预约演示

更新于：2025-03-29

Durvalumab

度伐利尤单抗

更新于：2025-03-29

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

子宫癌晚期子宫内膜癌复发性子宫内膜癌+ [193]

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

MedPacto, Inc.

Juno Therapeutics, Inc.

Fred Hutchinson Cancer Research Center

+ [5]

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

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结构/序列

Sequence Code 10069506H

来源: *****

Sequence Code 13384675L

来源: *****

关联

877

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]

NCT06287775

/ Recruiting临床1/2期IIT

A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer

This phase I/II trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab, and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body (extensive stage) who initially received standard of care chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer.

开始日期2025-08-17

申办/合作机构

National Cancer Institute

NCT06858735

/ Not yet recruiting临床2期

HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma

This study will compare outcomes for M1 iCCA patients treated with and without L-RT by reviewing iCCA patients found to have M1 disease at initial diagnosis at a single institution between 2010 and 2021 who received L-RT.

开始日期2025-08-01

申办/合作机构

AstraZeneca PLC

[+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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6,109

项与度伐利尤单抗相关的文献（医药）

2025-12-31·OncoImmunology

The immune checkpoint LAG-3 is expressed by melanoma cells and correlates with clinical progression of the melanoma

Article

作者: Richter, Jasmin ; Halama, Niels ; Eurich, Rosa ; Hassel, Jessica C ; Wiecken, Melanie ; Pfarr, Nicole ; Lenoir, Bénédicte ; Mayr, Eva-Maria ; Chakraborty, Shounak ; Machiraju, Devayani

Immune checkpoint blockers have substantially improved prognosis of melanoma patients, nevertheless, resistance remains a significant problem. Here, intrinsic and extrinsic factors in the tumor microenvironment are discussed, including the expression of alternative immune checkpoints such as lymphocyte activation gene 3 (LAG-3) and T-cell immunoglobulin and mucin domain-containing protein 3 (TIM-3). While most studies focus on immune cell expression of these proteins, we investigated their melanoma cell intrinsic expression by immunohistochemistry in melanoma metastases of 60 patients treated with anti-programmed cell death protein 1 (PD-1) and/or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) therapy, and correlated it with the expression of potential ligands, RNA sequencing data and clinical outcome. LAG-3 and TIM-3 were commonly expressed in melanoma cells. In the stage IV cohort, expression of LAG-3 was associated with M1 stage (p < 0.001) and previous exposure to immune checkpoint inhibitors (p = 0.029). Moreover, in the anti-PD-1 monotherapy treatment group patients with high LAG-3 expression by tumor cells tended to have a shorter progression-free survival (p = 0.088), whereas high expression of TIM-3 was associated with a significantly longer overall survival (p = 0.007). In conclusion, we provide a systematic analysis of melanoma cell intrinsic LAG-3 and TIM-3 expression, highlighting potential implications of their expression on patient survival.

2025-12-31·Journal of Immunotoxicology

Immunotoxicological disruption of pregnancy as a new research area in immunotoxicology

Review

作者: Nakamura, Kazuichi

Immune mechanisms associated with normal pregnancy have only been being substantively investigated since the early 1990s. In parallel with the progress in that area of research, in the past few years it has become increasingly clear that several xenobiotics - including a variety of environmental chemicals, pharmaceuticals, and metals are considered to be both generally immunotoxic and specifically able to affect pregnancy. Among these, there is intense interest regarding potential effects from synthetic cannabinoids, immune checkpoint inhibitors, nanometals, and microplastics, with immunotoxic events that impact on pregnancy being shown for these agents. For instance, phytocannabinoids have been shown to interfere with reproduction in mice through effects on the endocannabinoid system. Because of effects of immune enhancement, as a requirement for regulatory submission, co-inhibitory immune checkpoint molecule inhibitors were also evaluated for effects on pregnancy. Similarly, because of increasing use and concerns about incidental environmental exposures, nanometals, and micro-plastics have also been examined for effects. Several studies in humans or mice showed that exposures to each during gestation increased the risk/rate of fetal loss, in part, by disruption of the placenta-associated immune system. Furthermore, signaling by endogenous danger molecules and/or impairment of physiological intercellular mediators may have contributed to the pregnancy loss. As there are clearly a variety of immunotoxic effects that can impact on a pregnancy, this review attempts to briefly introduce immune mechanisms associated with pregnancy as well as reasons for its loss, and proposes that 'immunotoxicological disruption of pregnancy' be accepted as a new research area in immunotoxicology.

