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

开始日期2026-09-21

申办/合作机构

City of Hope National Medical Center

[+1]

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2026-06-30

申办/合作机构

University of Maryland Baltimore

[+1]

NCT05253131

/ Not yet recruiting临床2期IIT

Phase 1/2 Trial of the MEK Inhibitor Selumetinib and Bromodomain Inhibitor ZEN-3694 With Durvalumab (MEDI4736), a PD-L1 Antibody for Sarcomas Including Malignant Peripheral Nerve Sheath Tumors

A multi-institutional open-label phase 1/2 trial of selumetinib in combination with ZEN-3694 and durvalumab in refractory/unresectable sarcomas including MPNST. The phase 1 portion will be separated in two parts and will be open to all patients with refractory/relapsed sarcomas. The phase 2 portion will be for patients with refractory/unresectable NF1-associated MPNST.

开始日期2026-05-15

申办/合作机构

The University of Alabama at Birmingham

[+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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1,983

项与度伐利尤单抗相关的文献（医药）

2026-03-01·LUNG CANCER

Durvalumab-containing treatment for recurrent or metastatic pulmonary sarcomatoid carcinoma: A pooled post hoc analysis of two KCSG phase II trials

Article

作者: Kim, Tae Min ; Kim, Yu Jung ; Kim, Dong-Wan ; Lee, Gyeong-Won ; Keam, Bhumsuk ; Kim, Miso ; Kim, Dong Hyun ; Kim, Joo-Hang ; Ahn, Mi Sun ; Hong, Sook-Hee ; Kim, Jin-Soo ; Kim, Se Hyun ; Shin, Seong Hoon ; Youk, Jeonghwan

INTRODUCTION:

Pulmonary sarcomatoid carcinoma (PSC) is a rare cancer characterized by a high programmed death-ligand 1 (PD-L1) expression, suggesting a potential therapeutic benefit from immune checkpoint inhibitors. We investigated the efficacy of durvalumab-containing combination therapy and explored potential predictive biomarkers in patients with recurrent or metastatic (R/M) PSC.

METHOD:

In this pooled post hoc analysis, data were integrated from two prospective phase II trials (NCT03022500 and NCT04224337) wherein durvalumab-containing combination therapies were evaluated in patients with R/M PSC. PD-L1 expression was assessed using 22C3 or SP263 assays, and circulating lymphocyte subsets were analyzed using flow cytometry.

RESULTS:

Overall, 33 patients were included, of whom 66.7 % had a PD-L1 tumor proportion score (TPS) ≥ 1 % and 45.5 % had a TPS ≥ 50 %. The overall response rate was 33.3 % (95 % confidence interval [CI], 18.0 %-51.8 %), and the disease control rate was 72.7 % (95 % CI, 54.5 %-86.7 %). The median progression-free survival and overall survival were 5.4 (95 % CI, 2.8-9.4) and 15.7 (95 % CI, 11.3-not estimated) months, respectively. PD-L1 expression was not associated with the response or survival outcomes. Patients who achieved disease control exhibited a higher proportion of circulating CD8⁺ T cells (mean, 28.5 % vs. 20.3 %, P = 0.083) and a lower CD4⁺/CD8⁺ ratio (median, 1.4 vs. 1.7, P = 0.048) than did those with progressive disease.

CONCLUSION:

Durvalumab-containing combination therapy showed promising efficacy in patients with R/M PSC, irrespective of PD-L1 expression. A lower CD4⁺/CD8⁺ ratio may be associated with favorable disease control.

2026-03-01·Case reports in women's health

Recurrent endometrial carcinoma with immune-mediated thrombocytopenia following durvalumab: A case report

Article

作者: Sakakibara, Ami ; Shirane, Terumi ; Sakai, Tomomi ; Nagai, Shimpei ; Hattori, Yoshihisa ; Kurahashi, Takashi ; Hino, Makiko ; Fujioka, Yoko

