A Phase II, Open-label, Single-arm, Multi-center Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer (NEPTUNE)

This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in cisplatin-eligible patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.

开始日期2025-06-01

申办/合作机构

Rogel Cancer Center: University of Michigan

NCT06809140

/ Recruiting临床2期IIT

Phase 2 Trial of Enfortumab Vedotin Plus Pembrolizumab with Selective Bladder Sparing for Treatment of Muscle-invasive Urothelial Cancer of the Bladder

Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (clinical complete response) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., >cTa disease) will undergo cystectomy.

开始日期2025-04-01

申办/合作机构

Hoosier Cancer Research Network

[+4]

NCT06862219

/ Not yet recruiting临床4期

A Multicenter, Phase 4, Open-label, Single-arm, Safety Study of Enfortumab Vedotin in Adult Indian Participants With Previously Treated Locally Advanced or Metastatic Urothelial Cancer

This study is for Indian adults in India who have cancer in the bladder lining (urothelial cancer). Their cancer is advanced or has spread to other parts of the body. Enfortumab vedotin is a treatment for this type of cancer.
The main aim of the study is to confirm the safety of enfortumab vedotin in Indian adults with urothelial cancer.
During the study, people will receive enfortumab vedotin. The study treatment will be given to people slowly through a tube into a vein. This is called an infusion. People will receive 3 separate infusions of enfortumab vedotin in each 28-day (4 weeks) treatment cycle.
People visit their study clinic for health-checks several times during and after they receive enfortumab vedotin.

开始日期2025-03-31

申办/合作机构

Astellas Pharma Global Development, Inc.

[+1]

100 项与维恩妥尤单抗相关的临床结果

登录后查看更多信息

100 项与维恩妥尤单抗相关的转化医学

登录后查看更多信息

100 项与维恩妥尤单抗相关的专利（医药）

登录后查看更多信息

1,004

项与维恩妥尤单抗相关的文献（医药）

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Model-informed development of a cost-saving dosing regimen for enfortumab vedotin

Article

作者: Koolen, Stijn Lw ; Boerrigter, Emmy ; van Kruchten, Michel ; Rieborn, Amy ; van der Hulle, Tom ; Willemsen, Annelieke Ecab ; Franken, Mira D ; Op 't Hoog, Catharina Jp ; van der Heijden, Michiel S ; Hendrikx, Jeroen Jma ; Ter Heine, Rob ; Moes, Dirk Jan Ar

Abstract:

Aim:

Enfortumab vedotin is an antibody-drug conjugate (ADC) that has been approved for locally advanced or metastatic urothelial cancer, as monotherapy and in combination with pembrolizumab, and has shown significant benefit in progression-free survival and overall survival for these patients. The economic burden of enfortumab vedotin hampers widespread patient access. The aim of this study was to develop a model-informed alternative dosing regimen that results in equivalent drug exposure while reducing the costs and prevent drug spillage.

Methods:

Population pharmacokinetic modelling was used to simulate a dosing regimen leading to equivalent exposure by using the published population pharmacokinetic model in the registration reports. The alternative dosing regimen was based on weight-bands derived from the established non-linear relationship between body weight and systemic exposure, and the usage of whole vials based on fixed doses to prevent spillage. Equivalent exposure compared to the approved body weight-based dosing regimen was defined as conservative equivalent boundaries of 90–111% for the calculated geometric mean ratios (GMRs) of area under the concentration-time curve and trough concentration.

Results:

A weight-band based dosing regimen for each dose level of enfortumab vedotin was developed. The GMRs for all pharmacokinetic outcomes were within the predefined equivalence boundaries. In addition, a more even exposure distribution was observed across the body weight quartiles. The average costs savings across all dose levels and per weight-band were approximately 15%.

Conclusion:

The proposed alternative dosing regimen shows that drug costs and spillage of enfortumab vedotin can be reduced while maintaining an equivalent and more evenly distributed exposure in treated patients.

2025-04-01·Clinical Genitourinary Cancer

Enfortumab Vedotin for Metastatic Urothelial Carcinoma: Comprehensive Treatment Outcomes and Prognostic Insights From a Multicenter Real-World Study (YUSHIMA Study)

Article

作者: Yoshida, Soichiro ; Uehara, Sho ; Yoshinaga, Atsushi ; Tanabe, Kenji ; Maezawa, Yuya ; Kawamura, Naoko ; Inoue, Masaharu ; Yamamoto, Takanobu ; Izumi, Keita ; Toide, Masahiro ; Araki, Saori ; Numao, Noboru ; Takazawa, Ryoji ; Soma, Takahiko ; Fujii, Yasuhisa ; Tanaka, Hajime ; Nakamura, Yuki

INTRODUCTION:

Enfortumab vedotin (EV) currently plays a predominant role in the evolving treatment paradigm of metastatic urothelial carcinoma (mUC). However, large-scale real-world data on EV remain limited. This multicenter retrospective study comprehensively evaluated treatment outcomes and prognostic factors of EV monotherapy for mUC.

PATIENTS AND METHODS:

A total of 115 consecutive patients with mUC who received EV monotherapy between 2021 and 2023 were analyzed. Baseline characteristics and treatment outcomes were collected. Progression-free survival (PFS), over-all survival (OS), best overall response, treatment-related adverse events (TRAEs), and prognostic factors associated with PFS and OS were analyzed.

RESULTS:

The median age was 74 years, and 18 patients (16%) had an performance status (PS) of ≥2. During the median follow-up of 7.1 months, median PFS was 6.7 months and median OS was 12.9 months. Eighty-six patients (74%) experienced interruption or dose reduction of EV, resulting in a median relative dose intensity (RDI) of 77.4%. The objective response rate was 49%, and the disease control rate was 69%. Eighty-eight patients (77%) experienced TRAEs, including cutaneous AEs observed in 58 patients (50%). In multivariable analysis using pretreatment factors, PS≥1, liver metastasis, and low albumin level were associated with shorter PFS and OS. With RDI and AEs incorporated in the models, the presence of cutaneous AE was independently associated with longer PFS and OS.

CONCLUSION:

This real-world study demonstrated comparable treatment efficacy and acceptable TRAEs compared to clinical trials. The presence of cutaneous AE is a potentially favorable prognostic factor for mUC patients treated with EV.

