预约演示

更新于：2025-05-29

Durvalumab

度伐利尤单抗

更新于：2025-05-29

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+ [209]

非在研适应症

急性髓性白血病肺腺癌晚期头颈癌+ [62]

原研机构

在研机构

+ [17]

非在研机构

Fred Hutchinson Cancer Research Center

Plexxikon, Inc.

Circio Holding ASA

+ [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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3,987

项与度伐利尤单抗相关的文献（医药）

2025-12-31·OncoImmunology

Avelumab induces greater Fc-Fc receptor-dependent natural killer cell activation and dendritic cell crosstalk compared to durvalumab

Article

作者: Srivastava, Raghvendra M ; Makarov, Vladimir ; Rupani, Amit ; Chan, Timothy A ; Osborne, Nicole

Several FDA-approved anti-PD-L1 (programmed cell death ligand-1) monoclonal antibodies (mAbs) are used to treat cancer. While these mAbs primarily target and intercept PD-L1:PD-1 inhibitory signaling in T-cells, the Fc-domains of these mAbs are distinct, and the unique cellular cascades triggered by differing Fc-domains of PD-L1 mAbs have not been directly investigated. In this study, we compared the innate immune effects of two widely used anti-PD-L1 IgG1 mAbs which bear distinct Fc-domains, avelumab (native-Fc) and durvalumab (mutated-Fc), using two-cell and three-cell co-culture systems containing Natural Killer cells (NK-cells), dendritic cells (DCs) and various tumor cell lines of multiple cancer origins. We show a robust enhancement in NK-cell effector function, DC maturation, reciprocal NK:DC crosstalk and DC editing that is unique to avelumab treatment using multiple functional immune assays. By transcriptomic analysis, we show for the first time pivotal differences in gene sets involved in NK-cell effector function, DC maturation, immunoregulatory interactions, and cytokine production between innate immune cells treated with avelumab versus durvalumab. Furthermore, we report several previously unknown Fc-receptor-associated biological pathways uniquely triggered by avelumab. Our findings elucidate novel mechanisms of Fc-dependent actions of PD-L1 mAbs which may inform their use in future clinical trials.

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.

