Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of PADCEV ® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus KEYTRUDA® (pembrolizumab), a PD-1 inhibitor, in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The results showed a sustained overall survival (OS) and progression-free survival (PFS) benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up (median follow-up of 29.1 months).1,2 These data will be presented during a rapid oral session (Abstract 664) at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2025 in San Francisco, CA, on February 14 at 4:10pm PT.

辉瑞公司 (NYSE: PFE) 和安斯泰来制药公司 (TSE: 4503，总裁兼首席执行官：Naoki Okamura，“安斯泰来”) 今天公布了 3 期 EV-302 临床试验 (也称为 KEYNOTE-A39) 的更多后续结果，该试验评估了 Nectin-4 靶向抗体药物偶联物 PADCEV® ( enfortumab vedotin-ejfv) 加 PD-1 抑制剂 KEYTRUDA® ( pembrolizumab) 对未经治疗的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，在额外 12 个月的随访 (中位随访期为 29.1 个月) 后，持续的总生存期 (OS) 和无进展生存期 (PFS) 获益与主要分析的结果一致。1,2 这些数据将于 2 月 14 日太平洋时间下午 4:10 在加利福尼亚州旧金山举行的美国临床肿瘤学会泌尿生殖系统癌症研讨会（ASCO GU）2025 的快速口头会议（摘要 664）上公布。

Thomas Powles, M.R.C.P., M.D., Professor of Genitourinary Oncology at Queen Mary University of London; Director, Barts Cancer Center, London; EV-302 Primary Investigator

Thomas Powles，MRCP，医学博士，伦敦玛丽女王大学泌尿生殖肿瘤学教授；伦敦巴兹癌症中心主任；EV-302 首席研究员

“These latest findings from the EV-302 trial reaffirm the primary results, which demonstrated survival improvements for patients treated with enfortumab vedotin and pembrolizumab that were previously unprecedented in locally advanced or metastatic urothelial cancer. These data show that the potential survival benefit has become even more robust with extended follow up and further solidify the combination as standard of care.”

“EV-302 试验的最新结果再次证实了主要结果，即使用 enfortumab vedotin 和 pembrolizumab 治疗的患者的生存率有所提高，这在局部晚期或转移性尿路上皮癌中是前所未有的。这些数据表明，随着随访时间的延长，潜在的生存益处变得更加显著，并进一步巩固了该组合作为标准治疗的地位。”

Results showed enfortumab vedotin plus pembrolizumab reduced the risk of death by 49% versus chemotherapy (hazard ratio [HR] = 0.51, 95% confidence interval [CI], 0.43-0.61). The median OS was 33.8 months for the combination versus 15.9 months for chemotherapy. The OS benefit was observed in all prespecified subgroups, including cisplatin eligible and ineligible subgroups. Enfortumab vedotin plus pembrolizumab also reduced the risk of disease progression or death by 52% versus chemotherapy (HR = 0.48, 95% CI, 0.41-0.57). The median PFS was 12.5 months for the combination versus 6.3 months for chemotherapy. The safety profile was consistent with previous findings and no new safety concerns were identified.

结果显示，与化疗相比，enfortumab vedotin 加 pembrolizumab 可将死亡风险降低 49%（风险比 [HR] = 0.51，95% 置信区间 [CI]，0.43-0.61）。联合治疗的中位 OS 为 33.8 个月，而化疗为 15.9 个月。在所有预先指定的亚组中均观察到 OS 获益，包括顺铂合格和不合格亚组。与化疗相比，enfortumab vedotin 加 pembrolizumab 还可将疾病进展或死亡风险降低 52%（HR = 0.48，95% CI，0.41-0.57）。联合治疗的中位 PFS 为 12.5 个月，而化疗为 6.3 个月。安全性与先前的研究结果一致，未发现新的安全问题。