2025-04-01·PROSTATE

Nectin‐4 Expression in Prostatic Adenocarcinoma: An Immunohistochemical Study

Article

作者: Matoso, Andres ; Johnson, Burles ; Vlachou, Evangelia ; Han, Misop ; Sharma, Shivang ; Kates, Max ; Denmeade, Samuel R. ; Smith, Armine ; Shenderov, Eugene ; Brame, Alex ; Baraban, Ezra G. ; De Marzo, Angelo M. ; Hoffman‐Censits, Jean ; Patel, Sunil

ABSTRACT:

Background:

The Nectin‐4 directed antibody drug conjugate enfortumab vedotin (EV) has emerged as frontline systemic therapy in combination with immune checkpoint blockade for urothelial carcinoma (UC), capitalizing on the ubiquitous expression of this protein in UC. There is limited data available regarding expression of Nectin‐4 by immunohistochemistry in prostate cancer, but this is of interest as a substantial number of UC patients likely to receive EV have concomitant prostate cancer.

Methods:

Nectin‐4 protein expression was evaluated by immunohistochemistry in tissue microarrays encompassing a cohort of 302 prostatic adenocarcinomas spanning Grade Groups 1–5. Intensity of expression was scored from 1 (weak) to 3 (intense staining readily apparent at low magnification). H‐scores were calculated by multiplying the percentage of cells staining by the intensity of expression.

Results:

Nectin‐4 expression was frequently observed in benign prostate tissue (86% of cases, mean H‐score of 40, median 20, interquartile range [IQR]: 10–60) and in prostatic adenocarcinoma (91% of cases, mean H‐score of 90, median 70, IQR: 20–150). Significant differences in Nectin‐4 expression among prostatic adenocarcinoma Grade Groups 1–5 were not observed. Across all prostatic adenocarcinomas evaluated, the mean Nectin‐4 H‐score of 90 was statistically significantly higher than the mean H‐score of 40 observed in benign prostate tissue (p < 0.001). Three of four prostatic ductal adenocarcinomas showed Nectin‐4 expression, with a median H‐score of 250 (IQR: 152–300).

Conclusions:

Nectin‐4 protein expression is common in benign prostate tissue and prostatic adenocarcinoma. These findings provide a rationale for future studies investigating potential activity of EV in prostate cancer.