1,619

项与度伐利尤单抗相关的新闻（医药）

2025-05-28

·肿瘤界

2025 ASCO | 10余项中国研究入选！肺癌口头报告摘要标题一文速览

点击蓝字关注我们前言作为肿瘤学领域的国际盛会，ASCO年会每年都吸引着来自世界各地的顶尖学者、临床专家与科研团队，共同分享最新研究成果、探讨创新疗法、展望未来趋势。随着2025年ASCO年会完整日程的正式公布，全球肿瘤学界的目光再次聚焦于此。在此，本文特整理了本届ASCO大会中肺癌领域入选的Oral Abstract Session（口头报告专场）、Rapid Oral Abstract Session（快速口头报告专场）以及Clinical Science Symposium（临床科学研讨会）的研究，让我们先一睹为快！Oral Abstract Session口头报告专场摘要号：2004研究英文名称：A phase II study of asandeutertinib (TY-9591) in advanced NSCLC patients with EGFR-positive mutations and brain metastases.研究中文名称：asandeutertinib（TY-9591）在EGFR阳性突变和脑转移的晚期NSCLC患者中的II期研究讲者：邢力刚 | 中国医学科学院肿瘤医院摘要号：3001研究英文名称：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.研究中文名称：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NSCLC的I期临床研究：一种靶向EGFR×HER3的双特异特异性抗体驱动药物偶联物（ADC）的评估讲者：杨云鹏 | 中山大学肿瘤防治中心摘要号：3002研究英文名称：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).研究中文名称：iza-bren（BL-B01D1），一种EGFR x HER3双特异性ADC，在局部晚期或转移性小细胞肺癌（SCLC）患者中的I期研究讲者：黄岩 | 中山大学肿瘤防治中心摘要号：LBA8000研究英文名称：Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816.研究中文名称：CheckMate 816研究中可切除NSCLC患者新辅助纳武利尤单抗联合化疗的总生存期分析讲者：Patrick M. Forde | Trinity St. James's Cancer Institute, Trinity College Dublin摘要号：8001研究英文名称：Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.研究中文名称：NeoADAURA研究：可切除EGFR突变NSCLC术前新辅助奥希替尼±化疗对比单纯化疗讲者：Jamie E. Chaft | Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY; Department of Medicine, Weill Cornell Medical College摘要号：8002研究英文名称：Lung cancer diagnosis rates (LCDR) in lung cancer screening (LCS) and incidental pulmonary nodule (IPN) cohorts in the Mississippi Delta.研究中文名称：密西西比三角洲地区肺癌筛查与偶然发现肺结节队列中的肺癌诊断率研究讲者：Raymond U. Osarogiagbon | Baptist Cancer Center, Multidisciplinary Thoracic Oncology Program摘要号：8003研究英文名称：SWOG/NRG S1914: Randomized phase III trial of induction/consolidation atezolizumab + SBRT versus SBRT alone in high risk, early-stage NSCLC.研究中文名称：SWOG/NRG S1914研究：高危早期NSCLC诱导/巩固期阿替利珠单抗联合SBRT对比单纯SBRT的随机III期试验讲者：Megan Eileen Daly | Department of Radiation Oncology, University of California Davis Comprehensive Cancer Center摘要号：LBA8004研究英文名称：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.研究中文名称：R-ALPS研究：贝莫苏拜单抗（TQB2450）联合或不联合安罗替尼维持治疗经同步或序贯放化疗后无进展的局部晚期不可切除（III期）NSCLC患者的随机、双盲、安慰剂对照、多中心III期临床试验讲者：陈明 | 中山大学肿瘤防治中心摘要号：LBA8005研究英文名称：Randomized phase II trial investigating whether atezolizumab after chemoradiotherapy (CRT) prolongs survival in limited stage (LS) small cell lung cancer (SCLC).研究中文名称：局限期小细胞肺癌（LS-SCLC）化放疗后使用阿替利珠单抗是否延长生存的随机II期试验讲者：Bjorn Henning Gronberg | Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology and Department of Oncology, St. Olavs Hospital摘要号：8006研究英文名称：Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial.研究中文名称：III期IMforte研究：芦比替定联合阿替利珠单抗作为广泛期小细胞肺癌（ES‑SCLC）患者一线维持治疗的主要结果讲者：Luis G. Paz-Ares | Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc摘要号：8007研究英文名称：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.研究中文名称：ZG006（一种靶向CD3/DLL3/DLL3的三特异性T细胞接合器）单药治疗晚期SCLC的II期剂量扩展研究讲者：艾星浩 | 上海交通大学医学院附属胸科医院摘要号：LBA8008研究英文名称：Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of Ph3 DeLLphi-304.研究中文名称：Tarlatamab对比化疗（CTx）二线（2L）治疗SCLC：III期DeLLphi-304研究的主要分析讲者：Charles M Rudin | Fiona and Stanley Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center摘要号：8500研究英文名称：First-line adagrasib (ADA) with pembrolizumab (PEMBRO) in patients (pts) with advanced/metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) from the phase 2 portion of the KRYSTAL-7 study.研究中文名称：II期KRYSTAL‑7研究：adagrasib联合帕博利珠单抗一线治疗晚期/转移性KRASG12C突变NSCLC患者讲者：Pasi A. Jänne | Department of Medical Oncology, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8501研究英文名称：TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC).