ESMO 2025 preview: Key late-breaking abstracts in genitourinary oncology

As the final quarter of 2025 comes into view, the calendar is filling with important scientific gatherings that will shape the next wave of urology practice and research. Among these, the European Society for Medical Oncology (ESMO) Congress has become one of the most anticipated fall meetings, particularly for clinicians and researchers focused on cancer care.

Scheduled for October 17–21 in Berlin, Germany, ESMO 2025 promises a robust program that spans the full spectrum of genitourinary malignancies. A major draw this year is the release of more than 20 late-breaking abstracts (LBAs). With topics expected to range from novel systemic therapies to advances in precision medicine and real-world outcomes, the meeting will provide attendees with both breadth and depth in emerging oncology research.

In the following preview, we take a closer look at what urologists can expect from the LBAs that will headline ESMO 2025.

Research to Watch for at ESMO 2025

1. LBA91 - Patient (pt) reported outcomes (PROs) from AMPLITUDE, a randomized placebo-controlled phase 3 trial of niraparib (NIRA) and abiraterone acetate (AA) plus prednisone (P) in metastatic hormone-sensitive prostate cancer (mHSPC) with homologous recombination repair mutations (HRRm)

Presentation Time: Friday, October 17, 14:00-14:05 CEST

Presenter: Dana E. Rathkopf, MD

Background Info: Earlier this year, investigators from the AMPLITUDE trial (NCT04497844) presenting at the American Society of Clinical Oncology Annual Meeting in Chicago, Illinois reported that adding niraparib (Zejula) to abiraterone acetate (Zytiga) plus prednisone (AAP) led to a statistically significant improvement in radiographic progression-free survival (rPFS) vs placebo plus AAP in patients with metastatic castration sensitive prostate cancer and homologous recombinant repair (HRR) gene mutations.¹ At ESMO, look for patient-reported outcomes data from AMPLITUDE.

2. LBA92 - 3-Weekly Docetaxel 75 mg/m² vs 2-Weekly Docetaxel 50 mg/m² in Combination with Darolutamide + ADT in Patients with mHSPC – Results from the Randomised Phase 3 ARASAFE Trial

Presentation Time: Friday, October 17, 14:10-14:15 CEST

Presenter: Marc-Oliver Grimm, MD

Background Info: Darolutamide (Nubeqa) achieved another milestone in June with the FDA’s approval of the drug for the treatment of adult patients with metastatic castration-sensitive prostate cancer.²

3. LBA37 - A phase 2 study of Avelumab in Locally Advanced or Metastatic Penile Cancer Patients Unfit for Platinum-based chemotherapy or Progressed On or After Platinum-based Chemotherapy (ALPACA)

Presentation Time: Friday, October 17, 15:08-15:13 CEST

Presenter: Srikala Sridhar, MD, MSc, FRCPC

Background Info: The PD-L1 inhibitor avelumab (Bavencio), which is already approved in the advanced renal cell carcinoma (in combination with axitinib [Inlyta]) and urothelial carcinoma spaces, is being investigated for the treatment of penile cancer.

4. LBA107 - ALBAN: A phase 3, randomized, open-label, international study of intravenous (iv) atezolizumab and intravesical Bacillus Calmette-Guérin (BCG) vs BCG alone in BCG-naïve high-risk, non-muscle-invasive bladder cancer (NMIBC)

Presentation Time: Friday, October 17, 14:00-14:10 CEST

Presenter: Morgan Rouprêt, MD, PhD

Background Info: Advances in non–muscle invasive bladder cancer continue to be a major storyline in urology, and these phase 3 data are just one of several notable presentations in this space for ESMO 2025.