931

项与维恩妥尤单抗相关的新闻（医药）

2025-03-12

·VIP说

超越靶点：深度理解ADC特性与疗效

ADC经过多年的研究已经彻底爆发，最近两年有多款ADC获批上市，为肿瘤患者提供了新的治疗方案，特别是第一三共DS8201在多种肿瘤及低表达和不表达的HER2的肿瘤中取得成功，为多种实体瘤患者带来了福音。但是迄今为止，ADC疗效和靶点表达的丰度之间的是否具有量效关系一直存在争议，在去年的ENA2024会议上，来自于Zymeworks的Raffaele Colombo博士系统的梳理了不同靶点ADC靶点表达与疗效之间的关系，为后续ADC的开发提供了思路。首先对于靶点表达多少的定量，目前有多种不同的测量标准，IHC，H-score，TPS和PS2等，这些不同的方法有不同的标准，IHC主要根据染色深浅进行判定，H-score主要是根据百分比的打分，TPS主要是基于表达靶点的肿瘤细胞的百分比。对于第一代HER2 ADC，T-DM1凭借其在HER2阳性的乳腺癌中的疗效获批上市，临床结果表明，对于HER2正常表达的队列，T-DM1具有更长的PFS，而且与Lapatinib + capecitabine联合疗法相比，其具有更好的PFS和OS，这表明，HER2高表达乳腺癌患者更易获益。而对于神药DS-8201，其在HER2不同表达水平的患者中都具有一定的疗效，但是在HER2高表达的患者中具有更好的疗效，并且与TPC疗法相比，DS-8201在HER2 High,low和ultralow队列中都具有更好的疗效，但是随着HER2表达降低，其与TPC的疗法的疗效差距逐渐接近。最重要的是，在多种实体瘤中，DS-8201在IHC 3+的患者都展现了更好的疗效。虽然在部分肿瘤中，IHC 2+和IHC≤ 1+不具有疗效，但是IHC 3+在大多数肿瘤中都具有较好的疗效，也是基于该结果，FDA加速批准DS-8201 在IHC 3+实体瘤的治疗。这也证明，对于多少肿瘤，DS-8201的疗效与靶点HER2的表达水平相关。对于ADC，其主要由三部分组成，抗体，载荷和linker，其中抗体和载荷发挥主要作用，但是linker的特性也会决定一个ADC药物是否能够成功。对于抗体其主要可能有两个方面的作用：1）递送载荷到靶标细胞，2）抗体本身可能也会发挥作用。而对于载荷，其也许也有两个主要作用：1）其系统性暴露可能对于药效有一定作用，2）肿瘤对载荷是否敏感也决定ADC疗效。首先对于抗体端的递送作用，抗体可以将相关载荷递送到肿瘤细胞，其递送量和抗原的表达丰度正相关。但是，相关研究表明，其最终进入肿瘤的量小于1%，多数分布在机体的相关组织中，并且其递送量和靶点没有关系。而抗体本身发生相关疗效主要可能是以下四个方面：1）阻断相关通路，2）ADCC效应，3）ADCP效应，4）CDC效应。这也是目前多数裸抗发挥作用的主要机制。 Trastuzumab即曲妥珠单抗又名赫赛汀(Herceptin)，其是目前多数ADC的母本抗体，该抗体本身已经获批上市，并且在HER2阳性和HER2-normal的乳腺癌肿瘤中展现了一定的疗效，这本身也证明，该抗体本身在抗肿瘤方面也发挥了一定作用。除了抗体本身，载荷在抗肿瘤中发挥了多少作用？目前的研究表明，ADC进入肿瘤的总量小于1%，但是无论其是否进入肿瘤，其最终都会被代谢并且释放载荷。Raffaele Colombo博士认为，游离载荷的系统性暴露最终使得ADC在靶点低表达或者不表达的也有一定的疗效。对于已经上市或者在临床中的多个HER2 ADC，虽然其疗效有一定的差异，但是都具有相似的趋势：在高表达的肿瘤中具有较好的疗效，但是在地表肿瘤中也具有一定的疗效。因此，对于ADC，抗体端的主要作用可能是：1）作为递送介质将载荷递送到肿瘤细胞；2）与靶点结合，从而抑制靶标相关的信号通路，从而抑制肿瘤细胞的生长；3）可能发挥相关效应功能，如ADCC，CDC和ADCP。而对于载荷，其在发挥作用主要是在肿瘤微环境或者肿瘤中代谢释放，或者是通过旁观者效应，当然也可以通过系统性暴露杀伤肿瘤细胞；另外，肿瘤对载荷的敏感性，也在一定程度上决定其疗效。当然，对于不同的ADC，这些机制并不是都发挥作用，这也导致其在临床中具有不同的疗效，其中DS-8201综合了所有特性，因此临床中目前疗效最好，当然载荷的特性也具有很关键的作用。那么对于其它靶点，是否也具有和HER2 ADC相似的特性呢? 首先来看看和HER2同一家族的HER3，目前临床中进展最快的是第一三共的HER3-DXd，目前该药物已经申请上市，但是对其靶点表达和疗效的相关性分析发现，其疗效和表达并没有显著的相关性，无论是在肺癌还是乳腺癌中。而其抗体端在疗效中应该不具有HER2裸抗Trastuzumab的相似作用，因为该靶点的裸抗已经开发了多年，在临床中无论单抗，都不具有疗效。特别是对于HER3-DXd的裸抗Patritumab，其无论是单独用药还是联合用药，都没有疗效，因此对于HER3-DXd，其疗效可能更多的因为载荷的系统性暴露以及抗体对载荷的递送。而对于TROP2，不同的ADC之间具有不同的趋势，其中Sacituzumab govitecan其在不同的肿瘤中，临床疗效和靶点表达多数情况下并不具有相关性，但是对于SKB264和Dato-DXd两者之间却展示了一定的相关性。对于该靶点的ADC药物，其不同的设计也导致靶点表达和疗效的相关性分析变得比较复杂。对于靶向FRα的ADC，Mirvetuximab soravtansine已经于2022年加速获批上市，其通过偶联叶酸受体α（FRα）抗体、可断裂的连接子和Maytansinoid DM4（微管蛋白抑制剂），靶向杀死表达FRα的肿瘤细胞。该抗体在2021年初次披露数据时并不能改善铂耐药上皮性卵巢癌(EOC)患者无进展生存，但是在次要终点上， MIRV治疗有获益倾向，尤其是高叶酸受体（FR）α表达人群。后续利用PS2+评分对患者进行进一步分析发现，该药物在高中低表达的患者中具有显著性差异，且高表达组具有更好的PFS。后续的临床证明，Mirvetuximab soravtansine在FRα高表达卵巢癌患者中显示出优于医生选择治疗方案的总生存期（OS），表明其在特定患者群体中具有显著疗效。后续临床中，新型TOPO1i ADC在FRα高、低表达患者中均显示出一定的疗效，表明其具有广泛的治疗潜力 Tisotumab vedotin正是由Genmab与Seagen联合开发的靶向组织因子的ADC，它将细胞毒性药物MMAE通过可被蛋白酶切割的连接子偶联在抗体上。2021年9月， FDA加速批准Tisotumab vedotin上市，用于治疗复发或转移性宫颈癌（r/mCC）患者。临床结果分析发现，Tisotumab vedotin的疗效与TF表达水平无关，表明其疗效可能不依赖于靶点表达。 2019年12月，美FDA批准Enfortumab vedotin用于治疗既往已接受一种PD-1/L1抑制剂治疗、并且在新辅助/辅助治疗或在局部晚期或转移性疾病治疗中已接受了一种含铂化疗方案的局部晚期或转移性尿路上皮癌患者。临床结果表明，Enfortumab vedotin在nectin-4高、低表达患者中均显示出显著的疗效，表明其具有广泛的治疗潜力。而在nectin-4高表达或扩增患者中，其显示出更好的疗效，表明nectin-4表达水平可能影响其疗效。最后，Raffaele Colombo博士汇总了ADC在实体瘤和血液流中，疗效和靶点表达丰度的关系。对于实体瘤，多数药物在所有靶点表达水平患者中均显示出一定的疗效，并且部分在高表达肿瘤中具有更好的治疗效果，但是对于部分药物，疗效和靶点表达之间没有相关性。而在血液瘤中，多数药物疗效和靶点表达没有相关效，这可能是因为实体瘤的肿瘤微环境和血液流完全不同，也证明了ADC的开发相对比较复杂，与肿瘤类型，靶点，抗体，payload，linker等设计都有关系。最后其讨论了未来ADC研究方向，包括蛋白质组学、质谱分析、液体活检和数字病理学等，这些方向有助于更好地识别和量化靶点表达，理解靶点的功能。