The use of immune checkpoint inhibitors (ICIs) has expanded the therapeutic landscape for advanced or recurrent endometrial carcinoma. Durvalumab-a programmed death-ligand 1 (PD-L1) inhibitor-demonstrated clinical benefit in the 2023 DUO-E trial when combined with carboplatin and paclitaxel. Immune thrombocytopenia (ITP) is an uncommon but potentially life-threatening immune-related adverse event (irAE). A 73-year-old woman with recurrent endometrial carcinoma developed severe ITP after three cycles of paclitaxel, carboplatin, and durvalumab. Fourteen days after cycle 3 she presented with pyelonephritis, bacteremia, and acute disseminated intravascular coagulation (DIC). Despite infection control, her platelet count declined to 1 × 10³/μL, with epistaxis, hematuria, and melena. Suspecting ITP as an irAE, intravenous immunoglobulin (IVIG 10 g/day × 5 days) and high-dose intravenous prednisolone (1 mg/kg/day) were administered. Platelet counts improved gradually to 85 × 10³/μL by hospital day 32, and she was discharged on a steroid taper. This appears to be the first Japanese report of durvalumab-associated ITP in endometrial carcinoma. Clinicians should maintain a high index of suspicion for ITP when unexpected thrombocytopenia or bleeding occurs during durvalumab therapy and initiate prompt treatment.

2026-03-01·JHEP Reports

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

Article

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

Background & Aims:

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

Methods:

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

Results:

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

Conclusions:

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

Impact and implications:

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

2,395

项与度伐利尤单抗相关的新闻（医药）

2026-02-20

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跨国药企TOP10排位生变，礼来称王...

2025财年全球制药企业TOP10年报已全部出炉。本文仅统计制药业务营收，不含非药板块。一、营收格局：礼来登顶，行业座次重排2025年全球TOP10药企名单未变，但规模与排名均出现明显调整。• TOP10入围门槛：482亿美元（百时美施贵宝），较2024年的446亿美元提升36亿美元，增幅8%。• 榜首规模：礼来652亿美元，较2024年榜首辉瑞的636亿美元提升16亿美元，增幅2.5%。整体排名变化：3家上升、6家下滑、1家保持不变。1. 礼来：从第9跃升至第1，成为新“药王”2025年礼来制药业务营收652亿美元，同比大增45%，直接从2024年第9位飙升至全球第一。按当前汇率折算，约合人民币4500亿元，规模接近2024年A股111家化学制剂企业营收总和（4525亿元），相当于16个恒瑞医药的营收体量。核心驱动：替尔泊肽注射液销售额365.07亿美元，同比增长115%，超越K药成为全球销量最高单品。2. 默沙东：大幅滑落，从第2跌至第6营收仅微增1%，核心产品增长明显放缓：• K药（帕博利珠单抗）增长7%至317亿美元，高增长阶段基本结束，专利将于2028年到期。• HPV疫苗（佳达修/佳达修9）同比下降39%至52亿美元。3. 艾伯维：升至第3，新旧主力顺利切换营收增长8.6%。曾霸榜9年的修美乐（阿达木单抗）受生物类似药冲击，降至45.4亿美元；新一代主力快速放量：• 利生奇珠单抗（Skyrizi）176亿美元• 乌帕替尼（Rinvoq）83亿美元• 肉毒毒素产品60亿美元4. 辉瑞：跌落榜首，新冠业务持续退潮从第1降至第2，营收下滑2%。主要受新冠相关产品拖累：• 新冠疫苗Comirnaty 43亿美元（-33%）• 新冠口服药Paxlovid 24亿美元（-59%）公司正加速转型，传统主力稳定贡献：• 阿哌沙班80亿美元• 肺炎疫苗65亿美元• 氯苯唑酸64亿美元5. 其他企业简要变动• 赛诺菲：升至第9，营收+10%，度普利尤单抗178亿美元（+25%）。• 强生、罗氏、诺华：均后退1位，营收分别增长6%、9%、8%，增长稳健但排名被动下滑。• 百时美施贵宝：下降2位至第10，营收微降1%。• 阿斯利康：排名唯一不变，稳居第5，营收+9%，达格列净、奥希替尼、度伐利尤单抗表现突出。若计入非药业务，强生、罗氏、默沙东总营收规模仍居前列，非药收入分别为338亿、170亿、69亿美元。二、市值：礼来一家独大，远超同行以2月11日收盘价计算，礼来以9592.77亿美元市值称霸全球：• 接近第2名强生（5802亿）+第3名罗氏（4777亿）之和；• 约等于第6～10名五家药企市值总和；• 折合人民币约6.62万亿元，是A股111家化学制剂总市值（2.1万亿）的3.2倍，相当于17个恒瑞医药。市值与营收背离最明显的是辉瑞：营收仅比礼来低6%，但市值比礼来低84%，市场更看好礼来的长期增长。2025年礼来净利润206.40亿美元，同比暴涨95%。三、总结单一爆款药物替尔泊肽，几乎以一己之力将礼来推上营收与市值双料第一。行业再次证明：创新是核心动力，重磅单品决定格局。

