neoCT] and perioperative pembrolizumab + neoadjuvant chemotherapy [periPembro + neoCT]). Cost inputs were obtained from published literature and standard US sources and expressed in 2024 USD. The base-case analysis adopted the perspective of a commercial payer with a lifetime time horizon and discounted cost and health outcomes by 3% annually.

RESULTS:

Model results showed that periNivo + neoCT is more effective and costly than comparators. Deterministic incremental cost-effectiveness ratios were $84,921, $153,557, $77,976, $60,826, $74,252, $32,069, and $21,974 vs. neoCT, neoNivo + CT, neoCRT, adjCT, surgery, periPembro + neoCT, and periDurva + neoCT, respectively. In probabilistic sensitivity analysis, periNivo + neoCT resulted in an ICER below $150,000/QALY in 93.3%, 58.2%, 82.4%, 95.1%, 98.3%, 69.9%, and 82.1% of iterations vs. neoCT, neoNivo + CT, neoCRT, adjCT, surgery only, periPembro + neoCT, and periDurva + neoCT, respectively.

LIMITATIONS:

Uncertainty in the survival extrapolations reflected the limited body of evidence informing the indirect treatment comparison. ICERs vs. perioperative IO treatment strategies were sensitive to small changes in predicted costs and QALYs, given low incremental base case costs and QALYs.

CONCLUSION:

PeriNivo + neoCT is a cost-effective treatment option for patients with resectable, non-metastatic NSCLC.

2025-12-31·Human Vaccines & Immunotherapeutics

Fundamental knowledge and research regarding the role of immunity in triple-negative breast cancer from 2014–2024: A bibliometric analysis

Article

作者: Ren, He ; Cui, Lina ; Chen, Kexin ; Li, Xudong ; Lou, Chun

Immunity has vital research value and promising applications in triple-negative breast cancer (TNBC). Nevertheless, few bibliometric analyses have systematically investigated this area. This study aimed to comprehensively review the collaboration and impact of countries, institutions, authors, and journals on the role of immunity in TNBC from a bibliometric perspective, evaluate the keyword co-occurrence of the knowledge structure, and identify hot trends and emerging topics. Articles and reviews related to immunity in TNBC were retrieved from the Web of Science core collection using subject search. A bibliometric study was conducted primarily using CiteSpace and VOSviewer. A total of 3,104 articles and reviews were included from January 1, 2014, through December 31, 2024. The number of articles on immunization in TNBC is rising. These publications are mainly from 415 institutions in 82 countries, led by China and the USA. Among these publications, Lajos Pusztai published the most papers, while Peter Schmid was co-cited the most. The most productive journals focused on molecular biology, biological immunology, and clinical medicine. Furthermore, co-citation analysis revealed that tumor microenvironment, biomarkers, and immune checkpoint inhibitors are current and developing research areas. The keywords "immunotherapy" and "nanoparticles" are also likely to be new trends and focal points for future research. This study adopted bibliometric and visualization methods to provide a comprehensive review of the research on immunization in TNBC. This article will help researchers better understand the dynamic evolution of the role of immunity in TNBC and identify areas for future research.