抗体药物偶联物临床结果临床研究多肽偶联药物临床申请

2025-03-12

·VIP说

ADC药物全面爆发，引领破局妇癌之王

抗体偶联药物（ADC）是继化疗、靶向治疗、免疫治疗之后肿瘤药物开发的另一个快速发展的领域，兼具靶向治疗和化疗的优势，已经在血液系统肿瘤和包括乳腺癌等多种实体瘤中取得了突破性的进展。近年来，随着贝伐珠单抗、PARP抑制剂等在卵巢癌中的获批，一定程度上延缓了疾病复发，但最终几乎所有患者都会转变为铂耐药卵巢癌（PROC）。而目前PROC的治疗方式非常有限，有效率极低，仍存在巨大的未满足需求，亟需突破性的治疗方式。 ADC药物的出现打破了这一僵局，随着索米妥昔单抗（MIRV）、替索单抗（TV）、德曲妥珠单抗（T-DXd）在妇科肿瘤的获批，越来越多的ADC药物开始在妇科肿瘤，尤其在铂耐药卵巢癌中进行探索，包括不同靶点和适应症的拓展。近期，在《International journal of biological macromolecules》上发表了一篇综述：A mini-overview of antibody-drug conjugates in platinum-resistant ovarian cancer: A preclinical and clinical perspective. 2023 IF=7.7。文章详细阐述了ADC药物在铂耐药卵巢癌中的治疗进展。一、ADC药物的关键组成要素 ADC药物主要由靶向肿瘤细胞表面特异性抗原的单克隆抗体、连接子、高活性的细胞毒素三部分偶联组成，凭借其独特的抗肿瘤机制能够对肿瘤细胞实现精准杀伤，并且各个组分都发挥不同的重要作用。首先理想的治疗靶点是在肿瘤细胞上高表达，而在正常组织中几乎不表达，从而确保异质性，减少脱靶效应并呈现更广泛的治疗窗口而减少毒性。目前ADC药物在PROC中的靶点主要包括FRα、TROP2、HER2、NaPi2b及MSLN等。抗体是ADC药物的重要组分之一，能够与肿瘤细胞表面的抗原特异性结合，相当于ADC药物的“导航”系统。抗体对于确定ADC的特异性，亲和力，免疫原性和分子量至关重要，会影响药物输送效率，体内分布，药代动力学/药效学（PK/PD）特征和治疗窗口。目前新一代ADC使用人源化抗体能够降低免疫原性。另一个关键参数是药物抗体比（DAR），一般DAR越高效力和毒性反应越强，但一些DAR较高的ADC药物由于具有较高的血浆清除率而与DAR较低的ADC药物具有同等效力。连接子是负责连接抗体与细胞毒性药物的关键组分，决定了ADC的稳定性、药代动力学特征和治疗窗。为了确保细胞毒性药物的有效释放，连接子需要在血液循环中保持稳定，并在内化后释放出细胞毒性药物。一般分为可裂解和不可裂解两大类，目前可裂解连接子为主流选择，在肿瘤微环境中选择性释放有效载荷，能够实现更精准的药物释放。其作用机制主要包括在酸性、还原条件或丰富的蛋白水解酶条件下发挥作用，例如还原型二硫键连接子（索米妥昔单抗）、PH敏感的腙键连接子（吉妥珠单抗）、酶响应的肽类连接子（恩诺单抗、德曲妥珠单抗）。不可裂解连接子通常具有较高的循环稳定性，但释放细胞毒性药物的效率较低，可能会影响抗肿瘤活性。细胞毒性药物是ADC药物发挥肿瘤杀伤作用的重要组分。当前细胞毒性药物相较传统化疗药物毒性更强，主要包括微管蛋白抑制剂（影响微管聚合和组装进而阻滞细胞周期，例如MMAE、MMAF、DM4）和拓扑异构酶抑制剂（干扰DNA合成和复制，例如DXd）。其中一些有效载荷，例如DM4和DXd，能够穿透细胞膜的脂质双分子层杀伤临近肿瘤细胞进而发挥“旁观者效应”，这种作用有利于克服肿瘤的异质性。二、靶向FRɑ的ADC药物索米妥昔单抗率先破局 FRα在多种实体瘤中广泛高表达，包括三阴性乳腺癌、卵巢癌，宫颈癌，子宫内膜癌和非小细胞肺癌等，但在正常组织中表达有限，因此成为理想的治疗靶点。据报道，FRα在超过80％的上皮性卵巢癌中过表达，并且与化疗的预后不良有关。免疫组织化学（IHC）是FRα检测的金标准，而VENTANA FOLR-1 RxDx试剂盒是经FDA批准用于确定FRα阳性的患者人群。根据PS2+评分，FRα阳性（高表达）、中表达和低表达分别定义为≥75%、50%-75%和25%-50%的存活肿瘤细胞染色强度≥2+。据相关数据报道，在高级别浆液性卵巢癌中，约32%-36%的患者为FRα高表达。在21例PROC患者中进行的I期临床研究结果显示，新鲜活检组织样本及其相应的存档样本之间的FRα表达具有71％的一致性，而临床实际过程中在卵巢癌的不同疾病阶段FRα表达是否会发生变化仍有待大型研究进一步验证。索米妥昔单抗是全球首个且唯一获批靶向FRα的ADC。主要由人源化抗FRα单克隆抗体、可裂解的连接子和微管蛋白抑制剂分子DM4三部分组成。 2022年11月，基于II期单臂SORAYA研究结果，索米妥昔单抗获得FDA加速批准，用于治疗既往接受过1-3线系统治疗的FRα阳性的铂耐药上皮性卵巢癌、输卵管癌或原发性腹膜癌的成年患者。全球多中心、确证性、III期MIRASOL研究结果显示，索米妥昔单抗相较化疗能够显著改善FRα阳性PROC患者的长期生存，降低35%的疾病进展风险（mPFS: 5.62 vs 3.98 月, HR=0.65, P＜0.0001 )和33%的全因死亡风险（mOS: 16.46 vs 12.75 月, HR=0.67, P=0.0046），并且极大提升患者的客观缓解率（ORR: 42.3% vs 15.9%）和CA125缓解率（58% vs 30.3%）。3级及以上不良事件发生率、严重不良事件（SAE）发生率和停药率均更低（41.7% vs 54.1%，23.9% vs 32.9%，9.2% vs15.9%），血液学优势明显。仅14%的患者出现3级眼部AE，随访中几乎所有的眼部AE均可缓解至0或1级，无永久性眼部后遗症。根据MIRASOL研究的优异数据，FDA已完全批准索米妥昔单抗用于治疗FRα阳性PROC患者。 IMGN853-301研究是首个索米妥昔单抗在中国人群中的III期研究。在FRɑ阳性的PROC患者中，BIRC确认的ORR为35.3%（95%CI:19.75%-53.51%），BIRC评估的PFS达5.5个月，且未出现新的安全性信号，初步证实索米妥昔单抗在中国FRɑ阳性的PROC人群中具有较好的疗效和安全性，与国际III期研究保持一致。基于此数据，2024年11月索米妥昔单抗被国家药监局附条件批准用于FRɑ阳性PROC患者的治疗。索米妥昔单抗不仅在PROC获得了疗效和安全性的双重优势，在PSOC中也取得了初步临床获益。在一项单臂、全球多中心的II期PICCOLO研究中，79例≥3线的FRɑ高表达PSOC患者接受MIRV单药治疗。研究结果显示，研究者评估的ORR达51.9%，中位DOR为8.25个月，中位PFS达6.93个月。无论既往治疗情况各亚组均取得ORR获益，尤其既往经PARPi治疗进展的患者仍能获得45.8%的ORR。并且整体安全性可控，以低级别AE为主。