财报疫苗生物类似药

2026-02-20

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2025全球药企TOP10洗牌：礼来登顶、默沙东跌出前五，GLP-1双雄对决，代谢领域彻底“翻身”……

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。近期，全球制药圈的财报分析群里弥漫着一股“格局碎了”的震撼。起因是2025年全球制药巨头年报集体揭晓——这份本该是年度常规“成绩单”的文件，却像一颗投入湖面的深水炸弹，炸出了行业格局的剧烈震荡：既有新王踩着GLP-1浪潮登顶的颠覆性突破，也有老牌豪强因单一爆品折戟的意外滑落，更有代谢赛道与肿瘤正式分庭抗礼的20年最大权力转移。最戳行业神经的几个“名场面”：礼来凭替尔泊肽的“双适应症屠榜”，终结默沙东“K药时代”的垄断，成为近五年首位新晋全球制药榜首；默沙东握着肿瘤王牌KEYTRUDA，却因HPV疫苗在中国市场断崖式下滑，业绩暴跌跌出前五；代谢领域双雄（礼来、诺和诺德）包揽全球畅销药前二，合计贡献超710亿美元营收——这是首次有非肿瘤药占据全球药品销售冠亚军，标志着代谢赛道完成近20年最大权力洗牌。当“专利悬崖焦虑”“中美价格博弈”“热门靶点泡沫预警”与“AI研发军备赛”交织成网，当“单一爆品撑不起永续增长”从口号变成血淋淋的现实，2025年的TOP10变局，本质上是“新增长引擎”对“传统底盘”的降维冲击，而中国市场的表现，成了检验药企韧性的“终极试金石”。 01 剥开迷雾：两张“王炸”改写格局，为何行业集体“炸锅”？要理解这轮洗牌的冲击力，必须先看懂过去全球制药格局的“旧稳态”——肿瘤药长期霸榜、单一爆品支撑巨头增长、中国市场是“增量补充”而非“战略核心”。但2025年的两张“王炸”，直接把这套逻辑砸得稀碎。摩熵数据整理：企业财报披露第一炸：礼来登顶，GLP-1把“新药王”刻进代谢赛道礼来的登顶，不是“突然逆袭”，而是GLP-1赛道爆发的必然结果。这家以“8位跃升”跻身榜首的药企，核心底气来自替尔泊肽的“双适应症屠榜”：其一款药就以365.07亿美元销售额登顶全球畅销药第一，叠加20%的高研发投入巩固GLP-1绝对优势，不仅拿下全球制药榜首，更成为首家市值登顶的药企——相当于用一款代谢药，把“新药王”的桂冠从肿瘤赛道抢了过来。为什么是GLP-1？本质是全球代谢疾病（尤其是肥胖）治疗的刚性需求爆发。过去20年，肿瘤药一直是“营收奶牛”，但2025年，礼来与诺和诺德的GLP-1双雄合计贡献超710亿美元营收，包揽全球畅销药前二——这是代谢领域第一次站到与肿瘤“分庭抗礼”的高度，相当于把“黄金赛道”的权杖从肿瘤手里抢了过来。第二炸：默沙东跌出前五，“单一爆品依赖症”反噬有多狠？默沙东的暴跌，是“把鸡蛋放在一个篮子里”的典型教训。作为曾经的“榜首常客”，默沙东的核心底盘是KEYTRUDA（K药）——这款肿瘤王牌曾撑起其半壁江山，但2025年，K药虽仍有316.4亿美元销售额（+7%），却挡不住两大危机：一是专利到期倒计时（剩余保护期不足5年），二是研发收缩的后遗症（百亿美元营收缺口的接棒者迟迟难产）。