Phase Ib/II Study of Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy as a Bladder-Sparing Trimodality Therapy in Muscle Invasive Bladder Cancer

This phase Ib/II trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, to shrink the tumor before the main treatment is given (neoadjuvant), followed by surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). In cases where patients are not candidates for the standard of care approach or prefer a bladder sparing option, tri-modality therapy with transurethral resection of bladder tumor (TURBT) followed by combined chemotherapy and radiation therapy is used. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Giving enfortumab vedotin with pembrolizumab and radiation therapy may work better in treating patients with muscle invasive bladder cancer.

开始日期2025-01-30

申办/合作机构

The University of California, San Francisco

[+2]

NCT06041503

/ Not yet recruiting临床2期IIT

A Phase II Multicenter Study of Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)

Background:
Many cancers of the testicles and urinary tract are rare diseases; these are diseases that affect less than 200,000 people in the United States. It can be hard to study treatments for these diseases. One combination of drugs-enfortumab vedotin (EV) and pembrolizumab-has already been approved to treat some urinary cancers. Researchers want to see if they can help people with other types of testicle and urinary cancers.
Objective:
To test EV, with or without pembrolizumab, in patients with rarer cancers of the testicles or urinary tract.
Eligibility:
People aged 18 and older with rarer cancers of the testicles or urinary tract.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. Their ability to perform normal daily activities will be tested. They will have exams of their skin and eyes. They will have imaging scans. A biopsy may be needed: A sample of tissue will be removed from the tumor.
The study drugs are both given through a tube attached to a needle inserted into a vein in the arm. Some participants will receive treatments 3 times during 28-week cycles; others will receive treatments 2 times during 21-day cycles.
All participants may continue to receive treatments for up to 5 years. Imaging scans and other tests will be repeated.
Participants who stop taking the drugs will have follow-up visits every 3 to 4 weeks until the disease gets worse. They will have imaging scans and blood tests.
After that, follow-up visits will continue by phone every 3 months for up to 5 years after study therapy is finished.

开始日期2025-01-12

申办/合作机构

National Cancer Institute

NCT06553885

/ Not yet recruiting临床2期IIT

A Phase II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic Colorectal Cancer or Hepatocellular Carcinoma

This study is a multi-indication, open-label, single-treatment arm, parallel-cohort phase II study of enfortumab vedotin in adult participants with advanced or metastatic colorectal cancer (CRC) or hepatocellular carcinoma (HCC) who have been previously treated with one or more lines of systemic therapy.

开始日期2025-01-01

申办/合作机构

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+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专利（医药）

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377

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2025-01-01·IN VIVO

Impact of Relative Dose Intensity of Enfortumab Vedotin for Advanced Urothelial Carcinoma

Article

作者: Mochida, Manabu ; Furubayashi, Nobuki ; Katsuki, Harumichi ; Negishi, Takahito ; Kijima, Atsuhiro ; Nakamura, Motonobu

BACKGROUND/AIM:

The impact of enfortumab vedotin (EV) dose reduction and/or interruption on its efficacy for advanced urothelial carcinoma (UC) is unclear.

PATIENTS AND METHODS:

We retrospectively analyzed consecutive patients with advanced UC who received EV after the failure of platinum-based chemotherapy and immune checkpoint inhibitors from December 2021 to June 2024. Patients were categorized into three groups based on the calculated relative dose intensity (RDI): RDI<50%, RDI ≥50 to <80%, and RDI ≥80%.

RESULTS:

A total of 26 patients (male, n=15; median age, 72 years) were enrolled. The RDI was categorized as follows: ≥80% (n=13; 50.0%), ≥50 to <80% (n=7; 26.9%), and <50% (n=6; 23.1%). There were no marked differences in the overall response (p=0.921) or disease control rates (p=0.859) among the three groups categorized by the RDI. A log-rank test revealed no significant differences in either the progression-free survival (p=0.309) or the overall survival (p=0.704) according to RDI. There were no marked differences in the incidence of any-grade adverse events (AEs) (p=0.405) or grade ≥3 AEs (p=0.018) according to RDI. There were significant differences in the incidence of any-grade cutaneous AEs (p=0.038) and grade ≥3 cutaneous AEs (p=0.007) according to RDI. A multivariate analysis revealed that ECOG PS≥2 (p=0.009) and mixed UC (p=0.011) were independently associated with the prognosis.

CONCLUSION:

Despite frequent dose reductions and interruptions required to manage treatment-emergent AEs during EV therapy, these adjustments did not significantly impair the drug's efficacy in patients with advanced UC.

2024-12-31·JOURNAL OF MEDICAL ECONOMICS

Narrative review of value frameworks in urothelial carcinoma and positioning of enfortumab vedotin

Review

作者: Ortiz Nunez, Aurora ; Zozaya, Néboa ; Fernández, Irene ; Gonzalez Portela, Judit

AIMS:

Evaluate existing oncology value frameworks in terms of their methodology, structure, characteristics, and functionality using the example of enfortumab vedotin, an approved therapy for urothelial carcinoma.

METHODS:

A search of PubMed, grey literature, and official websites of relevant international organizations was performed from January 2022 to March 2023.

RESULTS:

Six frameworks were identified and analyzed, including the American Society of Clinical Oncology's assessment framework, European Society for Medical Oncology's Magnitude of Clinical Benefit Scale, the National Comprehensive Cancer Network's Evidence Blocks, Memorial Sloan Kettering Cancer Center's DrugAbacus, Institute for Clinical and Economic Review's assessment framework, and the Drug Assessment Framework. Comparisons across frameworks were challenging, owing to differing approaches, objectives, perspectives, methodology, and criteria. Based on the results of the EV-301 study (NCT03474107), the European Society for Medical Oncology's Magnitude of Clinical Benefit Scale assigned a score of 4 out of 5 to enfortumab vedotin administered after chemotherapy and immunotherapy. The National Comprehensive Cancer Network's Evidence Blocks enabled assessment of enfortumab vedotin compared with other treatments for locally advanced or metastatic urothelial carcinoma, resulting in the positioning of enfortumab vedotin as a preferred regimen after chemotherapy and immunotherapy.

