Exploring the ESMO 2025 Presentations That May Shift GU Oncology

Ahead of the European Society for Medical Oncology Congress (ESMO) 2025, Oncology Decoded hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, convened to discuss the late-breaking abstracts and presentations in genitourinary cancer management they anticipated the most. Bupathi is executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers. Garmezy is associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers.

The hosts reviewed upcoming trial data that may shift therapeutic standards across bladder cancer, prostate cancer, kidney cancer, and other genitourinary malignancy populations. Presentations of interest included those on the following studies:

• Phase 3 PSMAddition trial (NCT04720157)¹
  • Investigators assessed whether the addition of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) to androgen deprivation (ADT) and androgen receptor pathway inhibitors (ARPIs) could improve radiographic progression-free survival (rPFS) vs standard of care alone in patients with metastatic hormone-sensitive prostate cancer.
  • Prior topline data showed a significant rPFS improvement in the lutetium Lu 177 arm.²
  • Findings may support moving radioligand therapy to an earlier prostate cancer treatment setting.
• Phase 3 KEYNOTE-905/EV-303 trial (NCT03924895)³
  • Patients with muscle-invasive bladder cancer who were ineligible for cisplatin were assigned to receive surgery plus perioperative pembrolizumab (Keytruda) and enfortumab vedotin-ejfv (Padcev) or surgery alone.
  • According to previous topline results, statistically significant and clinically meaningful rPFS and overall survival (OS) improvements occurred in the enfortumab vedotin plus pembrolizumab arm.⁴
  • Data may pose questions about the future role that chemotherapy may play in the perioperative space among patients with MIBC.
• Phase 3 RAMPART trial (NCT03288532)⁵
  • Investigators evaluated durvalumab (Imfinzi) with or without tremelimumab-actl (Imjudo) among patients with resected primary renal cell carcinoma.
  • If the data are positive, trials like RAMPART may clarify the role that immunotherapy can play in the perioperative treatment setting.

References

1. An international prospective open-label, randomized, phase III study comparing 177Lu-PSMA-617 in combination with SoC, versus SoC alone, in adult male patients with mHSPC (PSMAddition). ClinicalTrials.gov. Updated September 23, 2025. Accessed October 15, 2025. https://tinyurl.com/ycbktner
2. Novartis Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer. News release. Novartis. June 2, 2025. Accessed October 14, 2025. https://tinyurl.com/fedzdhfx
3. Perioperative pembrolizumab (MK-3475) plus cystectomy or perioperative pembrolizumab plus enfortumab vedotin plus cystectomy versus cystectomy alone in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MK-3475-905/​KEYNOTE-905/​EV-303). ClinicalTrials.gov. Updated August 28, 2025. Accessed October 15, 2025. https://tinyurl.com/5ddk6hrw
4. PADCEV plus KEYTRUDA significantly improves survival for certain patients with bladder cancer when given before and after surgery. News release. Pfizer and Astellas Pharma. August 12, 2025. Accessed October 15, 2025. https://tinyurl.com/mtnvfvv2
5. Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART). ClinicalTrials.gov. Updated September 7, 2020. Accessed October 15, 2025. https://tinyurl.com/26w8whuk