研究中文名称：TROPION‑Lung02研究：Dato-DXd联合帕博利珠单抗±铂类化疗一线治疗晚期NSCLC讲者：Benjamin Philip Levy | Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine摘要号：LBA8502研究英文名称：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.研究中文名称：CAMPASS研究：贝莫苏拜单抗联合安罗替尼对比帕博利珠单抗一线治疗晚期NSCLC：一项随机、单盲、多中心III期研究讲者：韩宝惠 | 上海交通大学医学院附属胸科医院摘要号：8503研究英文名称：Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab.研究中文名称：zipalertinib对既往接受过含或不含埃万妥单抗铂类化疗的EGFR外显子20插入突变NSCLC患者的疗效评估讲者：Helena Alexandra Yu | Memorial Sloan Kettering Cancer Center摘要号：8504研究英文名称：SOHO-01: Safety and efficacy of BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) who were pretreated but naïve to HER2-targeted therapy or had not received any treatment for advanced disease.研究中文名称：SOHO-01研究：BAY 2927088治疗既往接受过治疗但未接受HER2靶向治疗或未接受过任何治疗的晚期HER2突变NSCLC患者的疗效和安全性研究讲者：Herbert H. Loong | 香港中文大学摘要号：LBA8505研究英文名称：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.研究中文名称：赛沃替尼联合奥希替尼对比化疗治疗EGFR-TKI治疗进展后EGFR突变伴MET扩增的晚期NSCLC：来自III期随机SACHI研究结果讲者：陆舜 | 上海市胸科医院摘要号：8506研究英文名称：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.研究中文名称：Patritumab-deruxtecan（HER3-DXd）治疗第三代EGFR-TKI治疗后耐药的EGFR突变晚期NSCLC：III期HERTHENA-Lung02研究讲者：莫树锦 | 香港中文大学摘要号：8507研究英文名称：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.研究中文名称：芦康沙妥珠单抗（sac-TMT）治疗既往接受过治疗的晚期EGFR突变NSCLC：来自OptiTROP-Lung03随机研究的结果讲者：张力 | 中山大学肿瘤防治中心Rapid Oral Abstract Session快速口头报告专场摘要号：8009研究英文名称：Association of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.研究中文名称：III期AEGEAN研究：术后MRD状态与新辅助ctDNA动态、基因突变特征及可切除NSCLC患者预后的相关性分析讲者：Martin Reck | Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research摘要号：LBA8010研究英文名称：Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: Updated survival and biomarker analyses from CheckMate 77T.研究中文名称：CheckMate 77T研究：可切除NSCLC患者围手术期纳武利尤单抗对比安慰剂治疗的生存及生物标志物更新分析讲者：Mariano Provencio | Hospital Universitario Puerta de Hierro摘要号：8011研究英文名称：ctDNA-based MRD detection in unresectable NSCLC undergoing curatively intended chemoradiotherapy and durvalumab.研究中文名称：在接受根治性放化疗及度伐利尤单抗治疗的不可切除NSCLC患者中基于ctDNA的MRD检测讲者：Aslaug Helland | University of Oslo, Clinical Medicine摘要号：8012研究英文名称：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).研究中文名称：InTRist研究：评估特瑞普利单抗联合诱导化疗，随后同步放化疗及特瑞普利单抗巩固治疗用于巨大不可切除的III期NSCLC的随机II期试验的初步结果讲者：Yu Wang | 中国医学科学院肿瘤医院摘要号：8013研究英文名称：Safety and efficacy of lurbinectedin plus atezolizumab as second-line treatment for advanced small-cell lung cancer: Results of the 2SMALL phase 1/2 study (NCT04253145).研究中文名称：I/II期2SMALL研究：芦比替定联合阿替利珠单抗作为晚期NSCLC二线治疗的疗效和安全性讲者：Santiago Ponce Aix | Hospital Universitario 12 de Octubre and Oncosur Foundation摘要号：8014研究英文名称：Clinical and molecular characteristics of early progressors (EPs) and long-term progression-free survivors (LTPs) from the phase 3 ADRIATIC trial of consolidation durvalumab (D) vs placebo (P) after concurrent chemoradiotherapy (cCRT) in limited-stage small-cell lung cancer (LS-SCLC).研究中文名称：III期ADRIATIC研究：同步放化疗后巩固度伐利尤单抗对比安慰剂治疗用于LS-SCLC患者中早期进展者与长期无进展生存者的临床与分子特征讲者：David Allen Barbie | Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8015研究英文名称：Alectinib as neoadjuvant treatment in potentially resectable stage III ALK-positive NSCLC: Final analysis of ALNEO phase II trial (GOIRC-01-2020-ML42316).研究中文名称：阿来替尼作为新辅助治疗用于潜在可切除III期ALK阳性NSCLC的ALNEO II期研究最终分析（GOIRC-01-2020-ML42316）讲者：Marcello Tiseo | Department of Medicine and Surgery, University of Parma; Medical Oncology Unit, University Hospital of Parma; Gruppo Oncologico Italiano di Ricerca Clinica, GOIRC摘要号：8016研究英文名称：Efficacy and safety of nivolumab plus ipilimumab for patients with pre-treated type B3 thymoma and thymic carcinoma: Results from the EORTC-ETOP NIVOTHYM phase II trial.