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

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，中国国家药品监督管理局 (NMPA) 已批准 PADCEV TM（enfortumab vedotin）与 KEYTRUDA ®（pembrolizumab）联合用于治疗局部晚期或转移性尿路上皮癌（la/mUC）成人患者。该治疗组合将为中国 la/mUC 患者提供新的治疗选择，并为近 40 年来的标准治疗方案——含铂化疗提供替代方案。

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.

膀胱癌是中国发病率和死亡率较高的疾病。2022 年，有超过 92,000 人被诊断出患有膀胱癌，约有 41,000 人因该疾病死亡。2尿路上皮癌 占所有膀胱癌的 90%，是一种使人衰弱且往往具有侵袭性的癌症。3当 疾病在晚期被诊断出来时，存活率通常极低，因此迫切需要新的治疗策略来延长患者的生命。

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.”

EV-302 中国临床试验首席研究员、北京肿瘤医院泌尿肿瘤科及黑色素瘤/肉瘤科主任、中国临床肿瘤学会副主任委员兼秘书长郭俊教授表示： “NMPA 批准 enfortumab vedotin 与 pembrolizumab 联合治疗，这是中国首个可用于一线治疗晚期尿路上皮癌的非铂类治疗方案。EV-302 研究结果表明，与铂类化疗相比，该联合治疗使中位总生存期 (OS) 延长近一倍，并提高了中位无进展生存期 (PFS)、总有效率和完全有效率。这些结果在广泛的局部晚期或转移性尿路上皮癌患者中均有体现，无论患者的生物标志物状态、是否适合使用顺铂或有无肝转移。我相信这一新的治疗方案将改变中国尿路上皮癌的临床治疗格局，为更多中国晚期尿路上皮癌患者带来更长生存的希望。”

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.”

EV-302 中国临床研究首席研究员、中华​​医学会泌尿外科分会主任委员、广州中山大学孙逸仙纪念医院泌尿外科黄健教授表示： “目前，中国晚期尿路上皮癌的一线治疗策略是铂类化疗，临床可选方案非常有限。enfortumab vedotin 联合帕博利珠单抗的获批代表了过去 20-30 年来首个在全人群中显示出优于铂类化疗的治疗方案。我们希望这种组合能成为未来的标准治疗方案。”

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.”

安斯泰来高级副总裁、肿瘤学开发负责人 Ahsan Arozullah 医学博士、公共卫生硕士： “我们很高兴 NMPA 认可了 enfortumab vedotin 在中国于 2024 年 8 月获批后为之前接受过治疗的局部晚期或转移性尿路上皮癌患者带来的益处。此次与派姆单抗联合用药的最新获批标志着我们向为中国患者提供全新创新治疗策略的使命又迈进了一步。我们期待为患者的生活带来重大影响，帮助减缓疾病进展，为他们争取更多宝贵的时间。”

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.

NMPA 批准 enfortumab vedotin 与 pembrolizumab 联合治疗，是基于 3 期 EV-302 临床试验（又名 KEYNOTE-A39）的结果。试验表明，与含铂化疗相比，该治疗组合改善了未经治疗的 la/mUC 患者的中位总生存期 (OS) 和中位无进展生存期 (PFS)，具有统计学意义和临床意义。治疗组合的中位 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）。据报道，联合治疗的中位 PFS 为 12.5 个月（95% CI：10.4-16.6），而含铂化疗的中位 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）。安全性结果与之前报告的联合治疗结果一致，未发现新的安全性问题。

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.

安斯泰来已在其截至 2025 年 3 月 31 日的本财年财务预测中反映了中国国家药品监督管理局最新批准的影响。