Phase II Multi-Center Open-Label Trial of Enfortumab Vedotin Treatment for Patients With Aggressive Radioiodine Refractory Differentiated Thyroid Cancer, Aggressive Poorly Differentiated Thyroid Cancer, Anaplastic Thyroid Cancer, Medullary Thyroid Cancer and NUT Carcinoma

This trial tests how well giving enfortumab vedotin works for the treatment of differentiated thyroid cancer that does not respond to treatment with radioiodine (refractory), anaplastic thyroid cancer, medullary thyroid cancer or NUT carcinoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). 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 cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate.

开始日期2027-05-05

申办/合作机构

Northwestern University

[+1]

NCT07217496

/ Not yet recruiting临床1期

Open-Label, Single-Arm, Phase 1b Clinical Trial of NAI Plus Pembrolizumab With Short Course of Enfortumab Vedotin in Treatment-Naïve Participants With Metastatic Urothelial Carcinoma

This phase Ib trial will investigate the effect of N-803 in combination with pembrolizumab and enfortumab vedotin in treating participants with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).

开始日期2026-12-01

申办/合作机构

ImmunityBio, Inc.

NCT07643519

/ Not yet recruiting临床2期IIT

Neoadjuvant Enfortumab Vedotin Plus Pembrolizumab in Muscle-Invasive Bladder Cancer and Upper Tract Urothelial Carcinoma

Radical cystectomy remains the standard curative-intent treatment for most patients with muscle-invasive bladder cancer, but it is associated with significant morbidity and long-term quality-of-life implications. Trimodality therapy is an accepted standard-of-care alternative for carefully selected patients who wish to preserve their bladder; however, optimal patient selection remains challenging.
The combination of enfortumab vedotin plus pembrolizumab (EV-P) has demonstrated remarkable activity in urothelial carcinoma, including in the perioperative setting, with pathologic complete response rates of approximately 50-60%. These results generate the hypothesis that a subset of patients may achieve sufficiently deep responses to allow selective deferral of cystectomy. Cohort A of this trial prospectively evaluates the use of multimodal response assessment (pelvic MRI and TURBT, ctDNA) to guide individualized decisions regarding cystectomy versus bladder preservation.
Radical nephroureterectomy (RNU) remains the standard curative-intent treatment for high-risk upper tract urothelial carcinoma (UTUC), but recurrence rates after surgery alone are high. Neoadjuvant cisplatin-based chemotherapy improves pathologic outcomes and is supported by phase II data, but its delivery is constrained by baseline renal dysfunction and the further decline in glomerular filtration that follows RNU - historically, only about 20% of patients remain cisplatin-eligible postoperatively, which is the principal rationale for delivering platinum in the neoadjuvant rather than adjuvant setting. A large fraction of patients with UTUC are cisplatin-ineligible at baseline, and no level 1 evidence supports a specific neoadjuvant regimen in this population.
EV-P is not constrained by renal function and has produced unprecedented activity in urothelial carcinoma. In the EV-302 upper tract subgroup, EV-P achieved an objective response rate of 67.7% and a complete response rate of 28.6%, with survival benefit preserved relative to platinum-based chemotherapy. In the perioperative bladder cancer setting, EV-P has yielded pathologic complete response rates of approximately 50-60%. However, available data on EV-P in UTUC are restricted to the metastatic setting, and prospective evaluation in the neoadjuvant setting is lacking. Cohort B of this trial addresses this gap by prospectively evaluating neoadjuvant EV-P followed by RNU in patients with high-risk UTUC, with pathologic complete response as the primary endpoint.

开始日期2026-12-01

申办/合作机构

University of Florida

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

1,205

项与维恩妥尤单抗相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of perioperative pembrolizumab plus enfortumab vedotin for cisplatin-ineligible or cisplatin-declining patients with muscle-invasive bladder cancer in the United States

Article

作者: Young, Joshua ; Ramamurthy, Chethan ; Reeve, Kelly ; Tzontcheva, Anjela ; Bensimon, Arielle G. ; Squires, Patrick ; Li, Haojie ; Mossanen, Matthew ; Hill-McManus, Daniel ; Lai, Yizhen

AIMS:

In the KEYNOTE 905/EV 303 study, perioperative enfortumab vedotin plus pembrolizumab (EV+Pem) improved event-free survival (EFS), overall survival (OS), and pathological complete response in a predominantly cisplatin-ineligible muscle-invasive bladder cancer (MIBC) population, compared with surgery alone with or without adjuvant nivolumab, as indicated (surgery ± adjuvant nivolumab). This study assessed the cost-effectiveness of perioperative EV+Pem for cisplatin-ineligible or declining patients with MIBC from a US third-party payer perspective.

METHODS:

This cost-utility analysis used a state-transition Markov model with event-free (EF), progressed or recurrent disease (PRD), and death health states. The target population included cisplatin-ineligible or cisplatin-declining adults with MIBC. Transitions from EF were estimated using parametric multistate survival models based on trial data, with extrapolation beyond follow-up. Survival following PRD was modeled using a treatment-mix approach reflecting US clinical practice. Costs were derived from US sources, and utilities from KEYNOTE-905 EQ-5D-5L data. Scenario analyses explored alternative extrapolations and structural assumptions, and sensitivity analyses assessed parameter uncertainty.

RESULTS:

In the base case, EV+Pem increased life-years by 3.08 (7.70 vs 4.62) and quality-adjusted life-years (QALYs) by 2.56 (6.19 vs 3.62) versus surgery ± adjuvant nivolumab. EV+Pem was associated with higher initial treatment costs, increasing total costs by $133,661 ($546,831 vs $413,171), partially offset by lower costs of treatment for PRD ($34,636 vs $129,813), yielding an incremental cost-effectiveness ratio (ICER) of $52,117 per QALY gained. Across scenario analyses, ICERs ranged from $50,363 to $69,703 per QALY gained. Probabilistic sensitivity analysis showed that EV+Pem had a 99.1% probability of being cost-effective at a $100,000 per QALY threshold.

LIMITATIONS:

Results are subject to uncertainty in long-term survival extrapolation and evolving treatment patterns following PRD.

CONCLUSIONS:

EV+Pem is cost-effective versus surgery ± adjuvant nivolumab for cisplatin-ineligible or cisplatin-declining patients with MIBC from a US third-party payer perspective at a willingness-to-pay threshold of $100,000 per QALY.