In addition to longer follow-up data, an exploratory analysis evaluating treatment outcomes and safety profile in patients with confirmed complete response (cCR) will also be presented. Among patients evaluable for response, confirmed objective response rate (cORR) was 67.5% for enfortumab vedotin plus pembrolizumab compared to 44.2% for chemotherapy. Median duration of response (DOR) was 23.3 months (95% CI, 17.8-not estimable [NE]) for the combination and 7.0 months (95% CI, 6.2-9.0) for chemotherapy. A cCR was achieved in 30.4% of patients treated with enfortumab vedotin plus pembrolizumab and 14.5% of patients treated with chemotherapy. Median duration of cCR was not reached for the combination and 15.2 months (95% CI, 10.3-NE) for chemotherapy. In patients with cCR, grade ≥3 treatment-related adverse events occurred in 61.7% of patients in the enfortumab vedotin plus pembrolizumab arm compared to 71.9% in the chemotherapy arm. There were no treatment-related deaths in the cCR subgroup.

除了长期随访数据外，还将介绍一项探索性分析，该分析评估了已确认完全缓解 (cCR) 患者的治疗结果和安全性。在可评估缓解的患者中，enfortumab vedotin 加 pembrolizumab 的确认客观缓解率 (cORR) 为 67.5%，而化疗为 44.2%。联合治疗的中位缓解持续时间 (DOR) 为 23.3 个月 (95% CI, 17.8-不可估计 [NE])，化疗为 7.0 个月 (95% CI, 6.2-9.0)。接受 enfortumab vedotin 加 pembrolizumab 治疗的患者中有 30.4% 达到了 cCR，接受化疗的患者中有 14.5% 达到了 cCR。联合治疗的中位 cCR 持续时间未达到，化疗的中位 cCR 持续时间为 15.2 个月 (95% CI, 10.3-NE)。在 cCR 患者中，enfortumab vedotin 加 pembrolizumab 组 61.7% 的患者发生了 ≥3 级治疗相关不良事件，而化疗组为 71.9%。cCR 亚组中没有治疗相关死亡病例。

Roger Dansey, M.D.​, Chief Oncology Officer, Pfizer “Patients with bladder cancer can face a poor prognosis, particularly in the advanced stages, and until recently had few available treatment options. The updated EV-302 results show sustained long-term efficacy in a broad population that includes both cisplatin eligible and ineligible patients and reinforce this combination’s ability to reshape the urothelial cancer treatment landscape.”

辉瑞公司首席肿瘤学官 Roger Dansey 医学博士 “膀胱癌患者的预后可能很差，尤其是晚期患者，而且直到最近，可用的治疗方案很少。最新的 EV-302 结果显示，在包括顺铂适用和不适用患者在内的广泛人群中，该药物具有持续的长期疗效，并增强了这种组合重塑尿路上皮癌治疗格局的能力。”

Ahsan Arozullah, M.D., M.P.H., Senior Vice President, Head of Oncology Development, Astellas “The combination of enfortumab vedotin and pembrolizumab was the first approval to offer an alternative to platinum-containing chemotherapy, which had been the standard of care for first-line locally advanced or metastatic urothelial cancer for decades. We are delighted that the additional follow-up results of the EV-302 trial show a durable benefit. These data represent yet another milestone in our long-standing commitment to helping patients around the world live longer and healthier lives.”

Ahsan Arozullah 医学博士、公共卫生硕士，安斯泰来高级副总裁、肿瘤学开发主管 “Enfortumab Vedotin 和派姆单抗的组合是首个获批的替代含铂化疗的药物，数十年来，含铂化疗一直是局部晚期或转移性尿路上皮癌的一线治疗标准。我们很高兴 EV-302 试验的额外后续结果显示出持久的益处。这些数据代表了我们长期致力于帮助世界各地的患者活得更长寿、更健康的另一个里程碑。”

Enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with la/mUC in the United States, the European Union, Japan and a number of other countries around the world. Enfortumab vedotin is also approved as a single agent for the treatment of adult patients with la/mUC who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy

Enfortumab vedotin 联合 pembrolizumab 已获准在美国、欧盟、日本和全球其他多个国家用于治疗 la/mUC 成人患者。Enfortumab vedotin 还被批准作为单一药物用于治疗既往接受过 PD-1/PD-L1 抑制剂和含铂化疗或不适合接受含顺铂化疗且既往接受过一线或多线治疗的 la/mUC 成人患者。