1,562

项与度伐利尤单抗相关的新闻（医药）

17 小时之前

·ioncology

肺癌领域中国之声亮相ASCO 2025，最新成果瞭望聚焦丨ASCO 2025

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”ASCO 2025 微专辑扫描二维码可查看更多内容2025年美国临床肿瘤学会（ASCO）年会定于5月30日至6月3日（美国东部时间，ET）在美国芝加哥举办。作为全球规模最大、学术水平最高且最具权威性的临床肿瘤学盛会，ASCO年会汇聚了全球肿瘤学领域的医生、专业人士、患者倡导者、工业界代表以及主流媒体，共同聚焦国际前沿的研究发现与临床试验成果。近日，大会官网公布了最新摘要题目信息，其中肺癌领域70余项来自中国的研究成果入选。《肿瘤瞭望》特此整理，以飨读者。口头摘要会议非小细胞肺癌（NSCLC）摘要号：LBA8004英文标题:R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy.中文标题：R-ALPS研究：一项随机、双盲、安慰剂对照、多中心III期临床试验，旨在评估贝莫苏拜单抗（TQB2450）联合或不联合安罗替尼作为维持治疗，在同步或序贯放化疗后未进展的局部晚期不可切除（III期）非小细胞肺癌患者中的疗效汇报者：陈明教授 | 中山大学肿瘤防治中心摘要号：LBA8502英文标题:CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC): A randomized, single-blind, multicenter phase 3 study.中文标题:CAMPASS 研究：Benmelstobart联合anlotinib对比帕博利珠单抗一线治疗晚期非小细胞肺癌（aNSCLC）：一项随机、单盲、多中心 3 期研究汇报者:韩宝惠教授｜上海市胸科医院摘要号：LBA8505英文标题:Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study.中文标题:SACHI Ⅲ期研究：赛沃替尼联合奥希替尼对比化疗用于 EGFR 突变且 MET 扩增的晚期NSCLC患者（在 EGFR TKI治疗失败后）的随机对照结果汇报者:陆舜教授｜上海市胸科医院摘要号：3001英文标题:Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with driver genomic alterations (GA) outside of classic EGFR mutations.中文标题:BL-B01D1（iza-bren）治疗携带经典EGFR突变以外驱动基因改变的局部晚期或转移性非小细胞肺癌的I期临床研究：一种靶向EGFR×HER3的双特异性ADC的评估汇报者:杨云鹏教授 | 中山大学肿瘤防治中心摘要号：8504英文标题:SOHO-01: Safety and efficacy of BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) who were pretreated but na?ve to HER2-targeted therapy or had not received any treatment for advanced disease.中文标题:SOHO-01：BAY 2927088 在既往接受治疗但未接受过 HER2 靶向治疗或对晚期疾病尚未进行任何治疗的 HER2 突变NSCLC患者中的安全性与疗效研究汇报者:Herbert H. Loong | 香港中文大学摘要号：8506英文标题:Patritumab deruxtecan (HER3-DXd) in resistant EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) after a third-generation EGFR TKI: The phase 3 HERTHENA-Lung02 study.中文标题:HERTHENALung02 Ⅲ期研究：Patritumab deruxtecan（HER3DXd）用于对三代 EGFR TKI 耐药的 EGFR 突变晚期NSCLC患者汇报者:莫树锦教授 | 香港中文大学摘要号：8507英文标题:Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.中文标题:OptiTROPLung03：芦康沙妥珠单抗在既往治疗过的 EGFR 突变晚期NSCLC患者中的应用——随机对照研究结果汇报者:张力教授｜中山大学肿瘤防治中心小细胞肺癌（SCLC）及其他胸部肿瘤摘要号：3002英文标题:Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic small cell lung cancer (SCLC).中文标题:iza-bren（BL-B01D1），一种EGFR x HER3双特异性抗体驱动药物偶联物（ADC），在局部晚期或转移性小细胞肺癌（SCLC）患者中的I期研究。汇报者:黄岩教授 | 中山大学肿瘤防治中心摘要号：8007英文标题:A phase 2 dose expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer.中文标题:ZG006治疗晚期小细胞肺癌的II期剂量扩展研究：靶向CD3/DLL3/DLL3的三特异性T接合器单药疗法评估汇报者:艾星浩教授｜上海市胸科医院快速口头摘要会议非小细胞肺癌（NSCLC）摘要号：8012英文标题:The preliminary results of a randomized phase II trial evaluating induction toripalimab plus chemotherapy followed by concurrent chemoradiotherapy and consolidation toripalimab in bulky unresectable stage III non-small-cell lung cancer (InTRist).中文标题:InTRist研究：特瑞普利单抗联合化疗诱导治疗序贯同步放化疗+特瑞普利单抗巩固治疗用于不可切除、肿块型III期NSCLC的随机II期研究初步结果汇报者:Yu Wang 教授｜中国医学科学院北京协和医学院肿瘤医院摘要号：8514英文标题:Phase 3 study of benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC).中文标题:评估贝莫苏拜单抗联合化疗，序贯安罗替尼一线治疗局部晚期或转移性鳞状非小细胞肺癌（sq-NSCLC）的疗效的III期临床研究汇报者:石远凯教授｜中国医学科学院肿瘤医院摘要号：8516英文标题:Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer.中文标题:评估免疫化疗给药时间对非小细胞肺癌患者无进展生存期和总生存期影响的随机临床试验汇报者:张永昌教授｜湖南省肿瘤医院摘要号：8517英文标题:Hypoxia-responsive CEA CAR-T cells therapy for relapsed or refractory non-small cell lung cancer: A single-arm, open-label, phase I trial.中文标题:缺氧响应性CEA CAR-T细胞治疗复发或难治性非小细胞肺癌：一项单臂、开放标签的I期临床试验汇报者:魏双教授｜华中科技大学同济医学院附属同济医院摘要号：8520英文标题:Sosimerasib monotherapy in patients with previously treated KRAS G12C–mutated non-small cell lung cancer: Primary results of a phase 2 study.中文标题:Sosimerasib单药治疗KRAS G12C突变非小细胞肺癌的II期研究主要结果汇报者:王洁教授｜中国医学科学院肿瘤医院小细胞肺癌（SCLC）及其他胸部肿瘤摘要号：8017英文标题:Integrin αVβ3-targeted imaging for identification of lung cancer and mapping of lymph-node metastases: A prospective, multicenter, self-controlled phase 3 trial (TRIIL study).中文标题:靶向整合素αVβ3显像在肺癌识别及淋巴结转移图谱绘制中的应用：TRIIL前瞻性、多中心、自身对照III期研究汇报者:Rongxi Wang 教授｜北京协和医院临床科学研讨会非小细胞肺癌（NSCLC）摘要号：8509英文标题:First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC).中文标题:IBI363（首创PD-1/IL-2双特异性抗体）治疗经免疫治疗后的晚期非小细胞肺癌患者汇报者:周建娅教授｜浙江大学医学院附属第一医院小细胞肺癌（SCLC）及其他胸部肿瘤摘要号：8510英文标题:Efficacy and safety of MHB088C, a novel B7-H3-targeted ADC, in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC): Subgroup analysis from a phase 1/2 multicenter study.中文标题:一项关于MHB088C（新型B7-H3靶向ADC）治疗复发广泛期小细胞肺癌的疗效与安全性的I/II期多中心研究的亚组分析汇报者:沈琳教授｜北京大学肿瘤医院摘要号：8511英文标题:First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line treatment (1L) in unresectable malignant mesothelioma.中文标题:BNT327/PM8002联合化疗一线治疗不可切除恶性间皮瘤的II期临床试验初步疗效与安全性结果的首次报告汇报者:程颖教授｜吉林省肿瘤医院壁报环节非小细胞肺癌（NSCLC）摘要号：1557壁报编号：343英文标题:Biologically interpretable pathomics-driven transformer model with self-supervised training for outcome prediction of immunotherapy in non-small cell lung cancer.中文标题:一种基于生物可解释的病理组学驱动的自我监督训练的转换器模型，用于预测非小细胞肺癌免疫治疗的结果。汇报者:李步托教授 | 山东省肿瘤医院摘要号：2530壁报编号：177英文标题:Comprehensive analysis of NSAIDs use and oncological outcomes in non-small cell lung cancer patients treated with immune checkpoint inhibitors.