2025-12-31·CANCER BIOLOGY & THERAPY

The search for a TNBC vaccine: the guardian vaccine

Review

作者: McCarthy, Helen ; Fines, Cory ; Buckley, Niamh

Nearly 20 million people are diagnosed with cancer each year with breast cancer being the most common among women. Triple negative breast cancer (TNBC), defined by its no/low expression of ER and PR and lack of amplification of HER2, makes up 15-20% of all breast cancer cases. While patients overall have a higher response to chemotherapy, this subgroup is associated with the lowest survival rate indicating significant clinical and molecular heterogeneity demanding alternate treatment options. Therefore, new therapies have been explored, with a large focus on utilizing the immune system. A whole host of immunotherapies have been studied including immune checkpoint inhibitors, now standard of care for eligible patients, and possibly the most exciting and promising is that of a TNBC vaccine. While currently there are no approved TNBC vaccines, this review highlights many promising studies and points to an antigen, p53, which we believe is highly relevant for TNBC.

1,489

项与度伐利尤单抗相关的新闻（医药）

2025-03-28

·ioncology

ELCC中国好声音｜张凌云教授解读CLOG2402-ADAPT研究：免疫联合方案一线维持及跨线治疗广泛期小细胞肺癌

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”ELCC 2025 微专辑扫描二维码可查看更多内容编者按在2025年欧洲肺癌大会（ELCC）上，CLOG2402-ADAPT研究的试验设计获选大会壁报展示（摘要344TiP）。研究作者、中国医科大学附属第一医院张凌云教授应本刊邀请，详细分析了这项研究的设计及临床意义。张凌云教授（上下滑动可查看）中国医科大学附属第一医院肿瘤内科三级教授，主任医师，硕士生导师MD Anderson Cancer Center 访问学者中国抗癌协会骨与软组织肿瘤整合康复专业委员会常委中国抗癌协会肿瘤临床化疗专业委员会青委中国抗癌协会抗癌药物专业委员会委员中国抗癌协会罕见突变及罕见肿瘤专委会委员中国研究型医院学会精准医学与肿瘤MDT专业委员会青委北京整合医学会肺癌专委会副主任委员北京整合医学会胸部肿瘤转化医学会常委辽宁省抗癌协会第二届肿瘤多学科协作诊疗专业委员会副主任委员辽宁省细胞生物学学会肺癌细胞靶向和免疫治疗专委会副主任委员辽宁省细胞生物学学会纵隔肿瘤细胞学专委会副主任委员辽宁省细胞生物学学会肿瘤MDT和细胞学研究专委会常委辽宁省预防医学会肿瘤防治专业委员会常委辽宁省免疫学会肿瘤免疫分会常委兼秘书《中华肿瘤杂志》第一届青年编委中国医科大学学报第四届编委中国医科大学主持国家自然基金青年基金及辽宁省科技厅各一项；参与多项国家、省级课题；以第一作者或通讯作者在JCO等杂志发表SCI论文30余篇；辽宁省自然科学成果奖一等奖（第一完成人）辽宁省科技进步一等奖（主要完成人）青年拔尖人才344TiP - Adebrelimab plus apatinib for maintenance treatment of extensive-stage small cell lung cancer after first-line induction with adebrelimab plus chemotherapy (CLOG2402-ADAPT): A multi-center, single-arm, phase II clinical trial阿得贝利单抗联合化疗一线诱导后阿得贝利单抗联合阿帕替尼维持治疗广泛期小细胞肺癌（CLOG2402-ADAPT）：一项前瞻性、单臂、II期临床实验研究背景根据GLOBOCAN 2022，肺癌的发病率和死亡率均在所有肿瘤类型中排名第一，发病例数和死亡例数分别为2480301例和1817172例[1]。小细胞肺癌（SCLC）约占所有肺癌患者的15%，由于其高度恶性和早期转移倾向，大约50%~80%的SCLC患者在首次诊断时即为广泛期[2–4]。对于初治的广泛期小细胞肺癌（ES-SCLC）患者，目前欧美小细胞肺癌诊疗指南如NCCN或ASCO，推荐的一线治疗标准治疗方案仍然是依托泊苷联合顺铂（EP）或卡铂（EC）基础上，加用PD-L1抑制剂[5,6]。我国的ES-SCLC患者一线治疗选择更多，近期发表的《小细胞肺癌免疫治疗专家共识（2025版）》推荐免疫检查点抑制剂（ICI），包括阿替利珠单抗、度伐利尤单抗、阿得贝利单抗、斯鲁利单抗、特瑞普利单抗或替雷利珠单抗，可联合铂类化疗作为一线治疗ES-SCLC的标准治疗方案（证据等级：高，推荐强度：强推荐）[7]。尽管一线含铂化疗联合ICI改善了ES-SCLC患者的总生存期（OS），但与单纯化疗相比，中位OS的延长不超过5个月（表1）。