更致命的是，HPV疫苗在中国市场的断崖式下滑——中国区营收暴跌66%，直接把默沙东从“前五阵营”踹了出去。群里有人调侃：“以前靠K药‘躺赢’，现在K药成了‘拖油瓶’，连中国市场的‘救命钱’都没了。” 传统巨头的“位次焦虑”：从“单品比拼”到“赛道统治力”较量礼来与默沙东的“一升一降”，本质是竞争维度的升级——过去药企拼“哪款药卖得好”，现在拼“哪个赛道能统治”。比如辉瑞回落至第2，暴露“缺重磅新药”的隐忧：阿哌沙班虽稳却难撑大盘，收购Seagen的肿瘤管线尚未释放势能，新冠红利退散后，增长后劲像“泄了气的皮球”。阿斯利康稳居第5，靠24%的高研发投入与中国调查后的平稳过渡，向800亿营收目标推进——它的聪明之处，是早早在代谢、肿瘤、自免多赛道布子，没把宝全押在一款药上。就连强生、罗氏这样的老牌玩家，也在悄悄调整策略：不再追求“单品爆款”，而是学礼来“押注赛道级机会”（比如罗氏的ADC药物Polivy增速38%、Columvi增速75%）。 02 “赛道定输赢”背后：代谢与肿瘤的“权力交接”，藏着行业的未来密码 2025年行业竞争的胜负手，从来不是“某款药的销量”，而是核心赛道的领跑权——代谢赛道的“双雄争霸”、肿瘤赛道的“前三换血”，本质上是一场“新赛道”对“旧赛道”的权力掠夺。摩熵数据整理：企业财报披露代谢赛道：20年最大权力转移，双雄包揽全球畅销药前二 GLP-1双雄的对决，让代谢领域彻底“翻身”。礼来的替尔泊肽系列以365.07亿美元登顶，诺和诺德的司美格鲁肽系列以345亿美元紧随其后，两款代谢药合计贡献超710亿美元营收——这是首次有非肿瘤药占据全球药品销售冠亚军。背后的逻辑很简单：全球肥胖人群超10亿，代谢疾病治疗从“可选”变成“刚需”，GLP-1类药物不仅能降糖，还能减重，相当于“一款药解决两个大问题”，自然成了药企必争的“黄金战场”。肿瘤赛道：前三换血，ADC成“破局关键词” 肿瘤仍是营收核心支柱，但竞争格局已变：默沙东凭K药以354.25亿美元肿瘤营收（+8%）蝉联榜首，但核心产品增速放缓（仅7%），专利到期压力像“悬顶之剑”；罗氏靠Polivy（+38%）、Columvi（+75%）等新药对冲经典产品的下滑（Perjeta、Avastin受生物类似药冲击）；阿斯利康成最大黑马，以18%同比增速取代BMS挺进前三——靠的是ADC药物Enhertu（+40%）与奥希替尼、Imfinzi形成合力，ADC技术成了肿瘤赛道的“创新密码”。自免与疫苗：强者恒强但“分化加剧” 自免赛道：艾伯维凭Skyrizi（+49.9%）、Rinvoq（+39.1%）抵消修美乐（-49.5%）下滑，仍居第一；赛诺菲靠度普利尤单抗（+20%）升至第二；强生因乌司奴单抗（-41.3%）下滑至第三——“老药下滑、新药补位”成自免赛道的常态。疫苗赛道：整体承压，仅GSK实现2%正增长；默沙东HPV、肺炎疫苗销量下滑致业务降22%；辉瑞Abrysvo（+37%）、GSK Arexvy（+2%）等细分品类成亮点，但美国政策不确定性仍存——“细分品类救不了整体颓势”。 03 中国定格局：本土化深浅，直接决定全球排位中国市场的变化，比全球格局更戳药企神经——它已从“增量补充”升级为“战略必争地”，其表现直接左右全球排名。