This study is a randomized, open-label, controlled, multicenter phase II clinical trial, which aims to evaluate the safety and efficacy of SYS6002 versus enfortumab vedotin in the treatment of participants with advanced urothelial carcinoma.
This study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will be initiated only after formal approval is obtained from the relevant Ethics Committee or Institutional Review Board.

开始日期2026-06-20

申办/合作机构

石药集团巨石生物制药有限公司

NCT07346053

/ Not yet recruiting临床3期IIT

CHRONO-EVP: Time-of-day Dependent Administration of Enfortumab Vedotin and Pembrolizumab (EV/P) in Advanced Bladder Cancer

The goal of this clinical trial is to learn if the timing of treatments plays a role in how effective the standard-of-care drugs enfortumab vedotin and pembrolizumab (EV/P) works to treat adults with advanced bladder cancer. The trial will also learn if time-of-day reduces EV/P side-effects.
Researchers will compare EV/P given in the morning (before 11:30am) vs in the afternoon (after 1:30pm), to see if circadian rhythm effects how EV/P works to treat advanced bladder cancer.
Participants will be randomized in Arm A or Arm B to receive drugs EV/P either in the morning (Arm A) or afternoon (Arm B) as part of their standard-of-care treatment for advanced bladder cancer. Participants will:
* Visit the clinic either in the morning (Arm A) or afternoon (Arm B) to receive EV/P treatment as part of their regular medical care for advanced bladder cancer
* Frequency of visits will follow standard-of-care guidelines
* Participants will be followed-up by the study team for up to 24 months.

开始日期2026-05-01

申办/合作机构

British Columbia Cancer Agency

[+1]

NCT07139977

/ Not yet recruiting临床2期IIT

Open-Label Phase II Trial of Enfortumab Vedotin in Recurrent or Persistent Endometrial Carcinoma

This study is testing a drug called enfortumab vedotin in up to 12 patients with advanced endometrial (uterine) cancer that has worsened after previous treatments, including immunotherapy. The goal is to see how well the drug works and how safe it is. Patients will be treated for up to one year and followed over time to monitor their health and response to the treatment.

开始日期2026-04-01

申办/合作机构

Medical College of Wisconsin

[+1]

100 项与维恩妥尤单抗相关的临床结果

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100 项与维恩妥尤单抗相关的转化医学

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100 项与维恩妥尤单抗相关的专利（医药）

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983

项与维恩妥尤单抗相关的文献（医药）

2026-04-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Real-world evidence for 10 oncology drugs approved in the last 5 years: A comprehensive narrative synthesis

Review

作者: Oggionni, Emanuela ; Balconi, Elena ; Parati, Maria Chiara ; Rossitto, Mauro ; Petrò, Daniela ; Petrelli, Fausto ; Ghilardi, Mara ; Colombo Zefinetti, Lara ; Dottorini, Lorenzo ; Borgonovo, Karen ; Zambelli, Alberto ; Dognini, Giuseppina ; Castelli, Emanuela

IMPORTANCE:

Randomized controlled trials (RCTs) establish the efficacy of new oncology drugs but often exclude older adults, patients with comorbidities, and individuals with poorer performance status. Real-world evidence (RWE) is therefore essential to determine whether trial benefits translate to the broader populations treated in routine practice.

OBJECTIVE:

To synthesize contemporary RWE on the effectiveness and safety of ten oncology drugs approved between 2020 and 2025 for solid tumors, focusing on studies with ≥ 100 patients to maximize robustness and generalizability.

EVIDENCE REVIEW:

A systematic search of PubMed/MEDLINE, Embase, Scopus, Web of Science, and major conference proceedings (ASCO, ESMO, AACR) identified observational cohorts, registries, expanded-access programs, and claims-based studies published from January 2020 to January 2025.

FINDINGS:

Twenty studies (N > 3400) met inclusion criteria: breast cancer (9), lung cancer (7), urothelial carcinoma (3), and endometrial cancer (1). In breast cancer, sacituzumab govitecan reproduced ASCENT outcomes (ORR 27-30 %; PFS 4.8-5.2 months), trastuzumab deruxtecan achieved ORRs near 70 % in HER2-positive disease and median PFS 7.5 months in HER2-low cohorts, and elacestrant showed real-world time-to-next-treatment of 7.9-10.8 months in ESR1-mutant ER+ /HER2 - disease. In NSCLC, sotorasib and adagrasib demonstrated ORRs of ∼28-34 % and PFS 3.5-6 months, selpercatinib provided durable disease control, and MET inhibitors (capmatinib, tepotinib) yielded PFS around 6-7 months. In urothelial carcinoma, enfortumab vedotin produced ORRs of 31-73 % across datasets. In endometrial cancer, dostarlimab generated highly durable responses in dMMR/MSI-H disease.

CONCLUSIONS:

RWE confirms the effectiveness and safety of multiple recently approved oncology drugs reinforcing the external validity of RCTs.

2026-03-15·INTERNATIONAL JOURNAL OF CANCER

Enfortumab vedotin plus pembrolizumab in treatment‐naïve metastatic urothelial carcinoma patients: An Austrian real‐world analysis

Article

作者: Taghizadeh, Hossein ; Pallauf, Maximillian ; Stoiber, Franz ; Hilbe, Wolfgang ; Mühlmann, Josef ; Franke, Johannes ; Taedcke, Roman ; Vais, Dominic ; Terbuch, Angelika ; Pichler, Renate ; Weibrecht, Sabine ; Niedersuess‐Beke, Dora ; Spielgelberg, Jasmin ; Schnabel, Susanne ; Pfuner, Jacob ; Gampenrieder, Simon Peter ; Wiesinger, Clemens ; Pichler, Martin ; Heintel, Daniel ; Mayrhofer, Karl ; Krauter, Johanna ; Miechowiecki, Jan ; Shariat, Shahrokh F. ; Vallet, Sonia ; Fajkovic, Harun ; Bauernhofer, Thomas ; Andalibi, Haleh ; Banner, Andreas ; Luger, Ferdinand ; Aufderklamm, Stefan ; Kiesl, David