CONCLUSIONS:

Application of value frameworks in oncology can contribute to informed value-based decision-making. However, comparisons across frameworks should be made with caution and limited to the same lines of treatment. Enfortumab vedotin may contribute to optimizing outcomes in patients previously treated with chemotherapy and immunotherapy for locally advanced or metastatic urothelial carcinoma.

2024-12-07·JAPANESE JOURNAL OF CLINICAL ONCOLOGY

Therapeutic efficacy and safety of biweekly administration of enfortumab vedotin for urothelial carcinoma

Article

作者: Mizokami, Atsushi ; Kamijima, Taiki ; Kano, Hiroshi ; Kawaguchi, Shohei ; Toriumi, Ren ; Yaegashi, Hiroshi ; Aoyama, Shuhei ; Shigehara, Kazuyoshi ; Iwamoto, Hiroaki ; Nakagawa, Ryunosuke ; Naito, Renato ; Makino, Tomoyuki ; Izumi, Kouji ; Nohara, Takahiro

Abstract:

Objectives:

Enfortumab vedotin (EV) is an established pharmacotherapy for metastatic urothelial carcinoma (mUC); however, its adverse events (AEs) cannot be overlooked. The study investigated the efficacy and safety of biweekly EV administration.

Methods:

Patients with mUC who received EV at our institution were included in the study. Eligible patients were classified into two groups as follows: those who received EV on a standard schedule (standard group) and those who received EV on a biweekly schedule (biweekly group); the treatment outcomes and AEs between the two groups were compared.

Results:

Nine and 19 patients were in the standard group and biweekly groups, respectively. The progression-free survival, overall survival, and overall response rate were not significantly different between the two groups. AEs following EV administration, such as decreased appetite (P < .01), pruritus (P < .01), rash maculopapular (P < .01), anemia (P = .04), and liver dysfunction (P = .04), were significantly more frequent in the standard group. Grade 3 or higher AEs, such as pruritus (P = .03) and rash maculopapular (P < .01), were significantly more frequent in the standard group. Furthermore, significantly more patients in the standard group had to be given a reduced dose due to adverse events (P = .02).

Conclusions:

Biweekly administration of EV may be safer without compromising therapeutic efficacy than the standard schedule.