研究中文名称：纳武利尤单抗联合伊匹木单抗治疗经治的B3型胸腺瘤和胸腺癌患者的疗效与安全性：EORTC-ETOP NIVOTHYM II期研究结果讲者：Nicolas Girard, MD | Institut du Thorax Curie Montsouris, Institut Curie, Paris, and UVSQ, Paris Saclay University摘要号：8017研究英文名称：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).研究中文名称：靶向整合素αVβ3的成像用于肺癌的识别和淋巴结转移的定位：一项前瞻性、多中心、自身对照的III期试验（TRIIL研究）讲者：Rongxi Wang | 北京协和医院摘要号：8512研究英文名称：Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced EGFR-mutated (MT) non-squamous (NSQ) non-small cell lung cancer (NSCLC): Results from a phase 1 study.研究中文名称：靶向c-Met的抗体偶联药物（ADC）Telisotuzumab adizutecan（ABBV-400；Temab-A）治疗晚期EGFR突变非鳞NSCLC的I期研究结果讲者：David Ross Camidge | University of Colorado Cancer Center摘要号：8513研究英文名称：Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO).研究中文名称：II期SAVANNAH研究随机亚组结果：赛沃替尼联合奥希替尼对比赛沃替尼联合安慰剂的疗效及中枢神经系统结果分析讲者：Benjamin Philip Levy | Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine摘要号：8514研究英文名称：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).研究中文名称：贝莫苏拜单抗联合化疗，随后序贯联合安罗替尼一线治疗局部晚期或转移性鳞状NSCLC的III期研究讲者：石远凯 | 中国医学科学院肿瘤医院摘要号：8515研究英文名称：Plasma-guided adaptive first-line chemoimmunotherapy for non-small cell lung cancer (NSCLC).研究中文名称：血浆引导的NSCLC一线个体化化免治疗探索讲者：Julia K. Rotow | Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8516研究英文名称：Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer.研究中文名称：NSCLC患者免疫化疗时间与无进展生存期及总生存期相关性的随机试验讲者：张永昌 | 湖南省肿瘤医院摘要号：8517研究英文名称：Hypoxia-responsive CEA CAR-T cells therapy for relapsed or refractory non-small cell lung cancer: A single-arm, open-label, phase I trial.研究中文名称：缺氧反应型CEA CAR-T细胞疗法治疗复发或难治性NSCLC：一项单臂、开放标签、I期试验讲者：魏双 | 华中科技大学同济医学院附属同济医院摘要号：8518研究英文名称：S1900E: A phase II study examining impact of co-mutations on sotorasib for previously treated stage IV/recurrent KRAS G12C mutated (MUT) non-squamous (Non-sq) non-small cell lung cancer (NSCLC) (ECOG-ACRIN led Lung-MAP Sub-study).研究中文名称：S1900E研究：评估合并突变对sotorasib治疗经治的KRAS G12C突变IV期/复发性非鳞NSCLC疗效影响的II期研究（ECOG-ACRIN主导Lung-MAP子研究）讲者：Sukhmani Kaur Padda | Fox Chase Cancer Center/Temple Health摘要号：8519研究英文名称：Safety and efficacy of olomorasib + immunotherapy in first-line treatment of patients with KRAS G12C-mutant advanced NSCLC: Update from the LOXO-RAS-20001 trial.研究中文名称：Olomorasib联合免疫治疗用于KRAS G12C突变晚期NSCLC一线治疗的疗效和安全性：LOXO-RAS-20001研究更新讲者：Konstantin H. Dragnev | Dartmouth Cancer Center摘要号：8520研究英文名称：Sosimerasib monotherapy in patients with previously treated KRAS G12C–mutated non-small cell lung cancer: Primary results of a phase 2 study.研究中文名称：Sosimerasib单药治疗KRAS G12C突变NSCLC：II期研究的主要结果讲者：王洁 | 中国医学科学院肿瘤医院摘要号：LBA8671研究英文名称：PRAGMATICA-LUNG (SWOG S2302): A prospective, randomized study of ramucirumab plus pembrolizumab versus standard of care for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer.研究中文名称：Practicala-LUNG研究（SWOG S2302）：雷莫芦单抗联合帕博利珠单抗对比标准治疗用于既往接受过免疫治疗的IV期或复发性NSCLC患者的前瞻性随机研究讲者：Konstantin H. Dragnev | Dartmouth Cancer CenterClinical Science Symposium临床科学研讨会摘要号：8509研究英文名称：First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC).研究中文名称：首创新药PD-1/IL-2双特异性抗体IBI363治疗经免疫治疗的晚期NSCLC患者讲者：周建娅 | 浙江大学医学院附属第一医院摘要号：8510研究英文名称：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.研究中文名称：一项评估新型靶向B7-H3的ADCMHB088C治疗复发ES-SCLC的疗效与安全性的I/II期多中心研究的亚组分析讲者：周彩存 | 同济大学附属东方医院摘要号：8511研究英文名称：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.研究中文名称：首个评估BNT327/PM8002联合化疗作为不可切除恶性胸膜间皮瘤一线治疗的II期试验的疗效及安全性结果报告讲者：程颖 | 吉林省肿瘤医院备注：如有遗漏或任何问题，请给我们留言~声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：医脉通胸部肿瘤编辑：lagertha审核：南星