中文标题:免疫检查点抑制剂治疗非小细胞肺癌患者非甾体抗炎药使用和肿瘤预后的综合分析。汇报者: Yanlin Li | 西安交通大学第二附属医院摘要号：2552壁报编号：199英文标题:Precision medicine research on chemo-immunotherapy combination treatment for locally advanced or metastatic non-small cell lung cancer based on deep plasma proteomics.中文标题:基于深度血浆蛋白质组学的局部晚期或转移性非小细胞肺癌化疗-免疫联合治疗的精准医学研究。汇报者: Qiuchi Chen | 华中科技大学同济医学院附属协和医院摘要号：2614壁报编号：261英文标题:Stereotactic radiotherapy plus immunotherapy and influence on prognosis in driver-gene–negative non-small cell lung cancer patients with brain oligo-metastases.中文标题:立体定向放疗加免疫治疗对驱动基因阴性非小细胞肺癌脑少转移患者预后的影响。汇报者: 宫晓梅教授 | 上海市肺科医院摘要号：2623壁报编号：270英文标题:Delineation of immunotherapeutic predictive versus prognostic transcriptional programs to identify SLC22A5-centric carnitine metabolism-driven resistance to anti-PD-L1 treatment in advanced non–small-cell lung cancer.中文标题:鉴定晚期非小细胞肺癌中免疫治疗预测性与预后性转录程序，揭示 SLC22A5 为中心的肉碱代谢驱动的抗 PD-L1 治疗耐药机制。汇报者: Yuze Wang | 中山大学附属第一医院摘要号：3075壁报编号：390英文标题:Efficacy and safety of distinct regimens for individuals with advanced EGFR-mutated non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitors: A systematic review and network meta-analysis.中文标题:不同方案对晚期EGFR突变的非小细胞肺癌患者的疗效和安全性：一项系统综述和网络荟萃分析。汇报者: 张文刚教授 | 上海市肺科医院摘要号：8021壁报编号：142英文标题:Adjuvant icotinib of 12 months versus observation as adjuvant therapy for completely resected EGFR-mutated stage IB non-small-cell lung cancer: 5-year update from CORIN (GASTO1003).中文标题:12个月的埃克替尼辅助治疗对比观察疗法辅助治疗完全切除的EGFR突变IB期NSCLC：CORIN研究（GASTO1003）的5年更新汇报者:王思愚教授｜中山大学孙逸仙纪念医院深汕中心医院摘要号：8024壁报编号：145英文标题:Ensartinib as postoperative adjuvant therapy in patients with ALK-positive non-small cell lung cancer (NSCLC): A registered, retrospective, real-world study.中文标题:恩沙替尼作为术后辅助治疗在ALK阳性NSCLC患者中的应用：一项注册的、回顾性的真实世界研究汇报者:汪麟教授｜中国医学科学院肿瘤医院摘要号：8025壁报编号：146英文标题:Molecular profiling of neoadjuvant immunochemotherapy and identification of residual cancer cells in pCR NSCLC: A single-cell analysis of CTONG 1804 clinical trial.中文标题:新辅助免疫化疗的分子特征分析及在病理完全缓解（pCR）的NSCLC中残留癌细胞的识别：CTONG 1804临床试验的单细胞分析汇报者:刘思阳教授 | 广东省人民医院摘要号：8043壁报编号：164英文标题:Safety and efficacy of radiotherapy combined with anlotinib in locally advanced non-small cell lung cancer patients intolerant to concurrent chemoradiotherapy: Preliminary result of a phase II clinical trial.中文标题:放疗联合安罗替尼治疗不能耐受同步放化疗的局部晚期NSCLC患者的疗效和安全性: 一项II期临床试验的初步结果汇报者:Yupei Yuan | 中国医学科学院肿瘤医院摘要号：8045壁报编号：166英文标题:Neoadjuvant immunotherapy and surgery in patients with stage IIIB-IIIC (N3) non-small cell lung cancer.中文标题:新辅助免疫治疗和手术用于IIIB-IIIC期（N3）NSCLC患者汇报者:Wen-Yu Zhai | 中山大学肿瘤防治中心摘要号：8049壁报编号：170英文标题:A prospective, single-arm, phase II study to evaluate the efficacy and safety of perioperative tislelizumab in resectable non-small-cell lung cancer (NSCLC).中文标题:一项用于评估替雷利珠单抗围术期治疗可切除NSCLC的疗效和安全性的前瞻性、单臂、II期研究汇报者:孙大强教授 | 天津市胸科医院摘要号：8062壁报编号：183英文标题:Differential prognostic significance of distant and locoregional recurrence on survival in surgically resected non-small cell lung cancer post-chemotherapy: Multicenter dynamic prediction with landmark model.中文标题:手术切除的NSCLC化疗后远处和局部复发对生存的差异预后意义: landmark模型的多中心动态预测。汇报者:马泽良教授 | 国家癌症中心摘要号：8063壁报编号：184英文标题:Neoadjuvant hypofractionated radiotherapy plus tislelizumab with anlotinib followed by adjuvant tislelizumab with anlotinib in patients with resectable non-small cell lung cancer (NSCLC): Preliminary analysis of a phase II trial (NEO-PIONEER).中文标题:可切除NSCLC患者接受新辅助低分次放疗联合替雷利珠单抗和安罗替尼治疗，随后进行替雷利珠单抗和安罗替尼辅助治疗：II期NEO-PIONEER研究的初步分析。汇报者:方敏教授 | 浙江省肿瘤医院摘要号：8073壁报编号：194英文标题:Sequential versus concurrent strategy of immunotherapy and radiotherapy in advanced non-small-cell lung cancer: A territory-wide multicenter study (OCEANUS study).中文标题:晚期NSCLC免疫治疗和放疗的序贯与同期策略：一项全地区多中心研究（OCEANUS研究）。汇报者:Han Zhou | 香港大学深圳医院摘要号：8076壁报编号：197英文标题:A retrospective study of induction immunochemotherapy followed by definitive chemoradiotherapy and consolidation immunotherapy in unresectable locally advanced non-small cell lung cancer.中文标题:一项关于不可切除的局部晚期NSCLC的回顾性研究：诱导免疫化疗后进行根治性放化疗和巩固免疫治疗。汇报者:Yuliang Meng | 山东省肿瘤医院摘要号：8529壁报编号：9英文标题:Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study.中文标题:芦康沙妥珠单抗 (sac-TMT) 联合塔戈利单抗(抗PD-L1) 一线治疗晚期NSCLC：II期 OptiTROP-Lung01 研究的非鳞状细胞亚组分析。汇报者:方文峰教授 | 中山大学肿瘤防治中心摘要号：8531壁报编号：11英文标题:Tumor-derived ILT5 and suppression of T cell immunity in non-small cell lung cancer.中文标题:肿瘤来源的ILT5及其在NSCLC中对T细胞免疫的抑制。汇报者:Xuebing Fu | 山东省肿瘤医院摘要号：8542壁报编号：22英文标题:Prediction of site-specific immune-related adverse events of PD-L1 blockade in advanced non-small cell lung cancer through baseline organ-metastatic landscape: Pooled post-hoc analyses of two randomized controlled trials.中文标题:通过基线器官转移情况预测晚期NSCLC癌患者在PD-L1阻断治疗过程中发生部位特异性免疫相关不良事件：两项随机对照试验的汇总事后分析。汇报者:Si-Heng Wang | 中山大学附属第一医院摘要号：8543壁报编号：23英文标题:A phase II trial to evaluate the safety and efficacy of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, as a monotherapy in patients with advanced NSCLC.中文标题:一项评估靶向PD-1和VEGF的双特异性抗体SSGJ-707单药治疗晚期NSCLC患者的疗效和安全性的II期临床试验。