835

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2025-01-08

·美通社

中国国家药品监督管理局批准备思复（维恩妥尤单抗）联合可瑞达（帕博利珠单抗）用于治疗晚期膀胱癌

中国批准的首个经验证疗效优于近 40 年来局部晚期或转移性尿路上皮癌沿用的标准疗法含铂化疗的治疗方案 [1] NMPA 的批准基于全球 3 期研究 EV-302 ，结果显示联合治疗显著延长了总生存期和无进展生存期 [1] 东京 2025年1月8日 /美通社/ -- 安斯泰来制药集团（TSE：4503，总裁兼首席执行官：冈村直树，"安斯泰来"）今日宣布，中国国家药品监督管理局（NMPA）批准备思复（通用名注射用维恩妥尤单抗）联合可瑞达（通用名帕博利珠单抗注射液）用于局部晚期或转移性尿路上皮癌成年患者。新的联合用药方案将为中国局部晚期或转移性尿路上皮癌患者提供替代近40年来沿用的标准疗法含铂化疗方案，成为全新的治疗选择。 [1] 在中国，膀胱癌的发病率和死亡率相对较高。2022年有超过9.2万人被诊断出患有膀胱癌，因该疾病导致的死亡人数约 4.1万人。 [2] 尿路上皮癌约占所有膀胱癌的90%，是一种严重影响健康且具有侵袭性的癌症。 [3] 当患者被诊断为晚期尿路上皮癌，其生存率通常非常低，因此迫切需要新的治疗策略以延长患者生命。 EV-302 试验中国主要研究者、北京大学肿瘤医院泌尿肿瘤暨黑色素瘤肉瘤内科主任、中国临床肿瘤学会副理事长兼秘书长郭军教授 "近日NMPA批准的维恩妥尤单抗联合帕博利珠单抗的治疗组合，是国内获批的首个针对晚期膀胱癌患者的非铂化疗的治疗方案，可用于一线治疗。基于EV-302研究数据，这一联合治疗方案相比于含铂化疗，在广泛的局部晚期或转移性尿路上皮癌人群（无论生物标志物状态、顺铂适用性或肝转移情况）中均显示出接近两倍的中位总生存期、更长的中位无进展生存期以及更高的总体缓解率和完全缓解率。我相信，这一新的治疗方案将改变国内尿路上皮癌临床治疗格局，并为中国晚期尿路上皮癌患者带来更多生存希望。" EV-302 试验中国主要研究者、中山大学孙逸仙纪念医院泌尿外科主任、中华医学会泌尿外科学分会主任委员黄健教授 "目前中国晚期尿路上皮癌的一线治疗策略仍为含铂化疗，临床上一线治疗手段极为有限，近日获批的维恩妥尤单抗联合帕博利珠单抗的新型治疗方案，是过去30多年来首个优于含铂化疗的治疗选择，我们期待其能成为新的标准治疗方案。" 安斯泰来高级副总裁兼肿瘤学领域开发负责人、医学博士、公共卫生硕士 Ahsan Arozullah "我们很高心中国国家药品监督管理局认可了维恩妥尤单抗带给既往经治的局部晚期或转移性尿路上皮癌患者的治疗获益，并在2024年8月批准了单一用药的治疗方案。这次批准维恩妥尤单抗联合帕博利珠单抗的治疗方案，标志着我们再一次为中国患者带来了创新治疗选择。我们期待这些突破能对患者的生活产生深远的影响，帮助他们延缓疾病进展，争取更多的宝贵时间。衷心感谢参与医学研究的专家、患者及其家属的无私奉献，共同推动了医疗领域的突破与发展！" NMPA对维恩妥尤单抗联合帕博利珠单抗治疗方案的批准是基于一项3期临床试验EV-302（也称为KEYNOTE-A39）的结果。临床研究在既往未经治疗的局部晚期或转移性尿路上皮癌（la/mUC）患者中验证了维恩妥尤单抗联合帕博利珠单抗显著改善了患者的中位总生存期和中位无进展生存期，且具有统计学意义和临床意义。研究数据显示联合治疗组的中位总生存期为31.5个月（95% CI：25.4-NR），含铂化疗组的中位总生存期为16.1个月（95% CI：13.9-18.3），即与化疗组相比，联合治疗组患者的死亡风险降低了53%（HR=0.47；95% CI：0.38-0.58；P<0.00001）。联合治疗组的中位无进展生存期为12.5个月（95% CI：10.4-16.6），含铂化疗组的无进展生存期为6.3个月（95% CI：6.2-6.5），即与化疗组相比，联合治疗组患者的疾病进展或死亡的风险降低了55%（HR=0.45；95% CI：[0.38-0.54]；P<0.00001）。研究的安全性结果与之前使用该联合疗法的已知安全性结果一致。没有发现新的安全性问题。 [1] 安斯泰来已经在2024财年（截止于2025年3月31日）的财务预测中，体现了这一最新批准带来的影响。有关更多信息，请参见2024年3月28日发布的新闻稿" 中国国家药品监督管理局受理安斯泰来和辉瑞的enfortumab vedotin与pembrolizumab（帕博利珠单抗）联合用药用于治疗晚期膀胱癌的补充生物制剂许可申请"。关于膀胱癌和尿路上皮癌尿路上皮癌或膀胱癌源于尿路上皮细胞，这些细胞分布在尿道、膀胱、输尿管、肾盂及一些其他器官中。 [4] 尿路上皮癌占所有膀胱癌病例的90%，也会发生在肾盂、输尿管和尿道。 [3],[5],[6] 如果肿瘤已经扩散到周边器官或肌肉，则其被称为局部晚期疾病。 [7] 如果肿瘤已经扩散到身体其他部位，则其被称为转移性疾病。 [8] 约有12%的病例在确诊时即为局部晚期或转移性尿路上皮癌。 [9] 在中国，2022年膀胱癌的发病率在所有癌症中排名第11位，据估计，当年新发病例超过92,000例。 [2] 中国膀胱癌的五年患病率估计为2.5/100,000例，即276,102例。 [2] 持续治疗以及监测使膀胱癌成为治疗成本昂贵的癌症之一，与其他恶性肿瘤相比，成本最高。 [10] 关于 EV-302 EV-302试验是一项开放标签、随机、对照3期试验，用于评估维恩妥尤单抗与帕博利珠单抗联合用药与含铂化疗相比对既往未经治疗的局部晚期或转移性尿路上皮癌患者的疗效。该试验招募了886名既往未经治疗的局部晚期或转移性尿路上皮癌且能耐受含铂化疗的患者，无论其PD-L1表达。患者随机接受维恩妥尤单抗与帕博利珠单抗联合用药治疗或含铂化疗。该试验的双重主要终点是总生存期和无进展生存期（根据实体瘤疗效评价标准1.1（RECIST v1.1），经盲态独立中心阅片（BICR）确定）。次要终点包括根据实体瘤疗效评价标准1.1（RECIST v1.1）经盲态独立中心阅片（BICR）的客观缓解率和缓解时间，以及安全性。 [1] 维恩妥尤单抗与帕博利珠单抗联合用药治疗相关的最常见（≥3%）的3级或以上不良事件，包括皮疹、血糖升高、中性粒细胞降低、周围神经病变、腹泻和贫血。EV-302研究的安全性结果与之前EV-103研究中顺铂不耐受的la/mUC患者使用该联合疗法的已知安全性结果一致。没有发现新的安全性问题。 [1] EV-302试验是评估该联合疗法在治疗尿路上皮癌和其他实体瘤的多个阶段疗效的全面计划的一部分。EV-302试验结果已于2023年10月在 2023年欧洲肿瘤内科学会（ESMO）大会上展示，并在《新英格兰医学杂志》上发表。 [1] 请访问 https://clinicaltrials.gov 了解EV-302研究( NCT04223856 )更为详细的信息。关于备思复（维恩妥尤单抗）备思复（维恩妥尤单抗）是直接作用于Nectin-4（位于细胞表面的一种蛋白，在膀胱癌中高度表达）的一种同类首创的抗体-药物偶联物（ADC）。 [11] 非临床数据显示，维恩妥尤单抗通过与表达Nectin-4蛋白的细胞结合，然后将抗肿瘤成分单甲基澳瑞他汀E（MMAE）内化并释放到细胞中，导致细胞停止增殖（细胞周期阻滞）和程序性细胞死亡（凋亡）来发挥其抗癌活性。 [12] 备思复（维恩妥尤单抗）目前在中国被批准作为单药治疗，用于治疗既往接受过含铂化疗和程序性死亡受体-1（PD-1）或程序性死亡配体1（PD-L1）抑制剂的la/mUC成年患者；联合可瑞达（帕博利珠单抗）用于局部晚期或转移性尿路上皮癌成年患者。