ETER701研究评估了四药方案（贝莫苏拜单抗+安罗替尼 + EC）vs EC一线治疗ES-SCLC的疗效和安全性，四药联合方案较EC组延长了中位OS（19.3个月 vs 11.9个月），两组中位OS差值达7.4个月[8]。但需要注意的是，ETER701研究中，抗血管生成药物的加入，导致超过一半(54.9%)的患者发生任何级别的严重不良事件，且主要为3级及以上的不良事件。并且增加了出血事件的发生率（所有级别的咯血发生率为：试验组vs对照组13.4% vs 7.3%，所有级别的潜血阳性发生率为：试验组vs对照组11.8% vs 6.9%）[8]。同样是在含铂双药化疗联合ICI的基础上增加抗血管生成药物，BEAT SC研究结果显示：阿替利珠单抗+贝伐珠单抗+EC对比阿替利珠单抗+EC一线治疗ES-SCLC患者并未改善患者的OS，这提示我们：小分子抗血管生成药物可能是ICI联合含铂双药化疗一线治疗ES-SCLC的最佳“搭档”[9]。DURABLE研究为以上推测进一步增加了证据，并且提示我们：仅在维持治疗阶段加入小分子抗血管生成药物，可能会增加治疗方案的安全性[10]。此外，不同药物组合的疗效和安全性仍需要进行广泛和深入的探索。CAPSTONE-1研究是一项在中国开展的多中心、随机、双盲、安慰剂对照III期临床试验，结果显示PD-L1抑制剂阿得贝利单抗联合EC对比EC显著降低了初治ES-SCLC患者的死亡风险[风险比=0.73（95% CI: 0.60-0.89）; p=0.0008][11]。阿得贝利单抗也因此在我国获批了一线治疗ES-SCLC的适应症。阿帕替尼是一款国产靶向治疗药物，是一种拥有自主知识产权的新型口服小分子抗血管生成制剂。阿帕替尼可高度选择性地结合并抑制血管内皮细胞生长因子受体-2（VEGFR-2），在治疗恶性肿瘤中主要是通过抑制VEGFR发挥抗血管生成作用。一项单臂II期临床试验中，阿帕替尼作为ES-SCLC一线维持治疗的中位OS为16.3个月(95% CI: 9.7–22.8个月)，仅有1例（8.3%）患者发生咯血，显示出与ICI联用的潜力和可接受的安全性[12]。另外，ASTRUM-005研究提示ES-SCLC一线治疗进展后, 免疫跨线治疗可能改善患者的OS[13]。但目前抗血管药物联合免疫检查点抑制剂跨线治疗的疗效尚不明确。因此在本研究中，我们允许患者疾病进展后，阿得贝利单抗和/或阿帕替尼继续跨线治疗，在此基础上，由医生决定联合其他化疗方案，以评价联合用药一线维持治疗及跨线治疗的疗效及安全性。研究设计本研究是一项多中心，单臂II期临床试验。旨在评价阿得贝利单抗联合化疗一线诱导后阿得贝利单抗联合阿帕替尼维持治疗ES-SCLC的疗效和安全性。本研究计划招募38例经组织学或病理学证实的ES-SCLC患者，筛选合格的患者将接受阿得贝利单抗(1200mg，IV，Day 1)+卡铂(AUC4- 5mg/mL/min)/顺铂(75mg/m2)+依托泊苷(100mg/m2，Day 1-3)，Q3W 治疗4-6周期，评估为部分缓解（PR）/完全缓解（CR）的患者将接受阿得贝利单抗（1200mg，IV，Day 1）+阿帕替尼（250mg，po, QD），Q3W 维持治疗，直至疾病进展或不可耐受。患者疾病进展后，由医生决定，阿得贝利单抗和/或阿帕替尼允许跨线应用。本研究的主要研究终点为第一次无进展生存期（PFS1)，次要研究终点包括第二次无进展生存期（PFS2），OS、客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DoR）以及安全性。探索性终点包括血细胞因子（如IL-6、IL-8、IL-10等）、T细胞亚群、T细胞免疫精准分型及调节性T细胞数量检测等与疗效的关系。本研究的临床试验注册号为NCT06480864。表1 我国广泛期小细胞肺癌一线治疗常用免疫检查点抑制剂+含铂化疗方案总生存期比较图1. 试验设计参考文献（上下滑动可查看）1.Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA A Cancer J Clinicians. 2024 May;74[3]:229–63. 2.Redin E, Quintanal-Villalonga á, Rudin CM. Small cell lung cancer profiling: an updated synthesis of subtypes, vulnerabilities, and plasticity. Trends in Cancer. 2024 Oct;10[10]:935–46. 3.Gao R, Wu P, Yin X, Zhuang L, Meng X. Deep analysis of the trials and major challenges in the first-line treatment for patients with extensive-stage small cell lung cancer. International Immunopharmacology. 2025 Feb;148:114116. 4.Sen T, Dotsu Y, Corbett V, Puri S, Sen U, Boyle TA, et al. Pulmonary neuroendocrine neoplasms: the molecular landscape, therapeutic challenges, and diagnosis and management strategies. The Lancet Oncology. 2025 Jan;26[1]:e13–33. 5.National Comprehensive Cancer Network?. NCCN-guidelines-Small Cell Lung Cancer 2025 version 4. Available at: https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf. 2024. 6.Khurshid H, Ismaila N, Bian J, Dabney R, Das M, Ellis P, et al. Systemic Therapy for Small-Cell Lung Cancer: ASCO-Ontario Health (Cancer Care Ontario) Guideline. THE BOTTOM LINE. 2023; 7.