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TOKYO, May 14, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a Supplemental New Drug Application (sNDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for PADCEVTM (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with Keytruda® (pembrolizumab), a PD-1 inhibitor, as neoadjuvant treatment (before surgery), and then continued after radical cystectomy (surgery) as adjuvant treatment (after surgery), for adults with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-containing chemotherapy.
The sNDA is based on results from the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15). In EV-304, neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab was compared with standard-of-care neoadjuvant gemcitabine and cisplatin chemotherapy in MIBC patients eligible for cisplatin-containing chemotherapy. In the Event-Free Survival (EFS) analysis, enfortumab vedotin plus pembrolizumab demonstrated a 47% reduction in the risk of tumor recurrence, progression, or death.1 In the Overall Survival (OS) analysis, enfortumab vedotin plus pembrolizumab demonstrated a 35% reduction in the risk of death.1 Results of EV-304 were presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU).
The safety profile of enfortumab vedotin plus pembrolizumab in EV-304 was consistent with prior experience, and no new safety signals were observed.1 The most common (≥30%) adverse events (AE’s) related to treatment with neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in the trial were pruritus (itching), alopecia, diarrhea, and anemia.1
Bladder cancer is the 9th most diagnosed cancer in Japan, with an estimated 25,900 people diagnosed with the disease in 2025.2,3 MIBC represents approximately 30% of bladder cancer cases, and despite curative-intent surgery, approximately half of MIBC patients experience recurrence.4,5
Astellas has already reflected the impact from this submission in its financial forecast of the current fiscal year ending March 31, 2027.
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.6 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).6
Enfortumab vedotin in combination with pembrolizumab or pembrolizumab and bera hyaluronidase alfa-pmph is approved as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy in the United States.
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 European Union, the combination is approved for the treatment of adult patients with la/mUC who are eligible for platinum-containing chemotherapy.
Enfortumab vedotin is also globally 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.
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 blinded independent central review (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.
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 muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. 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).
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.
Contacts for inquiries or additional information:
Astellas Pharma Inc.
Corporate Communications
+81-3-3244-3201
References
1. Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer who are eligible for cisplatin: randomized, open-label, phase 3 KEYNOTE-B15 study. Abstract #LBA630. 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) Congress.
2. Cancer Information Service, Cancer Statistics in Japan. Published 2025. Available at: hhttps://ganjoho.jp/reg_stat/statistics/stat/short_pred_en.html#:~:text=Table_title:%20Projected%20cancer%20incidence%20in%202025%20Table_content:,sexes:%20(Corpus%20uteri)%20%7C%20:%2019%2C100%20%7C. Last accessed: April 2026
3. World Bladder Cancer Patient Coalition. Japan. Available at: https://worldbladdercancer.org/countries/japan/#:~:text=Prevalence,Link%20to%20guide. Last accessed: April 2026
4. Bladder Cancer Awareness Network. What is Muscle Invasive Bladder Cancer? Available at: https://bcan.org/what-is-muscle-invasive-bladder-cancer/. Last Accessed: April 2026
5. Squires P, Cook EE, Song Y, Wang C, Zhang A, Seshasayee SM, Rogiers A, Li H, Mamtani R. Treatment Patterns, Disease Recurrence, and Overall Survival in Patients with Muscle-Invasive Bladder Cancer after Radical Cystectomy: A Population-Level Claims-Based Analysis. Clinical Genitourinary Cancer. 2025 Nov;102466. https://doi.org/10.1016/j.clgc.2025.102466.
6. 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.
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