进行中的研究 EV-302临床试验（ NCT04223856 ）是一项开放标签、随机、对照的3期临床试验，旨在评估维恩妥尤单抗与帕博利珠单抗联合用药与含铂化疗相比，在耐受含顺铂或卡铂治疗的、既往未经治疗的局部晚期或转移性尿路上皮癌（la/mUC）患者中的疗效，无论其PD-L1表达。 EV-103临床试验（ NCT03288545 ）是一项正在进行中的多队列、开放标签、多中心1b/2期临床试验，旨在研究维恩妥尤单抗单药或与帕博利珠单抗联合用药和/或化疗用于一线或二线治疗患有局部晚期或转移性尿路上皮癌及肌层浸润性膀胱癌（MIBC）患者的疗效。 EV-203临床试验（ NCT04995419 ）是一项在中国开展的多中心、II期单臂桥接研究，旨在评估维恩妥尤单抗在中国患者中的有效性、安全性和药代动力学特征。该研究共入组40例患者。目前安斯泰来正在一项全面计划中开展对维恩妥尤单抗与帕博利珠单抗联合用药治疗多阶段尿路上皮癌的研究，其中包括肌层浸润性膀胱癌的两项3期临床试验EV-304（ NCT04700124 ，也被称为KEYNOTE-B15试验）和EV-303（ NCT03924895 , 也被称为KEYNOTE-905试验）。维恩妥尤单抗与帕博利珠单抗联合用于二线尿路上皮癌和肌层浸润性膀胱癌（MIBC）的安全性和疗效尚未证实。 EV-104试验（ NCT05014139 ）是一项1期研究，探索在非肌层浸润性膀胱癌（NMIBC）患者中使用维恩妥尤单抗。该研究将分为两部分进行，评估维恩妥尤单抗作为术后单药治疗时的剂量递增和剂量扩展。 EV-202试验（ NCT04225117 ）是一项正在进行中的多队列、开放标签、多中心2期临床试验，旨在研究维恩妥尤单抗单独用药对既往接受过治疗的晚期实体瘤患者的疗效。该试验还有一个队列，旨在研究维恩妥尤单抗与帕博利珠单抗联合用药治疗既往未经治疗的复发转移的头颈部鳞状细胞癌患者。关于安斯泰来安斯泰来是一家全球生命科学公司，致力于将创新科学转化为患者的价值。我们在肿瘤、眼科、泌尿、免疫和女性健康等疾病领域提供变革性的治疗方案。通过我们研究与开发项目，我们正在为具有高度未满足医疗需求的疾病开创全新的医疗解决方案。了解更多信息，请访问： www.astellas.com 关于安斯泰来、辉瑞与默沙东的合作安斯泰来和辉瑞与默沙东公司共同签署了一项临床合作协议，以评估安斯泰来和辉瑞的备思复（维恩妥尤单抗）与默沙东公司的可瑞达（帕博利珠单抗）联合用药治疗既往未经治疗的转移性尿路上皮癌患者的疗效。可瑞达是Merck Sharp & Dohme Corp. 的注册商标，该公司是美国新泽西州拉韦市 Merck & Co., Inc. 的子公司。安斯泰来警戒声明本新闻稿中，有关当前计划、估计、战略和信念以及其他非历史事实的陈述，均为关于安斯泰来未来表现的前瞻性陈述。这些陈述是根据管理层结合当前可获得的信息而形成的当前假设和信念得出的，并涉及已知和未知的风险与不确定性。许多因素可能导致实际结果与前瞻性陈述中讨论的结果产生重大差异。这些因素包括但不限于：（i）与制药市场有关的一般经济条件和法律法规的变化，（ii）货币汇率波动，（iii）新产品上市的延迟，（iv）安斯泰来无法有效地销售现有产品和新产品，（v）安斯泰来无法继续有效地研究和开发在竞争激烈的市场中被客户接受的产品，以及（vi）第三方侵犯安斯泰来的知识产权。本新闻稿中包含的有关药品（包括当前正在开发的产品）的信息并不构成广告或医疗建议。 [1]Powles T, Valderrama BP, Gupta S, et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med . 2024;390:875-888. [2] International Agency for Research on Cancer (IARC). Global Cancer Observatory. China factsheet. (2022). Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf . Last accessed: January 2025. [3] Leslie SW, Soon-Sutton TL, Aeddula NR. Bladder Cancer: StatPearls. (Updated 2024 Aug 15]. Available at: https://www.ncbi.nlm.nih.gov/books/NBK536923 . Last accessed: January 2025. [4] National Cancer Institute. What is bladder cancer? (February 2023) Available at: https://www.cancer.gov/types/bladder . Last accessed: January 2025. [5] Leow JJ, Liu Z, Tan TW, et al. Optimal management of upper tract urothelial carcinoma: Current perspectives. Onco Targets Ther . 2020;13:1-15. [6] Petros FG. Epidemiology, clinical presentation, and evaluation of upper-tract urothelial carcinoma. Transl Androl Urol . 2020;9(4):1794-8. [7] National Cancer Institute. NCI dictionary of cancer terms: Locally advanced cancer. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/locally-advanced-cancer . Last accessed: January 2025. [8] American Cancer Society. If you have bladder cancer. (March 2024). Available at: https://www.cancer.org/cancer/types/bladder-cancer/if-you-have-bladder-cancer.html . Last accessed: January 2025. [9] National Cancer Institute. Cancer stat facts: bladder cancer. Available at: https://seer.cancer.gov/statfacts/html/urinb.html . Last accessed: January 2025. [10] Aly A, Johnson C, Doleh Y, et al. The real-world lifetime economic burden of urothelial carcinoma by stage at diagnosis. J Clin Pathw . 2020;6(4):51-60. [11] Challita-Eid PM, et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res. 2016;76(10):3003-13. [12] PADCEV [package insert]. Northbrook, IL: Astellas Pharma US, Inc.