汇报者:邬麟教授 | 湖南省肿瘤医院摘要号：8546壁报编号：26英文标题:Association between pretreatment emotional distress and survival outcomes in patients with advanced non–small-cell lung cancer: An individual patient data meta-analysis of 4632 patients in 7 trials.中文标题:晚期NSCLC患者治疗前情绪困扰与生存结果之间的关联：基于7项试验中4632例患者的个体患者数据的荟萃分析。汇报者:周建国教授 | 遵义医科大学第二附属医院摘要号：8548壁报编号：28英文标题:Camrelizumab combined with 2 cycles of chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC): A two-arm, single-center, phase 2 study.中文标题:卡瑞利珠单抗联合2个周期化疗一线治疗晚期NSCLC：一项双组单中心II期研究。汇报者:刘红兵教授 | 南京医科大学第二附属医院摘要号：8553壁报编号：33英文标题:Circulating CD28-KLRG1+CD8+ T cells as prognostic indicators in advanced NSCLC chemoimmunotherapy.中文标题:循环CD28-KLRG1+CD8+ T细胞作为晚期NSCLC化学免疫治疗的预后指标。汇报者:颜次慧教授 | 天津医科大学肿瘤医院摘要号：8559壁报编号：39英文标题:Predictive value of circulating tumor DNA detection for long-term survival in patients with advanced lung cancer undergoing chemoimmunotherapy.中文标题:循环肿瘤DNA检测对于接受化学免疫治疗的晚期肺癌患者长期生存的预测价值。汇报者:李晖教授 | 浙江省肿瘤医院摘要号：8560壁报编号：40英文标题:Phase 2 study of pembrolizumab (pembro) plus plinabulin (plin) and docetaxel (doc) for patients (pts) with metastatic NSCLC after progression on first-line immune checkpoint inhibitor alone or combination therapy: Initial efficacy and safety results on immune re-sensitization.中文标题:帕博利珠单抗联合普那布林和多西他赛治疗在一线免疫检查点抑制剂单独或联合治疗后出现进展的转移性NSCLC患者的II期研究：免疫再致敏的初步疗效和安全性结果。汇报者:徐雁教授 | 中国医学科学院北京协和医院摘要号：8561壁报编号：41英文标题:A phase 2 study of HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy as first-line therapy in advanced squamous non-small cell lung cancer.中文标题:HLX07联合斯鲁利单抗加或不加化疗对比斯鲁利单抗联合化疗一线治疗晚期鳞状NSCLC的II期研究果。汇报者:吴一龙教授 | 广东省人民医院摘要号：8564壁报编号：44英文标题:Efficacy and safety of metronomic oral vinorelbine combined with PD-1 inhibitors as first-line therapy in advanced non-small-cell lung cancer in elderly patients.中文标题:口服长程低剂量长春瑞滨联合PD-1抑制剂作为老年晚期NSCLC患者一线治疗的疗效和安全性。汇报者:Yumeng Tian | 北京大学肿瘤医院摘要号：8570壁报编号：50英文标题:SMET12 and toripalimab combined chemotherapy in patients with advanced non-small cell lung cancer who are treatment-naive or have developed resistance to standard therapy.中文标题:SMET12和特瑞普利单抗联合化疗用于初治或对标准治疗产生耐药的晚期NSCLC患者。汇报者:林景辉教授 | 福建省肿瘤医院摘要号：8571壁报编号：51英文标题:Exploratory study on the impact of intestinal low-dose radiation on the efficacy and prognosis of immunotherapy in metastatic non-small cell lung cancer.中文标题:探讨肠道低剂量放疗对转移性NSCLC免疫治疗疗效及预后的影响。汇报者:Baiyang Huang | 山东省肿瘤医院摘要号：8573壁报编号：53英文标题:First-line envafolimab in combination with recombinant human endostatin and chemotherapy for advanced squamous non-small cell lung cancer: Updated results from a prospective, single-arm, multicenter phase II study.中文标题:恩沃利单抗联合重组人血管内皮抑制素和化疗用于晚期鳞状NSCLC的一线治疗：来自一项前瞻性、单组、多中心 II 期研究的更新结果。汇报者:刘联教授 | 山东大学齐鲁医院摘要号：8600壁报编号：80英文标题:A retrospective study of anlotinib plus third-generation EGFR-TKIs in advanced non-small cell lung cancer with gradual or oligo progression after EGFR-TKIs treatment (ALTER-L058).中文标题:安罗替尼联合第三代EGFR-TKIs治疗在接受过EGFR-TKIs治疗后出现渐进性或寡进展的晚期NSCLC的回顾性研究（ALTER-L058）。汇报者:周彩存教授 | 同济大学附属东方医院摘要号：8601壁报编号：81英文标题:First-in-human phase I/II study of BYS10 in patients (pts) with locally advanced or metastatic RET-altered solid tumors: Preliminary dose escalation results.中文标题:BYS10在局部晚期或转移性RET突变的实体瘤患者中的首次人类I/II期研究：初步剂量递增结果。汇报者:王洁教授 | 中国医学科学院肿瘤医院摘要号：8602壁报编号：82英文标题:Dysregulation of DNA damage repair in lung cancer driven by MTAP loss: Mechanistic insights and target discovery.中文标题:MTAP缺失导致的肺癌DNA损伤修复失调：机制和靶点发现。汇报者:姜波教授 | 中山大学附属第八医院摘要号：8609壁报编号：89英文标题:High-dose furmonertinib combined with bevacizumab and pemetrexed in non-small cell lung cancer patients with?EGFR?mutations and leptomeningeal metastasis: A prospective real-world study.中文标题:高剂量伏美替尼联合贝伐珠单抗和培美曲塞用于伴有EGFR突变和脑膜转移的NSCLC患者：一项前瞻性真实世界研究。汇报者:Qi Zhao | 河南省肿瘤医院摘要号：8615壁报编号：95英文标题:Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study.中文标题:芦康沙妥珠单抗 (sac-TMT) 治疗既往接受过治疗且携带罕见EGFR突变的局部晚期或转移性NSCLC患者：一项II期研究的初步结果。汇报者:张力教授 | 中山大学肿瘤防治中心摘要号：8616壁报编号：96英文标题:Phase I/II study of DZD6008, a 4th-generation EGFR TKI with full BBB penetration, in EGFR-mutant NSCLC.中文标题:具有完全穿透血脑屏障能力的第四代EGFR-TKI DZD6008在EGFR突变NSCLC中的I/II期研究。汇报者:王孟昭教授 | 中国医学科学院北京协和医院摘要号：8627壁报编号：107英文标题:Osimertinib plus anlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer with concurrent gene alterations: A single-arm, prospective, multicenter phase II study.中文标题:奥希替尼联合安洛替尼治疗未治疗、EGFR突变、合并基因改变的晚期NSCLC患者：一项单组、前瞻性、多中心的II期研究。汇报者:Xiaojun Yang | 东莞市人民医院摘要号：8629壁报编号：109英文标题:Safety and efficacy of ifebemtinib (IN10018) combined with garsorasib (D-1553) in KRAS G12C mutant solid tumors from a phase Ib/II study: Results from single-arm of non-small-cell lung cancer (NSCLC) and randomized part of colorectal cancer (CRC).中文标题:Ifebermtinib（IN10018）联合garsorasib（D-1553）治疗 KRAS G12C突变实体瘤的Ib/II 期研究安全性和有效性：非小细胞肺癌（NSCLC）单臂及结直肠癌（CRC）随机部分结果。汇报者:王在琪博士 | 应世生物科技（上海）有限公司摘要号：8632壁报编号：112英文标题:Vebreltinib plus PLB1004 in EGFR-mutated NSCLC with acquired MET amplification or overexpression after failure on EGFR-TKI treatment: A phase Ib/II study.中文标题:伯瑞替尼联合PLB1004用于在EGFR-TKI治疗失败后伴随获得性MET扩增或过表达的EGFR突变NSCLC患者：一项Ib/II期研究。