由于抗血管生成药物可能会通过克服肿瘤内皮屏障和改善肿瘤细胞暴露进而增强ADC药物的活性。因此，索米妥昔单抗联合贝伐珠单抗有望在卵巢癌中显示出巨大治疗潜力。在一项多队列、II期的FORWARDII研究中，94例PROC患者接受MIRV联合贝伐治疗，ORR达44%，中位PFS达8.2个月。亚组分析表明，不同FRα表达水平的患者均可获益，高中低表达患者的ORR分别为48%、41%、36%，中位PFS分别为9.7、 6.9和8.6个月。因此，联合治疗有望突破FRα表达水平限制，即使在FRα中低表达亚组，仍可观察到联合治疗的抗肿瘤活性。另外，在31例MIRV联合贝伐治疗PSOC的人群中，ORR达48%，mPFS达9.6个月，仍然显示出良好获益。根据FORWARDII研究MIRV联合贝伐的结果，目前已于2024年12月正式启动了全球III期GLORIOSA研究，进一步评估MIRV联合贝伐对比贝伐二线维持治疗铂敏感复发人群的疗效和安全性，有望进一步拓展前线治疗。三、多种ADC药物在PROC中持续探索前行随着ADC技术逐渐成熟，当前多种ADC药物也正在进行临床前或临床研究的探索。目前已经有多项初步研究数据公布，具体汇总如下表所示：当前主要ADC药物在PROC中的治疗进展四、ADC药物的安全性优化策略虽然ADC药物能够实现精准打击作用，极大降低了传统化疗的不良反应。然而在使用过程中仍存在脱靶毒性、靶标毒性和难以预知的不良反应，并且与细胞毒性药物的种类密切相关。例如，以MMAE作为有效载荷的ADC会发生周围神经病变和血液毒性，包括贫血和中性粒细胞减少，以MMAF或DM4作为有效载荷的ADC会发生眼毒性。因此不良事件的管理对于临床疗效的优化至关重要，需要进一步改进ADC设计进而降低毒性反应。一些ADC药物会发生眼部不良反应，例如索米妥昔单抗（MIRV）、替索单抗（TV）、Enfortumab vedotin（EV）等。尽管MIRV影响角膜上皮细胞的确切机制尚不清楚，但鉴于眼部缺乏FRɑ受体，因此目前认为是由于角膜上皮的脱靶效应导致。相反，由于组织因子（TF）在角膜上皮细胞广泛表达，因此TV可引起靶向眼部效应。一项纳入682例接受MIRV治疗的患者的安全性汇总数据显示，59%的患者发生眼部不良事件，主要以视物模糊（43%）、角膜病变（29%）、干眼症（27%）为主，其中82%为1-2级，未出现不可逆的眼部不良事件。为了预防和减少眼部不良事件的发生，建议患者每日使用润滑滴眼液，并根据需要使用皮质类固醇滴眼液。在开始MIRV治疗前应进行眼科检查，并在整个治疗过程进行密切监测和管理，同时根据不良事件的级别及时进行剂量调整。眼科医生应遵循眼部不良事件管理指南进行对症治疗。此外，需要加强眼科医生和妇瘤科医生的多学科合作，有利于最大限度发挥MIRV的临床疗效。五、ADC药物的未来展望与挑战目前ADC药物已经初显疗效，但ORR大多不超过40%，因此提高缓解率是ADC药物发展的一个重要目标。既往研究结果显示，ADC联合贝伐或免疫治疗已经取得了初步获益。此外，ADC联合PARP抑制剂也在卵巢癌中显示出潜在的协同作用。目前多项ADC联合治疗研究正在进行中，未来有望进一步改变卵巢癌的治疗前景。目前III期研究结果显示MIRV对于FRɑ高表达的患者更有效，但在中低表达的患者中也观察到了临床获益。因此，筛选最佳获益患者人群至关重要，需要根据不同表达状态优化患者分层来进一步实现个体化治疗。尽管ADC药物已经取得了令人鼓舞的进展，但仍存在一些重大挑战，特别是在毒性管理方面。目前ADC药物观察到的常见不良反应主要包括血液学毒性、周围神经病变、眼毒性和胃肠道毒性等。通常需要减少剂量或中断治疗，可能会影响整体治疗效果及患者的生活质量。通过给予一定预防措施或确定风险相关的生物标志物将有利于更个性化的治疗方案，确保患者接受最有效的治疗，同时最大限度降低不良反应。此外，优化给药方案和进行联合治疗可能有助于降低毒性的严重程度，同时提高整体治疗获益。由于ADC的抗肿瘤活性是基于抗体的靶向作用和有效载荷的细胞毒性作用，因此如何克服ADC耐药至关重要。耐药的主要机制包括抗体介导的耐药和有效载荷相关的耐药。在一项乳腺癌的研究中观察到由于靶标表达降低和结合减少而导致的ADC获得性耐药，并且在原发性耐药中也注意到靶点表达的缺失。此外，受损的内吞作用和ADC在循环系统中输送的方式也会导致抗体介导的耐药性。虽然ADC携带的有效载荷效力较强，但一些肿瘤细胞可以通过上调药物外排泵和干扰药物沉积而产生耐药性。在不同的T-DM1耐药细胞系中，已经证实了多药耐药相关蛋白1（MRP1，由ABCC1编码）、MRP2（ABCC2）和MDR1等药物外排蛋白的过度表达，并且通过分别同时使用MRP1、MRP2和MDR1的抑制剂可以恢复其敏感性。迄今为止，MIRV和DS-8201已被FDA批准用于治疗卵巢癌，其他多项研究也在探索中。然而，在毒性管理、克服耐药性和优化患者选择方面仍然存在挑战。为了克服临床使用的限制，ADC的结构优化必不可少。同时，更多靶点的ADC药物仍在探索中，能够为现有ADC治疗耐药的患者提供更多潜在选择。此外，多项联合治疗的研究正在进一步探索疗效和安全性。这些发展将有助于改进卵巢癌的临床治疗策略，为卵巢癌患者带来更多获益和希望。参考文献： 1.YuXi Zhao, et al. A mini-overview of antibody-drug conjugates in platinum-resistant ovarian cancer: A preclinical and clinical perspective. Int J Biol Macromol. 2025 Feb 6; 304(Pt 2):140767. 2.D. Wang, et al. 2024 ESMO 715MO. 3.G.E.Konecny, et al. 2024 ESMO 721MO. 4.Ronnie Shapira-Frommer, et al. 2024 ESMO 754P. 5.Lainie P. Martin, et al. 2024 ESMO e-poster 749. 6.Ning Li, et al. 2024 ESMO 787P. 7.Ana Oaknin, et al. 2023 ESMO Abstract 5508. 8.Clin Cancer Res. 2021 Jul 15; 27(14):3905-3915. 9.Haiyan Jia, et al. 2024 ASCO Abstract 5550. 10.Meric-Bernstam F, et al. J Clin Oncol. 2024;42(1):47-58. 11.Yutao Liu, et al. 2024 ASCO Abstract 5551. 12.Moore KN, et al. Ann Oncol. 2023; 34 (Suppl, 2): Abstr 745MO. 13.Debra L, et al. 2024 SGO LBA.