Abstract:

Antibody‐drug conjugates (ADCs) and immunotherapy have changed the treatment landscape for locally advanced and metastatic urothelial carcinoma (la/mUC). Clinical trials have demonstrated the superiority of enfortumab vedotin (EV) combined with pembrolizumab (P) over chemotherapy. This retrospective, multicentre Austrian registry analysis evaluated the effectiveness and safety of EV + P in treatment‐naïve la/mUC patients in a real‐world setting. This study included 203 first‐line EV + P treated patients from 20 Austrian centres. The majority were male (77.3%), with a median age of 70 years (range, 26–92), while 33.5% were ≥75 years. Comorbidities were common, with 25.1% having a Charlson Comorbidity Index (CCI) ≥ 5, and 46.3% moderate to severe renal impairment. Among 195 evaluable patients, the objective response rate (ORR) was 63.6% (95% CI, 56.6–70.0), including 21.5% complete responses and 42.1% partial responses. Disease control was achieved in 75.4% (95% CI, 68.9–80.9). Median progression‐free survival (PFS) and overall survival (OS) were not reached after a median follow‐up of 5.8 months. Poor outcomes were associated with ECOG PS >2 (PFS, p = .003; OS, p < .001) and CCI ≥5 (PFS, p = .011; OS, p = .08). EV + P was generally well tolerated; grade ≥3 treatment‐related adverse events occurred in 38.4% of patients and immune‐related adverse events in 19.2%. Limitations of this study include its retrospective design and short follow‐up. These findings support the clinical use of EV + P as first‐line treatment for la/mUC, demonstrating substantial effectiveness and manageable toxicity in a large real‐world population, including elderly and comorbid patients. Extended follow‐up is warranted to determine long‐term survival and predictive markers of response.

2026-03-01·CLINICAL PHARMACOLOGY & THERAPEUTICS

Respiratory Disorders Associated with Antibody–Drug Conjugates: A Combined Analysis of the French and the WHO Pharmacovigilance Databases

Article

作者: Lafay‐Chebassier, Claire ; Jutant, Etienne‐Marie ; Freppel, Romane ; Bihan, Kévin ; Mahé, Julien ; Bourneau‐Martin, Delphine ; Allouchery, Marion ; Hlavaty, Alex ; Cholle, Clément ; Hennegrave, Florence ; Mirleau, Victor ; Bainaud, Matthieu

Antibody–drug conjugates are proving to be highly effective in oncology, yet their real‐world respiratory safety profile remains largely unknown. This study sought to characterize drug‐linked respiratory disorders and identify safety signals. We performed a descriptive analysis with expert review of respiratory adverse drug reactions related to antibody–drug conjugates from the French pharmacovigilance database. We also conducted disproportionality analyses for interstitial lung disease, pulmonary arterial hypertension, and pleural disorder using VigiBase®. Among the 71 patients included in the descriptive study, 56 (78.9%) were women, and the median age was 60 years. Most (71.8%) were treated for breast cancer. Fifty‐nine patients (83.1%) developed antibody–drug conjugate‐related interstitial lung disease, primarily after trastuzumab deruxtecan. Nine patients (12.7%) developed pulmonary arterial hypertension and three (4.2%) contracted pleural disorders, mainly after trastuzumab emtansine. The median time to onset varied by clinical feature, with 1 month for pleural disorder, 4 months for interstitial lung disease, and 45 months for pulmonary arterial hypertension. The disproportionality analysis showed a significant signal for interstitial lung disease with brentuximab vedotin, polatuzumab vedotin, trastuzumab emtansine, and trastuzumab deruxtecan. Only trastuzumab emtansine had a significant signal for pulmonary arterial hypertension. All antibody–drug conjugates, except belantamab mafodotin and enfortumab vedotin, were associated with a significant signal for pleural disorders. Our study highlights the risk of interstitial lung disease with these drugs in real‐world settings and identified pulmonary arterial hypertension and pleural disorders as additional safety signals. Further research is needed to confirm these findings in population‐based studies and to identify antibody–drug conjugates and patient‐related risk factors.

1,487

项与维恩妥尤单抗相关的新闻（医药）

2026-02-12

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2025年全球制药行业TOP10深度点评：格局重塑与超级赛道主导时代

