Core Insights - Astellas Pharma and Pfizer announced positive results from the Phase 3 EV-303 clinical trial for PADCEV in combination with KEYTRUDA, showing significant improvements in event-free survival (EFS) and overall survival (OS) for muscle-invasive bladder cancer (MIBC) patients who are ineligible for cisplatin-based chemotherapy [1][2][3] Group 1: Clinical Trial Results - The EV-303 trial demonstrated a 60% reduction in the risk of tumor recurrence, progression, or death for patients treated with PADCEV plus KEYTRUDA compared to surgery alone, with a Hazard Ratio (HR) of 0.40 [2] - The estimated median EFS has not yet been reached for the combination arm, while it was 15.7 months for the surgery alone arm [2] - An estimated 74.7% of patients treated with the combination were event-free at two years, compared to 39.4% for surgery only [2] - The OS results showed a 50% reduction in the risk of death for the combination treatment, with an HR of 0.50 [3] - The estimated median OS has not yet been reached for the combination arm, while it was 41.7 months for the surgery arm [3] - An estimated 79.7% of patients were alive at two years in the combination group, compared to 63.1% for surgery alone [3] Group 2: Safety and Efficacy - The safety profile of the combination treatment was consistent with previous reports, with common adverse events including pruritus, alopecia, diarrhea, fatigue, and anemia [5] - Grade 3 adverse events occurred in 71.3% of patients treated with the combination, compared to 45.9% for surgery alone [5] - The pathologic complete response (pCR) rate was 57.1% for the combination treatment versus 8.6% for surgery only, indicating a significant difference [6] Group 3: Implications for Treatment - The results from the EV-303 trial may redefine the standard of care for MIBC patients who are cisplatin-ineligible, offering a new systemic treatment approach that improves survival [7][8] - The trial's findings will be discussed with global health authorities for potential regulatory filings, indicating a pathway for future approval [10] - The combination of PADCEV and KEYTRUDA is currently not approved for neoadjuvant and adjuvant treatment in this patient population, but the results suggest a transformative potential [10][9]

Core Insights - Astellas Pharma is set to present significant clinical data at the ESMO congress, showcasing advancements in its oncology programs, particularly in muscle-invasive bladder cancer and hormone-sensitive prostate cancer [1][2][3] Astellas' Oncology Programs - The company will present ten abstracts, including new data for PADCEV (enfortumab vedotin) combined with pembrolizumab in muscle-invasive bladder cancer, which will be featured in an ESMO Presidential Symposium [1][2] - Final overall survival data for XTANDI (enzalutamide) in high-risk, biochemically recurrent non-metastatic hormone-sensitive prostate cancer will also be shared [1][2] Clinical Trials and Data - The EV-303 trial (KEYNOTE-905) will evaluate enfortumab vedotin plus pembrolizumab as neoadjuvant and adjuvant treatment in patients with muscle-invasive bladder cancer who are not eligible for cisplatin-based chemotherapy [3][4] - Long-term follow-up data from the EV-302 trial will explore the utility of enfortumab vedotin in patients with challenging baseline characteristics, including older patients and those with comorbidities [3][4] - The EMBARK trial will present final data assessing overall survival with enzalutamide in combination with leuprolide and as monotherapy in patients with non-metastatic hormone-sensitive prostate cancer [3][4] Innovative Treatments - Astellas is advancing its investigational bispecific T cell engager ASP2138, targeting CLDN18.2 in solid tumors, with initial clinical data being presented [2][3][5] - The company continues to explore treatment options for gastric and gastroesophageal junction cancers with new clinical data for ASP2138 [2][5]

Core Insights - Astellas Pharma will present 16 abstracts at the 2025 ASCO Annual Meeting, showcasing new clinical data from its oncology portfolio, emphasizing its commitment to improving cancer care and patient outcomes [1][3] Group 1: Clinical Data Highlights - The abstracts include long-term overall survival (OS) data for XTANDI (enzalutamide) and PADCEV (enfortumab vedotin), demonstrating their effectiveness in treating various forms of prostate and urothelial cancers [2][4] - Astellas will feature a five-year follow-up OS analysis of enzalutamide combined with androgen-deprivation therapy in metastatic hormone-sensitive prostate cancer patients [4][6] - The company is also supporting investigator-sponsored studies, including an eight-year data analysis comparing enzalutamide to non-steroidal anti-androgen in metastatic hormone-sensitive prostate cancer [4] Group 2: Focus on Overall Survival - Astellas emphasizes that long-term overall survival is a critical endpoint in cancer research, with new analyses from the ARCHES trial indicating a commitment to enhancing patient longevity and quality of life [6] - Presentations will include subgroup analyses and exploratory studies from the phase 3 EV-302 trial of enfortumab vedotin in combination with pembrolizumab for previously untreated locally advanced or metastatic urothelial carcinoma [7][10] Group 3: Company Commitment and Future Directions - Astellas is dedicated to transforming cancer care through innovative treatment approaches and a growing pipeline that incorporates novel modalities and precision medicine [3][6] - The company aims to maximize the impact of its therapies, continuing to pioneer oncology medicines that address high unmet medical needs [3][6]