临床3期申请上市临床结果AHA会议

2025-01-08

·医药观澜

晚期癌症总生存期几乎翻倍！重磅ADC+PD-1联合疗法在华获批

▎药明康德内容团队报道今日（1月8日），中国国家药监局（NMPA）官网最新公示，安斯泰来（Astellas）提交的注射用维恩妥尤单抗（enfortumab vedotin）和默沙东（MSD）提交的帕博利珠单抗联合用药的上市申请已获得批准。根据安斯泰来此前新闻稿介绍，该联合疗法本次获批用于一线治疗既往未经治疗的局部晚期或转移性尿路上皮癌（la/mUC）成年患者。截图来源：NMPA官网维恩妥尤单抗是一款靶向Nectin-4的抗体偶联药物（ADC），由安斯泰来和Seagen公司（已被辉瑞收购）联合开发。Nectin-4是位于细胞表面的一种蛋白，在膀胱癌中高度表达。维恩妥尤单抗可与表达Nectin-4蛋白的细胞结合，然后将抗肿瘤成分单甲基澳瑞他汀E（MMAE）内化并释放到细胞中，导致细胞停止增殖（细胞周期阻滞）和程序性细胞死亡（凋亡）。2024年8月，维恩妥尤单抗在中国获批上市，用于治疗既往接受过PD-1/PD-L1抑制剂和含铂化疗治疗的局部晚期或转移性尿路上皮癌患者。帕博利珠单抗是默沙东开发的一款抗PD-1单抗。此前，安斯泰来和辉瑞与默沙东公司共同签署了一项临床合作协议，以评估安斯泰来和辉瑞的维恩妥尤单抗联合默沙东的帕博利珠单抗用于治疗此前未接受过治疗的转移性尿路上皮癌患者的疗效。美国FDA、欧盟委员会（EC）和日本厚生劳动省已先后批准该联合疗法用于一线治疗晚期尿路上皮癌。根据安斯泰来新闻稿介绍，维恩妥尤单抗联用帕博利珠单抗一线治疗晚期尿路上皮癌的sBLA是基于一项3期临床试验EV-302（也称为KEYNOTE-A39）的结果。该项研究发现，联合疗法可改善既往未经治疗的局部晚期或转移性尿路上皮癌（la/mUC）患者的总生存期（OS）和无进展生存期（PFS），其结果具有统计学显著性和临床意义。联合疗法的中位总生存期为31.5个月（vs 化疗组为16.1个月），即与化疗组相比，联合疗法组患者的死亡风险降低了53%。联合用药的中位无进展生存期为12.5个月（vs 化疗组为6.3个月），即与化疗组相比，联合疗法组患者的癌症进展或死亡风险降低了55%。在包括顺铂耐受性和PD-L1表达水平在内的预设亚组中观察到了一致的总生存期和无进展生存期结果。在顺铂耐受亚组和顺铂不耐受亚组（人数分别为244人和198人），死亡风险分别降低了47%和57%，病情进展或死亡风险分别降低了52%和57%。PD-L1低表达亚组和PD-L1高表达亚组（分别为184和254人）的死亡风险分别降低了56%和51%，病情进展或死亡风险分别降低了50%和58%。安斯泰来此前新闻稿介绍，中国晚期尿路上皮癌的一线治疗策略仍为含铂化疗，尚无其他获批的一线治疗方案。而这种以化疗为主的一线治疗方案有效率及无进展生存期都有待进一步提高。维恩妥尤单抗与帕博利珠单抗联合用药有可能改变现有的治疗模式，成为替代含铂化疗的联合疗法。 [1] 2025年01月08日药品批准证明文件送达信息. From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250108154612147.html [2]安斯泰来和辉瑞的enfortumab vedotin联合pembrolizumab用于一线治疗晚期膀胱癌sBLA获CDE受理. Retrieved Mar 28, 2024, from https://mp.weixin.qq.com/s/gLNxv-NxAnV27OlJFhNT9A [3] International Agency for Research on Cancer (IARC). Bladder Fact Sheet. Lyon, France. 2022 (02-2024). Available at: 160-china-fact-sheet.pdf (who.int) [4] 日本厚生劳动省批准备思复（维恩妥尤单抗）联合可瑞达（帕博利珠单抗）用于一线治疗不可根治性切除的尿路上皮癌. Retrieved Sep 26 , 2024, from https://mp.weixin.qq.com/s/CIOYAOjO2ijBM4EvaNTmTw [5] FDA批准PADCEV®与可瑞达（KEYTRUDA®）联合用药治疗晚期膀胱癌，作为首款也是唯一一款ADC加PD-1抑制剂联合疗法. Retrieved Dec 20, 2023, from https://mp.weixin.qq.com/s/VRDMDPu4bBSLfJQES18I1A 本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权及其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

抗体药物偶联物临床3期上市批准临床结果临床成功

2025-01-08

·astellas.com

China’s National Medical Products Administration (NMPA) Approves PADCEV(TM) in combination with KEYTRUDA(®) (pembrolizumab) for the Treatment of Advanced Bladder Cancer

