Top 5 urologic oncology headlines you missed in August 2025

August 2025 ushered in several notable developments in urologic oncology, with trial readouts in both bladder and kidney cancer signaling practice-changing progress ahead. This month also marked the launch of Urology Times®’ new podcast series on advancements in the field, hosted by Taylor Goodstein, MD.

In this recap, Urology Times highlights the key clinical trial milestones, regulatory updates, and practice-shaping advances from August 2025.

Scroll down for the top stories from the past month.

1. Perioperative EV plus pembrolizumab significantly extends EFS, OS in MIBC

Topline findings from the phase 3 EV-303 (KEYNOTE-905) trial demonstrated that adding enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda) before and after surgery significantly improved event-free survival, overall survival, and pathologic complete response rates compared with cystectomy alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).

This marks the first systemic approach to show survival benefit over surgery alone in this high-risk population. Safety was consistent with the known profiles of both agents. Full data will be presented at an upcoming medical congress and submitted to regulatory authorities.

2. IMvigor011: ctDNA test can predict adjuvant immunotherapy benefit in MIBC

Topline findings from the phase 3 IMvigor011 trial showed that the Signatera ctDNA-based MRD assay successfully identified patients with MIBC who benefit from adjuvant atezolizumab (Tecentriq) following cystectomy. Among MRD-positive patients, adjuvant immunotherapy led to significant improvements in disease-free and overall survival compared with placebo. Conversely, patients who remained MRD-negative on serial testing demonstrated favorable outcomes without adjuvant therapy, supporting treatment de-escalation in this subgroup.

Natera said it plans to pursue FDA approval of Signatera as a companion diagnostic to guide adjuvant immunotherapy selection in MIBC.

3. Pembrolizumab plus axitinib shows sustained benefit vs sunitinib in ccRCC

Final 5-year results from the phase 3 KEYNOTE-426 trial, published in Nature Medicine, confirm pembrolizumab plus axitinib (Inlyta) as a durable standard of care for patients with previously untreated advanced clear cell renal cell carcinoma (ccRCC).

The combination maintained superiority over sunitinib, with sustained improvements in overall survival (47.2 vs 40.8 months), progression-free survival (15.7 vs 11.1 months), and objective response rate (60.6% vs 39.6%). Long-term response durability favored the combination, with 26% of responders maintaining benefit at 5 years. Exploratory biomarker analyses highlighted potential predictive value of T-cell–inflamed gene expression, angiogenesis signatures, and PBRM1 mutation, underscoring the need for further prospective validation of biomarker-guided therapy in RCC.

4. Updated ENVISION data show sustained efficacy of mitomycin intravesical solution for LG-IR-NMIBC

Updated findings from the phase 3 ENVISION trial show durable benefit with mitomycin intravesical solution (Zusduri) in patients with recurrent low-grade, intermediate-risk non–muscle invasive bladder cancer. Among patients achieving complete response at 3 months, 72.2% remained event-free at 24 months, with the median duration of response not yet reached at nearly 2 years of follow-up. Adverse events (AEs) were generally mild to moderate, with serious AEs occurring in 12% of patients.

These results, building on the FDA’s June 2025 approval, reinforce mitomycin for intravesical solution as a meaningful and durable chemoablative option in this recurrent disease setting.

5. First Assist: The Historical Context of Advanced Kidney Cancer, with Eric A. Singer, MD

In this episode of First Assist: GU Oncology Unpacked, host Taylor Goodstein, MD, speaks with Eric A. Singer, MD, MA, MS, FACS, FASCO, of The Ohio State University, about how historical milestones in kidney cancer management have shaped current practice.

Singer highlights the field’s evolution from radical nephrectomy to precision, patient-centered approaches informed by imaging, minimally invasive techniques, and molecular insights. The conversation also traces the trajectory of immunotherapy, from cytokines to immune checkpoint inhibitors, and examines how biomarkers and trial design are guiding individualized care.

Looking ahead, Singer emphasizes the importance of multidisciplinary collaboration, equitable trial access, and thoughtful integration of novel therapies, underscoring that future progress will continue to build on decades of incremental but transformative advances.