2026-12-01·Clinical Genitourinary Cancer

Real-World Treatment Duration With First-line Enfortumab Vedotin Plus Pembrolizumab for Advanced Urothelial Cancer: A National Electronic Health Record Study

Article

作者: Seewald, Nicholas J ; Homet Moreno, Blanca ; Babcock, Aram ; Li, Haojie ; Ulloa-Pérez, Ernesto ; Mamtani, Ronac ; Ramamurthy, Chethan ; Mayer, Melanie

BACKGROUND:

Enfortumab vedotin plus pembrolizumab (EV+P) received accelerated approval (AA) from the US Food and Drug Administration in April 2023 for cisplatin-ineligible patients with advanced urothelial cancer (aUC), followed by full approval (FA) in December 2023 regardless of cisplatin eligibility. While clinical trial data demonstrate durable treatment exposure, real-world treatment patterns after approval in large, multi-institutional populations remain less well characterized. We evaluated real-world time on treatment (rwToT) with first-line EV+P in a large US oncology network.

METHODS:

We conducted a retrospective cohort study using deidentified patient-level electronic health record-derived data from the Flatiron Health database, representing approximately 280 US cancer clinics. Included were patients with aUC initiating EV+P between April 5, 2023 and January 30, 2025. Follow-up extended through April 30, 2025. We summarized characteristics of EV+P users using descriptive statistics and computed time on treatment using the Kaplan-Meier method. A prespecified subgroup analysis evaluated patients initiating therapy between AA and FA to approximate a primarily cisplatin-ineligible population with longer potential follow-up.

RESULTS:

Five hundred ten aUC patients initiated first-line EV+P after AA. Median age was 74 years and 75.7% were male. Approximately, 61.2% met real-world criteria for cisplatin ineligibility. At data cut-off, 60.4% (308/510) had discontinued EV+P, most commonly due to death (52.6%, 162/308), followed by initiation of second-line therapy (30.2%, 93/308), and treatment gap exceeding 60 days (17.2%, 53/308). Median rwToT was 7.5 months (IQR, 6.4-8.7). In the AA to FA subgroup, median rwToT was 7.1 months (IQR, 5.5-8.9). Among patients receiving subsequent therapy post EV+P, platinum-gemcitabine was the most common regimen (39.8%, 37/93).

CONCLUSIONS:

In this large US cohort of primarily cisplatin-ineligible patients, rwToT with first-line EV+P approximated that observed in clinical trials, though modestly shorter. These findings likely reflect the greater clinical frailty of patients treated in routine practice. Continued follow-up will be needed to evaluate long-term outcomes and treatment sequencing following EV+P adoption.

2026-12-01·CURRENT TREATMENT OPTIONS IN ONCOLOGY

Antibody-Drug Conjugates in the Treatment of Esophageal Cancer

Review

作者: Zhao, Qi ; Zhu, Wenjing ; Chen, Wei ; Xu, Jian ; Wu, Dapeng

OPINION STATEMENT:

Esophageal cancer remains one of the most lethal malignancies worldwide, with particularly poor outcomes following disease progression after first-line chemoimmunotherapy. Antibody-drug conjugates (ADCs) have emerged as a transformative therapeutic class that combines the targeting precision of monoclonal antibodies with potent cytotoxic payloads, enabling selective tumor cell killing while minimizing off-target toxicity. In the management of advanced esophageal cancer, I advocate for the integration of ADCs as a therapeutic option following progression on first-line chemoimmunotherapy. For patients with human epidermal growth factor receptor 2 (HER2)-positive gastroesophageal junction adenocarcinoma, trastuzumab deruxtecan is my preferred choice based on its superior overall survival benefit and robust bystander killing effect, which also confers activity in HER2-low tumors. For HER2-negative gastroesophageal adenocarcinoma, trophoblast cell-surface antigen 2 represents a promising target given its high prevalence of moderate to strong expression in nearly 80% of cases, and sacituzumab tirumotecan is currently under phase III investigation in this setting. In esophageal squamous cell carcinoma, I recommend biomarker-guided selection among ADCs targeting B7-H3, given its overexpression in over 90% of cases. For Nectin-4-expressing tumors, enfortumab vedotin may be considered as a later-line alternative despite modest activity. Notably, the bispecific ADC targeting both epidermal growth factor receptor and human epidermal growth factor receptor 3, BL-B01D1, has demonstrated compelling efficacy in immunotherapy-refractory esophageal squamous cell carcinoma, and I consider it a breakthrough option in this subtype. For claudin-18.2-positive gastroesophageal junction adenocarcinoma, several ADCs including CMG901, IBI343, and tecotabart vedotin represent promising later-line choices. I emphasize that patient selection should be guided by validated predictive biomarkers, and treatment decisions must account for distinctive toxicity profiles, particularly interstitial lung disease with trastuzumab deruxtecan. Finally, I strongly support advancing ADCs into earlier lines of therapy and perioperative settings through well-designed clinical trials to further improve long-term outcomes in this aggressive malignancy.

2,452

项与维恩妥尤单抗相关的新闻（医药）

2026-10-22

·Pharmaceutical Technology

MSD’s Keytruda and Padcev combination receives EC approval

The EC assessment was based on the Phase III KEYNOTE-B15 study, conducted alongside Astellas and Pfizer. Credit: PeopleImages / Shutterstock.com. The European Commission (EC) has approved Merck & Co’s (MSD) Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as perioperative treatment for resectable muscle-invasive bladder cancer (MIBC) in adults. The clearance permits the therapies to be administered before radical cystectomy as neoadjuvant therapy and continued following surgery as adjuvant treatment. Applicable to patients irrespective of cisplatin eligibility, the authorisation covers Iceland, Liechtenstein, Norway, and all 27 EU member states. The regulatory decision also encompasses Keytruda SC, marketed in the US as Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph). MSD research laboratories senior vice-president and oncology, global clinical development head Dr Marjorie Green said: “Building on the previous approval of Keytruda plus Padcev in the European Union less than six months ago, we’re pleased to bring this important treatment option to a broader patient population as the first PD-1 inhibitor plus antibody-drug conjugate regimen approved for people with muscle-invasive bladder cancer regardless of cisplatin eligibility. “This approval represents encouraging progress in bladder cancer care and underscores our commitment to addressing the needs of people who are living with this disease.” The decision follows a positive opinion granted last month by the European Medicines Agency’s Committee for Medicinal Products for Human Use. The assessment was based on the open-label, randomised Phase III KEYNOTE-B15 study, also designated EV-304, conducted alongside Astellas and Pfizer. In 808 patients, perioperative treatment lowered the risk of disease recurrence, progression, or death by 47% compared to neoadjuvant cisplatin and gemcitabine chemotherapy alongside surgical resection. MSD stated that local availability across Europe will depend on country-level reimbursement processes. The decision follows regulatory clearance from the US Food and Drug Administration in July 2026.