- First regimen to be approved in China to demonstrate superiority to platinum-containing chemotherapy for the treatment of locally advanced or metastatic urothelial cancer, the standard of care for nearly 40 years1 - NMPA approval based on the global Phase 3 EV-302 trial (also known as KEYNOTE-A39) where the treatment combination significantly improved overall survival and progression-free survival outcomes1 TOKYO, January 8, 2025 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that China’s National Medical Products Administration (NMPA) has approved PADCEVTM (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for adult patients with locally advanced or metastatic urothelial cancer (la/mUC). The treatment combination will provide a new therapeutic option to patients with la/mUC in China and offer an alternative to platinum-containing chemotherapy, the standard of care for nearly 40 years.1 Bladder cancer leads to significant morbidity and mortality across China. Over 92,000 people were diagnosed with bladder cancer in 2022, and approximately 41,000 deaths were reported as a result of the disease.2 Urothelial cancer, which accounts for 90% of all bladder cancers, is a debilitating and frequently aggressive cancer.3 When the disease is diagnosed at a late stage, survival rates are often extremely poor, driving the urgent need for new treatment strategies that can extend patients’ lives. Professor Guo Jun, Lead Primary Investigator of the EV-302 trial in China, Director of the Department of Urologic Oncology and Melanoma/Sarcoma, Beijing Cancer Hospital, China, Vice Chairman and Chief-Secretary of the Chinese Society of Clinical Oncology (CSCO):“The NMPA approval of enfortumab vedotin in combination with pembrolizumab is the first non-platinum treatment for Chinese patients with advanced urothelial cancer that can be used in the first-line setting. The results of the EV-302 study demonstrate that this combination nearly doubled median overall survival (OS), and increased median progression-free survival (PFS), overall response rate and complete response rate compared to platinum-based chemotherapy. These results were seen in a broad population of patients with locally advanced or metastatic urothelial cancer, regardless of patients’ biomarker status, cisplatin eligibility or liver metastasis. I believe that this new treatment regimen will change the clinical treatment landscape of urothelial carcinoma in China and bring hope of longer survival to more Chinese patients with advanced urothelial carcinoma.” Professor Huang Jian, Lead Primary Investigator of the EV-302 Study in China, Chairman of the Urology Subcommittee of the Chinese Medical Association, Department of Urology at Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China:“The current first-line treatment strategy for advanced urothelial carcinoma in China is platinum-based chemotherapy, with very limited clinical options available. The approval of enfortumab vedotin in combination with pembrolizumab represents the first treatment regimen in the past 20-30 years that has shown superiority over platinum-based chemotherapy in the entire population. We hope that this combination could become the future standard of care treatment.” Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas:“We are delighted that the NMPA has recognized the benefits that enfortumab vedotin has offered to patients with previously treated locally advanced or metastatic urothelial cancer in China following its approval in August 2024. This latest approval in combination with pembrolizumab marks another step forward in our mission to bring new, innovative treatment strategies to patients in China. We look forward to making a significant impact on patients’ lives, helping to slow disease progression and give them precious more time.” The NMPA’s approval of enfortumab vedotin in combination with pembrolizumab is supported by the results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The trial demonstrated that the treatment combination improved median overall survival (OS) and median progression-free survival (PFS) with statistically significant and clinically meaningful results in patients with previously untreated la/mUC compared to platinum-containing chemotherapy. A median OS of 31.5 months (95% CI: 25.4-NR) was achieved with the treatment combination compared to 16.1 months (95% CI: 13.9-18.3) with platinum-containing chemotherapy, representing a 53% reduction in risk of death (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). A median PFS of 12.5 months (95% CI: 10.4-16.6) was reported with the treatment combination compared to 6.3 months (95% CI: 6.2-6.5) with platinum-containing chemotherapy, representing a 55% reduction in the risk of cancer progression or death (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). The safety results were consistent with those previously reported with this treatment combination, and no new safety issues were identified.1 Astellas has already reflected the impact from this latest approval from the NMPA in China in its financial forecast for the current fiscal year ending March 31, 2025. For more information, please see the press release “China's National Medical Products Administration Accepts Astellas and Pfizer's Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer” issued on March 28, 2024: https://www.astellas.com/en/news/28961 About Bladder and Urothelial CancerUrothelial cancer, or bladder cancer, begins in the urothelial cells, which line the urethra, bladder, ureters, renal pelvis, and some other organs.4 Urothelial cancer accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra.3,5,6 If bladder cancer has spread to surrounding organs or muscles, it is called locally advanced disease.7 If the cancer has spread to other parts of the body, it is called metastatic disease.8 Approximately 12% of cases are locally advanced or metastatic urothelial cancer at diagnosis.9 In China, the incidence rate of bladder cancer in 2022 ranked 11th among all cancers, with over 92,000 new cases diagnosed that year.2 The five year prevalence of bladder cancer in China is estimated to be 2.5/100,000 cases, or 276,102 cases.2 Continuous treatment and surveillance makes bladder cancer one of the most expensive cancer types over the lifetime of a patient, and the costliest cancer