中国临床肿瘤学会小细胞肺癌专家委员会, 中国医师协会肿瘤多学科诊疗专业委员会. 小细胞肺癌免疫治疗专家共识（2025版）[J]. 中华肿瘤杂志, 2025, 47[1]: 65-75. DOI: 10.3760/cma.j.cn112152-20240905-00383. 8.Cheng Y, Chen J, Zhang W, Xie C, Hu Q, Zhou N, et al. Benmelstobart, anlotinib and chemotherapy in extensive-stage small-cell lung cancer: a randomized phase 3 trial. Nat Med. 2024 Oct;30[10]:2967–76. 9.Annals of Oncology (2024) 35 (suppl_2): S1062-S1076. 10.1016/annonc/annonc1611. 10.B. Han, B. Zhang, R. Zhong, et al. Durvalumab Plus Anlotinib Versus Durvalumab as Maintenance Treatment in ES-SCLC (DURABLE): A Randomized, Phase 2 Trial. 2024 WCLC, MA17.07. 11.Cheng Y, Wang J, Zhou C, Yao W, Wang QM, Min X, et al. 84P Adebrelimab plus chemotherapy (chemo) as first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC): 3-year update of the phase III CAPSTONE-1 study. Immuno-oncology and technology [Internet]. 2023;20. Available from: https://www.cochranelibrary.com/central/doi/10.1002/central/CN-02660516/full12.Teng F, Xing P, Yang K, Gao L, Tian Z, Li J. Apatinib as maintenance therapy following standard first‐line chemotherapy in extensive disease small cell lung cancer: A phase II single‐arm trial. Thoracic Cancer. 2022 Feb;13[4]:557–62. 13.Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, et al. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer The ASTRUM-005 Randomized Clinical Trial. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. 2022 Sep 27;328[12]:1223–32. 14.Cheng Y, Fan Y, Zhao Y, Huang D, Li X, Zhang P, et al. Tislelizumab Plus Platinum and Etoposide Versus Placebo Plus Platinum and Etoposide as First-Line Treatment for Extensive-Stage SCLC (RATIONALE-312): a Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase 3 Clinical Trial. Journal of thoracic oncology. 2024;19[7]:1073‐1085. 15.Cheng Y, Zhang W, Wu L, Zhou C, Wang D, Xia B, et al. Toripalimab Plus Chemotherapy as a First-Line Therapy for Extensive-Stage Small Cell Lung Cancer: the Phase 3 EXTENTORCH Randomized Clinical Trial. JAMA oncology [Internet]. 2024; Available from: https://www.cochranelibrary.com/central/doi/10.1002/central/CN-02776599/full16.Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, et al. Serplulimab vs. placebo combined with chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: Extended follow-up results and patient-reported outcomes from the international phase 3 ASTRUM-005 study. JCO. 2024 Jun 1;42(16_suppl):8100–8100. 17.Paz-Ares L, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN. ESMO Open. 2022 Apr;7[2]:100408. 18.Liu SV, Reck M, Mansfield AS, Mok T, Scherpereel A, Reinmuth N, et al. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021 Feb 20;39[6]:619–30. （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。

