ASCO 2025: What to watch for in GU oncology

The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting is set to kick off on May 30, 2025 in Chicago, Illinois. Spanning 5 days, the conference will feature several notable sessions across prostate cancer, bladder cancer, kidney cancer, and other genitourinary malignancies. In this article, we highlight practice-shifting abstracts that urologists should keep an eye on during this year’s meeting.

You can keep up with Urology Times® full coverage of ASCO here.

This year's meeting will take place in Chicago, Illinois from May 30-June 4, 2025.

Prostate

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

Data from the phase 3 AMPLITUDE trial (NCT04497844) will be shared by Gerhardt Attard, MD, PhD, FRCP, of the University College London. The study is seeking to determine if the addition of niraparib to abiraterone acetate (AA) plus prednisone provides superior efficacy vs AA plus prednisone alone in patients with mCSPC with HRR alterations.¹ In total, the study planned to enroll 696 patients. The primary end point is radiographic progression-free survival.

Phase 3, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer.

Presented by Theodore DeWeese, MD, of Johns Hopkins Medicine, phase 3 data from the PrTK03 trial (NCT01436968) will highlight the safety and efficacy of aglatimagene besadenovec (CAN-2409) in patients with localized prostate cancer. Topline results from the study, which were shared in December 2024, confirmed that the trial met its primary end point by demonstrating that the addition of CAN-2409 to radiation therapy significantly improved disease-free survival (DFS) vs radiation alone in this patient population.²

CAN-2409 was recently granted a Regenerative Medicine Advanced Therapy Designation by the FDA.

ARCHES: 5-year follow-up overall survival (OS) analysis of enzalutamide (ENZA) plus androgen-deprivation therapy (ADT) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC)

Long-term follow-up data from the phase 3 ARCHES trial (NCT02677896) will be presented by Andrew Armstrong, MD, MSc, of Duke University Health. Initial results from the trial showed an OS benefit with enzalutamide plus ADT vs ADT alone in patients with metastatic hormone-sensitive prostate cancer (mHSPC), which supported the FDA approval of the combination in December 2019.³

Bladder

ENLIGHTED phase 3 study: Interim results of efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) in the treatment of low-grade upper tract urothelial cancer (LG UTUC).

Vitaly Margulis, MD, of UT Southwestern Medicine will report on interim findings from the phase 3 ENLIGHTED trial (NCT04620239)of padeliporfin vascular targeted photodynamic therapy in low-grade upper tract urothelial carcinoma. ImPact Biotech, the developer of the therapy, has previously noted that results from this trial are expected to support an application to the FDA for VTP therapy in this indication.⁴

Mitomycin plus BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: A randomized phase 3 trial (ANZUP 1301).

Phase 3 data on mitomycin plus BCG as an adjuvant intravesical regimen for high-risk non–muscle invasive bladder cancer (NMIBC) will be shared by Prof Dickon Hayne of the University of Western Australia. Overall, the open-label, randomized study (NCT02948543; ANZUP 1301) aimed to compare DFS with mitomycin plus BCG vs BCG alone. The study enrolled approximately 500 patients across clinical trial sites in Australia and the UK.⁵

Kidney

Five-year follow-up results from the phase 3 KEYNOTE-564 study of adjuvant pembrolizumab (pembro) for the treatment of clear cell renal cell carcinoma (ccRCC).

Long-term data from the phase 3 KEYNOTE-564 trial (NCT03142334) will be presented by Naomi B. Haas, MD, of the University of Pennsylvania. Previously reported data from the trial showed that adjuvant pembrolizumab improved DFS and OS vs placebo in patients with clear cell renal cell carcinoma who were at a high-risk of recurrence following nephrectomy. These data supported the FDA approval of adjuvant pembrolizumab in this patient population in November 2021.⁶

Penile

An open label randomized non-inferiority trial comparing adjuvant platinum plus paclitaxel to platinum plus 5-FU after curative resection in high-risk penile carcinoma.

Aditya Dhanawat, MD, DM, of Tata Memorial Centre, India, will share results from a non-inferiority trial comparing 2 chemotherapy regimens in patients with high-risk penile carcinoma. Specifically, the trial is comparing adjuvant platinum chemotherapy plus paclitaxel vs platinum plus 5-FU following resection for high-risk penile carcinoma.

REFERENCES

1. A study of niraparib in combination with abiraterone acetate and prednisone versus abiraterone acetate and prednisone for the treatment of participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC) (AMPLITUDE). ClinicalTrials.gov. Last updated May 23, 2025. Accessed May 30, 2025. https://clinicaltrials.gov/study/NCT04497844

2. Candel Therapeutics announces CAN-2409 achieved primary endpoint in phase 3 prostate cancer trial, showing significantly improved disease-free survival. News release. Candel Therapeutics. December 11, 2024. Accessed May 30, 2025. https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-announces-can-2409-achieved-primary-endpoint

3. FDA approves enzalutamide for metastatic castration-sensitive prostate cancer. News release. US Food & Drug Administration. December 16, 2019. Accessed May 30, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enzalutamide-metastatic-castration-sensitive-prostate-cancer

4. ImPact Biotech presents updated efficacy data from evaluation of padeliporfin VTP in LG UTUC and intermediate risk prostate cancer at AUA 2025. News release. ImPact Biotech. April 29, 2025. Accessed May 30, 2025. https://impactbiotech.com/impact-biotech-presents-updated-efficacy-data-from-evaluation-of-padeliporfin-vtp-in-lg-utuc-and-intermediaterisk-prostate-cancer-at-aua-2025/

5. Adding mitomycin to BCG as adjuvant intravesical therapy for high-risk non-muscle-invasive bladder cancer (BCG+MM). ClinicalTrials.gov. Last updated June 18, 2023. Accessed May 30, 2025. https://clinicaltrials.gov/study/NCT02948543

6. FDA approves pembrolizumab for adjuvant treatment of renal cell carcinoma. News release. US Food & Drug Administration. November 17, 2021. Accessed May 30, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma