Petros Grivas, MD, recaps key bladder cancer data from ESMO 2025

In a recent interview with Urology Times®, Petros Grivas, MD, PhD, highlighted several notable data readouts in the bladder cancer space from the 2025 European Society for Medical Oncology Congress, held in in Berlin, Germany. Grivas is a professor at the University of Washington and a genitourinary oncologist at the Fred Hutchinson Cancer Center in Seattle, Washington.

In non–muscle-invasive bladder cancer (NMIBC), the phase 3 POTOMAC study (NCT03528694) in BCG-naïve NMIBC demonstrated benefits from adding the immune checkpoint inhibitor durvalumab to intravesical BCG, adding on to the previous positive results from the phase 3 CREST trial (NCT04165317) with sasanlimab plus BCG.¹ However, the phase 3 ALBAN trial (NCT03799835) did not show improvement with atezolizumab when added to BCG. Grivas also highlighted the INTerpath-011 trial (NCT06833073), which is evaluating intismeran autogene (V940/mRNA-4157), a personalized antigen-based vaccine, alone or in combination with intravesical BCG for patients with high-risk NMIBC.

For muscle-invasive bladder cancer (MIBC), Grivas discussed the evolution of perioperative therapy. The NIAGARA trial (NCT03732677) previously established perioperative durvalumab plus cisplatin-based chemotherapy as a new standard in cisplatin-eligible patients, showing significant gains in event-free survival (EFS) and overall survival (OS) vs chemotherapy alone.² At ESMO 2025, the EV-303/KEYNOTE-905 trial provided practice-changing data for cisplatin-ineligible patients. Results showed that perioperative enfortumab vedotin plus pembrolizumab achieved a 57% pathologic complete response rate (vs 9% with surgery alone) and improved both EFS (HR, 0.40) and OS (HR, 0.50).³

Additional updates included results from IMvigor011 (NCT04660344) (adjuvant atezolizumab in ctDNA-positive patients), ctDNA analyses from CheckMate 274 (NCT02632409), and promising early-phase data in metastatic urothelial carcinoma from the DISCUS (NCT06892860) and disitamab vedotin + toripalimab (NCT05302284) studies.

Overall, Grivas emphasized that the expanding role of immunotherapy, antibody–drug conjugates, and personalized vaccines is transforming the management of bladder cancer across disease stages.

REFERENCES

1. Shore ND, Powles T, Bedke J, et al. Sasanlimab in combination with Bacillus Calmette-Guérin improves event-free survival versus Bacillus Calmette Guérin as standard of care in high-risk non-muscle invasive bladder cancer: Phase 3 CREST study results. J Urol. 2025;213(5S)

2. Powles T, Catto JWF, Galsky MD. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med. 2024;391:1773-1786. doi:10.1056/NEJMoa2408154

3. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. Abstract LBA2. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/LBA2.html.pdf