5. LBA108 - Durvalumab (D) in combination with bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): final analysis of the phase 3, open-label, randomised POTOMAC trial

Presentation Time: Friday, October 17, 14:10-14:20 CEST

Presenter: Maria De Santis, MD

Background Info: Durvalumab (Imfinzi) made a splash earlier this year with the FDA’s approval of neoadjuvant durvalumab in combination with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy following radical cystectomy, for adult patients with muscle invasive bladder cancer.³

6. LBA 109 - DISCUS: A phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cancer

Presentation Time: Friday, October 17, 14:40-14:50 CEST

Presenter: Enrique Grande, MD

Background Info: The phase 2 DISCUS trial (NCT06892860) is seeking to determine whether reducing the number of first-line platinum-based chemotherapy cycles has an impact on oncologic or quality of life (QOL) outcomes in patients with locally advanced or metastatic urothelial carcinoma.⁴ Patients in the study are randomly assigned to receive either 3 cycles or 6 cycles of 3-weekly gemcitabine plus cisplatin/carboplatin, followed by 2-weekly maintenance avelumab until disease progression or intolerable toxicities. The primary end point is change in QOL from baseline to the completion of 6 cycles.

7. LBA110 - A blinded, exploratory phase 2 trial of nivolumab and the GDF-15 neutralizing antibody visugromab or placebo as neoadjuvant treatment of patients with muscle-invasive bladder cancer (MIBC): Primary results of the GDFather-NEO trial

Presentation Time: Friday, October 17, 15:00-15:10 CEST

Presenter: Andrea Necchi, MD

Background Info: This phase 2 trial is examining the impact of neutralizing Growth and Differentiation Factor 15 (GDF-15), which may play a critical role in local immunosuppression in patients with muscle-invasive bladder cancer (MIBC). Patients in the trial will be assigned 1:1 to receive either visugromab (CTL-002), a GDF-15 neutralizing IgG4 monoclonal antibody, in combination with nivolumab (Opdivo) vs nivolumab alone. The co-primary end points for the study are complete pathologic response rate and radiologic response.⁵

8. LBA111 - Randomized Comparison of upfront Magnetic Resonance Imaging Versus Transurethral Resection for Staging New Bladder Cancers: Final survival analysis from the BladderPath trial

Presentation Time: Friday, October 17, 16:30-16:35 CEST

Presenter: Nicholas D. James, MD, PhD

Background Info: Earlier this year, investigators from the BladderPath trial reported that adding multiparametric MRI into the initial staging pathway for MIBC can expedite the time to definitive treatment.⁶ At ESMO 2025, final survival analysis data will be presented from BladderPath.

9. LBA112 - Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results

Presentation Time: Friday, October 17, 16:45-16:50 CEST

Presenter: Andrea Necchi, MD

Background Info: Earlier this month, the FDA approved gemcitabine intravesical system (Inlexzo; formerly TAR-200) for adult patients with BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors.⁷ At ESMO 2025, Andrea Necchi, MD, will present data evaluating drug releasing system in combination with cetrelimab vs cetrelimab alone in the muscle-invasive bladder cancer space.

10. LBA96 - First-line Pembrolizumab-based Regimens for Advanced Clear Cell Renal Cell Carcinoma: KEYMAKER-U03 Substudy 03A

Presentation Time: Saturday, October 18, 8:30-8:40 CEST

Presenter: Cristina Suárez Rodríguez, MD, PhD

Background Info: The phase 1/2 KEYMAKER-U03 trial is evaluating different combinations of immunotherapy and targeted drugs for patients with renal cell carcinoma (RCC). In substudy 03A (NCT04626479), investigators are specifically assessing the safety and efficacy of these experimental regimens as first-line therapy for patients with advanced clear cell RCC (ccRCC).

11. LBA94 - LenCabo: A randomized phase II multicenter trial of lenvatinib plus everolimus (len/eve) versus (vs) cabozantinib (cabo) in patients (pts) with metastatic clear cell RCC (ccRCC) that progressed on PD-1 immune checkpoint inhibition (ICI)

Presentation Time: Saturday, October 18, 8:40-8:50 CEST

Presenter: Andrew W. Hahn, MD

Background Info: The phase 2 LenCabo trial (NCT05012371) is comparing the efficacy of lenvatinib plus everolimus vs cabozantinib in patients with metastatic ccRCC who progressed on a prior PD-1 ICI. The primary end point is progression-free survival, with secondary end points including objective response rate, disease control rate, overall survival, safety, and health-related QOL.