临床3期上市批准临床结果

2026-10-21

·安斯泰来中国

安斯泰来将在ESMO 2026展示推动难治性癌症患者诊疗与创新的最新数据

东京，2026年10月7日——安斯泰来制药集团（TSE：4503，总裁兼首席执行官：冈村直树，以下简称“安斯泰来”）今日宣布，将在2026年欧洲肿瘤内科学会（ESMO）大会上（10月23日至27日在西班牙马德里举行），公布其肿瘤产品组合的21篇摘要。相关报告覆盖前列腺癌、尿路上皮癌、胃癌/胃食管结合部（GEJ）癌、肺癌及胰腺癌，体现了安斯泰来致力于推动诊疗标准进步，并针对仍存在重大未满足医疗需求的癌症探索新的科学路径。安斯泰来执行副总裁、肿瘤研发负责人Moitreyee Chatterjee-Kishore博士、工商管理硕士 “诊疗标准的改变绝非偶然。此次在ESMO 2026公布的数据表明，对疾病生物学的深入理解和差异化治疗方式，正助力推动膀胱癌、胃癌和前列腺癌患者的诊疗进步，其中包括备思复（维恩妥尤单抗）联合帕博利珠单抗、威络益（佐妥昔单抗）以及安可坦（恩扎卢胺）等治疗方案。我们正在此基础上，针对仍存在未满足需求的癌症开发下一代治疗选择，并期待在本届大会上就相关工作开展深入交流。” 安斯泰来在ESMO 2026大会上的重点报告包括： • 维恩妥尤单抗联合帕博利珠单抗的报告展示了局部晚期或转移性尿路上皮癌迄今最长的随访数据，以及针对不同患者亚组和治疗策略的分析。其他报告包括正在进行中的探索肌层浸润性膀胱癌保膀胱治疗的研究。 • 佐妥昔单抗相关报告将探讨CLDN18.2评估、患者识别及真实世界应用，进一步丰富CLDN18.2指导胃及胃食管结合部癌治疗决策的支持证据。 • 研发管线的报告涵盖了安斯泰来多项在研项目，包括setidegrasib治疗KRAS G12D突变胰腺癌及非小细胞肺癌的III期研究、ASP5834治疗泛KRAS突变或扩增实体瘤的I期研究，以及ASP546C治疗CLDN18.2表达实体瘤的Ib/II期研究。这些研究项目体现了安斯泰来持续投入推动创新的治疗路径，以应对长期制约难治性癌症治疗进展的挑战。安斯泰来在ESMO 2026大会上的报告详情如下报告标题主要作者报告详情药品注册和药物警戒部 EV-103 DE/A队列及K队列最终分析：维恩妥尤单抗联合或不联合帕博利珠单抗一线治疗顺铂不耐受的局部晚期或转移性尿路上皮癌：EV-103 DE/A队列及K队列长期随访分析 J. P. Maroto Rey 类型 / 摘要编号 / 日期/时间：口头报告 | 4740RO | 10月24日（星期六）10:15-11:45 EV-302合并症分析（DCO3）：维恩妥尤单抗联合帕博利珠单抗治疗既往未经治疗的局部晚期或转移性尿路上皮癌：EV-302研究中老年患者及合并症患者的更新探索性分析 S. S. Sridhar 类型 / 摘要编号 / 日期/时间：壁报 | 4761P | 10月23日（星期五）15:15-16:00 EV-302临床亚组（DCO3）：维恩妥尤单抗联合帕博利珠单抗治疗既往未经治疗的局部晚期或转移性尿路上皮癌：基于EV-302研究疾病相关特征的探索性分析 J. Bedke 类型 / 摘要编号 / 日期/时间：壁报 | 4760P | 10月23日（星期五）15:15-16:00 EVOLVE 3：法国局部晚期及转移性尿路上皮癌患者的真实世界治疗模式 F. Joly 类型 / 摘要编号 / 日期/时间：电子壁报 EV-303/KN-905 ITT3：围手术期帕博利珠单抗或维恩妥尤单抗联合帕博利珠单抗治疗顺铂不耐受的肌层浸润性膀胱癌患者：KEYNOTE-905研究事后分析 A. Ullén 类型 / 摘要编号 / 日期/时间：优选论文专场 | 4733O | 10月23日（星期五）13:30-15:00 EV-304/KN-B15 ctDNA：III期KEYNOTE-B15研究的ctDNA分析：维恩妥尤单抗联合帕博利珠单抗新辅助及辅助治疗顺铂耐受的肌层浸润性膀胱癌患者 J. Chatzkel 类型 / 摘要编号 / 日期/时间：优选论文专场 | 4734O | 10月23日（星期五）13:30-15:00 EV-304/KN-B15 ePRO：III期KEYNOTE-B15研究中，维恩妥尤单抗联合帕博利珠单抗新辅助及辅助治疗顺铂耐受的肌层浸润性膀胱癌患者的健康相关生活质量 A. Gómez De Liaño 类型 / 摘要编号 / 日期/时间：口头报告 | 4738RO | 10月24日（星期六）10:15-11:45 EV-209 TiP：一项开放标签、单臂II期研究，评估维恩妥尤单抗联合帕博利珠单抗用于适合根治性膀胱切除术的肌层浸润性膀胱癌患者保膀胱治疗 Thomas Powles 类型 / 摘要编号 / 日期/时间：壁报 | 4769TiP | 10月23日（星期五）15:15-16:00 EV-309 TiP：一项开放标签、随机III期研究，评估维恩妥尤单抗联合帕博利珠单抗用于肌层浸润性膀胱癌患者保膀胱治疗 Matthew D. Galsky 类型 / 摘要编号 / 日期/时间：壁报 | 4770TiP | 10月23日（星期五）15:15-16:00 恩扎卢胺 