ASCO会议免疫疗法临床结果

2025-03-28

·BiG生物创新社

10亿美元，阿斯利康「跑步」入场

作者｜momo日前，阿斯利康宣布以10亿美元的总价收购EsoBiotec，布局体内CAR-T等细胞疗法。这家曾错失商业化CAR-T疗法首班车的跨国药企，如今借EsoBiotec的体内CAR-T技术「跑步」入场。 01 加码CAR-T尽管阿斯利康在CAR-T领域的起步晚于诺华、吉利德等先驱，但其近年来通过密集收购与合作，展现出惊人的追赶速度。2023年12月8日，阿斯利康和西比曼生物就CAR-T疗法C-CAR031达成联合开发协议，在中国共同开发和商业化C-CAR031。C-CAR031（AZD7003）是一款针对肝细胞癌（HCC）的自体抗磷脂酰肌醇蛋白聚糖3（GPC3）的装甲型CAR-T疗法，C-CAR031靶向在肝癌中高表达的GPC3，并通过装甲抵抗肿瘤微环境中的免疫抑制影响。西比曼在2024年ASCO年会上公布了C-CAR031的临床数据，数据显示在晚期肝细胞癌患者中该疗法展现了初步的抗肿瘤活性。在所有剂量水平（DLs）的晚期肝癌患者中实现91.3%的疾病控制率（DCR）和56.5%的客观缓解率（ORR），尤其是在DL4患者中的ORR达到75.0%（图1）。图1.C-CAR031的临床数据仅仅数天之后的12月底，阿斯利康又以12亿美元收购中国CAR-T疗法公司亘喜生物，从而囊获亘喜生物旗下核心产品GC012F（AZD0120）。GC012F（AZD0120）是一种使用新型 FasTCAR-T 平台开发的B 细胞成熟抗原（BCMA）和 CD19 双靶点自体CAR-T 细胞疗法，用于治疗多发性骨髓瘤和系统性红斑狼疮。图2.AZD0120的I期临床研究数据2024年6月，阿斯利康在欧洲血液学协会（EHA）年会上公布了AZD0120一线治疗多发性骨髓瘤患者的I期临床研究结果。研究数据显示，在中位随访时间25.2个月时，22名接受AZD0120治疗的高风险、适合移植、新确诊的多发性骨髓瘤患者的总缓解率高达100%，微小残留病灶阴性严格完全缓解率（MRD-sCR）同样高达95%（图2）。或许是受到强生与传奇生物合作的启发，阿斯利康在2023年底集中从中国biotech引进的两款细胞疗法AZD7003、AZD0120，并获得一举成功。这让阿斯利康尝到了甜头，也更加坚定继续在CAR-T领域大举进军。2025年3月17日，阿斯利康宣布收购生物技术公司EsoBiotec，以加强其在细胞治疗领域的能力。EsoBiotec的体内技术（ENaBL技术平台）通过病毒载体直接将CAR基因递送至患者体内T细胞，大幅简化生产流程并降低成本。这一革新或将成为阿斯利康突破CAR-T疗法商业化瓶颈的关键，尤其是在实体瘤治疗这一传统CAR-T的“硬骨头”领域。图3.EsoBiotec管线其中，ESO-T01是EsoBiotec依托ENaBL技术平台开发首个实现体内BCMA靶向的CAR-T疗法（图3），也是该技术路线下首款进入人体临床试验的创新药物。2025年1月，该产品在华启动研究者发起的临床试验（IIT），针对复发/难治性多发性骨髓瘤患者进行安全性及有效性验证。值得注意的是，在未实施预处理淋巴清除的情况下，基线剂量组已观察到突破性药效特征：T细胞重编程效率与CAR-T扩增水平均超越预期，且受试者在给药28天后达到骨髓肿瘤细胞清零的显著缓解。尽管在CAR-T领域属于“后来者”，阿斯利康凭借资本运作与战略眼光，正以惊人的速度缩小与行业先驱的差距。未来，随着ENaBL等技术商业化落地，这家巨头或将在细胞治疗领域掀起新一轮革命。 02 多线布局细胞疗法在细胞治疗领域，阿斯利康正以“广撒网”策略加速扩张版图。除CAR-T外，阿斯利康在慢性病领域还与Quell Therapeutics公司达成金额超过20亿美元的独家合作（图4），开发多种Treg细胞疗法，这些疗法可能用于1型糖尿病（T1D）和炎症性肠病（IBD）的治疗。图4.阿斯利康与Quell Therapeutics达成合作此外，2023年11月阿斯利康与Cellectis达近2.5亿美元战略合作，加速基因治疗开发。阿斯利康将利用Cellectis前沿的基因编辑技术（TALEN）和生产能力来开发多达 10 款针对癌症、免疫和罕见病的基因和细胞疗法，以加速在肿瘤学、免疫学和罕见疾病等需求高度未满足的领域开发下一代疗法。