看完记得点赞 + 分享，让更多人看见！关注后星标，下次推送不迷路～一起探寻中国仿制药企业的未来之路。仿制药企出海路径抉择与实施策略——借鉴日企、外资与资本运作模式 2025年全球制药行业TOP10深度点评：格局重塑与超级赛道主导时代 2025年全球制药行业TOP10榜单尘埃落定，以制药业务营收为核心口径的排名，彻底颠覆了过去多年的稳定格局。礼来凭借GLP-1/GIP双靶点药物一骑绝尘登顶，辉瑞在新冠业务退潮后稳住第二，艾伯维、强生、阿斯利康、默沙东、罗氏、诺华、赛诺菲、百时美施贵宝依次上榜。这份榜单呈现出超级大单品决定位次、赛道分化加剧、传统巨头转型、美国企业主导、创新与商业化双轮驱动的鲜明特征，标志着全球医药行业进入代谢疾病狂飙、自免与肿瘤长期坚挺、疫苗周期退潮、管线迭代加速的全新阶段。本文基于精准营收数据，对十强企业逐一解析，提炼核心变化与行业底层逻辑。一、2025年全球制药TOP10精准榜单（制药业务营收） 1. 礼来：652亿美元，同比+44% 2. 辉瑞：626亿美元 3. 艾伯维：612亿美元（含医美） 4. 强生：604亿美元 5. 阿斯利康：587亿美元，同比+9% 6. 默沙东：581亿美元 7. 罗氏：577亿美元 8. 诺华：545亿美元 9. 赛诺菲：495亿美元 10. 百时美施贵宝：482亿美元二、TOP10企业核心表现与关键变化（一）礼来：GLP-1史诗级爆发，登顶全球第一礼来以652亿美元制药营收、44%的同比增速成为2025年最大赢家，替尔泊肽贡献压倒性增长，推动企业从传统 Pharma 一跃成为代谢疾病龙头，市值一度突破万亿美元。其登顶意味着慢病+减重+消费医疗赛道的价值重估，证明单一超级赛道足以改写全球行业格局。礼来的成功不是偶然，而是靶点前瞻、临床开发、全球商业化、适应症拓展全方位领先的结果。（二）辉瑞：后新冠时代企稳，专科药与疫苗托底辉瑞以626亿美元位居第二，虽新冠相关产品大幅下滑，但非新冠业务实现强势对冲。肿瘤领域Padcev、Lorbrena高速增长，疫苗板块Abrysvo、沛儿13价抵消回落影响，显示出强大的管线调整与商业韧性。辉瑞正从“事件驱动型巨头”回归创新药常态发展路径，通过并购与自研补强肿瘤、罕见病、炎症等高价值领域，短期阵痛不改长期龙头地位。（三）艾伯维：自免帝国稳固，医美成新增长极艾伯维以612亿美元稳居前三，修美乐后继产品组合强劲，Skyrizi176亿美元、Rinvoq83亿美元，免疫学统治力持续强化。肉毒杆菌毒素等医美业务成为重要增量，与制药板块形成协同。艾伯维证明自免赛道长坡厚雪，精细化商业化与适应症持续拓展，可有效对冲专利悬崖，实现业绩稳健增长。（四）强生：全产业链均衡，盈利韧性冠绝行业强生制药业务营收604亿美元，达雷妥尤单抗144亿美元，Stelara等持续贡献现金流，净利润大增90%。肿瘤、免疫、神经、感染四大板块无明显短板，叠加医疗健康业务协同，抗风险能力极强。强生是典型的平台型生态巨头，增长稳健、盈利丰厚，虽被礼来超越，但综合竞争力仍属全球第一梯队。（五）阿斯利康：稳健长跑选手，多元驱动高质量增长阿斯利康587亿美元营收、9%增速，达格列净、奥希替尼、度伐利尤单抗三大核心品种持续放量。肿瘤、呼吸、慢性肾病三大支柱均衡发力，全球化布局与中国市场深度深耕成效显著。阿斯利康不依赖单一爆款，依靠管线均衡+商业化高效实现穿越周期的稳定增长，是欧洲药企的标杆。（六）默沙东：K药依旧称王，疫苗下滑拖累整体默沙东以581亿美元位列第六，K药316.8亿美元蝉联全球药王，但HPV疫苗受市场环境影响同比下滑39%，成为主要拖累。企业面临核心产品增长见顶与管线青黄不接压力，亟需在传染病、自免、神经领域打开新增长点，摆脱对单一重磅药的过度依赖。（七）罗氏：诊断+制药协同，创新药接力增长罗氏以577亿美元位居第七，乳腺癌、哮喘、多发性硬化症等新品推动增长，Phesgo、Xolair、Ocrevus表现亮眼。作为全球肿瘤与精准医疗龙头，罗氏依托制药+诊断闭环生态，持续在靶向、免疫、ADC领域迭代，基本盘稳固，创新后劲充足。（八）诺华：战略聚焦见效，高价值产品持续爆发诺华545亿美元，诺欣妥、可善挺贡献巨大，Kisqali、Kesimpta、Pluvicto等实现双位数增长。