Adelpi REALIZE：高危生化复发激素敏感性前列腺癌：关于风险分层、PSMA PET应用及医生诊疗实践的欧洲真实世界证据 A. Merseburger 类型 / 摘要编号 / 日期/时间：电子壁报 | 2063eP | 不适用 mHSPC中的AMNOG网状荟萃分析：基于德国AMNOG档案的转移性激素敏感性前列腺癌患者(mHSPC)使用雄激素受体通路抑制剂安全性的网状荟萃分析 C. Ohlmann 类型 / 摘要编号 / 日期/时间：壁报 | 2295P | 10月23日（星期五）15:15-16:00 CASPER：恩扎卢胺与阿帕他胺治疗转移性激素敏感性前列腺癌的结局：加拿大真实世界研究 B. Shayegan 类型 / 摘要编号 / 日期/时间：电子壁报 | 2329eP | 不适用 ARCHES/ARANOTE间接安全性比较：恩扎卢胺或达罗他胺联合雄激素剥夺治疗用于转移性激素敏感性前列腺癌的间接安全性比较 S. Shariat 类型 / 摘要编号 / 日期/时间：壁报 | 2294P | 10月23日（星期五）15:15-16:00 EMBARK深度PSA应答：不同既往根治性治疗的高危生化复发前列腺癌患者深度前列腺特异性抗原(PSA)应答：EMBARK事后分析 S. Freedland 类型 / 摘要编号 / 日期/时间：壁报 | 2293P | 10月23日（星期五）15:15-16:00 佐妥昔单抗 SPOTLIGHT ctDNA：SPOTLIGHT研究中CLDN18.2阳性、HER2阴性、局部晚期不可切除或转移性胃或胃食管结合部腺癌患者的ctDNA评估 K. Shitara 类型 / 摘要编号 / 日期/时间：电子壁报 | 2882eP | 不适用加拿大患者支持项目：加拿大患者支持项目中佐妥昔单抗联合化疗治疗CLDN18.2阳性、HER2阴性、局部晚期不可切除或转移性胃或胃食管结合部癌患者的真实世界应用 H. Karachiwala 类型 / 摘要编号 / 日期/时间：壁报 | 2941P | 10月25日（星期日）12:00-12:45 研发管线 III期PDAC TiP：setidegrasib联合mFOLFIRINOX或NALIRIFOX一线治疗携带KRAS G12D突变的转移性胰腺导管腺癌患者的III期、双盲、随机研究：进行中研究 T. Macarulla 类型 / 摘要编号 / 日期/时间：壁报 | 3190TiP | 10月25日（星期日）12:00-12:45 III期NSCLC TiP：setidegrasib对比多西他赛治疗含铂化疗及免疫检查点抑制剂治疗期间或之后进展的KRAS G12D突变局部晚期或转移性非小细胞肺癌患者的III期、随机、开放标签研究：进行中研究 F. Skoulidis 类型 / 摘要编号 / 日期/时间：电子壁报 | 2871eTiP | 不适用 Ib/II期TiP：ASP546C（一种携带拓扑异构酶1抑制剂载荷、靶向Claudin 18.2的抗体-药物偶联物）治疗Claudin 18.2表达、不可切除局部晚期或转移性实体瘤患者的Ib/II期研究 T. Macarulla 类型 / 摘要编号 / 日期/时间：电子壁报 | 1133eTiP | 不适用首次人体（FiH）TiP：ASP5834治疗携带Kirsten大鼠肉瘤病毒癌基因同源物（KRAS）突变或扩增的局部晚期或转移性实体瘤患者的I期研究 S. Sen 类型 / 摘要编号 / 日期/时间：电子壁报 | 1145eTiP | 不适用 MSS CRC联合治疗临床数据：ASP1570治疗局部晚期/转移性微卫星稳定型（MSS）结直肠癌的I/II期研究 V. Boni 类型 / 摘要编号 / 日期/时间：电子壁报 | 1090eP | 不适用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 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。这些陈述基于管理层结合当前可获得信息而形成的现有假设与信念，并涉及已知和未知的风险与不确定性。多种因素可能导致实际结果与前瞻性陈述中讨论的结果存在重大差异，包括但不限于：（i）与医药市场相关的一般经济状况及法律法规的变化；（ii）汇率波动；（iii）新产品上市延迟；（iv）安斯泰来无法有效推广现有及新产品；（v）安斯泰来无法继续在竞争激烈的市场中有效研发能够获得客户认可的产品；以及（vi）第三方侵犯安斯泰来知识产权。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.本文翻译自安斯泰来全球新闻稿，原文为： Astellas Highlights Data Advancing Cancer Care and Innovation for Patients with Hard-to-Treat Cancers at ESMO 2026 2.本文旨在传递医药前沿信息，不构成对任何药物或诊疗方案的推荐或推广。 3.如您想了解更多疾病知识或药品、诊疗相关信息，请咨询医疗卫生专业人士。 MAT-CN-MTA-2026-00009