抗体药物偶联物免疫疗法

2025-03-10

·PRNewswire

BAVENCIO Continues to Strengthen Its Position in the Immuno-Oncology Landscape | DelveInsight

With the rising adoption of checkpoint inhibitors and combination therapies, BAVENCIO's market growth is driven by expanding indications and strategic partnerships. However, competition from KEYTRUDA and TECENTRIQ poses challenges, making differentiation through combination strategies key to its success. LAS VEGAS, March 10, 2025 /PRNewswire/ -- DelveInsight's " BAVENCIO Market Size, Forecast, and Market Insight Report" highlights the details around BAVENCIO, a human IgG1 lambda monoclonal antibody that targets programmed death-ligand 1 (PD-L1). The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of BAVENCIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Pfizer/Merck/EMD Sereno's BAVENCIO (avelumab) Overview BAVENCIO is a human antibody targeting programmed death ligand-1 (PD-L1). Preclinical studies have demonstrated its ability to activate both adaptive and innate immune responses. By inhibiting the interaction between PD-L1 and PD-1 receptors, BAVENCIO helps restore T cell-mediated antitumor immunity in preclinical models. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and commercialize BAVENCIO. In the U.S., BAVENCIO is approved for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-based chemotherapy. It is also indicated for patients with locally advanced or metastatic UC who experience disease progression during or after platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-based treatment. Additionally, BAVENCIO in combination with axitinib is approved in the U.S. for the first-line treatment of patients with advanced renal cell carcinoma. The FDA has also granted accelerated approval for BAVENCIO in the treatment of adults and pediatric patients (12 years and older) with metastatic Merkel cell carcinoma, based on tumor response rate and duration of response. Continued approval may depend on further clinical trials confirming its benefits. Currently, BAVENCIO is approved in 50 countries for at least one indication. Learn more about BAVENCIO projected market size for merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma @ BAVENCIO Market Potential Urothelial carcinoma is the most common cancer of the urinary system, arising from urothelial cells and primarily affecting individuals over the age of 50. It is more prevalent in males, with an incidence rate two to three times higher than in females. According to DelveInsight's analysis, approximately 41 million new cases of urothelial carcinoma were reported across the 7MM in 2023. The standard treatment primarily involves chemotherapy, particularly cisplatin-based regimens. For patients who do not respond to initial systemic therapy, immunotherapy—using agents such as atezolizumab and pembrolizumab—serves as a secondary option. In some cases, surgical interventions like nephroureterectomy are also performed. Approved treatment options for urothelial carcinoma include OPDIVO (nivolumab), PADCEV (enfortumab vedotin-ejfv), KEYTRUDA (pembrolizumab), and BAVENCIO (avelumab), among others. The urothelial carcinoma treatment market is projected to experience substantial growth, rising from USD 900 million in 2023 at a notable CAGR through 2034, driven by the introduction of innovative therapies currently in clinical trials. However, challenges such as treatment complications in elderly patients and dependence on blood transfusions may pose barriers to market expansion. Dive deep into an in-depth assessment of the Urothelial Carcinoma Market Merkel cell carcinoma is a rare and aggressive neuroendocrine skin cancer that originates from Merkel cells—specialized mechanoreceptors located at the dermo-epidermal junction responsible for touch sensation. According to DelveInsight's estimates, approximately 9,000 new cases of MCC were reported in the 7MM in 2023, with the United States accounting for 37% of these cases. Several approved treatments for MCC are currently available, primarily focusing on immune modulation. Notable therapies include BAVENCIO, a monoclonal antibody developed by Merck KGaA; KEYTRUDA (pembrolizumab), a PD-1 inhibitor from Merck; and ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor co-developed by Incyte Corporation and MacroGenics. DelveInsight's analysis estimates that the MCC treatment market in the 7MM was valued at approximately USD 411 million in 2023. Over the forecast period from 2024 to 2034, this market is expected to grow at a CAGR of 8.7%, driven by the introduction of innovative therapies. Discover more about the Merkel cell carcinoma market in detail @ Merkel Cell Carcinoma Market Report Renal cell carcinoma is the most prevalent form of kidney cancer, comprising approximately 90% of all cases. It ranks among the ten most common cancers worldwide. The prognosis for advanced RCC remains poor, with a five-year survival rate of around 11-12%. Research indicates that RCC accounts for the vast majority of kidney cancer cases. Over the past decade, the treatment landscape for advanced RCC has evolved significantly, driven by the introduction of novel therapies and advancements in surgical and ablative techniques. Treatment approaches have become increasingly personalized, with prognostic groups established to tailor interventions based on disease severity. For patients in good health with isolated metastases, surgical excision, radiotherapy, or ablative therapy may be recommended to postpone systemic treatment. Meanwhile, those ineligible for surgical removal may benefit from alternatives such as cryoablation, thermal ablation, or stereotactic ablative body radiation therapy. Additionally, targeted treatments like tyrosine kinase inhibitors (TKIs) and anti-VEGF antibodies have become essential in both first- and second-line therapy, offering effective management options for advanced RCC. The market outlook for advanced RCC appears promising, driven by ongoing innovations and the expansion of therapeutic options. As investigational treatments advance through clinical trials, they have the potential to significantly improve patient outcomes and address existing gaps in care. The competitive landscape is rapidly evolving, with developments in targeted therapies, immunotherapies, and combination treatments aiming to enhance survival rates and quality of life for patients with advanced RCC. For more insights on the evolving landscape of renal cell carcinoma, visit @ Advanced Renal Cell Carcinoma Market Emerging Competitors of BAVENCIO The urothelial carcinoma pipeline is highly dynamic, with promising new therapies in development, including IMFINZI + IMJUDO + SoC (AstraZeneca), Disitamab vedotin (Pfizer), Vactosertib + IMFINZI (MedPacto), TYRA-300 (Tyra Biosciences), LYTGOBI + KEYTRUDA (Taiho Oncology), UGN-104 (UroGen Pharma), and others. In the Merkel cell carcinoma space, the potential emerging competitors of BAVENCIO include IFx-2.0 (TuHURA Biosciences), NIDLEGY (L19-IL2/L19-TNF) (Philogen), ITI 3000 (Immunomic Therapeutics), PH 762 (Phio Pharmaceuticals/AgonOx), KT 253 (Kymera Therapeutics), MCLA 145 (Merus N.V.), and others. Key companies such as Exelixis/Bristol-Myers Squibb (Zanzalintinib (XL092) + Nivolumab), AstraZeneca/ HUTCHMED (Savolitinib + Durvalumab), Corvus Pharmaceuticals (Ciforadenant (CPI-444)), Xynomic Pharmaceuticals (Abexinostat), NiKang Therapeutics (NKT2152), and others are involved in developing drugs for advanced RCC. To know more about the number of competing drugs in development, visit @ BAVENCIO Market Positioning Compared to Other Drugs Key Milestones of BAVENCIO In January 2021, EMD Serono and Pfizer Inc. announced that the European Commission (EC) approved BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In December 2020, EMD Serono and Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In June 2020, EMD Serono and Pfizer Inc. announced that the FDA has approved the supplemental Biologics License Application (sBLA) for BAVENCIO as a maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed following first-line platinum-based chemotherapy. In June 2020, Merck KGaA and Pfizer Inc. announced that the European Medicines Agency (EMA) had accepted for review the Type II variation application for BAVENCIO as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma. In April 2020, EMD Serono and Pfizer Inc. finalized the submission of a supplemental Biologics License Application (sBLA) to the FDA for BAVENCIO as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma. In October 2019, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has granted approval for BAVENCIO in combination with axitinib as a first-line treatment for adults with advanced renal cell carcinoma (RCC). In May 2019, Merck KGaA and Pfizer Inc. announced that the FDA granted approval for BAVENCIO in combination with INLYTA as a first-line treatment for patients with advanced renal cell carcinoma (RCC). In December 2017, Merck KGaA and Pfizer Inc. announced that the FDA had awarded Breakthrough Therapy Designation to avelumab in combination with INLYTA (axitinib) for newly diagnosed patients with advanced renal cell carcinoma (RCC). In September 2017, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has approved BAVENCIO as a standalone treatment for adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive form of skin cancer. In September 2017, Merck KGaA and Pfizer Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO as the first and only treatment for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive cancer, in Japan. In May 2017, EMD Serono and Pfizer Inc. announced that the FDA approved BAVENCIO Injection to treat patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after platinum-based chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-based treatment. In March 2017, EMD Serono and Pfizer Inc. announced that the FDA has approved BAVENCIO Injection 20 mg/mL, an intravenous treatment for adults and pediatric patients aged 12 and older with metastatic Merkel cell carcinoma (mMCC). In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and market BAVENCIO. Discover how BAVENCIO is shaping the merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma treatment landscape @ BAVENCIO Injection BAVENCIO Market Dynamics BAVENCIO, co-developed by Merck KGaA and Pfizer, is an anti-PD-L1 checkpoint inhibitor primarily approved for urothelial carcinoma and Merkel cell carcinoma. Its key differentiation lies in its first-in-class approval for maintenance therapy in locally advanced or metastatic urothelial carcinoma, setting it apart from competitors like KEYTRUDA (pembrolizumab) and TECENTRIQ (atezolizumab). However, in the broader immuno-oncology (IO) landscape, BAVENCIO faces stiff competition from other PD-1/PD-L1 inhibitors that dominate indications in lung, renal, and other cancers. BAVENCIO's market uptake has been driven by its unique approval in the urothelial carcinoma maintenance setting, where it demonstrated a significant survival benefit. The drug has gained traction in major markets like the U.S., Europe, and Japan, benefiting from increased awareness and inclusion in treatment guidelines. However, its adoption has been tempered by physician familiarity with established IO therapies and payer considerations around cost-effectiveness, especially in competitive oncology segments. One of BAVENCIO's primary challenges is its limited label expansion compared to blockbuster PD-1 inhibitors like OPDIVO (nivolumab) and KEYTRUDA. While its urothelial carcinoma approval has a strong foothold, its lack of widespread use in high-incidence cancers like NSCLC constrains its market potential. Nonetheless, ongoing clinical trials exploring novel combination strategies with other immunotherapies and targeted agents could enhance its market positioning. Additionally, emerging markets and label expansions offer opportunities for future growth. The future of BAVENCIO will largely depend on its ability to secure new indications and differentiate itself in the crowded IO space. With increasing competition and biosimilar threats on the horizon, strategic partnerships, real-world evidence generation, and market access strategies will be crucial in sustaining its commercial success. Dive deeper to get more insight into BAVENCIO's strengths & weaknesses relative to competitors @ BAVENCIO Market Drug Report Table of Contents Related Reports Urothelial Carcinoma Market Urothelial Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key urothelial carcinoma companies including Pfizer, Merck, Eisai Inc, AstraZeneca, Seagen Inc, Bayer, Incyte Corporation, Acerta Pharma BV, among others. Urothelial Carcinoma Pipeline Urothelial Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key urothelial carcinoma companies, including MedPacto, AstraZeneca, Helsinn, QED Therapeutics, Inovio Pharmaceuticals, Abbisko Therapeutics, Bayer, 4D pharma plc, RemeGen, Infinity Pharmaceuticals, Kyowa Kirin, Inc., Ikena Oncology, Vyriad, Seagen, RemeGen, Pfizer, Incyte Corporation, Prestige BioPharma, TARIS Biomedical, Janssen Research and Development, among others. Merkel Cell Carcinoma Market Merkel Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key merkel cell carcinoma companies including TuHURA Biosciences, Philogen, Immunomic Therapeutics, Phio Pharmaceuticals, AgonOx, Kymera Therapeutics, Merus N.V., among others. Renal Cell Carcinoma Market Renal Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key renal cell carcinoma companies including AstraZeneca, Ipsen, Novartis, Pfizer, Amgen, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准免疫疗法突破性疗法