抗体药物偶联物临床结果ASCO会议临床1期

2025-05-27

·小药说药

巨噬细胞肿瘤免疫治疗的研究进展

-01-引言肿瘤相关巨噬细胞（TAM）是免疫抑制细胞和细胞因子网络的核心，在肿瘤免疫逃避中起着至关重要的作用。因此，了解巨噬细胞和其他免疫细胞之间的相互作用以及增强现有抗癌治疗的因素至关重要。TAM在功能上是异质性的，分为两个主要亚群，M1和M2巨噬细胞。M1巨噬细胞是抵抗微生物感染的第一道防线，M1巨噬细胞还保持强大的抗原呈递能力，诱导强烈的Th1反应。相反，M2巨噬细胞在限制免疫反应、诱导血管生成和组织修复方面起着关键作用。因此，M2型TAM的存在与促肿瘤活性相关，而M1型TAM的存在与抗肿瘤活性相关。总之，TAM是产生免疫抑制性TME的关键，并且巨噬细胞与TME中的各种免疫细胞和细胞因子之间的串扰起着不可替代的作用。了解巨噬细胞参与肿瘤免疫逃逸的主要机制和相关靶向治疗，有助于我们改善临床方案，制定克服巨噬细胞相关免疫耐受的潜在新策略。-02-一、调节巨噬细胞吞噬的信号途径CD47/SIRPαCD47是一种广泛分布于正常细胞表面的免疫球蛋白，可通过抑制吞噬作用负调节抗肿瘤免疫，并参与介导细胞增殖、迁移、凋亡和免疫稳态。其主要配体信号调节蛋白α（SIRPα）是一种在髓细胞膜上高表达的跨膜蛋白，其胞外区的N末端可与CD47结合，导致免疫受体酪氨酸抑制基序（ITIM）上的酪氨酸磷酸化，释放“不要吃我”信号，从而抑制巨噬细胞介导的吞噬作用，保护正常细胞免受免疫系统的破坏。研究表明CD47在多种肿瘤中高表达，如恶性血液肿瘤和肝细胞癌（HCC），这也与不良预后相关。给予CD47阻断抗体或靶向灭活CD47基因可显著抑制肿瘤生长。此外，抗CD47治疗还可以改变TME中巨噬细胞的极化状态，诱导TAM转化为抗肿瘤状态。LILRB1/MHCI白细胞免疫球蛋白样受体B（LILRB）在大多数免疫细胞上表达，由细胞外Ig样区、跨膜区和含有ITIM的细胞内区组成。它与主要配体主要组织相容性复合体I（MHCI）结合后可介导免疫细胞激活的负调控。MHCI是由HLAα链和β2-微球蛋白（β2M）形成的复合体，某些肿瘤细胞高表达β2M，其可与巨噬细胞上的LILRB1结合以抑制吞噬作用，导致免疫监视丧失。因此，在肿瘤细胞上MHCI正常或高表达的患者中，靶向MHCI/LILRB1轴的药物可能促进抗肿瘤免疫反应，并与靶向CD47/SIRPα轴的药物发挥协同作用。CD24/Siglec-10CD24，也称为热稳定抗原，是一种高度糖基化的表面蛋白，由糖基磷脂酰肌醇锚定，可与唾液酸结合免疫球蛋白样凝集素-10（Siglec-10）相互作用，以减少感染或肝损伤引起的先天免疫介导的有害炎症。肿瘤细胞高表达CD24，而TAM高表达Siglec-10。与CD24结合后，Siglec-10的ITIM可招募并激活含有SH2结构域的酪氨酸磷酸酶SHP-1或SHP-2，从而阻断巨噬细胞吞噬所需的细胞骨架重排，触发抑制性信号转导级联。“不要吃我”发出CD47、β2M和CD24信号，所有这些信号都涉及基于ITIM的巨噬细胞信号，导致巨噬细胞耐药癌细胞亚群的免疫选择，使肿瘤细胞逃避巨噬细胞的监视和清除。因此，掌握肿瘤细胞表达抗吞噬信号的机制可以更好地预测治疗效果以及靶向治疗。-03- 二、巨噬细胞参与免疫逃避的机制巨噬细胞参与形成抑制性髓系微环境TME中的各种介质参与调节MDSC和单核细胞的募集，并通过不同的信号通路极化巨噬细胞，从而促进免疫抑制髓系微环境的形成。此外，巨噬细胞、MDSC和树突状细胞之间的串扰进一步形成免疫抑制髓系微环境。卵巢癌细胞高表达CD39和CD73，有助于催化细胞外ATP转化为腺苷，腺苷可以招募单核细胞并诱导它们分化为分泌IL-10的TAM。TAM表达CD39和CD73，进一步增加MDSC和TAM的浸润，从而形成一种自我放大机制，促进局部免疫逃逸。肿瘤相关中性粒细胞（TAN）也是免疫抑制髓系微环境的重要组成部分。与巨噬细胞一样，中性粒细胞可以被描述为两个亚群，N1和N2，N1表现出抗肿瘤活性，N2被认为能促进肿瘤转移。在乳腺癌模型中，TAMs分泌的IL-1β诱导γδT细胞释放IL-17以调节G-CSF的释放并促进中性粒细胞的募集以刺激转移，表明TANs在肿瘤进展中与TAMs密切相关。然而，TAN和TAM在肿瘤发生和免疫逃逸中的特异性相互作用机制尚不清楚。巨噬细胞影响Th细胞巨噬细胞和辅助性T细胞之间存在相互调节作用。巨噬细胞依赖TGF-β和IL-10将Th1细胞转化为Th2细胞，以逆转CD8+细胞毒性T细胞和CD4+Th1细胞的抗肿瘤作用，这被认为是一种肿瘤免疫逃逸机制。而Th细胞通过改变巨噬细胞的极化方向影响肿瘤TME。Th1细胞分泌IFN-γ以诱导M1极化，而Th2细胞可分泌IL-4、IL-5和IL-10以促进M2巨噬细胞的生成。此外，Treg表型和功能对免疫抑制性TME发挥重要作用。最近的研究表明，巨噬细胞可以通过各种途径影响Treg的增殖、迁移和功能。首先，TAMs可分泌IL-23，促进Treg的增殖以及IL-10和TGF-β的表达，抑制CTL杀伤肿瘤细胞；其次，巨噬细胞过度表达CCL1，即Treg上表达的CCR8的配体，以吸引Treg进入肿瘤区域；类似地，巨噬细胞分泌CCL22以诱导Treg迁移到卵巢癌的肿瘤区域，抑制T细胞免疫并促进肿瘤生长。巨噬细胞与CAF 的相互作用CAF是TME中最丰富的基质细胞，可释放大量细胞因子，合成和重塑细胞外基质，形成促瘤纤维微环境。CAF可分泌IL-6、M-CSF、MCP-1和基质细胞衍生因子-1，以促进巨噬细胞的浸润和分化。而M2可分泌TGF-β，以促进内皮细胞向间质细胞的转化，并增加CAF的反应性，从而增强癌细胞的侵袭性。巨噬细胞通过PD-1/PD-L1轴介导免疫逃逸TAMs调节肿瘤细胞上PD-L1和CD8+T细胞上PD-1的表达。