公司剥离非核心资产、聚焦创新药战略成效显著，研发投入转化效率提升，在心血管、自免、神经、放射配体疗法领域多点开花，长期增长确定性强。（九）赛诺菲：达必妥一枝独秀，自免与疫苗双支撑赛诺菲495亿美元，重磅产品Dupixent销售额178亿美元，同比增长25.2%，成为全球自免领域标杆。公司聚焦免疫学、罕见病、疫苗三大领域，战略收缩与重点倾斜清晰，依靠超级大单品实现稳健增长，后续管线有望打开新空间。（十）百时美施贵宝：老药承压，创新与存量平衡 BMS以482亿美元守住前十，艾乐妥144亿美元增长8%，O药破百亿美元，但来那度胺等受仿制药冲击下滑。企业处于新老产品交替阶段，通过肿瘤与自免核心资产守住基本盘，后续管线兑现将决定其能否稳住头部位置。三、2025年TOP10榜单核心变化与行业特点（一）GLP-1时代正式到来，代谢疾病超越肿瘤成第一引擎礼来登顶是2025年最标志性事件，GLP-1/GIP双靶点药物从糖尿病治疗扩展至减重、心血管、肾病等泛健康领域，市场空间呈指数级扩张。代谢疾病已成为全球制药第一增长赛道，营收规模、增速、市值拉动能力全面超越传统肿瘤药，行业格局被彻底重构。（二）排名剧烈洗牌，超级大单品决定位次榜单位次不再由规模与历史地位决定，而是由核心产品销售额直接决定。礼来、赛诺菲、艾伯维依靠单一/少数超级大单品实现强势增长；默沙东、BMS因老药下滑与新品不及预期位次受压。行业进入单品定乾坤、管线定未来的极致竞争阶段。（三）新冠红利消退，行业回归创新基本面辉瑞是最典型案例，疫情相关业务退潮后，企业依靠专科创新药与常规疫苗实现企稳。榜单证明：医药行业长期增长动力源于未满足临床需求的持续创新，而非事件性红利。全行业回归常态化研发与商业化轨道。（四）自免赛道长牛确认，与代谢、肿瘤形成三大黄金赛道艾伯维、赛诺菲、强生、诺华在自免领域持续放量，Skyrizi、Rinvoq、Dupixent、Stelara、Cosentyx均为百亿美元级产品。自身免疫性疾病成为仅次于代谢疾病的第二大现金牛赛道，与肿瘤、代谢并称为全球制药三大黄金赛道。（五）美国企业绝对主导，欧洲药企精细化差异化竞争 TOP10中美国企业占据6席，礼来、辉瑞、艾伯维、强生、默沙东、BMS掌控行业话语权；欧洲企业以罗氏、诺华、阿斯利康、赛诺菲为代表，走精准聚焦、技术深耕、全球化均衡路线，凭借细分领域优势稳固地位。（六）专利悬崖压力加剧，管线迭代速度决定生死默沙东、BMS、辉瑞均面临核心产品专利到期与仿制药冲击，行业产品生命周期缩短，研发效率与商业化速度成为核心竞争力。只有持续产出创新药，才能避免排名剧烈波动。四、行业深层逻辑与未来趋势 2025年榜单背后，是全球制药行业三大底层逻辑切换：第一，支付端向高临床价值、大适应症、慢病长期用药集中，医保与商保优先倾斜真正解决未满足需求的药物。第二，技术端向大分子、多肽、ADC、基因细胞治疗、长效缓释升级，低水平同质化仿制药被持续挤出。第三，需求端向老龄化、慢病化、健康管理升级，代谢、自免、神经、老年病成为未来主流方向。未来3-5年，GLP-1赛道将持续内卷并拓展更多适应症；ADC与放射配体疗法进入爆发期；AI全面赋能研发与生产；行业集中度进一步提升，强者恒强。五、对中国医药企业的启示第一，聚焦黄金赛道，优先布局代谢、自免、肿瘤、呼吸、老年慢病，避免靶点扎堆与伪创新。第二，以临床价值为核心，做全球可比、患者可及、医保可负担的真正创新药。第三，强化全球商业化能力，从中国市场走向全球注册与销售，参与国际竞争。第四，打造大单品平台化，集中资源打造重磅炸弹，以点带面构建产品矩阵。第五，坚守合规与质量底线，对标国际GMP与数据标准，以全球品质支撑长期发展。结语 2025年全球制药TOP10榜单，是创新胜利、赛道胜利、商业化胜利的集中体现。礼来的登顶、辉瑞的转型、艾伯维与赛诺菲的自免霸权、罗氏与强生的稳健，共同勾勒出行业未来走向：超级赛道主导格局，大单品驱动增长，创新与效率决胜未来。对于全球药企而言，超越对手的唯一路径，是持续为患者创造不可替代的临床价值。对于中国药企，这份榜单既是参照系，也是冲锋号——在全球医药创新浪潮中，抓住黄金赛道，打造世界级产品，方能实现从跟随到引领的跨越。仿制药企出海路径抉择与实施策略——借鉴日企、外资与资本运作模式 #全球医药行业分析