摩熵数据整理：企业财报披露 AZ稳坐第一：深度本土化是“护城河” 阿斯利康以66.54亿美元营收稳坐跨国药企在华榜首，秘诀是“研产销一体化”：产品端：Breztri市场份额扩张、Tezspire商业化推进，对冲Farxiga的医保集采冲击；合作端：与加科思、石药的重磅合作，绑定本土创新资源；战略端：2030年前在华投资150亿美元的承诺，把中国当成“第二总部”。第二梯队集体提速：本土化“深浅”决定增速诺华（8%增速）：凭Leqvio入医保、Entresto双适应症落地与Pluvicto本土化生产，平衡现金流与创新；罗氏（10%增速）：靠Phesgo医保放量、Xofluza流感季需求增长，但难逃生物类似药冲击；诺和诺德：以Wegovy（+306%）对冲Ozempic波动，尽显GLP-1统治力——GLP-1的中国需求，比全球更猛。礼来成黑马：18%增速的秘密是“提前布局” 礼来的中国区排名跃升，核心是Mounjaro在华两位数增长，更关键的是2026年纳入医保的前瞻布局——相当于“提前占好赛道位置”，把中国市场的“后续空间”锁死了。默沙东：单一爆品折戟，本土化“太浅” 默沙东的中国区营收暴跌66%，根源是佳达修（HPV疫苗）需求锐减，而与恒瑞、科伦的合作暂难扭转颓势——它的错误在于，把中国市场的希望全押在“单一爆品”上，没做本土化的“多产品矩阵”。结语 2025年的TOP10变局，不是“偶然的业绩波动”，而是行业逻辑的彻底切换：过去，“单一爆品+专利保护”能撑起巨头增长；现在，“赛道统治力+多产品矩阵”才是核心；过去，中国是“增量补充”；现在，中国是“战略必争地”，本土化深浅直接决定全球排位；过去，肿瘤是“唯一黄金赛道”；现在，代谢、自免、罕见病成“新蓝海”。当专利悬崖、价格博弈、靶点泡沫与AI竞赛交织，当“慢一步即被甩开，守成即意味着掉队”成为行业共识，药企的生存法则已经变了：不能只盯着“某款药的销量”，要押注“能统治的赛道”（比如GLP-1、ADC）；不能把中国市场当“卖货场”，要做“研产销一体化”的深度本土化；不能靠“单一爆品”撑永续增长，要靠“多产品矩阵”对冲风险。毕竟，无论K药多厉害，无论替尔泊肽多火，没有“赛道统治力”和“本土化根基”，再牛的药也撑不起巨头的永续增长。2025年的TOP10变局，既是过去数年战略布局的结果，也为未来十年埋下了伏笔——抓得住新赛道机遇、筑牢中国市场根基的企业，才能在这场洗牌中站稳脚跟。 END 本文为原创文章，转载请留言获取授权近期热门资源获取中国临床试验趋势与国际多中心临床展望-202505 2024年医药企业综合实力排行榜-202505 中国带状疱疹疫苗行业分析报告-202505 2023H2-2024H1中国药品分析报告-202504 2024年中国1类新药靶点白皮书-202503 中国AI医疗健康企业创新发展百强榜单-202502 2024年FDA批准上市的新药分析报告-202501 小分子化药白皮书（上）-202501 2024年中国医疗健康投融资全景洞察报告-202501 2024年医保谈判及市场分析报告-202501 近期更多摩熵咨询热门报告识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作点击阅读原文，申请摩熵医药企业版免费试用！