when compared to other malignancies.10 About EV-302EV-302 is an ongoing, open-label, randomized, controlled Phase 3 trial, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated la/mUC. The trial enrolled 886 patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status. Patients were randomized to receive either enfortumab vedotin in combination with pembrolizumab or platinum-containing chemotherapy. The dual primary endpoints of this trial are OS and PFS per RECIST v1.1 by blinded independent central review (BICR). Select secondary endpoints include ORR per RECIST v1.1 by BICR, DOR per RECIST v1.1 by BICR, and safety.1 The most common (≥3%) Grade 3 or higher adverse events related to treatment with enfortumab vedotin and pembrolizumab were maculo-papular rash, hyperglycemia, neutropenia, peripheral sensory neuropathy, diarrhea, and anemia. The safety results in EV-302 are generally consistent with the known safety events previously reported with each agent alone, and with the safety profile of this combination in EV-103 in cisplatin-ineligible patients with la/mUC. No new safety issues were identified.1 The EV-302 trial is part of an extensive clinical program evaluating this combination in multiple stages of urothelial cancer and other solid tumors. Findings from EV-302 were presented at the 2023 European Society for Medical Oncology (ESMO) Congress and were published in the New England Journal of Medicine.1 For more information on the EV-302 trial (NCT04223856) go to https://clinicaltrials.gov. About PADCEVTM (enfortumab vedotin)PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.11 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).12 PADCEV is indicated in China as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer after prior treatment with platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors, and in combination with KEYTRUDA® (pembrolizumab) for adult patients with locally advanced or metastatic urothelial cancer. Ongoing Investigational TrialsEV-302 (NCT04223856) is an open-label, randomized, controlled Phase 3 trial, evaluating enfortumab vedotin in combination with pembrolizumab versus platinum-containing chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC) who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status. EV-103 (NCT03288545) is an ongoing, multi-cohort, open-label, multicenter Phase 1b/2 trial investigating enfortumab vedotin alone or in combination with pembrolizumab and/or chemotherapy in first- or second-line settings in patients with la/mUC and in patients with muscle-invasive bladder cancer (MIBC). EV-203 (NCT04995419) is a Phase 2, multicenter, single-arm bridging trial in China designed to evaluate the efficacy, safety, and pharmacokinetic performance of enfortumab vedotin as treatment for patients in China. A total of 40 patients were enrolled in the trial. Enfortumab vedotin in combination with pembrolizumab is being investigated in an extensive program in multiple stages of urothelial cancer, including two Phase 3 clinical trials in MIBC in EV-304 (NCT04700124, also known as KEYNOTE-B15) and EV-303 (NCT03924895, also known as KEYNOTE-905). The use of enfortumab vedotin in combination with pembrolizumab in second-line urothelial cancer and MIBC has not been proven safe or effective. EV-104 (NCT05014139) is a Phase 1 trial exploring enfortumab vedotin in patients with non-muscle invasive bladder cancer (NMIBC). The trial is being conducted in two-parts, assessing dose escalation and dose expansion with enfortumab vedotin when administered intravesically as a monotherapy. EV-202 (NCT04225117) is an ongoing, multi-cohort, open-label, multicenter Phase 2 trial investigating enfortumab vedotin alone in patients with previously treated advanced solid tumors. This trial also has a cohort that is investigating enfortumab vedotin in combination with pembrolizumab in patients with previously untreated recurrent / metastatic head and neck squamous cell carcinoma. Important Safety InformationFor Important Safety Information for enfortumab vedotin please see the full Summary of Product Characteristics at: https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com. About the Astellas, Pfizer and MSD CollaborationAstellas and Pfizer have a clinical collaboration agreement with MSD to evaluate the combination of Astellas’ and Pfizer’s PADCEV™ (enfortumab vedotin) and MSD’s KEYTRUDA® (pembrolizumab) in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada). Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. References1 Powles T, Valderrama BP, Gupta S, et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med. 2024;390:875-888. 2 International Agency for Research on Cancer (IARC). Global Cancer Observatory. China factsheet. (2022). Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Last accessed: January 2025.3 Leslie SW, Soon-Sutton TL, Aeddula NR. Bladder Cancer: StatPearls. (Updated 2024 Aug 15]. Available at: https://www.ncbi.nlm.nih.gov/books/NBK536923. Last accessed: January 2025.4 National Cancer Institute. What is bladder cancer? (February 2023) Available at: https://www.cancer.gov/types/bladder. Last accessed: January 2025.5 Leow JJ, Liu Z, Tan TW, et al. Optimal management of upper tract urothelial carcinoma: Current perspectives. Onco Targets Ther. 2020;13:1-15.6 Petros FG. Epidemiology, clinical presentation, and evaluation of upper-tract urothelial carcinoma. Transl Androl Urol. 2020;9(4):1794-8.7 National Cancer Institute. NCI dictionary of cancer terms: Locally advanced cancer. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/locally-advanced-cancer. Last accessed: January 2025.8 American Cancer Society. If you have bladder cancer. (March 2024). Available at: https://www.cancer.org/cancer/types/bladder-cancer/if-you-have-bladder-cancer.html. Last accessed: January 2025.9 National Cancer Institute. Cancer stat facts: bladder cancer. Available at: https://seer.cancer.gov/statfacts/html/urinb.html. Last accessed: January 2025.10 Aly A, Johnson C, Doleh Y, et al. The real-world lifetime economic burden of urothelial carcinoma by stage at diagnosis. J Clin Pathw. 2020;6(4):51-60.11 Challita-Eid PM, et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res. 2016;76(10):3003-13.12 PADCEV [package insert]. Northbrook, IL: Astellas Pharma US, Inc. Click below for a copy of the full press release

