安斯泰来 PADCEV 联合 Keytruda 获 CHMP 积极意见，用于可切除肌层浸润性膀胱癌围手术期治疗
PADCEV™ (enfortumab vedotin) in Combination with Keytruda® (pembrolizumab) Receives Positive CHMP Opinion for the Treatment of Adults with Resectable Muscle-Invasive Bladder Cancer
CHMP建议批准PADCEV联合Keytruda用于可切除MIBC成人围手术期治疗。III期EV-304显示，相比吉西他滨联合顺铂新辅助化疗，该方案将肿瘤复发、进展或死亡风险降低47%（HR 0.53），死亡风险降低35%（HR 0.65）。若获批，适应症将从顺铂不耐受扩展至无论顺铂是否适用人群。
可跟踪EC最终决定及适应症扩展后欧洲MIBC围手术期竞争格局变化。
PADCEV™ (enfortumab vedotin) in Combination with Keytruda® (pembrolizumab) Receives Positive CHMP Opinion for the Treatment of Adults with Resectable Muscle-Invasive Bladder Cancer
- Opinion based on data from pivotal Phase 3 EV-304 trial, which showed a 47% reduction in the risk of tumor recurrence, progression or death and a 35% reduction in the risk of death for the combination regimen compared to the current standard of care among MIBC patients who were cisplatin-eligible -
- If approved, the MIBC indication would extend from cisplatin-ineligible patients to cover adults in the EU with resectable MIBC regardless of cisplatin eligibility -
TOKYO, September 18, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of PADCEV™ (enfortumab vedotin), in combination with Keytruda® (pembrolizumab), as neoadjuvant treatment (before surgery) and then continued after radical cystectomy (surgery) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) in the European Union (EU).
The CHMP based its positive opinion on results from the Phase 3 EV-304 clinical trial (KEYNOTE-B15), in which perioperative (neoadjuvant and adjuvant) enfortumab vedotin plus pembrolizumab significantly improved Event-Free Survival (EFS) and Overall Survival (OS) compared to standard-of-care neoadjuvant gemcitabine and cisplatin chemotherapy in adults with MIBC who were cisplatin-eligible.
Moitreyee Chatterjee-Kishore, Ph.D., MBA, Executive Vice President and Head of Oncology Development, Astellas
“Nearly half of patients with MIBC see their cancer return within five years, even after receiving neoadjuvant gemcitabine and cisplatin chemotherapy. This positive CHMP opinion brings us closer to changing that for patients across Europe, based on the significant survival improvements seen with perioperative enfortumab vedotin plus pembrolizumab.”
In the trial, perioperative enfortumab vedotin plus pembrolizumab reduced the risk of tumor recurrence, progression, or death by 47% (Hazard Ratio (HR) 0.53; CI, 95%, 0.41–0.70; 1-sided p<0.0001) and reduced the risk of death by 35% (HR 0.65; 95% CI, 0.48-0.89; 1-sided p=0.0029).1
The safety profile was consistent with the known profiles of the individual medicines, and no new safety signals were observed.1 Grade ≥3 adverse events due to any cause occurred in 75.7% of patients treated with perioperative enfortumab vedotin plus pembrolizumab compared to 67.2% of patients treated with neoadjuvant chemotherapy.1
Results from the trial were recently published in The New England Journal of Medicine.1
Bladder cancer affects an estimated 200,000 people in Europe each year, with the region reporting the highest global incidence rates – particularly in Southern and Western Europe.2,3 MIBC accounts for approximately 30% of bladder cancer cases and is an advanced, aggressive form of the disease, in which cancer cells have entered the muscle wall of the bladder – increasing the risk that the disease will spread to other parts of the body if not treated effectively.4
Enfortumab vedotin plus pembrolizumab was approved by the European Commission (EC) in June 2026 as neoadjuvant and adjuvant treatment for cisplatin-ineligible adults with resectable MIBC. Approval in this setting would extend that indication to cisplatin-eligible patients, collectively covering adults with resectable MIBC regardless of cisplatin eligibility.
The EC is expected to issue a final decision on the application for enfortumab vedotin plus pembrolizumab within approximately two months. If approved, the EC's decision will apply to all 27 European Union member states, as well as Iceland, Liechtenstein and Norway.
Astellas has already reflected the impact of the CHMP’s opinion in its financial forecast for the current fiscal year ending March 31, 2027.
补充资料（7 节）药物、疾病与研究背景 · 公司与合作方信息 · 法律与声明 · 投资者与媒体联系 · 参考文献与尾注
药物、疾病与研究背景
About PADCEV (enfortumab vedotin)
PADCEV (enfortumab vedotin) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.5 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).5
Enfortumab vedotin in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is approved as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) regardless of eligibility for cisplatin-containing chemotherapy in the United States. In the European Union (EU), enfortumab vedotin in combination with pembrolizumab is approved as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adult patients with resectable MIBC who are ineligible for cisplatin-based chemotherapy.
Additionally, enfortumab vedotin plus pembrolizumab is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) regardless of cisplatin eligibility in the United States, Japan, and a number of other countries around the world. In the EU, the combination is approved for the treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.
About the EV-304/KEYNOTE-B15 Trial
The EV-304 trial is an ongoing, open-label, randomized, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab versus neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with MIBC who are eligible for cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant (before and after surgery) enfortumab vedotin in combination with pembrolizumab (arm A) or neoadjuvant chemotherapy (arm B). Curative-intent surgery (cystectomy) was performed in both arms. Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab, split before and after surgery.
The primary endpoint of this trial is EFS, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes RC or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on BICR or death due to any cause. Key secondary endpoints include OS and pCR rate. For more information on the global EV-304 trial, go to clinicaltrials.gov.
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
公司与合作方信息
About the Pfizer, Astellas and MSD Collaboration
Seagen and Astellas previously entered a clinical collaboration agreement with MSD to evaluate the combination of Seagen and Astellas’ PADCEV (enfortumab vedotin) and MSD’s KEYTRUDA (pembrolizumab) in patients with urothelial cancer. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of MSD, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada).
法律与声明
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
投资者与媒体联系
Contacts for inquiries or additional information
Astellas Pharma Inc.
Corporate Communications
+81-3-3244-3201
参考文献与尾注
References
1. Galsky MD, et al. Enfortumab Vedotin and Pembrolizumab in Cisplatin-Eligible Bladder Cancer. N Engl J Med. 2026;395:338-348.
2. European Association of Urology. Bladder Cancer: The Forgotten Cancer. Available at: https://uroweb.org/news/bladder-cancer-the-forgotten-cancer. Date Accessed: September 2026.
3. Zhang Y, et al. The global landscape of bladder cancer incidence and mortality in 2020 and projections to 2040. J Glob Health. 2023;13:04109.
4. Bladder Cancer Awareness Network. What is Muscle Invasive Bladder Cancer? Available at: https://bcan.org/what-is-muscle-invasive-bladder-cancer/. Date Accessed: September 2026.
5. Challita-Eid PM., et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res. 2016;76(10):3003-13.
来源：Astellas Pharma｜安斯泰来 · newsroom.astellas.com