新型联合疗法在顺铂不耐受膀胱癌中显示显著生存获益。顺铂不耐受肌层浸润性膀胱癌患者面临有限治疗选择和不良预后。三期临床试验EV-303测试PADCEV与KEYTRUDA在顺铂不耐受的MIBC中的效果-动脉网

New Combo Therapy Shows Major Survival Gains in Cisplatin-Ineligible Bladder Cancer Cisplatin-Ineligible Muscle-Invasive Bladder Cancer Patients Face Limited Treatment Options and Poor Prognosis Phase 3 EV-303 Tests PADCEV and KEYTRUDA in Cisplatin-Ineligi

GeneOnline 等信源发布 2025-08-13 11:24

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by Denisse Sandoval

由丹妮丝·桑多瓦尔

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fizer Inc. and Astellas Pharma Inc.

辉瑞公司和安斯泰来制药公司

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已报告

positive topline results from the Phase 3 EV-303 (KEYNOTE-905) clinical trial. The study evaluated PADCEV™ (enfortumab vedotin), a Nectin-4-directed antibody-drug conjugate, in combination with KEYTRUDA™ (pembrolizumab), a PD-1 inhibitor, as neoadjuvant and adjuvant treatment compared with surgery alone in patients with muscle-invasive bladder cancer (MIBC) who were ineligible for or declined cisplatin-based chemotherapy.

EV-303（KEYNOTE-905）III期临床试验取得了积极的初步结果。该研究评估了PADCEV™（enfortumab vedotin），一种针对Nectin-4的抗体药物偶联物，联合KEYTRUDA™（pembrolizumab），一种PD-1抑制剂，作为新辅助和辅助治疗，与单独手术相比，用于不符合顺铂化疗条件或拒绝接受顺铂化疗的肌层浸润性膀胱癌（MIBC）患者。

The first interim efficacy analysis showed that PADCEV plus KEYTRUDA achieved a clinically meaningful and statistically significant improvement in event-free survival (EFS), the trial’s primary endpoint, and overall survival (OS), a key secondary endpoint, compared with surgery alone. The combination also met the secondary endpoint of pathologic complete response (pCR) rate..

第一次中期疗效分析显示，与单独手术相比，PADCEV联合KEYTRUDA在无事件生存期（EFS，试验的主要终点）和总生存期（OS，一个关键的次要终点）方面实现了具有临床意义且统计学显著的改善。该组合还达到了病理完全缓解（pCR）率的次要终点。

Cisplatin-Ineligible Muscle-Invasive Bladder Cancer Patients Face Limited Treatment Options and Poor Prognosis

顺铂不耐受的肌层浸润性膀胱癌患者面临有限的治疗选择和不良预后

The trial is continuing to evaluate the secondary endpoints of EFS, OS, and pCR rate for neoadjuvant and adjuvant KEYTRUDA versus surgery alone as the data mature. The safety profiles of PADCEV plus KEYTRUDA and KEYTRUDA monotherapy remained consistent with the known profiles of each regimen.

试验继续评估无事件生存期（EFS）、总生存期（OS）和病理完全缓解（pCR）率等次要终点，比较新辅助和辅助治疗使用KEYTRUDA与单独手术的效果，随着数据的成熟。PADCEV联合KEYTRUDA以及KEYTRUDA单药治疗的安全性与其已知的治疗方案特征保持一致。

Christof Vulsteke, M.D., Ph.D., Head of the Integrated Cancer Center Ghent (IKG, Belgium) and Clinical Trial Unit Oncology Ghent, and principal investigator of EV-303, said patients with muscle-invasive bladder cancer who are ineligible for cisplatin have not had a significant treatment advance in decades, facing high recurrence rates and poor prognosis even after bladder removal.

克里斯托夫·沃尔斯特克医学博士、哲学博士，根特综合癌症中心（IKG，比利时）及根特肿瘤临床试验单位负责人，同时也是EV-303的主要研究者，他表示，那些不符合顺铂治疗条件的肌层浸润性膀胱癌患者数十年来未有显著的治疗进展，即使在膀胱切除后仍面临高复发率和不良预后。

He noted that EV-303 marks the first time a systemic treatment used before and after surgery has significantly extended survival over standard-of-care surgery in this population..