财报疫苗核酸药物

2026-02-19

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年度盘点丨2025年妇瘤研究进展（三）：子宫内膜癌和外阴癌

点击蓝字关注我们妇科癌症涵盖卵巢癌、子宫内膜癌、宫颈癌以及外阴与阴道恶性肿瘤，是全球范围内重要的公共卫生挑战。本文重点梳理Nabil Ismaili在《Biomedicines》期刊发表的一篇综述，介绍2025年子宫内膜癌和外阴癌研究方面的最新进展，以期为同行提供参考。生物标志物定义子宫内膜癌治疗巩固一线免疫化疗方案的地位，MMR/MSI检测很重要发表在《自然·医学》上的NRG GY018研究更新报告了更长随访后的次要终点数据[1]。NRG GY018旨在验证在标准化疗（紫杉醇+卡铂）基础上，联合并维持使用帕博利珠单抗治疗晚期或复发性子宫内膜癌患者，是否优于单纯化疗。虽然总生存（OS）数据仍不成熟，但帕博利珠单抗联合卡铂-紫杉醇的无进展生存（PFS）获益在错配修复正常（pMMR）人群和错配修复缺陷（dMMR）人群中均得以持续。安全性特征保持稳定，未加重化疗相关毒性。 ENGOT-EN6-NSGO/GOG-3031/RUBY试验在《妇科肿瘤学》发表了完整的错配修复功能缺陷/微卫星高度不稳定（dMMR/MSI-H）队列结果：中位随访37.2个月，dostarlimab联合化疗对比安慰剂联合化疗显示出显著的PFS改善（HR=0.28）和具有临床意义的OS获益（HR=0.32；p<0.0001），36个月OS率分别为77% vs. 52%。该方案治疗产生缓解的患者中，缓解时间持久。[2] ESMO 2025发布了AtTEnd/ENGOT-EN7试验（阿替利珠单抗）的最终OS分析：总体人群和dMMR人群中均达到主要PFS终点，但dMMR和pMMR人群最终的OS分析结果不同：阿替利珠单抗联合化疗相比对照组在dMMR亚组有显著的OS获益（HR=0.49），在pMMR亚组未观察到OS获益（HR=1.02）[3]。研究结果显示，对于dMMR/MSI-H肿瘤患者，一线免疫化疗产生显著的生存优势；而对于pMMR肿瘤患者，获益主要是延迟进展。这要求在诊断时必须进行普遍的、快速的MMR/MSI检测，以指导一线治疗选择。生物标志物动态变化一些研究继续探索改善患者结局的策略，特别是在pMMR疾病中。DUO-E试验（度伐利尤单抗联合化疗）的转化研究探索了纵向ctDNA变化[4]。在ASCO 2025报告的分析发现，在度伐利尤单抗组中，48%的pMMR肿瘤患者在一个治疗周期后（至C7D1→C9D1）实现了ctDNA清除，而对照组为17%，并且这种清除是加用度伐利尤单抗带来PFS和OS获益的强有力的早期预测指标。该研究发现提供了另一个动态工具来评估治疗反应，并可能用于调整治疗持续时间。综上，2025年的子宫内膜癌研究在确立一线免疫化疗疗效的基础上，进一步通过精确的生物标志物分析来完善其应用。2025年的数据明确了晚期子宫内膜癌的治疗流程：普遍的MMR/MSI检测现在绝对必要，未来的研究必须聚焦如何克服pMMR肿瘤耐药，以及使用ctDNA清除等动态生物标志物。外阴癌：免疫/放化疗新标准通过免疫/放化疗建立新标准外阴癌作为一种罕见且常被忽视的恶性肿瘤，在2025年取得了有意义的进展。Yeku等人的II期研究评估了同步帕博利珠单抗联合顺铂增敏放疗的疗效[5]。在ASCO 2025报告的主要结果显示，在接受放化疗-免疫治疗后进行手术的患者中，病理完全缓解率高达58%，并且2年PFS和OS率与单独放化疗的历史对照数据相比具有优势。该方案的主要毒性来自放疗，总体可控。该研究提供了首个前瞻性证据，支持将免疫疗法整合到局部晚期外阴癌的根治性治疗管理中，与宫颈癌中KEYNOTE-A18研究发现相呼应。这项研究虽然是II期，但对这种罕见癌症具有重要的实践指导意义。通过证明在标准顺铂放化疗基础上加用帕博利珠单抗的可行性和高效性，它为局部晚期不可切除疾病建立了一个新的潜在基准，应推动更大规模的验证性研究。参考文献（上下滑动可查看） 1. Eskander, R.N. et al. Pembrolizumab plus chemotherapy in advanced or recurrent endometrial cancer: Overall survival and exploratory analyses of the NRG GY018 phase 3 randomized trial. Nat. Med. 2025, 31, 1539–1546. 2. Powell, M.A. et al. Efficacy and safety of dostarlimab in combination with chemotherapy in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in a phase 3, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY). Gynecol. Oncol. 2025, 192, 40–49. 3. Barretina Ginesta, M.P. et al. LBA39 Final Overall Survival Results from the Randomized Double-Blind Phase III AtTEnd/ENGOT-EN7 Trial Evaluating Atezolizumab in Combination with Paclitaxel and Carboplatin in Women with Advanced/Recurrent Endometrial Cancer. Ann. Oncol. 2025, 36, S1583. 4. Westin, S.N. et al. Durvalumab Plus Carboplatin/Paclitaxel Followed by Durvalumab with or without Olaparib as First-Line Treatment for Endometrial Cancer: Longitudinal Changes in Circulating Tumor DNA. J. Clin. Oncol. 2025, 43, 5512. 5. 25. Yeku, O.O. et al. Primary Results of a Phase 2 Study of Cisplatin-Sensitized Radiation Therapy and Pembrolizumab for Unresectable Vulvar Cancer. J. Clin. Oncol. 2025, 43, 5511. （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会议临床结果申请上市