临床3期

2026-10-21

·默沙东中国

默沙东将在2026 ESMO大会展示在研肿瘤管线III期关键研究首次结果及现有产品组合的持续创新潜力

默沙东将在2026 ESMO大会展示在研肿瘤管线III期关键研究首次结果及现有产品组合的持续创新潜力 INTerpath-001研究结果将于主席专题研讨会（Presidential Symposium）公布，首次发布在研个体化新抗原疗法intismeran autogene联合帕博利珠单抗的III期研究数据芦康沙妥珠单抗（sacituzumab tirumotecan，sac-TMT）TroFuse-005研究数据将于主席专题研讨会公布 KEYNOTE-C93研究数据将于主席专题研讨会公布，进一步探索帕博利珠单抗单药一线治疗在错配修复缺陷（dMMR）的晚期或复发性子宫内膜癌患者中的重要作用美国新泽西州罗威市，2026年10月13日——默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号）宣布公司三项关键性临床研究的首次结果将于2026年欧洲肿瘤内科学会（ESMO）大会期间的最新突破性研究主席专题研讨会（Late-Breaking Presidential Symposia）公布。大会将于10月23日至27日在西班牙马德里举行。此外，公司还将在本次大会期间发布来自20余种肿瘤类型、覆盖肿瘤产品组合及研发管线的90余项摘要研究成果。 Marjorie Green博士默沙东实验室高级副总裁肿瘤学全球临床开发负责人 “ 本届ESMO大会公布的新数据，包括来自三项关键性研究的主席专题研讨会报告，彰显了默沙东业界领先的肿瘤产品组合及研发管线的广度与深度。我们很高兴首次分享intismeran[1]和芦康沙妥珠单抗[2]的III期研究结果，并同步展示来自公司肿瘤产品组合的最新研究进展，这进一步体现了我们致力于推动多种癌症领域创新研究的坚定承诺。 ” 将在ESMO大会公布的默沙东产品组合及在研管线关键数据包括： III期INTerpath-001研究首次数据发布。该研究评估在研个体化新抗原疗法intismeran autogene（intismeran；V940/mRNA-4157）联合帕博利珠单抗用于完全切除后的IIB-IV期黑色素瘤患者辅助治疗。相关结果将入选ESMO主席专题研讨会（摘要编号#LBA1，主席专题研讨会I）[3]。 III期TroFuse-005研究首次数据发布。该研究评估在研TROP2靶向抗体偶联药物（ADC）芦康沙妥珠单抗（sacituzumab tirumotecan，sac-TMT）用于既往接受含铂化疗以及程序性死亡受体-1（PD-1）抑制剂或程序性死亡配体-1（PD-L1）抑制剂治疗后发生疾病进展的晚期或复发性子宫内膜癌患者。相关结果将入选ESMO主席专题研讨会（摘要编号#LBA11，主席专题研讨会III）[4],[5]。 III期KEYNOTE-C93研究首次数据发布。该研究评估帕博利珠单抗[6]单药一线治疗既往未接受过系统性化疗或在接受辅助治疗后出现疾病复发的错配修复缺陷（dMMR）晚期或复发性子宫内膜癌患者的疗效。相关结果将入选ESMO主席专题研讨会（摘要编号#LBA12，主席专题研讨会III）[5]。 III期OptiTROP系列研究数据发布，评估芦康沙妥珠单抗（sacituzumab tirumotecan，sac-TMT）在非小细胞肺癌（NSCLC）中的应用，包括OptiTROP-Lung06研究（摘要编号#LBA66）在一线PD-L1阴性晚期非鳞状NSCLC患者中的研究结果；以及OptiTROP-Lung04研究（摘要编号#LBA67）在EGFR酪氨酸激酶抑制剂（TKI）治疗进展后EGFR突变NSCLC患者中的最终总生存期（OS）结果（口头报告专场1：转移性NSCLC）[7]。 III期LITESPARK-011研究最终分析结果发布。该研究评估贝组替凡[8]，默沙东首创口服缺氧诱导因子-2α（HIF-2α）抑制剂，与仑伐替尼[9]联合用于接受PD-1抑制剂或PD-L1抑制剂治疗后、伴透明细胞成分的晚期肾细胞癌患者的疗效。仑伐替尼是卫材研发的一种口服多靶点TKI药物（摘要编号#3587O，口头报告专场2：泌尿系统肿瘤-肾癌及尿路上皮癌）[10]。默沙东投资者活动：默沙东将在ESMO大会期间，于10月26日晚上7:30（欧洲中部时间）举办肿瘤业务投资者活动，分享公司肿瘤战略及项目进展。活动将在西班牙马德里举行，并同步线上播出。投资者、分析师、媒体以及公众可点击文章下方“阅读原文”访问活动。上述摘要及默沙东其他重点摘要的详细信息：乳腺肿瘤 Final OS analysis of sacituzumab tirumotecan versus chemotherapy in previously treated locally recurrent or metastatic triple-negative breast cancer: Phase III OptiTROP-Breast01. M. Li.[7] Presentation #4639RO, Rapid oral session 2: Breast cancer, advanced stage Results from KEYNOTE-B49: A Phase 3, randomized, double-blind study of pembrolizumab (pembro) vs placebo (pbo) plus chemotherapy (CT) in participants (pts) with HR+/HER2− advanced breast cancer (ABC). H. S. Rugo. Presentation #LBA51, Proffered paper session 2: Breast cancer, early and advanced stage Association between disease control and patient-reported functioning and quality of life in the ASCENT-04/KEYNOTE-D19 study. K. Kalinsky.[11] Presentation #4659P, Poster session: Triple negative breast cancer 消化道肿瘤 Adjuvant intismeran autogene plus FOLFIRINOX in resectable pancreatic ductal adenocarcinoma: Results from a Phase I study. D. J. Pinato.[3] Presentation #3151P, Poster session: Pancreatic cancer 泌尿系统肿瘤 Final analysis of the Phase 3 LITESPARK-011 study: Belzutifan (bel) plus lenvatinib (len) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti-PD-(L)1 therapy. D. Y. Heng.[10] Presentation #3587O, Proffered paper session 2: Genitourinary tumours, renal and urothelial Final protocol-prespecified analysis of the Phase 3 KEYNOTE-564 trial of adjuvant pembrolizumab versus placebo in clear cell renal cell carcinoma (ccRCC). T. K. Choueiri. Presentation #3589RO, Rapid oral session 2: Genitourinary tumours, renal and urothelial Enfortumab vedotin (EV) with or without pembrolizumab (P) as first-line (1L) treatment for cisplatin (cis)-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC): Long-term follow-up analysis from EV-103 cohorts DE/A and K. J. P. Maroto Rey.[12] Presentation #4740RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial ctDNA analysis of the Phase 3 KEYNOTE-B15 trial: Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) + pembrolizumab (pembro) for participants (pts) with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin. J. A. Chatzkel.[12] Presentation #4734O, Proffered paper session 1: Genitourinary tumour, renal and urothelial Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) eligible for cisplatin in the Phase 3 KEYNOTE-B15 study. A. Gomez de Liano Lista.[12] Presentation #4738RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial Perioperative pembrolizumab (pembro) or enfortumab vedotin (EV) plus pembro in pts with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: Ad hoc analysis from KEYNOTE-905. A. Ullén.