汇报者:周斐教授 | 上海市东方医院摘要号：8637壁报编号：117英文标题:Efficacy and omics-based insights of TROP2 ADC in non–small cell lung cancer with or without actionable genomic alterations (AGAs).中文标题:TROP2 ADC在具有或不具有可操作基因组改变 (AGAs) 的NSCLC中的疗效和基于组学的见解。汇报者:李岸霖教授 | 中山大学肿瘤防治中心摘要号：8638壁报编号：118英文标题:Real-world data on the efficacy and safety of iruplinalkib (WX-0593) in ALK-positive advanced lung adenocarcinoma patients previously treated with lorlatinib.中文标题:伊鲁阿克（WX-0593）治疗既往接受过洛拉替尼治疗的ALK阳性晚期肺腺癌患者的疗效和安全性的真实世界数据。汇报者:王芬教授 | 北京大学深圳医院摘要号：TPS8647壁报编号：127a英文标题:TROPION-Lung14: A phase 3 study of osimertinib ± datopotamab deruxtecan (Dato-DXd) as first-line (1L) treatment for patients with EGFR-mutated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC).中文标题:TROPION-Lung14：一项关于奥希替尼 ± datopotamab deruxtecan (Dato-DXd)作为EGFR突变局部晚期或转移性NSCLC患者一线治疗的III期研究。汇报者:陆舜教授 | 上海市胸科医院摘要号：TPS8661壁报编号：134a英文标题:A multicenter, open-label, single-arm phase I/II study to assess the efficacy and safety of WSD0922-FU in patients with EGFR C797Sm+ advanced non-small cell lung cancer (NSCLC) in China (NCT06631989).中文标题:WSD0922-FU治疗EGFR C797Sm+晚期非小细胞肺癌（NSCLC）中国患者的多中心开放标签单臂I/II期研究（NCT06631989）。汇报者:钟卫博士 | 威尚(上海)生物医药摘要号：10556壁报编号：281英文标题:Lung cancer combined with interstitial lung disease: Controversial role of preexisting hypertension and emphysema observed in a fully followed 20-year patient cohort.中文标题:肺癌合并间质性肺疾病：20年完整随访队列中高血压和肺气肿的争议性作用。汇报者:王志超教授 | 南京中医药大学附属医院小细胞肺癌（SCLC）及其他胸部肿瘤摘要号：3036壁报编号：351英文标题:Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with lung cancer.中文标题:7MW3711，一种含有拓扑异构酶I抑制剂的新型B7-H3抗体-药物偶联物（ADC）用于肺癌患者的1/2期研究结果。汇报者:李子明教授 | 上海市胸科医院摘要号：2549壁报编号：196英文标题:An exploratory study to predict the efficacy and prognosis of immunotherapy for extensive-stage small cell lung cancer based on peripheral blood dynamic immune profiles.中文标题:基于外周血动态免疫谱预测广泛期小细胞肺癌免疫治疗疗效和预后的探索性研究。汇报者:邬麟教授 | 湖南省肿瘤医院摘要号：2566壁报编号：213英文标题:Identifying peripheral cancer-associated TCR signals for the early-detection of lung cancer.中文标题:鉴别外周肿瘤相关TCR信号用于肺癌的早期检测。汇报者:陈皇教授 | 中日友好医院摘要号：8030壁报编号：151英文标题:Genomic and immunophenotypic landscape of early-stage pulmonary carcinoid tumors.中文标题:早期肺类癌肿瘤的基因组和免疫表型特征汇报者:苏春霞教授 | 上海市肺科医院摘要号：8044壁报编号：165英文标题:Clinical characteristics and prognosis of pulmonary lymphoepithelioma-like carcinoma: A multicentre retrospective study.中文标题:肺淋巴上皮瘤样癌的临床特征和预后：一项多中心回顾性研究汇报者:Zan Hou | 四川省肿瘤医院摘要号：8055壁报编号：176英文标题:Lung cancer screening in high-risk never-smokers with artificial intelligence (LC-SHIELD study).中文标题:使用人工智能对高危从不吸烟者进行肺癌筛查（LC-SHIELD研究）汇报者:Molly SC Li | 香港中文大学摘要号：8057壁报编号：178英文标题:Enhancing early detection of lung cancer: Methylation anchor probe for low-signal enrichment (MAPLE).中文标题:增强肺癌的早期检测: 低信号富集的甲基化锚定探针 (MAPLE)汇报者:钟文昭教授 | 广东省人民医院摘要号：8089壁报编号：210英文标题:A phase 1 dose escalation and expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with refractory small cell lung cancer or neuroendocrine carcinoma.中文标题:ZG006，一种靶向CD3/DLL3/DLL3的三特异性T细胞接合器，用于难治性小细胞肺癌或神经内分泌癌的单药治疗。汇报者:王启鸣教授 | 河南省肿瘤医院摘要号：8090壁报编号：211英文标题:Efficacy and safety of envafolimab plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer: A prospective, single-arm, phase II trial.中文标题:恩沃利单抗联合卡铂和依托泊苷一线治疗广泛期ES-SCLC的疗效和安全性：一项前瞻性、单臂、II期试验。汇报者:孙胜杰教授 | 中国人民解放军总医院摘要号：8093壁报编号：214英文标题:Serplulimab versus placebo plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: Efficacy and safety from the end-of-study analysis of the international phase 3 ASTRUM-005 study.中文标题:斯鲁利单抗联合化疗对比安慰剂联合化疗作为ES-SCLC一线治疗：国际III期ASTRUM-005研究的终止研究分析中的疗效和安全性。汇报者:程颖教授 | 吉林省肿瘤医院摘要号：8097壁报编号：218英文标题:Efficacy and safety of HTMC0435 combination with temozolomide in relapsed extensive-stage small-cell lung cancer (ES-SCLC): A phase Ib/II study.中文标题:HTMC0435联合替莫唑胺治疗复发性广泛期小细胞肺癌（ES-SCLC）的疗效和安全性：Ib/II期研究。汇报者:范云教授 | 浙江省肿瘤医院摘要号：8101壁报编号：222英文标题:Multi-omic analysis and overall survival update of phase II TRIDENT study: Durvalumab plus olaparib in extensive-stage small-cell lung cancer (ES-SCLC).中文标题:II期TRIDENT研究的多组学分析和总体生存更新：度伐利尤单抗联合奥拉帕利治疗ES-SCLC。汇报者:赵媛媛教授 | 中山大学肿瘤防治中心摘要号：8105壁报编号：226英文标题:Association of IFITM3 with the efficacy of anti-PD1/PD-L1 therapy and regulation of immunosensitivity via MHC-I regulation in SCLC.中文标题:IFITM3与SCLC中抗PD1/PD-L1治疗疗效的关联及其通过MHC-I调节免疫敏感性的机制汇报者:任胜祥教授 | 同济大学附属上海市肺科医院摘要号：8109壁报编号：230英文标题:A prospective, single-arm, phase II trial of adebrelimab plus nab-paclitaxel and carboplatin in patients with unresectable advanced metastatic or recurrent thymic carcinomas.中文标题:阿得贝利单抗联合白蛋白结合型紫杉醇和卡铂治疗不可切除的晚期转移性或复发性胸腺癌的前瞻性、单臂、II期临床研究。汇报者:许宁教授 | 上海市胸科医院摘要号：8110壁报编号：231英文标题:Combining SBRT with GM-CSF and peg-IFNα to induce abscopal effects in previously treated patients with stage IV thymic tumors: A single arm, single center, phase II trial.中文标题:将立体定向体部放射治疗（SBRT）与粒细胞-巨噬细胞集落刺激因子（GM-CSF）和聚乙二醇干扰素α（peg-IFNα）结合诱导经治IV期胸腺肿瘤患者的远隔效应：单臂、单中心、II期试验。汇报者:樊旼教授 | 复旦大学附属肿瘤医院大会官网：https://conferences.asco.org/am/program排名不分先后，按照摘要类别划分；如有遗漏或任何问题，请后台留言（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