2026-02-12

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2025年药企营收TOP10

2025年，药企营收TOP10名单中，大部分公司实现了业绩增长。礼来凭借GLP-1药物的爆发式增长，营收飙升45%，排名大幅跃升，跻身全球制药企业营收前三。另一家排名上升的赛诺菲则手握度普利尤单抗这一自免重磅炸弹，推动公司营收在2025年增长了10%，达到436亿欧元。然而，辉瑞和BMS两家公司在增长动能转换的挑战下，营收出现下滑。而在2024年TOP10药企均实现了业绩增长。表1 2025年全球制药企业营收TOP10概览资料来源：根据公开资料整理 01 礼来狂飙礼来无疑是本年度最耀眼的主角，其连续三年占据行业增幅榜首。凭借替尔泊肽（糖尿病药物Mounjaro和减肥药Zepbound）的惊人表现，礼来2025年营收同比暴涨约45%，公司市值在2025年突破万亿美元，成为行业历史首例。根据礼来财报，替尔泊肽产品系列的年收入达到365亿美元，占礼来营收的56%，并且超越默沙东的Keytruda和诺和诺德的司美格鲁肽，成功登顶全球药品销售额榜首。而且在GLP-1领域，礼来已准备好迭代产品。小分子口服GLP-1受体激动剂奥氟格列隆（Orforglipron）已在美国、中国提交上市申请，最快有望在今年上半年获得批准。该药的优势在于其是小分子药物，具有口服便利性，并且生产成本相较于多肽类药物有很大优势，有望在价格竞争中脱颖而出。 GLP-1/GIP/GCG三靶点受体激动剂Retatrutide的首个3期临床已成功，治疗肥胖合并骨关节炎患者，68周减重幅度达28.7%，安慰剂组减重2.1%；骨关节炎评分指数（WOMAC）也实现显著改善，有望成为减重领域新的“杀手锏”。另外，礼来的第二款GLP-1/GIP受体激动剂Brenipatide已启动两项3期临床，用于治疗酒精依赖和抑郁症，有望将GLP-1药物的应用领域从代谢延伸至神经系统。礼来GLP-1产品矩阵图片来源：药智数据-全球药物分析系统赛诺菲是另一家排名上升的企业。其营收在2025年增长了10%，达到436亿欧元。这一成绩主要得益于核心产品如Dupixent的持续放量，全年销售额达157亿欧元（约178亿美元），增长25%。该药在特应性皮炎、哮喘、慢性鼻窦炎伴鼻息肉等多个适应症中保持领先地位，并且新拓展适应症慢性阻塞性肺病（COPD）、慢性自发性荨麻疹（CSU）和大疱性类天疱疮（BP）也贡献了不少销售增量。强生、罗氏、艾伯维、阿斯利康、诺华也取得了不错的营收增速。强生堪称稳健增长的范例，其2025年收入942亿美元，增长6%，预计2026年收入将达到1000亿美元，稳居全球药企营收榜首。罗氏2025年营收615亿瑞士法郎（约744亿美元），同比增长7%。其制药业务中，肿瘤、神经科学、免疫、眼科领域均保持增长趋势。Phesgo、Xolair、Ocrevus、Hemlibra、Vabysmo五大重磅产品合计销售额达214亿瑞士法郎。艾伯维则成功演绎了“华丽转身”。在曾经的全球“药王”修美乐因专利到期销售额腰斩的同时，其新一代免疫“双子星”——Skyrizi和Rinvoq持续高速增长，合计销售额达到259亿美元，推动公司总营收突破600亿美元大关，较2024年增长8.6%，超过了公司在2022年创下的580亿美元的前期收入峰值。阿斯利康2025年营收587亿美元，同比增长8%。其有10余款药物在2025年至少实现了双位数增长，其中ADC产品Enhertu（德曲妥珠单抗）销售额达到50亿美元，增长33%，给阿斯利康贡献了28亿美元，PD-L1抑制剂Imfinzi（度伐利尤单抗）销售额61亿美元，增长28%。阿斯利康预测，2026年营收将继续实现强劲增长。诺华2025年营收545亿美元，同比增长8%。其增长得益于多款创新药的爆发式表现，CDK4/6抑制剂Kisqali销售额达48亿美元，同比增长57%；核药Pluvicto销售额19.9亿美元，增长42%，小核酸药物Leqvio销售额达12亿美元，同比增长57%。但在2026年，诺华多款重磅产品将面临仿制药冲击，包括心力衰竭治疗药物Entresto、血液疾病药物Promacta和肿瘤药物Tasigna。这三款药物在2025年第四季度的销售额已开始下滑，预计在2026年将造成40亿美元的营收缺口。但诺华认为，一系列新的重磅药物将在年底前推动公司重回增长轨道，实现低的个位数销售额整体增长。 02 多家MNC业绩承压然而，另一部分巨头则面临增长压力。辉瑞继续受新冠产品影响，成为TOP10中少数营收下滑的企业。其2025年总收入为626亿美元，较2024年的636亿美元下降2%。 2025年，辉瑞的新冠疫苗Comirnaty全年营收43亿美元，同比下降33%，口服药Paxlovid营收24亿美元，同比下降59%，成为营收下降的主要原因。剔除COVID-19产品影响后，辉瑞核心业务组合实现6%的营业增长。其中，来源于Seagen的ADC明星产品Padcev营收达19亿美元，同比增长22%；肺癌药物Lorbrena（洛拉替尼）营收突破10亿美元，同比大幅增长40%；心脏病药物Vyndaqel家族全年收入64亿美元，增长17%；偏头痛药物Nurtec ODT/Vydura收入14亿美元，增长13%；RSV疫苗Abrysvo收入10亿美元，增长37%。 2026年，辉瑞预计收入将继续下滑至595亿至625亿美元。 BMS则处于“新旧交替”之际，全年收入482亿美元，较2024年的483亿美元略有下降。成熟产品组合受专利到期冲击，收入下滑15%。Revlimid（来那度胺）销售额30亿美元，暴跌49%；Pomalyst（泊马度胺）销售额为27亿美元，下滑23%。但在增长产品组合中，总体销售额增长了17%，达到264亿美元，占总营收比重已过半。 CAR-T疗法Breyanzi全年收入达到14亿美元，增长了82%；心脏病药物Camzyos销售额飙升77%，也突破了十亿美元；血液疾病治疗药物Reblozyl的销售额增长了31%，超过了20亿美元。据BMS预测，2026年其成熟产品组合将面临仿制药竞争，收入继续下滑，增长产品组合的增长将部分抵消这一影响。整体而言，公司收入预计将在460亿美元至475亿美元之间，较2025年微降。默沙东则因核心产品（Keytruda）增速放缓而增长乏力。其2025年实现了650亿美元的收入，增长仅1%。 Keytruda销售额达317亿美元，较2024年增长7%，不复往年两位数的强势增长趋势。而且该药专利悬崖已近在咫尺，两项主要化合物专利期将于2028年届满。同时，HPV疫苗再次拖累销售，全年销售额下降39%至52亿美元。 2026年，默沙东预计销售额预计在655亿美元至670亿美元之间，保持微增。 03 百亿并购打造新爆款面对业绩增长的压力，并购成为补充管线、增加收入来源的核心手段。事实上，2025年制药行业的并购活动异常活跃，总金额超过千亿美元。其中，超过百亿美元的交易达到3笔，另有3笔接近百亿美元。默沙东豪掷100亿美元收购Verona Pharma，获得其慢性阻塞性肺病新药Ohtuvayre；又以92亿美元收购了Cidara，获得一款临床3期的流感预防药物CD388。其中Ohtuvayre已开始贡献收入，仅2025Q4就给默沙东创收1.78亿美元。分析师预测，Ohtuvayre年销售额峰值在30亿至40亿美元。而CD388的销售额峰值有望达到50亿美元。在已完成的2b期NAVIGATE研究中，CD388在2b期研究中展现出76%的预防效力。作为参考，季节性流感疫苗在匹配良好的年份效力通常可达40%-60%。基于该积极数据，美国FDA已授予CD388“突破性疗法”与“快速通道”双认定。辉瑞在400多亿美元收购Seagen后，又不惜以总价值约为92亿美元的高价竞购生物科技公司Metsera，重押下一代GLP-1药物。其核心管线是一款全偏向超长效GLP-1受体激动剂MET-097i，半衰期达到380小时，有望实现每月一次给药；以及一款超长效amylin类似物MET-233i，同样有望每月一次给药。另外，Metsera的两大技术平台HALO和MOMENTUM同样价值匪浅。HALO脂质化平台能显著延长多肽药物的半衰期，实现每月注射一次且无需滴定；MOMENTUM平台则专注于优化多肽药物的口服递送。此外，强生和诺华均以超百亿美元，押注神经科学领域，拓展业务线。强生以146亿美元收购Intra-Cellular，获得一款已上市的精神病药物Caplyta（卢美哌隆），以及一款2期临床阶段候选药物线ITI-1284。诺华以120亿美元收购Avidity Biosciences，获得三款神经肌肉RNA疗法，均已临近上市。 Avidity公司核心产品图片来源：药智数据-全球药物分析系统 04 结语近几年，制药行业热点快速切换，肿瘤和自免领域新旧技术更迭，而代谢与慢病领域强势崛起，成为新的主战场。展望未来，多款重磅品牌药将陆续迎来专利悬崖，收入压力不容忽视。对于手握众多资源的MNC而言，能否挖掘并推出下一个“重磅炸弹”，保持其产品矩阵的“新鲜度”，将是决定其未来排位的关键。声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 小月石合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

