Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Commission has granted Marketing Authorization for PADCEVTM (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.

安斯泰来制药公司（TSE：4503，总裁兼首席执行官：Naoki Okamura，“安斯泰来”）今天宣布，欧盟委员会已授予 PADCEV TM （enfortumab vedotin，一种抗体-药物偶联物 [ADC]）与 KEYTRUDA ® （pembrolizumab，一种 PD-1 抑制剂）联合用于一线治疗适合含铂化疗的不可切除或转移性尿路上皮癌成年患者。

The approval is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival (OS) and signficantly extended progression-free survival (PFS) compared to platinum-containing chemotherapy

此次批准基于 3 期 EV-302 临床试验（也称为 KEYNOTE-A39）的结果，该研究表明，与含铂化疗相比，enfortumab vedotin 与 pembrolizumab 联合使用几乎使中位总生存期 (OS) 增加了一倍，并且显著延长了无进展生存期 (PFS) 。

Dr. Thomas Powles, Barts Cancer Institute Biomedical Research Centre, UK

英国巴兹癌症研究所生物医学研究中心 Thomas Powles 博士

“Having an effective new first-line treatment for advanced urothelial cancer is opening a long-awaited new chapter in the management of this usually fatal disease. The impressive effects of the treatment combination were clearly seen during the Phase 3 clinical trial program, with enfortumab vedotin in combination with pembrolizumab significantly extending overall survival and progression-free survival compared to platinum-containing chemotherapy. I look forward to seeing the treatment combination implemented as a first-line regimen in the clinical setting.”

“晚期尿路上皮癌的有效新一线治疗方案的出现，为这种通常致命的疾病的治疗开启了期待已久的新篇章。在 3 期临床试验计划中，这种治疗组合的显著效果显而易见，与含铂化疗相比，enfortumab vedotin 与 pembrolizumab 联合使用可显著延长总生存期和无进展生存期。我期待看到这种治疗组合作为一线方案在临床环境中实施。”

Alex Filicevas, Executive Director, World Bladder Cancer Patient Coalition

世界膀胱癌患者联盟执行董事 Alex Filicevas

“Despite Europe having the highest reported rates of new bladder cancer cases in the world, awareness remains low, resulting in many patients only being correctly diagnosed at the stage of advanced disease. New treatment options are desperately needed to improve disease outcomes for these patients and provide hope for a better future for the whole bladder cancer patient community.”

“尽管欧洲是世界上膀胱癌新发病例报告率最高的地区，但人们对该病的认识仍然很低，导致许多患者在疾病晚期才得到正确诊断。迫切需要新的治疗方案来改善这些患者的疾病结果，并为整个膀胱癌患者群体带来更美好的未来。”

Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas

安斯泰来高级副总裁兼肿瘤学开发主管 Ahsan Arozullah 医学博士、公共卫生硕士

“In line with the recent updates to European clinical guidelines, we are delighted that the European Commission has approved enfortumab vedotin in combination with pembrolizumab as first-line treatment for patients with unresectable or metastatic urothelial cancer. This approval is testament to our ongoing partnership with clinical trial investigators, study participants and their families, and the broader bladder cancer community. We look forward to patients across the European Union gaining benefit from this combination early in their treatment journey.”

“根据欧洲临床指南的最新更新，我们很高兴欧盟委员会批准 enfortumab vedotin 与 pembrolizumab 联合用于治疗无法切除或转移性尿路上皮癌患者。这项批准证明了我们与临床试验研究人员、研究参与者及其家人以及更广泛的膀胱癌社区的持续合作。我们期待整个欧盟的患者在治疗早期从这种组合中受益。”

Bladder cancer is the fifth most commonly diagnosed cancer across the European region.2 Every year, more than 165,000 people are diagnosed with the disease and it claims the lives of over 50,000 people in the European Union (EU).3 Diagnosis often comes late, with many patients presenting with advanced or metastatic disease where survival outcomes are particularly poor.