12. LBA93 - First results from RAMPART: An international phase 3 randomised-controlled trial of adjuvant durvalumab monotherapy or combined with tremelimumab for resected primary renal cell carcinoma (RCC) led by MRC CTU at UCL

Presentation Time: Saturday, October 18, 9:20 – 9:30 CEST

Presenter: James Larkin, PhD, FRCP F Med Sci

Background Info: This interim analysis from the phase 3 RAMPART trial (NCT03288532) will report on the efficacy of immune checkpoint inhibition after nephrectomy in patients with resected locally advanced renal cell carcinoma (RCC) at intermediate or high risk of recurrence. The study is assessing both single and combination ICIs across 3 study arms: Arm A, with active monitoring (no placebo); Arm B, assessing adjuvant durvalumab; or Arm C, assessing combination durvalumab plus 2 doses of tremelimumab. The co-primary end points are disease-free survival (DFS) and overall survival (OS).

13. LBA95 - Neoadjuvant immunotherapy in locally advanced clear cell renal cell carcinoma at risk for recurrence or distant metastases: the randomized phase II NESCIO trial

Presentation Time: Saturday, October 18, 9:30 – 9:40 CEST

Presenter: Femke Burgers, PhD candidate

Background Info: The phase 2 NESCIO trial (NCT05148546) is evaluating different combinations of neoadjuvant immunotherapy in patients with primary, resectable, intermediate- to high-risk clear cell RCC (ccRCC). Patients in the study are randomly assigned 1:1:1 to receive either nivolumab (Opdivo) monotherapy, nivolumab plus ipilimumab (Yervoy), or nivolumab plus relatlimab prior to surgery. The primary end point is pathologic response rate.

14. LBA89 - A randomized phase 2 study of 177Lu-PSMA-617 vs docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) and PSMA-positive disease: Canadian Cancer Trials Group (CCTG) study PR.21

Presentation Time: Saturday, October 18, 16:40 - 16:50 CEST

Presenter: Kim Nguyen Chi, MD, FRCPC

Background Info: The phase 2 CCTG PR.21 trial (NCT04663997) is evaluating the efficacy of lutetium (¹⁷⁷Lu) vipivotide tetraxetan (¹⁷⁷Lu-PSMA-617; Pluvicto) plus standard chemotherapy (docetaxel) in patients with metastatic castration-resistant prostate cancer (mCRPC). The primary end point is radiographic progression-free survival (rPFS).

15. LBA90 - Prospective Randomized Phase 2 trial of 177Lutetium-PSMA therapy Neoadjuvant to Stereotactic Ablative Radiotherapy for recurrent Oligo-Metastatic Hormone-Sensitive Prostate Cancer (LUNAR NCT05496959)

Presentation Time: Saturday, October 18, 16:50 – 17:00 CEST

Presenter: Jeremie Calais, MD, PhD

Background Info: The phase 2 LUNAR trial (NCT05496959) is assessing the safety and efficacy of neoadjuvant ¹⁷⁷lutetium-PSMA therapy with stereotactic body radiotherapy (SBRT) in patients with oligorecurrent metastatic hormone-sensitive prostate cancer (mHSPC). The trial is specifically evaluating the impact of ¹⁷⁷lutetium-PSMA therapy on progression-free survival. These results will mark the first randomized controlled trial to assess the added benefit of ¹⁷⁷lutetium-PSMA with SBRT in these patients.

16. LBA2 - Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study

Presentation Time: Saturday, October 18, 16:52 – 17:04 CEST

Presenter: Christof Vulsteke, PhD

Background Info: Interim data from the phase 3 KEYNOTE-905 (also known as EV-303) trial will highlight the efficacy of perioperative enfortumab vedotin-ejfv (EV; Padcev) plus pembrolizumab (Keytruda) vs cystectomy alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). In August 2025, Pfizer and Merck issued separate news releases confirming that the trial had met its primary end point, with the combination of EV plus pembrolizumab showing a significant improvement in event-free survival and OS vs cystectomy alone.^8,9

These results mark the first time that a systemic treatment approach given before and after surgery extended survival over SOC in this patient population.