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
早期胃癌	美国	AstraZeneca PLC	2025-11-25
胃食管交界处癌	美国	AstraZeneca PLC	2025-11-25
局部晚期胃癌	美国	AstraZeneca PLC	2025-11-25
不可切除的非小细胞肺癌	中国	AstraZeneca UK Ltd.	2025-11-18
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

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
胃食管交界处腺癌	申请上市	澳大利亚	AstraZeneca Pty Ltd.	2025-06-11
胃癌	申请上市	澳大利亚	AstraZeneca Pty Ltd.	2025-06-11
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

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临床结果

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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


ASCO_GI2026	N/A	晚期胆道癌一线	581	durvalumab + gemcitabine + cisplatin	積餘繭膚醖簾遞窪繭鹹(範鹹簾鹽製鹹憲糧艱願) = 艱願夢觸憲繭築憲觸顧鑰構膚鹹鹽繭糧餘鑰顧 (艱觸衊遞鑰膚鏇壓鏇廠, 0.47 ~ 0.63) 更多	积极	2026-01-08
				gemcitabine + cisplatin	積餘繭膚醖簾遞窪繭鹹(範鹹簾鹽製鹹憲糧艱願) = 淵築憲積積構網廠齋簾鑰構膚鹹鹽繭糧餘鑰顧 (艱觸衊遞鑰膚鏇壓鏇廠, 0.36 ~ 0.68) 更多
NCT02962063 (ASCO_GI2026)	临床2期	食管腺癌	20	Durvalumab + Tremelimumab + PET-directed chemoradiation	選鑰繭鑰窪糧願築醖遞(襯餘願製膚艱觸淵願製) = 齋淵獵淵網鏇廠構築壓遞蓋憲築廠顧憲範鬱鏇 (築齋積網遞襯選鑰餘鏇 ) 更多	积极	2026-01-08
				Durvalumab + Tremelimumab + PET-directed chemoradiation (resected Pts)	選鑰繭鑰窪糧願築醖遞(襯餘願製膚艱觸淵願製) = 窪鹹廠範醖憲鏇顧鹽餘遞蓋憲築廠顧憲範鬱鏇 (築齋積網遞襯選鑰餘鏇 )
NCT06501625 (ASCO_GI2026)	临床1/2期	IDH1突变的胆管癌一线 IDH1 Mutation	7	Ivosidenib 500 mg + Durvalumab + Gemcitabine/Cisplatin	觸夢遞繭選獵鹹壓顧蓋(夢蓋範範廠糧鏇醖願獵) = 蓋糧簾鹹蓋鬱鏇齋獵築顧網願範鏇選齋製糧夢 (範廠願鬱鏇廠獵範蓋衊 ) 更多	积极	2026-01-08
ASCO_GI2026	N/A	肝内胆管癌 \| 胆管癌一线	175	Durvalumab plus gemcitabine/cisplatin (CCA)	製獵簾襯鹽壓願構齋壓(醖構糧網顧鑰築壓淵憲) = The most common toxicities were hematologic events, with both groups demonstrating similar rates of anemia, thrombocytopenia, leukopenia, and neutropenia. 選醖築構顧願衊簾鬱積 (壓衊淵遞積齋襯憲製願 ) 更多	积极	2026-01-08