2026-02-12

·BioSpace

Merck Advances Treatment of Bladder and Kidney Cancers with New Data at 2026 ASCO GU Cancers Symposium

Late-breaking KEYNOTE-B15 data show KEYTRUDA ® (pembrolizumab) plus Padcev ® (enfortumab vedotin-ejfv) significantly improved event-free survival, overall survival and pathologic complete response rates for patients with certain types of bladder cancer New LITESPARK-022 and LITESPARK-011 data highlight the disease-free survival benefit of WELIREG ® (belzutifan) plus KEYTRUDA and progression-free survival benefit of WELIREG in combination with LENVIMA ® (lenvatinib), respectively All three studies will be featured in the official ASCO GU Press Program RAHWAY, N.J.--(BUSINESS WIRE)-- $MRK #MRK --Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that data across multiple genitourinary cancers from several approved and investigational medicines will be presented at the 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium from Feb. 26-28. These data, including three studies that will be featured in the symposium’s press program, underscore Merck’s commitment to advancing research across its broad portfolio to improve patient outcomes. “We’re excited to share new results from our portfolio and pipeline for more patients with certain types of bladder and kidney cancers, with new data in muscle invasive bladder cancer and earlier stages of renal cell carcinoma,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “The results we’re presenting at ASCO GU underscore our leadership across the genitourinary cancer landscape and our commitment to advance standards of care for these patients.” Data presentations will feature new findings from Merck’s broad portfolio of cancer medicines, including key data for KEYTRUDA ® (pembrolizumab), WELIREG ® (belzutifan) and LENVIMA ® (lenvatinib), in collaboration with Eisai, as well as new results for the investigational antibody-drug conjugate (ADC) from Merck’s innovative pipeline: sacituzumab tirumotecan (sac-TMT), a TROP2-directed ADC being developed in collaboration with Kelun-Biotech. Key data from Merck’s portfolio and pipeline to be presented at the 2026 ASCO GU Cancers Symposium: First-time data from the Phase 3 KEYNOTE-B15/EV-304 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus Padcev ® (enfortumab vedotin-ejfv) as neoadjuvant and adjuvant treatment (before and after surgery) for patients with muscle-invasive bladder cancer who are eligible for cisplatin (abstract #LBA630, Oral abstract session B: Urothelial carcinoma), which will be featured in the official ASCO GU Press Program. 1 Results from the first interim analysis of the Phase 3 LITESPARK-022 trial evaluating KEYTRUDA in combination with WELIREG, Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as a treatment for patients with clear cell renal cell carcinoma (RCC) following nephrectomy (abstract #LBA418, Oral abstract session C: Renal cell cancer and testicular cancer), which will be featured in the official ASCO GU Press Program. First presentation of data from the Phase 3 LITESPARK-011 trial evaluating WELIREG plus LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, as a treatment for patients with advanced RCC whose disease progressed on or after treatment with anti-PD-1/L1 therapy (abstract #LBA417, Oral abstract session C: Renal cell cancer and testicular cancer), which will be featured in the official ASCO GU Press Program. 2 First-time data presentation for the Phase 2 MK-2870-002 study evaluating sac-TMT plus KEYTRUDA for patients with advanced urothelial carcinoma (abstract #744, Poster session B: Prostate cancer and urothelial carcinoma). 3 Details on abstracts listed above and additional key abstracts for Merck Bladder cancer Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, Phase 3 KEYNOTE-B15 study. M. D. Galsky. 1 Abstract #LBA630, Oral abstract session B: Urothelial carcinoma Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (pembro) in participants (Pts) with advanced urothelial carcinoma (UC): Results from the Phase 2 2870-002/SKB264-II-06 study. X. Bian. 3 Abstract #744, Poster session B: Prostate cancer and urothelial carcinoma Pathological outcomes and disease-free survival (DFS) in KEYNOTE-905: Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible. To be determined. 1 Abstract #638, Rapid oral abstract session B: Urothelial carcinoma KEYMAKER-U04 substudy 04B: First-line (1L) enfortumab vedotin (EV) plus pembrolizumab (pembro)-based immune checkpoint inhibitor (ICI) combinations for advanced urothelial cancer (UC). A. Peer. 1 Abstract #634, Rapid oral abstract session B: Urothelial carcinoma SWOG 2427: Single arm Phase II study of bladder preservation with immunoradiotherapy after a clinically meaningful response to neoadjuvant therapy in patients with muscle invasive bladder cancer (BRIGHT). L. K. Ballas. 4 Abstract #TPS913, Trials in progress poster session B: Urothelial carcinoma Kidney cancer Adjuvant pembrolizumab plus belzutifan versus pembrolizumab for clear cell renal cell carcinoma (ccRCC): The randomized Phase 3 LITESPARK-022 study. T. K. Choueiri. Abstract #LBA418, Oral abstract session C: Renal cell cancer and testicular cancer Belzutifan (bel) plus lenvatinib (lenva) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti-PD-(L)1 therapy: Open-label Phase 3 LITESPARK-011 study. R. J. Motzer. 2 Abstract #LBA417, Oral abstract session C: Renal cell cancer and testicular cancer Ascending dose escalation of belzutifan plus palbociclib for previously treated advanced clear cell renal cell carcinoma (ccRCC): Phase 1/2 LITESPARK-024 study Part 1. D. F. McDermott. 5 Abstract #423, Rapid oral abstract session C: Renal cell cancer and testicular cancer KEYMAKER-U03 substudy 03B: Novel investigative regimens for previously treated advanced clear cell renal cell carcinoma (ccRCC). L. Albiges. Abstract #505, Poster session C: Renal cell cancer; adrenal, penile, testicular and urethral cancers Phase 2 trial of belzutifan in participants from China and Japan with von Hippel-Lindau disease-associated tumors: Results from LITESPARK-015 cohort B1. G. Naik. Abstract #494, Poster session C: Renal cell cancer; adrenal, penile, testicular and urethral cancers Prostate cancer Efficacy and safety of the DLL3 T-cell engager gocatamig in participants (pts) with neuroendocrine prostate cancer (NEPC) and other neuroendocrine neoplasms (NEN). H. Beltran. 6 Abstract #182, Poster session A: Prostate cancer 1 In collaboration with Astellas/Pfizer 2 In collaboration with Eisai 3 Led by Kelun-Biotech, conducted in China 4 Sponsored by National Cancer Institute 5 In collaboration with Pfizer 6 In collaboration with Daiichi Sankyo About Merck’s early-stage cancer clinical program Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is evaluating our portfolio of medicines and pipeline candidates in earlier disease states, with more than 30 ongoing registrational studies across multiple types of cancer. About Merck’s research in genitourinary cancers Merck is advancing research aimed at helping transform the treatment landscape and broaden options for people with genitourinary (GU) cancers, including bladder, kidney and prostate cancers. Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equaling over 1 in 8 of all cancer incidences. Through a robust clinical development program with more than 50 clinical trials evaluating more than 22,000 patients around the world, Merck is investigating the potential of several portfolio medicines and pipeline assets, leveraging multiple novel combination strategies, across various stages of disease, to help address unmet needs in GU cancers. About KEYTRUDA ® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: who are not eligible for any platinum-containing chemotherapy, or who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of adult patients with advanced RCC. KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information. Selected Important Safety Information for KEYTRUDA Severe and Fatal Immune-Mediated Adverse Reactions KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution. Immune-Mediated Colitis KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients. Hepatotoxicity and Immune-Mediated Hepatitis KEYTRUDA as a Single Agent KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients. KEYTRUDA With Axitinib KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event. Immune-Mediated Endocrinopathies Adrenal Insufficiency KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypophysitis KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Thyroid Disorders KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients. Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism. Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Immune-Mediated Nephritis With Renal Dysfunction KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients. Immune-Mediated Dermatologic Adverse Reactions KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti–PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. Contacts Media Contacts: Julie Cunningham (617) 519-6264 John Infanti (609) 500-4714 Investor Contacts: Peter Dannenbaum (732) 594-1579 Steven Graziano (732) 594-1583 Read full story here