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·CPHI制药在线

2025 Q1 财报：MNC肿瘤业务大PK

关注并星标CPHI制药在线近日，多家跨国巨头（MNC）发布今年一季度财报，在诸多压力和多变市场格局的裹挟下，MNC们的业绩继续出现分化，不过，肿瘤领域仍是大部分MNC的基本盘。那么，今年第一季度，MNC的肿瘤业绩走向如何？默沙东默沙东今年一季度全球销售额为155亿美元，同比下降2%。制药业务收入136.38亿美元（占比88%），同比下降3%，主要受疫苗和抗病毒产品下滑拖累。尽管业绩出现波动，但肿瘤领域实现增长，核心产品PD-1抑制剂K药（Keytruda，帕博利珠单抗）表现依旧亮眼。K药一季度销售额为72.05亿美元，同比增长4%，占整个制药业务的53%。在美国市场，K药的业绩增长主要得益于非小细胞肺癌（NSCLC）的辅助/新辅助治疗，以及晚期尿路上皮癌适应症；而在美国之外的市场，K药的增长主要得益于三阴性乳腺癌（TNBC）、肾癌的辅助/新辅助治疗，以及转移适应症的需求。事实上自从2021年开始，辅助/新辅助治疗的肿瘤早期适应症已成为PD-1的新战场。在TNBC的辅助/新辅助治疗临床中，K药展现出了惊艳的效果。KEYNOTE-522研究结果显示，中位随访39.1个月，K药+化疗组较单纯化疗组取得EFS（无事件生存期）显著改善，HR=0.63（95%CI 0.48～0.82，P=0.00031）。基于该研究优异表现，FDA和欧洲药品管理局（EMA）以及NMPA，均批准帕博利珠单抗联合化疗应用于高危早期TNBC的新辅助治疗及后续辅助治疗。在NSCLC领域，K药效果同样突出。根据III期KEYNOTE-091试验数据，在手术切除后接受铂类辅助化疗的患者中，与安慰剂组相比，K药能够减少患者疾病复发或死亡风险达27%。在其主要终点无疾病生存期（DFS）方面，K药组患者的中位DFS为58.7个月，而安慰剂组患者则仅为23.8个月。默沙东曾预计到2028年，K药辅助/新辅助治疗适应症相关销售额占比能达到30%，可见早期癌症治疗领域的巨大潜力。其他抗肿瘤药物，默沙东的口服低氧诱导因子2α（HIF-2α）抑制剂Welireg（belzutifan）于今年2月19日获欧盟批准，用于治疗von Hippel-Lindau（VHL）病相关肿瘤，是首个获批上市的HIF-2α抑制剂，此前已在美国、英国、加拿大等多个国家和地区获得批准。一季度，Welireg销售额为1.37亿美元，同比增长62%。另外，默沙东与阿斯利康联合开发的PARP抑制剂Lynparza（奥拉帕利）、与日本卫材合作的Lenvima（仑伐替尼）、与BMS合作开发的Reblozyl（罗特西普）分别为默沙东带来了3.21、2.58、1.19亿美元的收入。在新进展方面，K药联合疗法用于局部晚期头颈鳞癌的围手术期治疗已获FDA优先审评，PDUFA日期为2025年6月23日。另外默沙东的皮下注射版K药的III期试验已在一季度公布了首批数据，结果显示，皮下注射K药联合透明质酸酶α（MK-3475A）在转移性NSCLC一线治疗中，其疗效和安全性不劣于静脉注射剂型，PDUFA目标日期为2025年9月23日。默沙东的 ROR1 ADC新药Zilovertamab Vedotin已启动针对弥漫大B细胞淋巴瘤的III期试验。该药是默沙东于2020年，以27.5亿美元收购VelosBio公司所得。罗氏罗氏2025年一季度营收 154.40 亿瑞士法郎，同比增长6%，制药部门营收达到 119.49 亿瑞士法郎，同比增长8%。肿瘤领域营收同比增长2%，其中HER2 产品组合（Phesgo、Perjeta 和 Kadcyla）和阿替利珠单抗（Tecentriq）贡献了主要业绩。Phesgo是由曲妥珠单抗+帕妥珠单抗和透明质酸酶构成的一种复方制剂皮下注射液，用于治疗早期和转移性HER2+乳腺癌。与传统静脉给药相比，Phesgo的给药时间缩短了90-95% （由原来150分钟降低至5分钟），大大提高了患者依从性。今年一季度，Phesgo销售额为5.93亿瑞士法郎，同比增长52%。Perjeta（帕妥珠单抗）是一款靶向HER2的重组人源化单抗，用于联合曲妥珠单抗和化疗辅助治疗HER2+早期乳腺癌、新辅助治疗HER2+局部晚期、炎性或早期乳腺癌患者（直径>2cm或淋巴结阳性），以及用于HER2+、转移性或不可切除的局部复发性乳腺癌等。一季度，Perjeta销售额为8.4亿瑞士法郎，同比减少10%。Kadcyla（恩美曲妥珠单抗）是一种靶向HER2 的ADC，由人源化IgG1曲妥珠单抗，通过MCC连接子，与DM1偶联而成，用于早期和转移性HER2+乳腺癌的二线治疗、辅助治疗等。一季度，Kadcyla销售额为5.06亿瑞士法郎，同比增长5%。Tecentriq是一款靶向PD-L1的单克隆抗体，目前，已在全球范围内获批用于治疗非小细胞肺癌（NSCLC）、小细胞肺癌（SCLC）、肝细胞癌、尿路上皮癌、PD-L1阳性转移性TNBC和BRAF V600突变的晚期黑色素瘤等多种癌症。一季度，Tecentriq营收8.7亿瑞士法郎，同比无变化。管线进展方面，罗氏启动了TIGIT单抗tiragolumab联合Tecentriq治疗局部晚期食管癌的III期研究。阿斯利康一季度，阿斯利康总营收135.88亿美元，同比增长10%。肿瘤领域业绩主要由Tagrisso（奥希替尼）、Imfinzi（度伐利尤单抗）、Enhertu（德曲妥珠单抗）等贡献。Tagrisso是第三代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），能够高效抑制EGFR敏感突变（如19号外显子缺失、L858R）及耐药突变（如T790M），并具备较强的血脑屏障穿透能力，而且是全球首个获批的第三代EGFR-TKI，因此，Tagrisso是三代EGFR-TKI的标杆药物。目前Tagrisso的适应症覆盖肺癌全周期治疗（一线、二线及辅助治疗）。今年一季度，Tagrisso营收16.79亿美元，同比增长8%。Imfinzi是一种PD-L1抑制剂，通过阻断肿瘤细胞表面的PD-L1与T细胞PD-1受体结合，解除免疫抑制信号，激活T细胞对癌细胞的杀伤作用。Imfinzi已在NSCLC、胆道癌等领域建立围手术期免疫治疗标杆，并于今年3月获FDA批准，联合吉西他滨与顺铂，用于肌层浸润性膀胱癌（MIBC）成人患者的围手术期治疗。一季度，Imfinzi营收12.61亿美元，同比增长16%。Enhertu（HER2-ADC）是第一三共/阿斯利康的明星产品，目前已获批用于HER2+乳腺癌二线治疗、HER2低表达乳腺癌、局部晚期或转移性HER2+胃或胃食管结合部腺癌、局部晚期或转移性NSCLC等。一季度，叠加第一三共负责的地区销售额，Enhertu全球销售额为10.86亿美元。Lynparza（奥拉帕利）是一种FIC的PARP抑制剂，也是首个合成致死靶向治疗药物，用于靶向带有同源重组修复（HRR）缺陷的细胞/肿瘤（如携带BRCA1和/或BRCA2突变的细胞）。目前，Lynparza已在美国、欧盟、日本及许多其他国家和地区获批，用于治疗gBRCAm、HER2-高危早期乳腺癌等。一季度，Lynparza销售额为7.26亿美元，同比增长5%。Calquence（阿可替尼）作为一款鲁顿氏酪氨酸激酶（BTK）抑制剂，已获批用于多种血液瘤治疗。一季度，Calquence营收7.62亿美元，同比增长8%。BMSBMS一季度总营收为112亿美元，同比减少6%。肿瘤领域，Opdivo（纳武利尤单抗）和Opdualag（纳武利尤单抗+瑞拉利单抗）贡献了主要业绩。Opdivo是一款PD-1免疫检查点抑制剂，旨在解除肿瘤对人体自身免疫系统的抑制，帮助恢复抗肿瘤免疫反应。一季度，Opdivo总营收为22.65亿美元，同比增长9%。Opdualag首个获得批准的PD-1+LAG-3组合抗体疗法，2022年3月，FDA批准Opdualag用于治疗患有不可切除或转移性黑色素瘤的12岁及以上儿童和成人患者。通过靶向两种免疫检查点通路，Opdualag增强了T细胞活性，以提升抗肿瘤反应。一季度，Opdualag营收6.24亿美元，同比增长7%。BMS的全球第2款口服KRAS G12C抑制剂Krazati(adagrasib)，一季度收入4800万美元，同比增长125%。该药具有长达24小时的半衰期和广泛的组织分布，而且能够穿过血脑屏障，有助于最大限度地发挥药物效力。2022年底，Krazati获FDA加速批准上市，用于治疗携带KRAS G12C突变的经治NSCLC患者。值得一提的是，Krazati由Mirati Therapeutics研发，2023年10月，BMS以48亿美元收购Mirati，囊获此款疗法。BMS的传统化疗药物Abraxane（白蛋白紫杉醇），一季度营收为1.05亿美元，同比降低52%。肿瘤领域作为大病赛道，当中纷争或永不落幕，在这片充满挑战与机遇的战场上，制药巨头们激烈角逐，在你追我赶中，推动了整个肿瘤治疗领域的进步。主要参考资料： 1. 药企2025Q1财报 2. https://www-merck-com.libproxy1.nus.edu.sg/news/welireg-belzutifan-receives-first-european-commission-approval-for-two-indications/. 3. https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-recommended-for-eu-approval-for-ls-sclc.html. 4. https://www.businesswire.com/news/home/20250117223765/en.END【企业推荐】领取CPHI & PMEC China 2025展会门票来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