17. LBA86 - Randomised phase 3 trial of androgen deprivation therapy (ADT) with radiation therapy with or without enzalutamide for high risk, clinically localised prostate cancer: ENZARAD (ANZUP 1303)

Presentation Time: Sunday, October 19, 10:15 – 10:25 CEST

Presenter: Paul L. Nguyen, MD, MBA

Background Info: This phase 3 trial, led by ANZUP, is seeking to determine the benefit of enzalutamide as part of adjuvant androgen deprivation therapy with radiation for patients with high-risk clinically localized prostate cancer. The primary end point for the study is metastasis-free survival.

18. LBA88 - Final Results from PRESTO: A Phase 3 Open-label Study of Combined Androgen Blockade in Patients (pts) with High-risk Biochemically Relapsed Prostate Cancer (BRPC) (AFT-19)

Presentation Time: Sunday, October 19, 10:45 – 10:55 CEST

Presenter: Rahul Aggarwal, MD

Background Info: Final results from the phase 3 PRESTO trial (NCT03009981) will report on long-term outcomes with an intensified androgen blockade regimen in patients with biochemical recurrence of prostate cancer. Previous analyses of the trial showed that treatment intensification with either apalutamide alone or apalutamide plus abiraterone plus prednisone improved prostate-specific antigen (PSA) progression-free survival (PFS) without a negative impact on health-related quality of life.

19. LBA87 - Overall survival with enzalutamide in biochemically recurrent prostate cancer

Presentation Time: Sunday, October 19, 10:55 – 11:05 CEST

Presenter: Stephen J. Freedland, MD

Background Info: Neal D. Shore, MD, FACS will offer additional insights into clinical outcomes with enzalutamide (Xtandi) in patients with biochemically recurrent prostate cancer.

In July 2025, Pfizer and Astellas announced additional data on enzalutamide from the phase 3 EMBARK trial (NCT02319837), showing that enzalutamide plus leuprolide acetate was associated with a statistically significant improvement in OS vs placebo plus leuprolide acetate.^10,11 These results validate previous metastasis-free survival data from EMBARK, which supported FDA approval of enzalutamide with or without a GnRH analog therapy in patients with nmCSPC with BCR at high risk for metastasis in November 2023.

20. LBA6 - Phase 3 trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition)

Presentation Time: Sunday, October 19, 17:14 – 17:24 CEST

Presenter: Scott T. Tagawa, MD, MS, FACP, FASCO

Background Info: Topline results from the phase 3 PSMAddition trial (NCT04720157) will report on the efficacy of adding ¹⁷⁷Lu-PSMA-617 to standard of care (SOC) hormone therapy in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). In June 2025, Novartis reported that the trial met its primary end point, demonstrating that ¹⁷⁷Lu-PSMA-617 plus hormone therapy significantly improved rPFS vs hormone therapy alone in this patient population.¹² The company also noted an observed trend toward improvement in OS.

21. LBA7 - Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression

Presentation Time: Sunday, October 19, 17:34-17:46 CEST

Presenter: Xinan Sheng, MD

Background Info: This study will further assess the combination of disitamab vedotin plus toripalimab-tpzi (Loqtorzi) as compared with chemotherapy in the first-line setting for patients with la/mUC. Data from a phase 1b/2 trial (NCT04264936; RC48-C014) on the combination of disitamab vedotin plus toripalimab were presented at the 2023 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois and subsequently published in Annals of Oncology.¹³ Overall, the combination demonstrated encouraging efficacy with a manageable safety profile in these patients.

22. LBA8 - IMvigor011: a Phase 3 trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer

Presentation Time: Monday, October 20, 16:30 – 16:42 CEST

Presenter: Thomas B. Powles, MBBS, MRCP, MD

Background Info: Results from this phase 3 trial will detail the clinical utility of the Signatera molecular residual disease (MRD) test in guiding adjuvant treatment decisions for patients with muscle-invasive bladder cancer (MIBC). In August 2025, Natera reported high-level findings from the study, which indicated that the Signatera test may accurately predict which patients will benefit from adjuvant treatment with atezolizumab.¹⁴ Overall, data showed that among those who were MRD-positive, patients who received adjuvant treatment with atezolizumab (Tecentriq) demonstrated a statistically significant and clinically meaningful improvement in DFS and OS vs those who received treatment with placebo.

