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Astellas to Unveil Significant Clinical Advances at ESMO 2025

Astellas Pharma Inc. is set to showcase groundbreaking advancements in its oncology portfolio at the upcoming European Society for Medical Oncology (ESMO) Congress, scheduled for October 17-21, 2025. The company will present a total of ten abstracts, featuring innovative research aimed at improving patient outcomes across various challenging cancer types.

One of the highlights will be the presentation of new clinical data regarding PADCEV™ (enfortumab vedotin) in combination with pembrolizumab for patients with muscle-invasive bladder cancer (MIBC). This study will be featured in an ESMO Presidential Symposium on October 18, underscoring Astellas' commitment to tackling complex cancers that significantly impact patients' lives.

Astellas' President and CEO, Naoki Okamura, expressed the company's dedication to advancing treatment options, noting, "These ESMO data demonstrate our 'bench to bedside' approach in action – from deep disease biology to measurable improvements in patient outcomes. We're proud to share breakthrough new survival data in muscle-invasive bladder cancer and hormone-sensitive prostate cancer."

Key Presentations Expected at ESMO 2025

Astellas aims to present pivotal findings from several major clinical trials:

• - EV-303 Trial (KEYNOTE-905): This Phase 3 trial evaluates the effectiveness of enfortumab vedotin combined with pembrolizumab as both neoadjuvant and adjuvant treatment for MIBC patients who are either ineligible or have declined cisplatin-based chemotherapy. This presentation is crucial as it contrasts the combination therapy against current standard treatments, emphasizing the potential for significant improvements.

• - Long-term Data from EV-302: Offering insights into the utility of enfortumab vedotin in combination with pembrolizumab, this study includes older patients with advanced or metastatic urothelial cancer, accounting for those with underlying health conditions such as diabetes and chronic kidney disease.

• - Final EMBARK Trial Outcomes: Astellas will disclose final survival data from the Phase 3 EMBARK trial that investigates enzalutamide, a key drug used for high-risk, non-metastatic prostate cancer. Providing clarity on treatment efficacy can greatly influence management strategies for these patients.

• - Introducing ASP2138: Early data for Astellas' next-generation bispecific CD3 T cell engager targeting CLDN18.2 will be shared, showcasing the potential for this innovative investigational drug in treating solid tumors. This indicates Astellas' pursuit of pioneering therapies in oncology.

Significance of ESMO 2025 Presentations

The presentations from Astellas at ESMO 2025 are expected to draw considerable attention from the global oncology community, emphasizing the importance of new therapeutic directions and clinical partnerships. As part of its ongoing commitment to R&D, Astellas remains dedicated to addressing high unmet medical needs in cancer treatment. The combination of data-driven insights and clinical innovation reflects a significant step towards transforming oncology practices, offering hope for improved survival rates and quality of life for patients.

These advancements underscore Astellas' proactive stance in the fight against cancer, aligning its strategic goals with emerging scientific discoveries that could lead to more effective treatment protocols.

For continued updates and insights into Astellas' initiatives and data presentations, interested parties can follow the ESMO Congress closely and access the company's resources and publications online.