他指出，EV-303标志着在这一群体中，术前和术后使用的全身治疗首次显著延长了生存期，超越了标准护理手术。

Bladder cancer is the ninth most common cancer worldwide, with more than 614,000 new cases diagnosed annually. Muscle-invasive bladder cancer accounts for approximately 30% of all bladder cancer cases. Standard treatment involves neoadjuvant cisplatin-based chemotherapy followed by surgery, which prolongs survival.

膀胱癌是全球第九大常见癌症，每年诊断出的新病例超过614,000例。肌层浸润性膀胱癌约占所有膀胱癌病例的30%。标准治疗包括新辅助顺铂化疗后进行手术，这可以延长生存期。

However, up to half of patients with MIBC are ineligible for cisplatin and typically undergo surgery alone, leaving them with limited treatment options..

然而，高达一半的 MIBC 患者不符合使用顺铂的条件，通常仅接受手术治疗，这使得他们的治疗选择有限。

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development at Astellas, said the EV-303 results represent a breakthrough for cisplatin-ineligible patients with muscle-invasive bladder cancer,

安斯泰来肿瘤学开发负责人Moitreyee Chatterjee-Kishore博士、工商管理硕士表示，EV-303结果代表了不适合使用顺铂的肌层浸润性膀胱癌患者的突破。

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the potential of PADCEV in combination with KEYTRUDA when used before and after surgery as a new standard of care.

PADCEV与KEYTRUDA联合使用在手术前后作为新的治疗标准的潜力。

Phase 3 EV-303 Tests PADCEV and KEYTRUDA in Cisplatin-Ineligible MIBC

第三阶段EV-303试验：在顺铂不耐受的MIBC中测试PADCEV和KEYTRUDA

EV-303 is an ongoing, open-label, randomized, three-arm, controlled Phase 3 study evaluating neoadjuvant and adjuvant PADCEV in combination with KEYTRUDA, or neoadjuvant and adjuvant KEYTRUDA alone, versus surgery alone in patients with MIBC who are either ineligible for or declined cisplatin-based chemotherapy.

EV-303是一项正在进行的开放标签、随机、三臂对照的三期临床研究，评估新辅助和辅助PADCEV联合KEYTRUDA，或单独使用新辅助和辅助KEYTRUDA，与单独手术相比，用于无法接受或拒绝顺铂化疗的肌层浸润性膀胱癌（MIBC）患者。

Patients were randomized to receive neoadjuvant and adjuvant KEYTRUDA (arm A), surgery alone (arm B), or neoadjuvant and adjuvant PADCEV plus KEYTRUDA (arm C)..

患者被随机分配接受新辅助和辅助KEYTRUDA（A组）、单独手术（B组）或新辅助和辅助PADCEV加KEYTRUDA（C组）。

The trial’s primary endpoint is EFS between arm C and arm B, defined as the time from randomization to the first occurrence of disease progression that precludes radical cystectomy (RC), failure to undergo RC in patients with residual disease, gross residual disease left after surgery, local or distant recurrence confirmed by imaging or biopsy, or death from any cause.

试验的主要终点是EFS（无事件生存期），定义为从随机化到首次出现以下情况的时间：阻止根治性膀胱切除术（RC）的疾病进展、残留病灶患者未能接受RC、手术后留下明显残留病灶、经影像学或活检确认的局部或远处复发，或任何原因导致的死亡。

Key secondary endpoints include OS and pCR rate between arm C and arm B, as well as EFS, OS, and pCR rate between arm A and arm B..

关键的次要终点包括C组与B组之间的OS和pCR率，以及A组与B组之间的EFS、OS和pCR率。

Johanna Bendell, M.D., Oncology Chief Development Officer, Pfizer, stated, “These latest results underscore the practice-changing potential of this combination in earlier stages of bladder cancer, where it has the potential to improve outcomes for even more patients.”

辉瑞肿瘤学首席开发官约翰娜·本德尔博士表示：“这些最新结果突显了这种组合在膀胱癌早期阶段的变革性潜力，有望为更多患者改善治疗效果。”