据Cellectis官网，阿斯利康与Cellectis合作的多款基因和细胞疗法目前正处于临床研发阶段（图5）。图5.阿斯利康与Cellectis合作的多款基因和细胞疗法值得注意的是，阿斯利康还曾以3.2亿美元收购 Neogene Therapeutics，布局TCR-T 细胞疗法。TCR-T细胞疗法是一种基于T细胞的免疫疗法，通过基因工程技术，将能够识别特定癌症抗原的TCR基因导入患者的T细胞中，使这些T细胞发挥特异性识别和杀伤肿瘤细胞的作用。目前，Neogene正在推进一款TCR疗法NT-125的I期临床试验。NT-125是一种针对癌症新抗原的多特异性自体T细胞受体疗法，用于治疗晚期实体瘤。该疗法包含多达五个不同的新抗原特异性T细胞受体，能够靶向由HLA I类和HLA II类分子呈递的众多新抗原，旨在为广大患者提供更为高效的治疗方案。2022年5月，NT-125的临床试验申请（CTA）得到了荷兰监管机构的批准，后续Neogene被阿斯利康公司收购，这款疗法也被阿斯利康纳入自身产品管线中。阿斯利康通过高额合作与收购，深度布局Treg、TCR-T及基因编辑疗法，覆盖慢性病、实体瘤等未满足的临床需求，展现出对下一代细胞疗法的全面野心。 03 筑起竞争壁垒2024年，阿斯利康营收540.73亿美元，同比增长21%（图6）。研发投入高达135.83亿美元，同比增长25%，收获9项关键III期试验成功，8个新分子实体（NME）获批，五大业务板块共同发力筑起竞争壁垒。图6.阿斯利康2024财年和第四季度报告损益其中肿瘤板块以223.53亿美元（+24%）的收入领跑，占比41%。核心产品奥希替尼（Tagrisso）凭借EGFR肺癌领域的绝对优势，通过适应症向早期患者扩展持续巩固市场地位；度伐利尤单抗（Imfinzi）在膀胱癌和小细胞肺癌领域的III期试验成功，进一步拓宽其临床应用场景；阿卡替尼（Calquence）则加速冲击慢性淋巴细胞白血病一线治疗市场。三大重磅药物形成的组合拳，不仅推动肿瘤板块高速增长，更强化了阿斯利康在癌症治疗领域的技术壁垒（图7）。图7.肿瘤学多种药物畅销2025年，公司将迎来7个NME的III期数据读出，同时Calquence、Dato-DXd等创新药计划在华上市，进一步打开中国市场增长空间（图8）。图8.2025年7个NME的III期数据读出至2030年，阿斯利康计划累计获批20个新药，总收入突破800亿美元，彰显其以研发驱动长期增长的野心。除肿瘤领域外，五大业务板块协同布局，形成差异化竞争优势。心血管、肾脏及代谢疾病（CVRM）板块收入125.17亿美元，同比增长20%，依托创新疗法持续突破；罕见病板块（87.68亿美元，+16%）受益于Alexion收购，补体抑制剂Ultomiris和Soliris加速放量；呼吸与免疫（R&I）板块（78.76亿美元，+25%）凭借呼吸系统疾病药物组合实现稳健增长；疫苗与免疫疗法（V&I）板块（14.62亿美元，+8%）则通过RSV疫苗Beyfortus及新冠疫苗长效化布局，为未来增长埋下伏笔。各板块的均衡发展与技术互补，支撑公司抵御单一领域风险的能力。结语阿斯利康的千亿布局，映射出跨国药企在“专利悬崖”与“创新内卷”双重压力下的生存逻辑，“买时间”以弥补技术短板，“赌未来”以抢占下一个十年。从CAR-T到ADC，从“买买买”到自研创新，阿斯利康正以千亿级投入构建抗癌药物版图，试图在肿瘤治疗领域筑起一道难以逾越的竞争壁垒。参考资料[1]https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.4019[2]https://cn.gracellbio.com/uploads/2024/06/171858955098269.pdf[3]https://www.astrazeneca.com/content/dam/az/PDF/2024/fy/Full-year-and-Q4-2024-results-presentation.pdf[4]https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-agreement-with-quell-therapeutics.html[5]阿斯利康官网、EsoBiotec官网、Cellectis官网、各种公开资料等共建Biomedical创新生态圈！如何加入BiG会员？