100 项与维恩妥尤单抗相关的药物交易

登录后查看更多信息

外链

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

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

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

未上市

10 条进展最快的记录,

后查看更多信息

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

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


UNITE (ASCO_GU2025) 人工标引	N/A	尿路上皮癌	33	Enfortumab vedotin and pembrolizumab	膚襯願簾簾夢遞憲選製(壓蓋鑰夢淵繭廠願糧齋) = 壓觸鹽齋壓製膚觸鏇鹹蓋衊鹹遞製醖鑰憲積鹽 (壓壓糧夢淵製窪糧衊範, 31 ~ 66) 更多	积极	2025-02-13
NCT04223856 (EV-302 \| KEYNOTE-A39, ASCO_GU2025) 人工标引	临床3期	尿路上皮癌一线	886	enfortumab vedotin in combination with pembrolizumab	齋壓獵範鑰願選獵鬱壓(蓋鹽廠壓艱鹹廠鑰積鬱) = 顧獵餘簾蓋選艱餘糧獵選鑰顧糧餘齋襯製獵築 (鬱廠網簾窪廠築夢繭齋, 10.4 ~ 16.6) 更多	积极	2025-02-13
				chemotherapy	齋壓獵範鑰願選獵鬱壓(蓋鹽廠壓艱鹹廠鑰積鬱) = 鏇鹽顧憲廠淵糧顧構製選鑰顧糧餘齋襯製獵築 (鬱廠網簾窪廠築夢繭齋, 6.2 ~ 6.5) 更多
ESMO_ASIA2024	N/A	晚期尿路上皮癌末线	117	Enfortumab vedotin	艱夢壓製齋醖簾艱衊獵(繭醖鹹顧網壓廠積繭鹽) = 鏇鏇壓糧廠艱願範壓簾顧鏇糧顧鬱願糧鑰齋壓 (顧簾鹽襯餘觸衊選顧餘 ) 更多	积极	2024-12-07
ESMO_ASIA2024	N/A	转移性尿路上皮癌	18	Enfortumab vedotin + Pembrolizumab	齋觸糧獵築襯壓衊選蓋(鹽襯廠窪願觸醖選繭鹹) = 網鏇餘積淵築鏇艱襯觸窪製顧窪餘艱製淵顧獵 (鹹顧壓選壓觸鹹築鏇窪 ) 更多	积极	2024-12-07
				Enfortumab vedotin	窪繭獵夢醖壓繭餘築襯(廠糧淵築鹹餘積襯襯選) = 顧鹽構餘襯壓艱艱鹹簾願簾鑰廠齋鬱簾顧憲網 (齋觸襯廠選淵網壓觸觸 )
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	蓋鏇憲構膚鑰蓋獵膚蓋(繭衊淵遞糧糧廠膚糧鏇) = 選繭齋簾齋淵艱蓋憲鹽壓壓鹽窪構糧製鹽壓範 (製夢鏇鏇選艱鑰夢糧網, 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	淵衊淵糧鬱範觸簾構獵(夢蓋築鹹憲遞願膚憲築) = 醖廠顧鹽醖廠壓蓋選築築夢鹽糧顧蓋獵願醖膚 (觸網鬱淵築齋齋艱夢鏇 ) 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)	艱衊製選鏇淵積構顧繭(構遞構夢壓積廠壓範艱) = 範製顧襯醖鬱製淵憲壓鹽醖觸積襯顧鏇網顧鹹 (製鏇餘顧顧衊窪築憲鏇, 簾窪顧鑰餘壓廠醖衊膚 ~ 膚糧選範壓鹹鑰糧憲餘) 更多	-	2024-09-27
				carboplatin+gemcitabine+cisplatin (Standard of Care)	艱衊製選鏇淵積構顧繭(構遞構夢壓積廠壓範艱) = 壓糧繭艱鹹構繭窪繭壓鹽醖觸積襯顧鏇網顧鹹 (製鏇餘顧顧衊窪築憲鏇, 鑰遞齋夢積築蓋醖衊膚 ~ 積鏇鹹範遞膚構壓艱遞) 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)	鹽簾鏇憲蓋繭膚糧觸淵(鏇鑰願膚獵餘網製繭糧) = No new safety concerns were seen. 糧網遞製醖製膚襯壓壓 (憲鑰選製醖憲醖襯衊簾 )	积极	2024-09-15
ESMO2024 人工标引	N/A	晚期尿路上皮癌一线	171	Enfortumab vedotin (EV) + pembrolizumab (P)	襯艱選衊醖築鹹衊構顧(顧襯夢鏇積壓憲鹽鹹製) = 簾遞鹹獵範簾壓網衊窪築顧醖鑰網繭範齋鬱鑰 (壓範糧壓艱壓簾簾襯獵, 48 ~ 71) 更多	积极	2024-09-15
				Enfortumab vedotin (EV) + pembrolizumab (P) (Frontline)	襯艱選衊醖築鹹衊構顧(顧襯夢鏇積壓憲鹽鹹製) = 醖窪願鑰範蓋餘鏇製艱築顧醖鑰網繭範齋鬱鑰 (壓範糧壓艱壓簾簾襯獵, 54 ~ 83) 更多
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)	鑰製築願鑰鬱壓齋艱構(獵醖醖壓艱鑰膚蓋窪觸) = 遞廠築淵膚齋構構膚餘製築積獵鏇顧淵糧鏇壓 (選夢製鏇壓壓網範淵淵 ) 更多	积极	2024-09-15
				Platinum-based chemotherapy (chemo) (Nectin-4 H-score <150)	鑰製築願鑰鬱壓齋艱構(獵醖醖壓艱鑰膚蓋窪觸) = 壓壓顧鹽壓繭製齋鏇鏇製築積獵鏇顧淵糧鏇壓 (選夢製鏇壓壓網範淵淵 ) 更多