临床3期临床结果临床2期ASCO会议

100 项与维恩妥尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	维恩妥尤单抗	L01XC	DB13007

研发状态

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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	Astellas Pharma US, Inc.	2025-11-21
不可切除的尿路上皮癌	欧盟	Astellas Pharma Europe Ltd.	2024-09-24
不可切除的尿路上皮癌	冰岛	Astellas Pharma Europe Ltd.	2024-09-24
不可切除的尿路上皮癌	列支敦士登	Astellas Pharma Europe Ltd.	2024-09-24
不可切除的尿路上皮癌	挪威	Astellas Pharma Europe Ltd.	2024-09-24
局部晚期尿路上皮癌	欧盟	Astellas Pharma Europe Ltd.	2022-04-13
局部晚期尿路上皮癌	冰岛	Astellas Pharma Europe Ltd.	2022-04-13
局部晚期尿路上皮癌	列支敦士登	Astellas Pharma Europe Ltd.	2022-04-13
局部晚期尿路上皮癌	挪威	Astellas Pharma Europe Ltd.	2022-04-13
转移性尿路上皮癌	欧盟	Astellas Pharma Europe Ltd.	2022-04-13
转移性尿路上皮癌	冰岛	Astellas Pharma Europe Ltd.	2022-04-13
转移性尿路上皮癌	列支敦士登	Astellas Pharma Europe Ltd.	2022-04-13
转移性尿路上皮癌	挪威	Astellas Pharma Europe Ltd.	2022-04-13
尿路上皮癌	美国	Astellas Pharma US, Inc.	2019-12-18

未上市

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适应症	最高研发状态	国家/地区	公司	日期
肌层浸润性膀胱尿路上皮癌	临床3期	美国	Astellas Pharma Global Development, Inc.	2020-03-30
肌层浸润性膀胱尿路上皮癌	临床3期	中国	Astellas Pharma Global Development, Inc.	2020-03-30
肌层浸润性膀胱尿路上皮癌	临床3期	日本	Astellas Pharma Global Development, Inc.	2020-03-30
肌层浸润性膀胱尿路上皮癌	临床3期	阿根廷	Astellas Pharma Global Development, Inc.	2020-03-30
肌层浸润性膀胱尿路上皮癌	临床3期	澳大利亚	Astellas Pharma Global Development, Inc.	2020-03-30
肌层浸润性膀胱尿路上皮癌	临床3期	比利时	Astellas Pharma Global Development, Inc.	2020-03-30
肌层浸润性膀胱尿路上皮癌	临床3期	加拿大	Astellas Pharma Global Development, Inc.	2020-03-30
肌层浸润性膀胱尿路上皮癌	临床3期	捷克	Astellas Pharma Global Development, Inc.	2020-03-30
肌层浸润性膀胱尿路上皮癌	临床3期	丹麦	Astellas Pharma Global Development, Inc.	2020-03-30
肌层浸润性膀胱尿路上皮癌	临床3期	法国	Astellas Pharma Global Development, Inc.	2020-03-30

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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