细胞疗法免疫疗法并购临床1期临床结果

2025-03-28

·fda

FDA approves durvalumab for muscle invasive bladder cancer

On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).Full prescribing information for Imfinzi will be posted on Drugs@FDA. Efficacy and SafetyEfficacy was evaluated in NIAGARA (NCT03732677), a randomized, open-label, multicenter, Phase III trial enrolling 1,063 patients who were candidates for radical cystectomy and had not received prior systemic therapy for bladder cancer. Patients were randomized (1:1) to receive neoadjuvant durvalumab with chemotherapy followed by adjuvant durvalumab after surgery or neoadjuvant chemotherapy followed by surgery alone.The major efficacy outcome was event-free survival (EFS) by blinded independent central review. Overall survival (OS) was an additional efficacy outcome. At a pre-specified interim analysis, the trial demonstrated a statistically significant improvement in EFS and OS. Median EFS was not reached (NR) (95% CI: NR, NR) in the durvalumab with chemotherapy arm and 46.1 months (95% CI: 32.2, NR) in the chemotherapy arm (hazard ratio 0.68 [95% CI: 0.56, 0.82]; two-sided p-value <0.0001). Median OS was not reached in either arm (hazard ratio 0.75 [95% CI: 0.59, 0.93]; two-sided p-value=0.0106).Adverse reactions were consistent with prior experience with durvalumab with platinum-based chemotherapy.The recommended durvalumab dose for patients with a body weight of ≥30 kg is 1,500 mg every 3 weeks with chemotherapy (neoadjuvant treatment) and 1,500 mg as a single agent every 4 weeks (adjuvant treatment). The recommended durvalumab dose for patients with a body weight <30 kg is 20 mg/kg with chemotherapy every 3 weeks (neoadjuvant treatment) and 20 mg/kg as a single agent every 4 weeks (adjuvant treatment). Treatment should continue until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery.Expedited ProgramsThis review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.This application was granted priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.Follow the Oncology Center of Excellence on X: @FDAOncology.

临床3期优先审批临床结果上市批准ASCO会议

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
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
转移性胆道癌	列支敦士登	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
肌层浸润性膀胱癌	申请上市	美国	AstraZeneca PLC	2024-12-06
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

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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