PD-L1在多种肿瘤组织中高表达，可被TAM衍生的TNF-α上调，并与肿瘤基质中的巨噬细胞浸润呈正相关。在TME中，PD-L1在TAMs上的表达也受到许多因素的影响。IL-27/STAT3轴在淋巴瘤浸润巨噬细胞中诱导PD-L1/2过表达。Progranulin可以通过STAT3途径上调TAMs上的PD-L1，从而促进乳腺癌的免疫逃避。同时，PD-1/PD-L1轴对巨噬细胞功能有着深刻的影响。TAMs上PD-1表达的增加可抑制其吞噬作用，并在结构上作用于mTOR途径，对巨噬细胞的增殖和活化起负调节作用。因此，PD-1/PD-L1阻断也可直接影响巨噬细胞。PD-1/PD-L1阻断剂可促进巨噬细胞的促炎极化，增强效应T细胞的活性，并与其他免疫检查点抑制剂合作限制肿瘤扩散。除了PD-1/PD-L1轴外，一些实验结果表明TAM还可以与其他免疫检查点（如CTLA/CD86轴和TIM3/galectin-9轴）一起诱导免疫逃逸，但仍缺乏确切的证据。巨噬细胞与这些免疫检查点在免疫逃逸中的相互作用值得进一步研究。巨噬细胞有助于形成免疫无反应部位免疫无应答是肿瘤组织逃避免疫监视的重要原因，巨噬细胞可能通过以下机制参与肿瘤组织的免疫豁免。首先，巨噬细胞可以通过聚集CAF到肿瘤区域，CAF沉积纤维胶原、透明质酸、纤维连接蛋白和其他物质，并分泌赖氨酰氧化酶刺激I型胶原交联，从而形成物理屏障。其次，与肿瘤细胞类似，诱导的TAM可表达Fas-L并释放活性可溶性Fas-L，诱导Fas+淋巴细胞凋亡，而CAF可通过MHC-1抗原交叉呈递上调Fas-L和PD-L2，抑制CD8+T细胞的活性，从而形成缺乏淋巴细胞浸润的TME。此外，肿瘤细胞分泌的透明质酸可与巨噬细胞表面的TLR4结合，诱导TAM迁移至肿瘤相关区域，并通过miR935抑制C/EBPβ的表达，促进巨噬细胞向M2表型的分化，从而促进恶性肿瘤细胞逃避免疫监视并“冷却”免疫反应。-04-三、巨噬细胞免疫治疗的临床进展靶向TAM越来越多的证据表明TAM有助于化疗耐药性,以TAM为靶点的单一疗法或联合化疗的治疗方法正在临床前和临床中进行试验。TAM被CSF-1招募到TME中，促进乳腺癌的发展和转移。因此，用单克隆抗体或小分子化合物靶向CSF-1/CSF-1R轴的治疗方法正在试验中。RG7155是一种靶向CSF-1R的单克隆抗体，在一项1期临床试验（NCT01494688）中对7名诊断为弥漫型巨细胞瘤的患者进行治疗，所有患者均出现PR，2名患者出现CR。此外，在RG7155治疗的患者肿瘤活检中，CD68+CD163+巨噬细胞的数量减少，表明TAM向TME的募集减少。靶向CSF-1R、c-Kit和Flt3的酪氨酸激酶抑制剂PLX3397通过使TAM的M2表型去极化来阻断肿瘤进展。PLX3397正在包括黑色素瘤（NCT02071940、NCT02975700）、前列腺癌（NCT0149043）和胶质母细胞瘤（NCT01349036）患者中进行临床试验。其他CSF-1R抑制剂，如ARRY-382（NCT01316822）、BLZ945（NCT02829723）、AMG820（NCT01444404）和IMC-CS4（NCT01346358）也正在各种实体瘤患者中进行测试。除了单药治疗外，针对CSF-1或CSF-1R的抑制剂还与化疗联合进行测试。例如，PLX3397与紫杉醇联合用于晚期实体瘤患者（NCT01525602）；PLX3397与eribulin联合用于乳腺癌患者的试验（NCT01596751）；PLX3397与vemurafenib用于BRAF突变黑色素瘤患者（NCT01826448）；PLX3397联合sirolimus用于晚期肉瘤患者（ NCT02584647）等。此外，TAM的靶向剂和免疫检查点抑制剂的联合应用也在开发中。IMC-CS4与durvalumab或tremelimumab联合用于实体瘤患者的临床试验（NCT02718911）正在进行中。还有PLX3397与pembrolizumab联合用于各种肿瘤患者的1期临床试验（NCT02452424），ARRY-382与pembrolizumab的联合试验（NCT02880371），BLZ945与PDR001（一种针对PD-1的单克隆抗体）的联合试验（NCT02829723），RG7155与atezolizumab的联合试验（NCT02323191），以及AMG820与使用pembrolizumab的联合试验（NCT02713529）。CAR-巨噬细胞直到2020年11月，两个基于CAR-M策略的临床试验已经获得FDA的批准。第一个是来自CARISMA Therapeutics的候选药物CT-0508，它用抗HER2的CAR-M治疗复发/难治性HER2过度表达的肿瘤患者（I期临床试验）。另一个是Maxyte的MCY-M11，它利用mRNA转染PBMC表达靶向间皮素的CAR（包括CAR-M），治疗复发/难治性卵巢癌和腹膜间皮瘤患者，目前正在招募志愿者进行I期临床试验。-05-结语越来越多的研究表明巨噬细胞在肿瘤发展、转移、免疫调节、肿瘤血管形成、TME重塑和癌症治疗反应中起着关键作用。巨噬细胞靶向治疗有望成为肿瘤免疫治疗的下一个前沿，阐明其相互作用模式将有助于对免疫抑制性TME形成更全面的认识，避免免疫反弹，减少肿瘤免疫逃避，促进相关研究的发展。参考资料：1.Next frontier in tumor immunotherapy:macrophage-mediated immune evasion. Biomark Res. 2021; 9: 72.公众号内回复“ADC”或扫描下方图片中的二维码免费下载《抗体偶联药物：从基础到临床》的PDF格式电子书！公众号已建立“小药说药专业交流群”微信行业交流群以及读者交流群，扫描下方小编二维码加入，入行业群请主动告知姓名、工作单位和职务。