[12] Presentation #4733O, Proffered paper session 1: Genitourinary tumour, renal and urothelial Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) for locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a Phase 2 Study (2870-002/SKB264-II-06). X. Bian.[7] Presentation #4739RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial Updated results from the Phase 1b/2 KEYNOTE-365 cohort I: Pembrolizumab (pembro) + carboplatin and etoposide chemotherapy (chemo) or chemo alone for neuroendocrine prostate cancer (NEPC). G. von Amsberg. Presentation #2217RO, Rapid oral session: Genitourinary tumours, prostate, penile and testis 妇科肿瘤 Sacituzumab tirumotecan in previously treated advanced or recurrent endometrial cancer: Results from the Phase 3 TroFuse-005/ENGOT-en23/GOG-3095 study. D. Lorusso.[4],[5] Presentation #LBA11, Proffered paper session: Presidential Symposium III KEYNOTE-C93/GOG-3064/ENGOT-en15: Phase 3, randomized, open-label study of first-line (1L) pembrolizumab (pembro) vs carboplatin (C) + paclitaxel (P) in mismatch repair-deficient (dMMR) advanced or recurrent endometrial carcinoma (a/rEC). B. M. Slomovitz.[5] Presentation #LBA12, Proffered paper session: Presidential Symposium III Raludotatug deruxtecan (R-DXd) + bevacizumab (bev) in participants (pts) with platinum-resistant recurrent ovarian cancer (PROC): Results for cohort B-1 of the Phase 1b/2 REJOICE-Ovarian02 study. A. Oaknin.[13] Presentation #1247RO, Rapid oral session 2: Gynaecological cancers Raludotatug deruxtecan (R-DXd) in patients (pts) with platinum-resistant ovarian cancer (PROC): An updated analysis of efficacy and tolerability from the Ph 2 part of REJOICE-Ovarian01. K. Hasegawa.[13] Presentation #1331P, Poster session: Gynaecological cancers NRG-GY020: Phase III randomized trial of radiation +/- MK-3475 (pembrolizumab) for newly diagnosed early-stage high intermediate risk (HIR) mismatch repair deficient (dMMR) endometrioid endometrial cancer. F. Backes.[14] Presentation #1239O, Proffered paper session: Gynaecological cancers Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) in post-platinum advanced mismatch repair proficient (pMMR) endometrial cancer (EC): Results from a Phase 2 study (2870-002/SKB264-II-06). L. Chen.[7] Presentation #1259P, Poster session: Gynaecological cancers 头颈肿瘤 Practical considerations for adopting perioperative pembrolizumab in locally advanced head and neck squamous cell carcinoma (LA HNSCC) in Europe: Insights from KEYNOTE-689. M. Oliva. Presentation #1580P, Poster session: Head and neck cancer, excluding thyroid 肺癌 Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1 negative advanced non-squamous (nsq) NSCLC: Randomized Phase 3 OptiTROP-Lung06 study. C. Zhou.[7] Presentation #LBA66, Proffered paper session 1: NSCLC, metastatic Final OS analysis of sacituzumab tirumotecan (sac-TMT) versus platinum-based chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) after progression on EGFR-TKI: Phase III OptiTROP-Lung04 study. W.F. Fang. [7] Presentation #LBA67, Proffered paper session 1: NSCLC, metastatic Calderasib (MK-1084), alone or in combination, for KRAS G12C-mutant metastatic non-small cell lung cancer (mNSCLC). M. A. N. Sendur.[15] Presentation #2680RO, Rapid oral session 2: NSCLC, metastatic Final analysis of adjuvant pembrolizumab (pembro) in resected early-stage non–small-cell lung cancer (NSCLC): Phase 3 PEARLS/KEYNOTE-091 study. M. E. O’Brien. Presentation #2511O, Proffered paper session: Non-metastatic NSCLC and other thoracic malignancies Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer (ES-SCLC): IDeate-Lung01 updated results. M. Ahn.[13] Presentation #3842P, Poster session: SCLC 黑色素瘤 INTerpath-001: Phase 3 study of the mRNA-based individualized neoantigen therapy (INT) intismeran autogene (intismeran) plus pembrolizumab (pembro) vs pembro alone for adjuvant treatment of resected stage IIB-IV melanoma (MEL). G. V. Long.[3] Presentation #LBA1, Proffered paper session: Presidential Symposium I STARBOARD Phase 3: A randomized, double-blind study of first-line (1L) encorafenib (enco), binimetinib (bini) and pembrolizumab (pembro) vs placebo (pbo) and pembro for unresectable locally advanced or metastatic BRAF V600-mutant melanoma. D. Schadendorf.