NCT04223856 (EV-302, Pubmed \| Int J Clin Oncol)	临床3期	晚期尿路上皮癌一线	176	Enfortumab vedotin-pembrolizumab (EV + P)	廠獵蓋糧鏇襯襯膚觸選(醖觸願網簾簾蓋鑰憲觸) = 簾獵憲繭壓窪製襯築獵淵鏇構選壓範齋衊艱簾 (齋鹹觸範網鑰鏇製齋醖 ) 更多	积极	2026-01-21
				Chemotherapy (gemcitabine plus cisplatin/carboplatin)	廠獵蓋糧鏇襯襯膚觸選(醖觸願網簾簾蓋鑰憲觸) = 簾繭鑰齋壓廠窪憲糧鏇淵鏇構選壓範齋衊艱簾 (齋鹹觸範網鑰鏇製齋醖 ) 更多
NCT05915351 (EPIC, ASCO_GI2026)	临床2期	转移性胰腺腺癌 Nectin-4	43	Enfortumab vedotin (pancreatic adenocarcinoma)	遞選構餘製壓網憲遞憲(獵鏇衊衊廠選願網衊網) = 築繭餘簾遞鏇鹹憲蓋鏇夢選鬱艱築蓋壓願膚膚 (願膚窪鏇壓網衊築夢積, 2.3 ~ 28.2) 更多	积极	2026-01-08
NCT04223856 (EV302/KEYNOTE-A39, Pubmed \| J Med Econ)	临床3期	转移性尿路上皮癌一线	468	Enfortumab vedotin plus pembrolizumab (EV + Pem)	觸網齋積淵範構窪範獵(蓋網築構範鹹餘壓鏇膚) = 淵繭夢積廠願鏇範鏇網廠窪範鹹遞鬱膚淵鏇積 (襯積鑰醖鹹鹽繭鏇遞鏇 ) 更多	积极	2025-12-31
				Nivolumab plus gemcitabine and cisplatin (Nivo + GP)	觸網齋積淵範構窪範獵(蓋網築構範鹹餘壓鏇膚) = 鏇廠壓積範願觸壓構鬱廠窪範鹹遞鬱膚淵鏇積 (襯積鑰醖鹹鹽繭鏇遞鏇 ) 更多
NCT04700124 (EV-304 \| KEYNOTE-B15, Company_Website) 人工标引	临床3期	肌层浸润性膀胱癌新辅助 \| 辅助	-	enfortumab vedotin + pembrolizumab	糧襯齋糧齋壓觸鏇鏇鑰(鏇構餘鬱簾遞製襯艱鹹) = demonstrating clinically meaningful and statistically significant improvements 艱鹹壓鬱獵顧鏇築鏇範 (鏇積壓繭選膚齋範壓廠 ) 达到更多	积极	2025-12-17
				Gemcitabine + cisplatin
ESMO_ASIA2025	N/A	晚期尿路上皮癌	32	Enfortumab vedotinDexamethasone (6.6 mg IV) + Enfortumab vedotinDexamethasone (6.6 mg IV)	鹽鑰衊遞襯選衊壓憲構(憲積鬱築憲膚憲鹽壓範): P-Value = >0.99 更多	积极	2025-12-05
				Enfortumab vedotin (No steroid premedication)
ESMO_ASIA2025	N/A	转移性尿路上皮癌	59	Enfortumab Vedotin (pure UC)	願糧艱積膚簾網壓淵餘(願蓋鬱觸積廠壓鑰淵齋) = 衊夢願鑰醖淵鬱膚淵醖鬱夢齋製簾蓋鏇膚範構 (製獵蓋齋觸積襯壓遞餘 ) 更多	积极	2025-12-05
				Enfortumab Vedotin (UC with histological variants)	願糧艱積膚簾網壓淵餘(願蓋鬱觸積廠壓鑰淵齋) = 淵夢願憲遞壓壓顧選淵鬱夢齋製簾蓋鏇膚範構 (製獵蓋齋觸積襯壓遞餘 ) 更多
NCT04225117 (EV-202, Pubmed \| ESMO Open)	临床2期	食管癌 \| 胃癌	84	Enfortumab vedotin (gastroesophageal adenocarcinoma)	鬱淵鬱憲廠製憲醖膚觸(鹹餘積鑰獵鏇蓋製網鹽) = 憲構築築夢繭積壓鹽製願範鏇選範蓋鏇鹽鹽鹽 (觸觸網蓋憲範願選築衊 ) 更多	积极	2025-11-01
				Enfortumab vedotin (esophageal squamous cell carcinoma)	鬱淵鬱憲廠製憲醖膚觸(鹹餘積鑰獵鏇蓋製網鹽) = 願範餘齋糧糧鹹鬱遞範願範鏇選範蓋鏇鹽鹽鹽 (觸觸網蓋憲範願選築衊 ) 更多
NCT03924895 (KEYNOTE-905 \| EV-303, ESMO2025 \| Company_Website) 人工标引	临床3期	肌层浸润性膀胱癌	344	Enfortumab vedotin + Pembrolizumab (prerioperative (followed by surgery))	糧鹹選廠鏇衊鬱觸糧鬱(選壓範積獵顧網艱淵製) = 製廠範築網範糧鏇築艱醖壓窪膚壓觸夢壓襯鬱 (醖鹽範蓋醖築鹹範構鑰 ) 更多	积极	2025-10-17
				Standard of care (surgery alone)	糧鹹選廠鏇衊鬱觸糧鬱(選壓範積獵顧網艱淵製) = 鏇艱顧壓選積糧願壓選醖壓窪膚壓觸夢壓襯鬱 (醖鹽範蓋醖築鹹範構鑰 ) 更多
NCT04225117 (EV-202, ESMO2025)	临床2期	转移性头颈部鳞状细胞癌一线 PD-L1 CPS ≥1 \| HPV+	41	Enfortumab vedotin + pembrolizumab (PD-L1 CPS ≥1)	醖衊醖簾淵鹹夢餘糧鹹(鬱夢鏇廠壓蓋淵繭糧獵) = 鏇願艱衊鹹鏇憲繭艱積顧鏇憲艱積構鑰範鹽醖 (願願襯夢獵積顧觸顧廠, 59.7 ~ 87.6) 更多	积极	2025-10-17
ESMO2025	N/A	转移性尿路上皮癌 NECTIN4 amplification	183	Enfortumab vedotin (NECTIN4 amplified)	淵蓋襯觸夢網顧艱醖製(廠醖餘鏇餘製鹽築糧築) = 鬱糧醖築鹽齋簾艱襯遞衊襯醖齋遞積襯膚獵醖 (觸齋鬱壓鬱餘遞鹹齋壓 ) 更多	积极	2025-10-17
				Enfortumab vedotin (non-amplified)	淵蓋襯觸夢網顧艱醖製(廠醖餘鏇餘製鹽築糧築) = 夢簾蓋簾築範鏇醖顧簾衊襯醖齋遞積襯膚獵醖 (觸齋鬱壓鬱餘遞鹹齋壓 ) 更多