REFERENCES

1. Attard G, Agarwal N, Graff J, et al. Phase 3 AMPLITUDE trial: Niraparib (NIRA) and abiraterone acetate plus prednisone (AAP) for metastatic castration-sensitive prostate cancer (mCSPC) patients (pts) with alterations in homologous recombination repair (HRR) genes. J Clin Oncol. 2025;43 (suppl 17; abstr LBA5006). doi:10.1200/JCO.2025.43.17_suppl.LBA5006

2. FDA approves darolutamide for metastatic castration-sensitive prostate cancer. News release. US Food & Drug Administration. June 3, 2025. Accessed September 25, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer

3. FDA approves durvalumab for muscle invasive bladder cancer. News release. US Food & Drug Administration. March 28, 2025. Accessed September 25, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer

4. Comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cancer (DISCUS). ClinicalTrials.gov. Last updated March 25, 2025. Accessed September 25, 2025. https://clinicaltrials.gov/study/NCT06892860

5. Necchi A. Neutralizing GDF-15 in muscle-invasive bladder cancer (MIBC): A neoadjuvant immunotherapy trial of visugromab (CTL-002) in combination with the anti-PD1 antibody nivolumab (GDFather-Neo). Presented at: 2024 ASCO Genitourinary Cancers Symposium. January 25-27, 2024. San Francisco, California. https://www.asco.org/abstracts-presentations/ABSTRACT437112

6. Bryan RT, Liu W, Pirrie SJ, et al. Randomized comparison of magnetic resonance imaging versus transurethral resection for staging new bladder cancers: results from the prospective BladderPath trial. J Clin Oncol. 2025:JCO2302398. doi:10.1200/JCO.23.02398

7. U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated. News release. Johnson & Johnson. September 9, 2025. Accessed September 25, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated

8. PADCEV Plus KEYTRUDA significantly improves survival for certain patients with bladder cancer when given before and after surgery. News release. Pfizer. August 12, 2025. Accessed September 25, 2025. https://www.pfizer.com/news/press-release/press-release-detail/padcevtm-plus-keytrudatm-significantly-improves-survival

9. KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) significantly improved event-free and overall survival and pathologic complete response rate for certain patients with muscle-invasive bladder cancer when given before and after surgery. News release. Merck. August 12, 2025. Accessed September 25, 2025. https://www.merck.com/news/keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-significantly-improved-event-free-and-overall-survival-and-pathologic-complete-response-rate-for-certain-patients-with-muscle/

10. XTANDI plus leuprolide significantly improves survival outcomes in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. News release. Pfizer. July 10, 2025. Accessed September 25, 2025. https://www.pfizer.com/news/press-release/press-release-detail/xtandir-plus-leuprolide-significantly-improves-survival

11. XTANDI plus leuprolide significantly improves survival outcomes in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. News release. Astellas Pharma Inc. July 10, 2025. Accessed September 25, 2025. https://newsroom.astellas.us/2025-07-10-XTANDI-R-Plus-Leuprolide-Significantly-Improves-Survival-Outcomes-in-Men-with-Non-Metastatic-Hormone-Sensitive-Prostate-Cancer-with-High-Risk-Biochemical-Recurrence

12. 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 September 25, 2025. https://www.novartis.com/us-en/news/media-releases/novartis-pluvicto-demonstrates-statistically-significant-and-clinically-meaningful-rpfs-benefit-patients-psma-positive-metastatic-hormone-sensitive-prostate-cancer

13. Zhou L, Yang KW, Zhang S, et al. Disitamab vedotin plus toripalimab in patients with locally advanced or metastatic urothelial carcinoma (RC48-C014): a phase Ib/II dose-escalation and dose-expansion study. Ann Oncol. 2024:S0923-7534(24)04977-9. doi:10.1016/j.annonc.2024.12.002

14. IMvigor011 bladder cancer trial achieves positive results, with Signatera strongly predicting adjuvant immunotherapy benefit. News release. Natera, Inc. August 18, 2025. Accessed September 25, 2025. https://www.natera.com/company/news/imvigor011-bladder-cancer-trial-achieves-positive-results-with-signatera-strongly-predicting-adjuvant-immunotherapy-benefit/