NCT04712903 (CANTABRICO, ESMO_ELCC2025)	临床3期	广泛期小细胞肺癌一线	101	Durvalumab plus carboplatin and etoposide	襯觸憲積鬱鏇獵壓製憲(壓鹹選襯衊製積製窪製) = 繭選繭襯淵選鹹網鹹獵齋鏇壓繭壓窪範衊構繭 (窪夢艱艱淵簾選淵鑰簾 ) 更多	积极	2025-03-26
ALLSTAR (ESMO_ELCC2025)	N/A	非小细胞肺癌 III期	188	Durvalumab	繭鑰獵憲獵範襯糧積淵(築鑰網願獵鹹襯顧鑰築) = grade 1-3 occurred in 93/188 (49%) cases 淵鬱壓鏇淵餘網遞艱築 (廠鑰網膚廠製衊窪範築 ) 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	蓋簾壓繭鬱製鹽製齋憲(積鑰醖顧鹽襯遞蓋簾選) = 網繭簾積築觸鬱壓鑰淵構艱構顧糧鏇窪餘窪顧 (醖糧遞艱糧獵觸糧窪壓, 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	願鹽淵網簾廠醖蓋醖簾(憲壓餘醖遞鏇鑰遞襯蓋) = 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) 構鏇積網鹹襯壓艱願網 (築鹽憲鹽齋憲齋餘範鹹 ) 更多	积极	2025-03-26
				Durvalumab + Chemotherapy
NCT03703297 (ADRIATIC, ESMO_ELCC2025)	临床3期	局限期小细胞肺癌巩固	95	Durvalumab 1500 mg	糧艱餘願鏇膚鬱淵襯願(夢廠壓廠蓋蓋餘窪窪膚) = 窪醖廠壓製網獵獵鬱廠築鏇衊範淵鏇鏇齋襯鬱 (餘鑰構製廠觸觸蓋憲窪 ) 更多	积极	2025-03-26
				Placebo	糧艱餘願鏇膚鬱淵襯願(夢廠壓廠蓋蓋餘窪窪膚) = 繭膚簾蓋艱選鹹鬱遞構築鏇衊範淵鏇鏇齋襯鬱 (餘鑰構製廠觸觸蓋憲窪 ) 更多
NCT03519971 (PACIFIC-2 \| PACIFIC, CTgov)	临床3期	非小细胞肺癌 III期 \| 不可切除的非小细胞肺癌	328	Durvalumab (Durvalumab + SoC CRT)	鏇觸選夢蓋鹽選憲衊製(廠製壓艱願襯鏇築網遞) = 願蓋簾鏇範憲鬱觸糧遞齋衊製鑰獵願獵選憲淵 (糧廠憲網願鏇觸觸鬱鬱, 衊廠積遞鏇鏇淵簾網壓 ~ 艱餘網壓艱蓋齋選餘願) 更多	-	2025-03-25
				Placebo (Placebo + SoC CRT)	鏇觸選夢蓋鹽選憲衊製(廠製壓艱願襯鏇築網遞) = 膚觸鹽顧壓淵壓鑰簾積齋衊製鑰獵願獵選憲淵 (糧廠憲網願鏇觸觸鬱鬱, 糧顧鹽憲觸鏇獵鑰窪網 ~ 獵淵夢壓積廠艱艱廠襯) 更多
NCT02879162 (CTgov)	临床2期	晚期癌症	140	Tremelimumab+Durvalumab	醖網範夢壓壓築繭鹽憲(觸衊艱遞鹽糧願鏇獵鹽) = 繭襯鏇衊顧鑰遞選蓋艱鏇壓蓋獵蓋獵鑰遞艱餘 (窪範艱夢衊糧艱獵憲網, 夢蓋艱構範糧蓋鬱製鹽 ~ 淵醖繭構糧餘鹽鏇夢簾) 更多	-	2025-03-25
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	蓋憲顧糧夢範廠鑰糧積 = 願獵蓋積範糧憲齋遞鑰襯築齋蓋鹹糧醖鑰簾遞 (獵選膚觸鑰鹹顧鹹範醖, 衊餘齋範獵繭衊醖廠餘 ~ 鹽齋蓋選憲顧顧積蓋選) 更多	-	2025-03-25
NCT03706690 (PACIFIC-5, CTgov)	临床3期	非小细胞肺癌 \| 局部晚期不可切除癌 \| 局部晚期非小细胞肺癌	407	Durvalumab (Durvalumab)	淵觸願選淵艱繭觸網構(憲憲齋憲鏇簾齋壓繭簾) = 範鏇齋願淵襯餘蓋餘願範鬱憲齋網醖膚鏇選艱 (鬱淵壓遞範艱壓餘廠繭, 窪餘壓選遞簾艱淵蓋餘 ~ 顧餘積簾顧顧網簾膚窪) 更多	-	2025-03-25
				placebo+durvalumab (Placebo)	淵觸願選淵艱繭觸網構(憲憲齋憲鏇簾齋壓繭簾) = 襯鬱蓋鬱繭製遞壓觸齋範鬱憲齋網醖膚鏇選艱 (鬱淵壓遞範艱壓餘廠繭, 範願鹹艱鹹鑰衊壓鹹觸 ~ 築廠構鑰選鏇構衊鏇觸) 更多
NCT04538378 (CTgov)	临床2期	腺癌 \| 小细胞癌 \| 小细胞肺癌 ... 更多	4	Tumor biopsy+Olaparib+Durvalumab	築膚糧鹹糧積鏇憲顧製 = 膚醖積繭蓋繭鬱衊淵鹽襯衊選鹽鑰衊願鹹顧獵 (淵觸鬱獵遞窪選餘顧衊, 夢簾壓齋製鏇窪築蓋壓 ~ 襯夢蓋觸鏇窪齋窪鬱築) 更多	-	2025-03-25