免疫疗法

2025-05-26

·药事纵横

全球首个！联合疗法III期结果刷新ES-SCLC一线维持治疗新标准

5月23日，ASCO官网公布了由芦比替定（lurbinectedin）联合阿替利珠单抗（atezolizumab）针对小细胞肺癌（ES-SCLC）治疗的III期IMforte试验（NCT05091567）结果。作为一线维持治疗，首次在全球III期研究中显著延长了患者的无进展生存期（PFS）和总生存期（OS），为这一难治性肺癌亚型带来了突破性进展。图源：ASCO官网广泛期小细胞肺癌约占所有肺癌的15%，确诊时约70%已处于广泛期，肿瘤进展迅猛，预后极差。尽管近年来免疫治疗联合化疗成为一线诱导治疗的新标准，但患者中位生存期仍不足1年，且多数在治疗后数月内复发。维持治疗虽能延缓进展，但单药免疫的疗效有限，临床亟需更优方案，芦比替定的加入填补了这一空白。芦比替定作为海洋来源的化疗药物，通过抑制肿瘤细胞转录过程直接杀伤癌细胞，同时调节肿瘤微环境，例如减少促癌细胞因子分泌、抑制肿瘤相关巨噬细胞的活性。这种“双重打击”与阿替利珠单抗的PD-L1阻断作用形成互补：化疗药物释放的肿瘤抗原可能增强免疫治疗的应答，而免疫治疗则延长化疗的疗效持续时间。这种协同效应在PFS和OS的双重获益中得以体现，也为后续联合疗法的开发提供了思路。 IMforte研究设计660名初治ES-SCLC患者首先接受4个周期的阿替利珠单抗+卡铂+依托泊苷诱导治疗，病情稳定或缓解的483名患者进入维持阶段，随机接受芦比替定联合阿替利珠单抗或单药阿替利珠单抗治疗。结果显示，联合组中位PFS达5.4个月，较单药组的2.1个月翻倍，疾病进展风险降低46%；中位OS也从10.6个月延长至13.2个月，死亡风险下降27%。联合组的维持治疗持续时间也更长（4.1个月 vs 2.1个月），提示患者对治疗的耐受性和依从性可能更优。但联合疗法的安全性问题比较让人担忧，数据显示，联合组治疗相关不良事件（TRAE）发生率达83.5%，显著高于单药组的40.0%；3/4级TRAE发生率为25.6%（单药组5.8%），5级TRAE（致死性）发生率为0.8%（单药组0.4%）。常见不良反应包括恶心（36.4%）、贫血（31.8%）、疲劳（20.2%）等，骨髓抑制相关事件也较为突出，因此临床实践中仍需权衡疗效与毒性，尤其是对体质较弱的患者。尽管副作用发生率较高，但专家认为其“总体可控”。联合组因不良事件停药的比例仅为6.2%，且未出现新的免疫相关毒性信号，主要副作用可通过剂量调整或支持治疗管理。对于ES-SCLC这类生存期短、治疗选择少的患者，适度的毒性增加若伴随显著生存获益，仍可能被临床接受。芦比替定本身是RNA聚合酶II抑制剂，2020年在美国获批用于SCLC二线治疗，2024年12月在中国获批同类适应症，若其适应症前移至一线维持，还需解决可及性与成本问题。当前，全球ES-SCLC治疗药物市场由罗氏的阿替利珠单抗、阿斯利康的度伐利尤单抗等跨国药企主导，但中国药企如恒瑞医药的斯鲁利单抗、信达生物的阿得贝利单抗通过自主研发和License out加速布局。芦比替定联合疗法的成功可能加剧这一领域的竞争，尤其是其与现有免疫药物的协同效应或成为差异化优势。尽管IMforte研究结果积极，ES-SCLC治疗仍面临多重挑战。首先，联合疗法的PFS和OS绝对值仍偏低，分别是5.4个月和13.2个月，提示患者生存获益仍有提升空间。其次，芦比替定的毒性问题可能限制其广泛应用，尤其在高龄或合并症患者中需谨慎评估风险收益比。ES-SCLC的异质性和耐药机制复杂，单纯延长数月生存是否足够？如何筛选获益人群、优化用药顺序、探索生物标志物，将是下一步重点。此外，近年来新兴疗法如抗体偶联药物（ADC）、T细胞衔接器（TCE）等快速发展，可能对现有方案形成冲击。安进的CD3/DLL3双抗塔拉妥单抗已获FDA附条件批准，其III期临床数据即将公布；恒瑞、信达等中国药企的B7-H3、TROP-2靶向ADC也进入关键试验阶段。芦比替定联合阿替利珠单抗的IMforte研究标志着ES-SCLC治疗迈出重要一步，但其临床应用仍需综合考虑疗效、安全性和成本效益。随着ADC、TCE等新疗法的涌现，未来治疗格局可能进一步多元化。信息来源：ASCO官网药事纵横投稿须知：稿费已上调，欢迎投稿