[12] Presentation #2071O, Proffered paper session: Melanoma and other skin tumours Physician perspectives on defining cure in early-stage melanoma. H. M. Shaw. Presentation #2173eP, ePoster session: Melanoma Patritumab deruxtecan (HER3-DXd) in melanoma after anti-PD-(L)1 therapy: Primary analysis from HERTHENA-PanTumor01. M. McKean.[13] Presentation #2073RO, Rapid oral session: Melanoma and other skin tumours 跨瘤种 Final results of the TUXEDO-3 Phase II trial of patritumab deruxtecan (HER3-DXd) in active brain metastases (BMs) and leptomeningeal disease (LMD). M. Preusser.[13] Presentation #690O, Proffered paper session: CNS tumours Calderasib monotherapy in various KRAS G12C-mutated advanced solid tumors: Results from the Phase 1 KANDLELIT-001 study. M Kwiatkowski.[15] Presentation #1039P, Poster session: Developmental therapeutics [1] 截至目前，intismeran autogene尚未获国家药品监督管理局（NMPA）批准 [2] 芦康沙妥珠单抗（sac-TMT）上市许可持有人为四川科伦博泰生物医药股份有限公司 [3] 与莫德纳合作 [4] 与科伦博泰合作 [5] 与欧洲妇科肿瘤试验网络（European Network for Gynaecological Oncology Trial, ENGOT）各研究组及GOG Foundation, Inc.（GOG）合作 [6] 截至目前，国家药品监督管理局（NMPA）批准帕博利珠单抗注射液下列适应症，除此以外其他适应症尚未获批： · 帕博利珠单抗适用于不可切除或转移性黑色素瘤的治疗。 · 帕博利珠单抗适用于由国家药品监督管理局批准的检测评估为PD-L1肿瘤比例分数（TPS）≥1%的表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性的局部晚期或转移性非小细胞肺癌一线单药治疗。 · 帕博利珠单抗联合培美曲塞和铂类化疗适用于表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性的转移性非鳞状非小细胞肺癌（NSCLC）的一线治疗。 · 帕博利珠单抗联合卡铂和紫杉醇适用于转移性鳞状非小细胞肺癌（NSCLC）患者的一线治疗。 · 帕博利珠单抗联合含铂化疗新辅助治疗并在手术后继续帕博利珠单抗单药辅助治疗，用于可手术切除的II、IIIA和IIIB期非小细胞肺癌患者。 · 帕博利珠单抗联合铂类和氟尿嘧啶类化疗药物用于局部晚期不可切除或转移性食管或胃食管结合部癌患者的一线治疗。 · 帕博利珠单抗单药用于由国家药品监督管理局批准的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥10）的、既往一线全身治疗失败的、局部晚期或转移性食管鳞状细胞癌（ESCC）患者的治疗。 · 帕博利珠单抗单药用于通过充分验证的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥1）的转移性或不可切除的复发性头颈部鳞状细胞癌（HNSCC）患者的一线治疗。 · 帕博利珠单抗用于通过充分验证的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥1）的可手术切除的局部晚期头颈部鳞状细胞癌成人患者，单药新辅助治疗，并在手术后联合放疗加或不加顺铂化疗进行辅助治疗，随后继续帕博利珠单抗单药治疗。 · 帕博利珠单抗单药用于KRAS、NRAS和BRAF基因均为野生型，不可切除或转移性微卫星高度不稳定型（MSI-H）或错配修复基因缺陷型（dMMR）结直肠癌（CRC）患者的一线治疗。 · 帕博利珠单抗和仑伐替尼联合经动脉化疗栓塞（TACE），用于治疗不可切除的非转移性肝细胞癌（HCC）患者。 · 帕博利珠单抗单药用于既往接受过索拉非尼或含奥沙利铂化疗的HCC患者的治疗。 · 帕博利珠单抗联合吉西他滨和顺铂用于局部晚期或转移性胆道癌（BTC）患者的一线治疗。 · 帕博利珠单抗联合化疗新辅助治疗并在手术后继续帕博利珠单抗单药辅助治疗，用于早期高危三阴性乳腺癌(TNBC)患者的治疗。 · 帕博利珠单抗单药用于不可切除或转移性微卫星高度不稳定型（MSI-H）或错配修复基因缺陷型（dMMR）成人晚期实体瘤患者 o既往接受过氟尿嘧啶类、奥沙利铂和伊立替康治疗后疾病进展的结直肠癌患者； o既往治疗后疾病进展且无满意替代治疗方案的其他实体瘤。 · 帕博利珠单抗联合含氟尿嘧啶类和铂类药物化疗用于局部晚期不可切除或转移性HER2阴性胃或胃食管结合部腺癌患者的一线治疗。 · 帕博利珠单抗联合曲妥珠单抗、含氟尿嘧啶类和铂类药物化疗，用于经充分验证的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥1）的局部晚期不可切除或转移性HER2阳性胃或胃食管结合部腺癌患者的一线治疗。 · 帕博利珠单抗联合放化疗（CRT）用于国际妇产科联盟（FIGO）2014 III-IVA期宫颈癌患者的治疗。 · 帕博利珠单抗联合注射用维恩妥尤单抗用于局部晚期或转移性尿路上皮癌成人患者。 · 帕博利珠单抗联合卡铂和紫杉醇用于错配修复缺陷（dMMR）的原发晚期或复发性子宫内膜癌成人患者的一线治疗，随后以帕博利珠单抗单药维持治疗。 ·帕博利珠单抗联合紫杉醇（联合或不联合贝伐珠单抗）用于经充分验证的检测评估肿瘤表达 PD-L1（综合阳性评分（CPS）≥1）的既往接受过一线或二线全身治疗的铂耐药上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者的治疗。 [7] 由科伦博泰主导，在中国开展 [8] 截至目前，国家药品监督管理局（NMPA）批准贝组替凡下列适应症，除此以外其他适应症尚未获批：适用于治疗不需要立即手术治疗的 von Hippel-Lindau（VHL）病相关肾细胞癌（RCC）、中枢神经系统（CNS）血管母细胞瘤或胰腺神经内分泌肿瘤（pNET）成人患者。 [9] 截至目前，国家药品监督管理局（NMPA）批准仑伐替尼下列适应症，除此以外其他适应症尚未获批： · 仑伐替尼和帕博利珠单抗联合经动脉化疗栓塞（TACE），用于治疗不可切除的非转移性肝细胞癌（HCC）患者。 · 仑伐替尼单药适用于既往未接受过全身系统治疗的不可切除的肝细胞癌患者。 · 仑伐替尼适用于进展性、局部晚期或转移性放射性碘难治性分化型甲状腺癌患者。 [10] 与卫材合作 [11] 与吉利德科学合作 [12] 与安斯泰来/辉瑞合作 [13] 与第一三共合作 [14] 由美国国家癌症研究所（NCI）资助 /由NRG Oncology牵头开展 [15] 与大鹏药品工业株式会社（Taiho Pharmaceutical Co., Ltd.）及Astex Pharmaceuticals（UK）（大塚制药株式会社全资子公司）合作开展若您想了解更多有关疾病知识的信息，请咨询医疗卫生专业人士 11-2026-CN-KEY-26079 关于默沙东在默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号），我们齐心协力追求共同的目标：我们发挥前沿科学的力量，在全球范围内拯救生命、改善生活。130多年来，我们通过研发重要药物和疫苗，为全人类带来希望。我们致力成为顶尖的研究密集型生物制药公司——当下，我们正处于研发前线，推出创新解决方案，以推进人类和动物疾病的预防和治疗。我们建立了一个多元、包容的全球员工体系，以负责的态度经营每一天，确保所有人、所有社区都能有一个安全、可持续和健康的未来。更多信息，请访问www.msd.com，并在X（前身为Twitter）、LinkedIn和Youtube平台关注我们。关于默沙东中国中国是默沙东全球增长战略中至关重要的一部分。默沙东中国总部设在上海，同时在北京设有研发中心、在杭州、宁波和天津分别设有工厂，实现了研发、制造和商业运营三擎合一。我们全心全意，向中国大众提供高质量的创新药物、疫苗和服务，造福中国社会。更多信息，敬请访问默沙东中国官网，或关注默沙东中国在微信上的官方社交媒体账号。默沙东前瞻性声明默沙东是美国新泽西州罗威市默克公司的公司商号（下称“公司”）。本新闻稿包含根据《1995 年美国私人证券诉讼改革法案》之安全条款而做出的“前瞻性声明”。本文内容基于公司管理层当前的看法和预期，并且受制于可能出现的重大风险和不确定因素。默沙东不保证在研产品能获得所需的监管部门批准或取得商业成功。如果相关假设与现实有所出入、出现风险，或发生不确定情况，实际结果可与前瞻性声明中的预期有实质上的差异。风险和不确定因素包括但不仅限于一般行业情况与竞争、一般经济因素（包括利率与汇率浮动）、美国及其他国家制药行业监管以及医疗政策的影响、全球范围内控制医疗成本的趋势、技术发展、竞争对手获得的新产品与专利、新产品开发固有的挑战（包括获得监管部门批准）、默沙东对未来市场形势做出准确预测的能力、生产上的困难或迟延、国际经济金融状况不稳定与主权风险、对默沙东专利和其它创新产品保护的有效性的依赖程度，以及公司面临专利诉讼和/或监管行动的风险。默沙东没有义务就新信息、未来事件或其它原因对任何前瞻性声明进行公开的更新。尚有其它因素可能导致实际结果与前瞻性声明存在实质性差异，请参见默沙东2025年年报10-K报表以及公司在美国证券交易所备案的其它文件（可在美国证券交易所网站www.sec.gov上查阅）。