膀胱癌是欧洲地区第五大常见癌症。2每年，欧盟有超过 165,000 人被诊断出患有膀胱癌，夺走了超过 50,000 人的生命。3 膀胱癌的诊断通常很晚，许多患者在确诊时已处于晚期或转移性病变，生存率极低。

The Phase 3 EV-302 clinical trial explored the efficacy and safety of enfortumab vedotin in combination with pembrolizumab in patients with previously untreated unresectable locally advanced or metastatic urothelial cancer (la/mUC). Results showed that the treatment combination resulted in a median OS of 31.5 months (95% CI: 25.4-NR) 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). The median PFS of 12.5 months (95% CI: 10.4-16.6) with the combination compared to 6.3 months (95% CI: 6.2-6.5) with chemotherapy represents a 55% reduction in the risk of cancer progression or death (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). During the EV-302 trial, approximately 30% of patients completed treatment with chemotherapy and then went on to receive maintenance therapy with avelumab, a PD-L1 inhibitor, which is reflective of current real world clinical practice.1 Results were presented at the 2023 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine

3 期 EV-302 临床试验探讨了 enfortumab vedotin 与派姆单抗联合治疗未经治疗的不可切除局部晚期或转移性尿路上皮癌 (la/mUC) 患者的疗效和安全性。结果显示，联合治疗的中位 OS 为 31.5 个月（95% CI：25.4-NR），而含铂化疗的中位 OS 为 16.1 个月（95% CI：13.9-18.3），死亡风险降低了 53%（风险比 [HR]=0.47；95% 置信区间 [CI]：0.38-0.58；P<0.00001）。联合治疗的中位 PFS 为 12.5 个月（95% CI：10.4-16.6），而化疗的中位 PFS 为 6.3 个月（95% CI：6.2-6.5），这意味着癌症进展或死亡风险降低了 55%（HR=0.45；95% CI：（0.38-0.54）；P<0.00001）。在 EV-302 试验期间，约 30% 的患者完成了化疗治疗，然后继续接受 PD-L1 抑制剂阿维单抗的维持治疗，这反映了当前现实世界的临床实践。1结果在2023 年欧洲肿瘤内科学会 (ESMO) 大会上公布，并发表在《新英格兰医学杂志》上

The European Marketing Authorization is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway, and is aligned to recently updated clinical guidelines from the European Society for Medical Oncology and European Association of Urology which recommend enfortumab vedotin in combination with pembrolizumab as first-line treatment for locally advanced or metastatic urothelial cancer.6,7 Astellas is working closely with local regulatory authorities and health technology assessment bodies across the EU to ensure that patients who may gain benefit are able to access the treatment combination as soon as possible.

欧洲营销授权在所有 27 个欧盟成员国以及冰岛、列支敦士登和挪威有效，并与欧洲肿瘤内科学会和欧洲泌尿外科协会最近更新的临床指南保持一致，该指南推荐将 enfortumab vedotin 与 pembrolizumab 联合作为局部晚期或转移性尿路上皮癌的一线治疗。6,7安斯泰来正与欧盟各地的当地监管机构和卫生技术评估机构密切合作，以确保可能受益的患者能够尽快获得这种治疗组合。

The approval follows the December 2023 approval of enfortumab vedotin in combination with pembrolizumab for the treatment of adult patients with la/mUC by the U.S. Food and Drug Administration (FDA), and the European Commission approval of enfortumab vedotin as a monotherapy for the treatment of adult patients with la/mUC who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in April 2022

此次批准是继 2023 年 12 月美国食品药品监督管理局 (FDA) 批准 enfortumab vedotin 与 pembrolizumab 联合用于治疗 la/mUC 成人患者，以及欧盟委员会于 2022 年 4 月批准 enfortumab vedotin 作为单一疗法用于治疗先前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) 抑制剂治疗的 la/mUC 成人患者之后的又一举措。

Astellas has already reflected the impact from this result in its financial forecast for the current fiscal year ending March 31, 2025.

安斯泰来已在截至 2025 年 3 月 31 日的本财年财务预测中反映了这一结果的影响。