临床结果ASCO会议临床3期免疫疗法

100 项与度伐利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10808	度伐利尤单抗	L01XC28	DB11714

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
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

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
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


NCT04441138 (ESR1814205, CTgov)	临床2期	非小细胞肺癌 III期	10	Durvalumab	遞膚窪選積鬱獵鹽齋範 = 憲鹹觸膚憲壓衊網廠齋餘憲淵鏇夢鹹製構願壓 (觸廠選築糧壓夢鏇淵餘, 餘構遞艱壓膚築鬱餘鹹 ~ 範鹽蓋糧餘簾構淵夢觸) 更多	-	2025-05-28
NCT05061134 (MONETTE, CTgov)	临床2期	局部晚期黑色素瘤	194	Durvalumab+Ceralasertib	願醖襯網遞鑰繭齋夢廠 = 鹹範製襯窪鏇蓋鹽艱夢齋憲窪簾夢築齋衊範齋 (淵鏇蓋膚鬱蓋淵選範夢, 繭觸構壓鏇製網襯範鬱 ~ 襯鏇構蓋範構憲鹹繭遞) 更多	-	2025-05-21
NCT03528694 (POTOMAC, Company_Website) 人工标引	临床3期	非肌层浸润性膀胱肿瘤	-	Imfinzi plus BCG induction and maintenance therapy	窪範艱構糧壓襯膚淵繭(衊鏇艱獵齋醖積齋艱鹽) = statistically significant and clinically meaningful improvement in disease-free survival (DFS) 繭顧鹽鑰襯鹽夢築壓齋 (淵窪憲顧範淵夢夢窪選 ) 更多	积极	2025-05-09
				Imfinzi plus BCG induction-only therapy
Pubmed 人工标引	N/A	晚期胆道癌	221	Durvalumab	醖製淵觸窪壓膚膚繭鹽(網願鏇製醖醖淵鑰鹽繭) = 簾蓋鏇糧醖憲膚鹹鹹糧繭窪餘醖選築鹹鏇夢憲 (構蓋鹽遞網選艱觸衊膚 ) 更多	积极	2025-03-31
				Sintilimab	醖製淵觸窪壓膚膚繭鹽(網願鏇製醖醖淵鑰鹽繭) = 襯築鏇獵齋鬱蓋壓製構繭窪餘醖選築鹹鏇夢憲 (構蓋鹽遞網選艱觸衊膚 ) 更多
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	遞簾鑰蓋鹽鹽襯遞衊繭(窪廠窪鏇鹽獵網窪獵獵) = 壓簾鹹膚艱鹽醖壓製遞糧製簾糧選鹽蓋廠襯網 (鹽壓鹽憲鹽顧觸夢網遞 ) 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	廠糧衊糧壓構遞蓋膚鬱(蓋築齋醖窪遞衊蓋鹹鹹) = 獵觸網壓網齋膚觸範膚憲遞範積鹽廠餘艱鏇積 (簾艱構壓艱鹹選觸夢衊, NR ~ NR) 更多	积极	2025-03-28
				Chemotherapy alone	廠糧衊糧壓構遞蓋膚鬱(蓋築齋醖窪遞衊蓋鹹鹹) = 網窪蓋蓋膚顧繭顧網夢憲遞範積鹽廠餘艱鏇積 (簾艱構壓艱鹹選觸夢衊, 32.2 ~ NR) 更多
ALLSTAR (ESMO_ELCC2025)	N/A	非小细胞肺癌 III期	188	Durvalumab	襯廠選繭鏇顧積艱鹽獵(鹽壓衊衊製襯憲選鹹淵) = grade 1-3 occurred in 93/188 (49%) cases 鬱衊顧鏇鹽窪鏇鑰繭膚 (壓廠繭繭觸積獵鹹製簾 ) 更多	积极	2025-03-26
				Durvalumab (Radiation dose >66 Gy)
NCT05683977 (ARSENAL, ESMO_ELCC2025)	N/A	广泛期小细胞肺癌一线	232	Durvalumab + Platinum-Etoposide	願顧艱襯願淵膚網鬱窪(鹽襯獵膚製觸鹹鑰鏇觸) = 積範鑰繭蓋積鬱網鑰襯壓製範築憲鬱壓繭廠餘 (簾範餘膚鑰鏇範齋壓衊, 4.9 ~ 6.0) 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	顧顧範齋範簾網獵製製(鏇淵遞夢艱齋簾築醖襯) = 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) 遞構鏇選廠觸窪簾餘積 (顧築構鏇遞鹹艱膚構鹽 ) 更多	积极	2025-03-26
				Durvalumab + Chemotherapy
NCT04712903 (CANTABRICO, ESMO_ELCC2025)	临床3期	广泛期小细胞肺癌一线	101	Durvalumab plus carboplatin and etoposide	鏇衊顧鹽鹽遞獵選糧淵(築淵鹽積獵製憲糧鹹築) = 範製醖鏇齋鹽糧廠遞夢醖淵築鹽網鏇選襯簾構 (觸網獵鹹築願觸製夢獵 ) 更多	积极	2025-03-26