财报临床3期疫苗上市批准

2025-05-07

·astrazeneca.com

Enhertu followed by THP before surgery showed statistically significant and clinically meaningful improvement in pathologic complete response in patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial

Positive high-level results from the DESTINY-Breast11 Phase III trial showed Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) rate versus standard of care (dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]) when used in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2-positive early-stage breast cancer. Pathologic complete response is defined as no evidence of invasive cancer cells in the removed breast tissue and lymph nodes following treatment. The secondary endpoint of event-free survival (EFS) was not mature at the time of analysis; however, EFS data showed an early positive trend favouring Enhertu followed by THP compared to standard of care. The trial will continue to follow EFS. Approximately one in three patients with early-stage breast cancer are considered high risk, as they are more likely to experience disease recurrence and have a poor prognosis.1,2 Achieving pCR in early-stage HER2-positive breast cancer is associated with improved long-term outcomes.2,3 The current standard of care in many regions of the world in this neoadjuvant setting involves combination chemotherapy regimens.2 These regimens often include anthracyclines, which can be challenging for patients to tolerate and may result in long-term cardiovascular side effects.4 Further, nearly half of patients who receive neoadjuvant treatment do not achieve pCR, reinforcing the need for new treatment options.2,3 Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The clinically meaningful improvement in pathologic complete response and the safety data seen in DESTINY-Breast11 highlight the potential of Enhertu to challenge the current standard of care in early-stage HER2-positive breast cancer. Enhertu is already an important treatment option in the metastatic setting, and these data have the potential to allow this medicine to move into early stages of disease where cure is possible.” Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “There are still many patients with early-stage breast cancer who do not achieve a pathologic complete response with treatment in the neoadjuvant setting, increasing the risk of disease recurrence. These topline results from DESTINY-Breast11 demonstrate that Enhertu followed by THP could offer patients with HER2-positive breast cancer a promising new treatment approach prior to surgery, setting more patients on a path towards a potential cure." Enhertu followed by THP showed an improved safety profile compared to ddAC-THP. The safety profiles of Enhertu and THP were consistent with the known profiles of each individual medicine with no new safety concerns identified. Rates of interstitial lung disease were similar across the Enhertu followed by THP and the ddAC-THP arms as determined by an independent adjudication committee. Following a recommendation by the Independent Data Monitoring Committee, patient enrolment in a third arm of the trial evaluating Enhertu alone was closed after a previous interim efficacy assessment of the trial arms. Data from DESTINY-Breast11 will be presented at an upcoming medical meeting and shared with regulatory authorities. Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Enhertu has demonstrated improved outcomes in six Phase III breast cancer trials across different subtypes and stages of disease, including the recently announced DESTINY-Breast09 Phase III trial in the 1st-line HER2-positive metastatic setting. Enhertu is also being studied in several ongoing breast cancer trials including the DESTINY-Breast05 Phase III trial which is evaluating Enhertu in the high-risk adjuvant early HER2-positive setting. Notes HER2-positive early breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.5 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.5 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.6 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.7 Approximately one in five cases of breast cancer are considered HER2-positive.8 DESTINY-Breast11 DESTINY-Breast11 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of neoadjuvant Enhertu (5.4mg/kg) monotherapy or Enhertu followed by THP vs. the standard of care regimen in patients with high-risk (lymph node positive [N1-3] or primary tumour stage T3-4), locally advanced or inflammatory HER2-positive early-stage breast cancer. Patients were randomised 1:1:1 to receive either eight cycles of Enhertu monotherapy; four cycles of Enhertu followed by four cycles of THP; or four cycles of ddAC (dose-dense doxorubicin and cyclophosphamide) followed by four cycles of THP. The primary endpoint of DESTINY-Breast11 is pCR (absence of invasive disease in the breast and lymph nodes). Secondary endpoints include EFS, invasive disease-free survival, overall survival and safety. DESTINY-Breast11 enrolled 927 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov. Enhertu Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Enhertu (5.4mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC 3+ or in-situ hybridisation [ISH]+) breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. Enhertu (5.4mg/kg) is approved in more than 75 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Enhertu (5.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. Enhertu (5.4mg/kg) is approved in more than 50 countries worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population. Enhertu (5.4mg/kg) is approved in the US and other countries for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on the results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication in the US is contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu development programme A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as monotherapy or in combination or sequentially with other anti-cancer therapies across multiple HER2-targetable cancers. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway (datopotamab deruxtecan) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and are exploring its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP2-directed ADC, Datroway (datopotamab deruxtecan), and next-generation oral SERD and potential new medicine camizestrant. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings and to explore its potential in earlier disease. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