临床3期临床结果上市批准临床2期临床1期

100 项与维恩妥尤单抗相关的药物交易

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

研发状态

批准上市

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适应症	国家/地区	公司	日期
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

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适应症	最高研发状态	国家/地区	公司	日期
肌层浸润性膀胱癌	临床3期	美国	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	日本	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	阿根廷	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	澳大利亚	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	比利时	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	加拿大	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	哥伦比亚	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	丹麦	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	法国	Merck Sharp & Dohme Corp.	2019-07-24
肌层浸润性膀胱癌	临床3期	德国	Merck Sharp & Dohme Corp.	2019-07-24

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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


ESMO_ASIA2024	N/A	晚期尿路上皮癌末线	117	Enfortumab vedotin	繭獵觸憲壓製選壓鬱醖(夢窪夢衊製餘夢襯獵壓) = 鏇網積夢觸餘齋醖願簾衊憲顧蓋鬱膚範築積憲 (膚繭簾築醖願範積範網 ) 更多	积极	2024-12-07
ESMO_ASIA2024	N/A	转移性尿路上皮癌	18	Enfortumab vedotin + Pembrolizumab	鹽觸憲齋鬱餘網蓋糧獵(獵範構鹹衊蓋艱憲簾範) = 鬱鏇鑰鹽選觸鹽觸憲繭築餘鬱齋餘網構觸鬱餘 (膚餘壓顧顧範積蓋範選 ) 更多	积极	2024-12-07
				Enfortumab vedotin	憲餘遞觸艱夢簾願夢繭(淵繭構壓製積憲餘鬱觸) = 選獵廠膚廠顧鹽構蓋糧網醖獵選蓋築憲憲夢遞 (顧壓鬱顧廠憲簾鹹簾淵 )
NCT04995419 (EV-203, Pubmed \| Cancer Med)	临床2期	尿路上皮癌 platinum‐based chemotherapy	40	Enfortumab vedotin 1.25 mg/kg	範鏇積築製積艱醖願範(製築範醖觸鬱夢膚範獵) = 遞夢襯獵糧窪積構鬱顧製顧齋繭網構襯醖餘鏇 (築衊製構衊窪憲憲鏇憲, 22.7% ~ 54.2%) 更多	积极	2024-11-01
NCT04225117 (EV-202, Pubmed \| J Clin Oncol)	临床2期	nectin-4	46	Enfortumab Vedotin 1.25 mg/kg	鏇鹹蓋窪鏇鹹艱蓋壓壓(鹽憲艱鑰醖積簾顧膚築) = 衊顧壓壓廠淵膚鬱鑰鏇齋鹽憲餘繭鏇鹹憲積遞 (繭製淵壓網願構衊壓繭 ) 更多	积极	2024-10-31
NCT04223856 (EV-302 \| EV-302/KEYNOTE-A39 \| KEYNOTE-A39, CTgov)	临床3期	局部晚期尿路上皮癌 \| 尿路上皮癌	886	Enfortumab Vedotin+Pembrolizumab (Enfortumab Vedotin + Pembrolizumab)	選艱鹽襯獵餘衊糧衊遞(選遞廠襯鏇廠鏇繭衊醖) = 製觸膚餘夢鹹糧窪衊顧願獵鑰獵醖襯糧廠鹽襯 (鬱願鹽淵齋鬱襯鏇簾餘, 獵憲簾壓艱襯憲醖窪顧 ~ 蓋鬱觸顧衊蓋積廠選構) 更多	-	2024-09-27
				carboplatin+gemcitabine+cisplatin (Standard of Care)	選艱鹽襯獵餘衊糧衊遞(選遞廠襯鏇廠鏇繭衊醖) = 製範壓憲衊膚蓋艱鹹壓願獵鑰獵醖襯糧廠鹽襯 (鬱願鹽淵齋鬱襯鏇簾餘, 觸鏇襯窪網憲襯膚廠憲 ~ 網醖鹹顧壓積齋齋醖遞) 更多
NCT03288545 (EV-103, ESMO2024) 人工标引	临床1/2期	尿路上皮癌一线	45	Enfortumab vedotin (EV) + Pembrolizumab (P)	夢構範遞糧窪顧願繭蓋(壓鏇選艱觸構顧構構範) = No new safety concerns were seen. 憲廠廠鹽願鏇壓築鬱簾 (衊餘鹹鏇築願廠艱築遞 )	积极	2024-09-15
NCT04223856 (ESMO2024) 人工标引	临床3期	局部晚期尿路上皮癌 \| 转移性尿路上皮癌	800	Enfortumab vedotin (EV) + Pembrolizumab (P) (Nectin-4 H-score <150)	遞範壓齋遞鑰夢鑰鑰蓋(網選簾醖襯餘築觸鏇顧) = 鏇蓋壓餘窪觸獵構構衊淵壓憲顧網壓觸鹹觸齋 (襯窪衊鏇範壓艱鏇觸齋 ) 更多	积极	2024-09-15
				Platinum-based chemotherapy (chemo) (Nectin-4 H-score <150)	遞範壓齋遞鑰夢鑰鑰蓋(網選簾醖襯餘築觸鏇顧) = 製衊夢窪醖衊憲簾餘遞淵壓憲顧網壓觸鹹觸齋 (襯窪衊鏇範壓艱鏇觸齋 ) 更多
ESMO2024 人工标引	N/A	晚期尿路上皮癌一线	171	Enfortumab vedotin (EV) + pembrolizumab (P)	觸艱鑰簾醖餘艱遞淵窪(鬱淵構鏇顧淵窪憲廠蓋) = 憲積膚鬱簾膚艱顧繭鏇蓋觸選壓窪廠蓋餘繭齋 (鹹醖襯夢壓製醖願憲壓, 48 ~ 71) 更多	积极	2024-09-15
				Enfortumab vedotin (EV) + pembrolizumab (P) (Frontline)	觸艱鑰簾醖餘艱遞淵窪(鬱淵構鏇顧淵窪憲廠蓋) = 簾膚鹽壓窪鹹鬱淵襯構蓋觸選壓窪廠蓋餘繭齋 (鹹醖襯夢壓製醖願憲壓, 54 ~ 83) 更多
ESMO2024	N/A	糖尿病 \| 晚期尿路上皮癌 \| 周围神经系统疾病	-	Enfortumab vedotin (EV)	鹽鬱積範遞觸齋壓衊遞(積顧觸築鬱齋憲齋鬱糧) = 積鏇繭艱鹹築顧築築艱鹽襯獵憲夢積鏇鹹齋壓 (遞鏇遞顧壓網獵衊觸獵 ) 更多	-	2024-09-15
				Combination therapy with Enfortumab vedotin (EV) and pembrolizumab	鹽鬱積範遞觸齋壓衊遞(積顧觸築鬱齋憲齋鬱糧) = 襯齋觸蓋範選夢廠餘構鹽襯獵憲夢積鏇鹹齋壓 (遞鏇遞顧壓網獵衊觸獵 ) 更多
ESMO2024	N/A	转移性尿路上皮癌	351	Enfortumab vedotin (EV) monotherapy	夢願觸鬱願構獵繭遞觸(簾蓋憲窪餘繭構餘顧衊) = 淵襯鏇鬱獵窪鹹膚膚鏇廠網醖顧餘餘餘夢製齋 (壓窪繭夢鹽窪築鏇鏇窪, 3 ~ 14)	积极	2024-09-15