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Practice-Changing Advances at ASCO GU 2025

A New Era in Genitourinary Cancer Treatment

The 2025 ASCO Genitourinary Cancers Symposium has unveiled several groundbreaking studies that promise to reshape the treatment landscape across renal cell carcinoma (RCC), bladder cancer, and prostate cancer. Let’s dive into the most significant findings that are set to influence clinical practice.

 

 

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Practice Changing Results

Renal Cell Carcinoma: Long-Term Benefits Confirmed

The final analysis of the CheckMate 9ER (Abstract 439) trial has provided compelling evidence supporting the combination of nivolumab plus cabozantinib (N+C) in previously untreated advanced RCC. With a median follow-up of 67.6 months, the combination demonstrated superior outcomes across all key endpoints. The median overall survival reached 46.5 months with N+C compared to 35.5 months with sunitinib, representing a 21% reduction in death risk (HR 0.79).

Particularly noteworthy was the depth of response, with complete response rates of 13.9% for N+C versus 4.6% for sunitinib. The durability of these responses was impressive, with 22% of N+C patients maintaining their response at 60 months compared to 10% in the sunitinib arm. These results firmly establish N+C as a standard of care in the first-line setting.

Bladder Cancer: Multiple Practice-Changing Approaches

The bladder cancer space saw several practice-changing developments:

Adjuvant Immunotherapy Delivers
Updated results from CheckMate 274 (Abstract 658) reinforced the role of adjuvant nivolumab in high-risk muscle-invasive urothelial carcinoma (MIUC). The trial demonstrated consistent disease-free survival benefits (HR 0.63) across patient subgroups, including those with and without prior neoadjuvant chemotherapy. This benefit was maintained regardless of PD-L1 status, suggesting broad applicability.

NIAGARA Sets New Standards
The NIAGARA trial (Abstract 659)introduced a promising perioperative approach combining durvalumab with neoadjuvant chemotherapy. This combination reduced the risk of distant metastases by 33% and death from bladder cancer by 31%. Importantly, the higher pathological complete response rate (37% vs 28%) didn’t come at the cost of increased surgical complications, making this a feasible option for clinical practice.

EV-302: Reshaping First-Line Metastatic Treatment
Perhaps the most striking results came from the EV-302 trial (Abstract 664), evaluating enfortumab vedotin plus pembrolizumab in previously untreated locally advanced or metastatic urothelial carcinoma. The combination showed remarkable improvements in both progression-free survival (HR 0.48) and overall survival (HR 0.51). The complete response rate of 30.4% (versus 14.5% with chemotherapy) is unprecedented in this setting. Notably, the safety profile was manageable, with fewer grade ≥3 treatment-related adverse events compared to chemotherapy (57.3% vs 69.5%).

Prostate Cancer: Innovation in Advanced Disease

The ENZA-p trial (Abstract 17) brought exciting news for patients with poor-risk metastatic castration-resistant prostate cancer. The addition of [177Lu]Lu-PSMA-617 to enzalutamide significantly improved overall survival (34 vs 26 months, HR 0.55, p=0.005). Beyond survival, the combination showed meaningful benefits in quality of life, with better pain control and fatigue management. The durability of response and manageable safety profile make this an attractive option for this challenging patient population.

Clinical Implications and Future Directions

These results collectively represent a significant step forward in genitourinary cancer treatment. Several key themes emerge:

  1. The power of combination approaches, particularly those incorporating immunotherapy
  2. The importance of early intervention in high-risk disease
  3. The ability to achieve deep and durable responses with novel treatment strategies
  4. The focus on maintaining quality of life while improving survival

Implementation Challenges

While these advances are exciting, several implementation challenges need to be addressed:

  • Cost considerations for novel combination therapies
  • Need for biomarker testing and patient selection
  • Management of new toxicity profiles
  • Integration into existing treatment algorithms
  • Access to specialized treatments like radioligand therapy

Looking Ahead

The field of genitourinary oncology continues to evolve rapidly. These studies provide a strong foundation for future research, including:

  • Optimal sequencing of available therapies
  • Identification of predictive biomarkers
  • Development of strategies to overcome resistance
  • Investigation of novel combination approaches
  • Extension of benefits to earlier disease settings

Conclusion

The 2024 ASCO GU Symposium has delivered practice-changing results across multiple genitourinary cancers. These advances offer new hope for patients and provide clinicians with more effective tools to combat these challenging diseases. As these treatments move into routine clinical practice, careful attention to patient selection, monitoring, and supportive care will be crucial to optimize outcomes. The focus now shifts to implementing these advances effectively and continuing to build upon these successes through ongoing research and clinical trials. The future of genitourinary cancer treatment looks brighter than ever, with more options and better outcomes for patients on the horizon.

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