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
D11525	维恩妥尤单抗	L04AG 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
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

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
非肌层浸润性膀胱肿瘤	申请上市	欧盟	Astellas Pharma Europe Ltd.	2026-05-21
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

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


ESMO2026	N/A	晚期尿路上皮癌	212	Enfortumab vedotin	憲網膚蓋繭網餘衊醖夢(範鹹遞鏇獵積繭觸鏇廠) = 選遞憲壓鹽衊顧糧淵襯窪獵醖獵壓獵壓醖蓋觸 (構糧淵遞觸壓鹹淵衊繭 ) 更多	积极	2026-10-23
				Enfortumab vedotin (Peripheral neuropathy)	積網壓鑰齋鹽觸獵憲鹽(蓋製範壓簾鑰憲淵齋壓) = 製廠繭廠觸築築觸鏇夢醖窪壓廠鹽齋糧夢蓋簾 (廠顧鹽築積膚獵壓製鹹 ) 更多
ESMO2026	N/A	转移性尿路上皮癌	216	Enfortumab Vedotin + Sacituzumab Govitecan	壓鹽襯蓋選鏇鏇遞窪餘(衊顧壓窪淵襯蓋鏇膚網) = 簾鑰壓餘獵膚範網簾壓選醖淵齋願淵構觸膚蓋 (餘膚選衊鬱簾夢構鑰鹹, 0.31 ~ 0.54) 更多	不佳	2026-10-23
ESMO2026	N/A	非肌层浸润性膀胱肿瘤新辅助	33	Enfortumab vedotin + immune-oncology agent	壓鬱壓顧衊鬱鹽觸廠壓(憲遞鏇製鑰構顧夢憲範) = 鏇鬱齋餘襯顧壓顧簾鑰蓋觸襯積蓋觸艱廠鏇襯 (齋範艱顧積範觸鏇鏇簾 ) 更多	不佳	2026-10-23
NCT06302569 (REPRINT - MeetURO 4/25, ESMO2026)	临床2期	肾髓样癌 \| 肾细胞癌	9	Enfortumab vedotin + pembrolizumab	醖醖鹹範範襯觸遞艱構(簾艱窪糧鏇蓋醖餘製醖) = 製壓築憲廠鹽憲築鏇製衊鏇鹽觸選蓋積夢觸觸 (壓鹹鑰夢膚製鹽壓鹽遞 ) 更多	积极	2026-10-23
ESMO2026	N/A	转移性尿路上皮癌	168	Enfortumab vedotin	築獵顧網構構鹹淵壓鑰(艱築獵網簾襯範廠衊繭) = 淵鬱餘築壓簾鹹壓構顧獵願鹽艱鹽齋製鹽遞鏇 (遞蓋衊鬱夢範蓋壓憲繭 ) 更多	积极	2026-10-23
				Enfortumab vedotin+pembrolizumab	築獵顧網構構鹹淵壓鑰(艱築獵網簾襯範廠衊繭) = 鹽顧衊壓顧鑰鹽築鹽鑰獵願鹽艱鹽齋製鹽遞鏇 (遞蓋衊鬱夢範蓋壓憲繭 ) 更多
ESMO2026	N/A	膀胱癌一线	80	Enfortumab Vedotin 1.25 mg/kg + Pembrolizumab	獵餘醖鏇範膚鏇遞網積(遞蓋觸製夢糧網蓋選繭) = 獵觸窪觸齋鏇鬱遞選夢觸顧壓簾鬱鑰餘鑰選鬱 (醖選構鹽製餘鑰鏇選構 ) 更多	积极	2026-10-23
				Enfortumab Vedotin 1.0 mg/kg + Pembrolizumab	獵餘醖鏇範膚鏇遞網積(遞蓋觸製夢糧網蓋選繭) = 製繭簾繭艱艱顧餘廠網觸顧壓簾鬱鑰餘鑰選鬱 (醖選構鹽製餘鑰鏇選構 ) 更多
ESMO2026	N/A	肌层浸润性膀胱癌新辅助	67	Chemotherapy (CT)	範積糧製窪餘製窪鏇窪(膚網遞糧鹽衊選壓鏇鑰) = 遞獵製願鬱廠獵糧網範窪鏇膚壓艱鬱繭網夢構 (鏇糧憲網壓鏇糧顧願顧 ) 更多	积极	2026-10-23
				Chemo-immunotherapy (CT-IO)	範積糧製窪餘製窪鏇窪(膚網遞糧鹽衊選壓鏇鑰) = 衊繭構製網夢糧願鏇壓窪鏇膚壓艱鬱繭網夢構 (鏇糧憲網壓鏇糧顧願顧 ) 更多
ESMO2026	N/A	晚期尿路上皮癌一线	643	Enfortumab vedotin plus pembrolizumab (EVP)	齋範膚醖獵構網鬱襯鏇(範餘淵選繭蓋願廠範憲) = 淵艱鏇簾淵淵艱顧餘顧膚衊鑰鏇鏇鏇鑰網齋齋 (鹽簾願鹹糧繭淵構繭觸 ) 更多	积极	2026-10-23
				conventional chemotherapy	齋範膚醖獵構網鬱襯鏇(範餘淵選繭蓋願廠範憲) = 廠獵築觸簾構憲製積衊膚衊鑰鏇鏇鏇鑰網齋齋 (鹽簾願鹹糧繭淵構繭觸 ) 更多
NCT06906822 (PLUG-IN GEM 2301, ESMO2026)	临床2期	难治性黑色素瘤	53	Enfortumab vedotin (EV) plus pembrolizumab (P)	廠網願築鹹鏇獵製憲鹹(淵鏇膚願鑰淵築蓋壓夢) = 齋膚憲獵獵網蓋鹽壓願鹽簾範糧餘獵鹽襯衊願 (範選製積繭夢構窪築鹽 ) 更多	积极	2026-10-23
				Enfortumab vedotin (EV) plus pembrolizumab (P) (BRAF-native)	廠網願築鹹鏇獵製憲鹹(淵鏇膚願鑰淵築蓋壓夢) = 積願觸窪蓋淵遞範衊憲鹽簾範糧餘獵鹽襯衊願 (範選製積繭夢構窪築鹽 )
ESMO2026	N/A	晚期尿路上皮癌一线	175	Enfortumab vedotin plus pembrolizumab (EV+P)	選獵繭範糧憲夢衊鏇醖(繭鏇襯艱蓋夢鑰觸鹹顧) = 鹹膚網齋鬱憲廠獵築淵夢願窪簾齋夢鏇獵選簾 (鹽製選獵糧淵鹽積蓋襯 ) 更多	积极	2026-10-23