				Durvalumab plus gemcitabine/cisplatin (cHCC-CCA)
TPAZ-1 (ASCO_GI2026)	临床3期	晚期胆管癌一线	3,373	Gemcitabine plus cisplatin plus durvalumab	鑰獵淵選窪繭膚糧觸壓(顧鏇願鑰夢廠夢簾鬱遞): HR = 0.6 (95.0% CI, 0.55 ~ 0.66), P-Value = < 0.001 更多	积极	2026-01-08
				Gemcitabine plus cisplatin plus pembrolizumab
NCT04592913 (MATTERHORN, ASCO_GI2026)	临床3期	胃食管交界处腺癌辅助 \| 新辅助	948	durvalumab + FLOT	築壓願憲糧膚築遞願鹽(衊廠膚窪廠鹽鏇膚簾構) = 窪鏇齋艱膚鬱憲窪積觸顧衊齋範淵醖艱壓製觸 (艱壓構觸獵範鏇選網憲 ) 更多	积极	2026-01-08
				placebo + FLOT	築壓願憲糧膚築遞願鹽(衊廠膚窪廠鹽鏇膚簾構) = 遞遞鹹齋齋夢衊廠範範顧衊齋範淵醖艱壓製觸 (艱壓構觸獵範鏇選網憲 ) 更多
TOPAZ-1 (ASCO_GI2026)	临床3期	晚期胆管癌一线	874	Gemcitabine + cisplatin + durvalumab	範襯鏇鬱鏇簾醖積鑰衊(願衊鏇顧膚製網蓋壓觸) = 鑰衊醖鏇鏇齋淵壓鏇製壓夢鹹蓋餘築壓醖構鏇 (鹽廠衊鹹衊願鏇鏇顧網 ) 更多	相似	2026-01-08
				Gemcitabine + cisplatin + pembrolizumab	範襯鏇鬱鏇簾醖積鑰衊(願衊鏇顧膚製網蓋壓觸) = 餘鑰鹹衊窪衊遞網積築壓夢鹹蓋餘築壓醖構鏇 (鹽廠衊鹹衊願鏇鏇顧網 ) 更多
NCT05733598 (RP2-003, ASCO_GI2026)	临床2期	晚期胆道癌 \| 晚期肝细胞癌二线 \| 一线	60	RP2 + Atezolizumab + Bevacizumab	醖鬱醖積範顧鏇齋網醖(餘遞壓構網淵襯襯艱蓋) = 鑰餘積觸選衊齋艱積壓網淵淵觸鑰蓋網選選壓 (餘齋壓窪鑰蓋顧繭蓋製 )	积极	2026-01-08
				RP2 + Durvalumab	醖鬱醖積範顧鏇齋網醖(範艱蓋鬱製廠積糧範壓) = 製獵製鏇繭醖夢遞製鏇觸鹹鬱蓋獵夢觸窪壓膚 (膚鏇窪簾齋鹽衊構鬱繭 )
ASCO_GI2026	N/A	晚期肝细胞癌一线	3,306	Bevacizumab-atezolizumab	網遞遞糧顧鑰鬱廠鏇壓(膚壓鹽築簾繭鑰製廠餘): HR = 0.873 (95.0% CI, 0.75 ~ 0.935), P-Value = 0.0016	积极	2026-01-08
				Lenvatinib
ASCO_GI2026	N/A	晚期胆道癌一线	172	Gemcitabine-cisplatin-durvalumab (GCD) (low-risk)	糧築蓋遞願選憲網顧網(構齋範夢鑰鹽遞觸蓋襯) = Magic-D achieved AUCs of 0.755 and 0.749 for 6- and 12- months survival prediction, respectively, outperforming NLR and other baseline factors. 構獵網築鏇窪遞選鹹鹹 (獵鹽獵糧網憲廠壓顧顧 )	积极	2026-01-08
				Gemcitabine-cisplatin-durvalumab (GCD) (intermediate-risk)