临床结果临床3期上市批准免疫疗法引进/卖出

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批准上市

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适应症	国家/地区	公司	日期
肌层浸润性膀胱癌	美国	AstraZeneca UK Ltd.	2025-03-28
子宫癌	日本	阿斯利康制药有限公司	2024-11-22
晚期子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	挪威	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	挪威	AstraZeneca AB	2024-08-15
可切除非小细胞肺癌	英国	AstraZeneca PLC	2024-07-09
晚期胆道癌	美国	AstraZeneca UK Ltd.	2024-06-14
错配修复缺陷子宫内膜癌	美国	AstraZeneca UK Ltd.	2024-06-14
非小细胞肺癌 III期	美国	AstraZeneca UK Ltd.	2024-06-14
晚期肝细胞癌	欧盟	AstraZeneca AB	2023-04-14
晚期肝细胞癌	冰岛	AstraZeneca AB	2023-04-14
晚期肝细胞癌	列支敦士登	AstraZeneca AB	2023-04-14
晚期肝细胞癌	挪威	AstraZeneca AB	2023-04-14
转移性胆道癌	欧盟	AstraZeneca AB	2023-04-14
转移性胆道癌	冰岛	AstraZeneca AB	2023-04-14

未上市

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适应症	最高研发状态	国家/地区	公司	日期
ALK阳性非小细胞肺癌	申请上市	中国	AstraZeneca AB	2025-02-21
EGFR突变的非小细胞肺癌	申请上市	中国	AstraZeneca UK Ltd.	2025-02-21
卵巢上皮癌	申请上市	中国	AstraZeneca UK Ltd.	2024-08-16
PD-L1阳性三阴性乳腺癌	临床3期	美国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	中国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	日本	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	阿根廷	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	澳大利亚	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	巴西	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	加拿大	AstraZeneca PLC	2023-11-23

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02572843 (SAKK 16/14, ESMO_ELCC2025) 人工标引	临床2期	非小细胞肺癌IIIA期 \| 非小细胞肺癌新辅助	68	Durvalumab + Neoadjuvant Chemotherapy	選範淵夢窪繭觸衊鹽繭(獵網製觸選膚繭網構鬱) = 積鬱膚觸壓製壓淵醖餘願糧廠鹹廠願觸艱衊醖 (襯網鏇願廠選獵淵衊積 ) 达到更多	积极	2025-03-28
NCT03732677 (NIAGARA, FDA) 人工标引	临床3期	肌层浸润性膀胱癌新辅助 \| 辅助	-	Durvalumab with chemotherapy	壓築鏇膚糧製範鹽襯窪(壓淵選膚蓋顧齋廠糧遞) = 獵鏇積餘選鹽鹹鹽餘膚獵獵簾構糧憲膚鹽願糧 (構壓艱鬱淵淵鹹遞艱選, NR ~ NR) 更多	积极	2025-03-28
				Chemotherapy alone	壓築鏇膚糧製範鹽襯窪(壓淵選膚蓋顧齋廠糧遞) = 築醖網襯觸範膚遞鹽築獵獵簾構糧憲膚鹽願糧 (構壓艱鬱淵淵鹹遞艱選, 32.2 ~ NR) 更多
NCT05683977 (ARSENAL, ESMO_ELCC2025)	N/A	广泛期小细胞肺癌一线	232	Durvalumab + Platinum-Etoposide	衊齋壓獵製窪簾憲選網(鹹範夢窪網鹽築餘艱獵) = 襯鬱築餘糧鏇壓鹽獵廠壓選網餘蓋夢獵顧夢鹽 (簾選獵鹹選遞醖獵廠繭, 4.9 ~ 6.0) 更多	积极	2025-03-26
ALLSTAR (ESMO_ELCC2025)	N/A	非小细胞肺癌 III期	188	Durvalumab	膚艱獵構蓋醖餘觸築襯(淵觸餘憲壓繭鑰廠醖築) = grade 1-3 occurred in 93/188 (49%) cases 醖範壓鹹鹹築蓋窪膚衊 (簾壓繭淵齋鹽衊衊鏇淵 ) 更多	积极	2025-03-26
				Durvalumab (Radiation dose >66 Gy)
NCT03703297 (ADRIATIC, ESMO_ELCC2025)	临床3期	局限期小细胞肺癌巩固	95	Durvalumab 1500 mg	憲淵醖蓋淵糧襯壓壓觸(鬱鹽築構鹹夢窪製築製) = 鏇窪廠積襯鹽夢憲繭壓膚衊範觸壓醖簾餘壓鏇 (鹽鏇淵簾壓鬱膚襯遞觸 ) 更多	积极	2025-03-26
				Placebo	憲淵醖蓋淵糧襯壓壓觸(鬱鹽築構鹹夢窪製築製) = 繭網壓淵網廠選壓選廠膚衊範觸壓醖簾餘壓鏇 (鹽鏇淵簾壓鬱膚襯遞觸 ) 更多
NCT04712903 (CANTABRICO, ESMO_ELCC2025)	临床3期	广泛期小细胞肺癌一线	101	Durvalumab plus carboplatin and etoposide	鬱選蓋觸鏇襯憲鹽襯艱(憲構窪築憲窪膚餘艱顧) = 夢鑰淵憲夢積糧願築廠廠襯襯憲顧齋遞齋鹽選 (築膚範膚鏇蓋衊鹽壓網 ) 更多	积极	2025-03-26
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	構積網淵觸襯鬱膚憲築(蓋蓋鑰衊壓齋艱鹽鑰淵) = 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) 醖選醖觸鑰蓋餘膚廠廠 (鹽鏇膚醖網醖窪獵憲網 ) 更多	积极	2025-03-26
				Durvalumab + Chemotherapy
NCT04003246 (CTgov)	临床2期	非小细胞肺癌 III期	10	Thoracic RT+Consolidative Durvalumab	膚憲醖淵簾鬱糧構獵遞(網觸鹽糧簾願願獵遞襯) = 廠襯選淵齋鑰膚憲觸製壓範憲顧衊網遞繭醖範 (觸襯願網鹽艱襯築鏇餘, 鬱觸壓窪構壓糧窪衊簾 ~ 艱願糧鹹顧鬱鹽淵醖觸) 更多	-	2025-03-21
NCT04592913 (MATTERHORN, Company_Website) 人工标引	临床3期	胃食管交界处癌 \| 胃癌	948	Durvalumab+fluorouracil+leucovorin+oxaliplatin+docetaxel	壓衊網蓋鏇願餘衊選簾(艱膚構鑰窪構壓製積構) = demonstrated a statistically significant and clinically meaningful improvement 壓製遞窪選遞襯顧襯願 (願遞壓廠膚觸襯糧艱淵 ) 更多	积极	2025-03-07
				Placebo+fluorouracil+leucovorin+oxaliplatin+docetaxel
NCT04322643 (CTgov)	临床2期	晚期尿路上皮癌 \| 膀胱尿路上皮癌	4	nivolumab+Avelumab+Atezolizumab+pembrolizumab+Durvalumab	艱衊艱壓鑰製齋觸繭繭 = 蓋選積膚糧糧憲選憲積觸遞積積憲餘鹽願簾遞 (窪淵構廠範顧糧範築鑰, 夢糧壓構遞蓋夢夢選膚 ~ 積築簾範憲鬱鏇糧遞鬱) 更多	-	2025-02-25