AUA 2025: A Sneak Peek for Community Oncologists/Urologists

Artistic rendering of bladder cancer: © reineg - stock.adobe.com

The American Urological Association (AUA) Annual Meeting consistently stands as a cornerstone for urologists, and AUA 2025, held in Las Vegas, Nevada, promises to be no exception. For the dedicated urologic oncologist, this year’s program is brimming with potentially practice-altering data, novel therapeutic strategies, and crucial updates across the spectrum of genitourinary malignancies.

This preview highlights key areas and presentations that should be high on your radar.

Bladder Cancer

Non-muscle invasive bladder cancer (NMIBC) remains a complex landscape, particularly in the Bacillus Calmette-Guérin (BCG)-unresponsive setting. AUA 2025 will showcase significant advancements with several highly anticipated presentations in the "Practice-changing, Paradigm-shifting Clinical Trials in Urology" session and beyond.

For novel intravesical therapies, oncologists should keep a close watch on the latest data for TAR-200, an innovative intravesical drug delivery system releasing gemcitabine. Presentations focusing on both papillary disease-only (cohort 4 of SunRISe-1; NCT04640623) and carcinoma in situ (CIS) in BCG-unresponsive patients will provide crucial insights into efficacy, durability (including 1-year outcomes), and patient-reported outcomes.

“We know that nearly 50% of patients are not eligible for neoadjuvant chemotherapy, so it is important to find ways to optimize their care and not go straight to cystectomy, because they do not always do as well unless they receive neoadjuvant therapy. Traditionally, that has been chemotherapy, but here we wanted to see if TAR-200...could be an alternative,” explained Neal Shore, MD, FACS, medical director of the Carolina Urologic Research Center, in a prior interview with Targeted Oncology^TM regarding another study evaluating TAR-200, the phase 2 SunRISe-4 trial (NCT04919512).

These findings could offer bladder-sparing alternatives for a challenging patient population.

The combination of sasanlimab (PF-06801591) with BCG in high-risk NMIBC is another eagerly awaited presentation. In January 2025, it was announced that the addition of sasanlimab to BCG met the primary end point of the phase 3 CREST trial (NCT04165317), showing clinically meaningful and statistically significant improvement for induction and maintenance with the combination over BCG alone by investigator assessment. Results comparing this combination to the standard of care BCG alone could redefine first-line treatment strategies for this patient group if event-free survival is significantly improved.¹

The phase 3 results for cretostimogene grenadenorepvec in BCG-unresponsive high-risk NMIBC with CIS will also be presented at this meeting. This intravesical viral gene therapy offers another potential avenue for patients who have failed BCG and are seeking alternatives to radical cystectomy.

“Cretostimogene is a conditionally replicating oncolytic serotype 5 adenovirus that has been designed to preferentially replicate in and kill cancer cells,” explained Mark D. Tyson, II, MD, MPH, a urologic oncologist at Mayo Clinic in Phoenix, Arizona, in an interview with Targeted Oncology^TMon findings from BOND-003.²

“After binding the [chimeric antigen] receptor, [cretostimogene] enters the malignant cell, where viral replication leads to tumor cell lysis and releases viral- and tumor-specific antigens. These antigens are picked up by dendritic cells and presented to T cells, which initiate the local antitumor immune response, thereby potentially getting the immunotherapeutic effect. This leads us to BOND-003 cohort C, a phase 3 study of cretostimogene in patients with BCG-unresponsive CIS, according to the strict definition laid out by the FDA in their 2018 guidance,” added Tyson.

Beyond novel agents, updates on UGN-102 (intravesical mitomycin) in recurrent low-grade intermediate-risk NMIBC from the phase 3 ENVISION trial (NCT05243550) will be important for understanding its role in managing this patient subgroup. The preliminary efficacy and safety data for disitamab vedotin (RC48) combined with BCG in HER2-expressing high-risk NMIBC offers a glimpse into personalized therapy in this disease. This biomarker-driven approach could pave the way for more tailored treatment strategies.

Updated results from QUILT-3.032 (NCT03022825) on the combination of N-803 plus BCG in BCG-unresponsive CIS, with or without papillary disease will also be presented. The trial has an estimated enrollment of 190 patients, and the primary end points are complete response (CR) and disease-free rate. The secondary end points of the study include duration of CR, disease-free survival, and CR and disease-free rate at 6, 9, 12, 18, and 24 months.³ Experts are hopeful this will provide further clarity on the potential of this combination to achieve durable complete responses.

Further, a phase 3 randomized clinical trial evaluating neoadjuvant intravesical mitomycin in NMIBC will shed light on the potential benefits of this approach in improving outcomes.

In advanced urothelial carcinoma, AUA will feature presentations relevant to this dynamic field, including one that is looking at consolidative surgery post novel systemic therapy. The perioperative outcomes of consolidative surgery following combination immunotherapy with pembrolizumab (Keytruda) plus enfortumab vedotin (Padcev) for advanced urothelial cancer will provide crucial data for optimizing the management of patients who achieve a significant response to initial systemic therapy.

Renal Cell Carcinoma

The first-line treatment landscape for advanced renal cell carcinoma (RCC) is becoming increasingly complex with multiple effective combination therapies. The 2025 AUA Meeting will offer comparative insights, including head-to-head comparisons and guidance for expanding treatment options.

First, a direct comparison of clinical outcomes between cabozantinib (Cometriq) plus nivolumab (Opdivo) and lenvatinib (Lenvima) plus pembrolizumab in advanced RCC is highly anticipated. Experts believe this can potentially help in guiding treatment selection based on efficacy and safety profiles.

Updated results on the combination of fruquintinib (Fruzaqla) and serplulimab (Hetronifly) as first-line treatment for metastatic or unresectable non-clear cell RCC will be important, as this histology often has fewer effective treatment options.

Further, a single-center phase 2 study evaluating tislelizumab-jsgr (Tevimbra) plus axitinib (Inlyta) in locally advanced clear cell RCC will add to the growing body of evidence for this combination.

Prostate Cancer

While several presentations focus on prostate cancer, one particularly relevant to community oncologists addresses risk stratification in the metastatic hormone-sensitive setting. A multicenter retrospective study examining the utility of frailty in predicting severe adverse events in patients with metastatic hormone-sensitive prostate cancer treated with upfront docetaxel or darolutamide (Nubeqa) plus docetaxel will provide valuable insights for tailoring treatment intensity based on patient fitness.

AUA 2025 promises to deliver critical updates and insights that will directly impact the care of your urologic oncology patients. By focusing on these key presentations and engaging with the latest research, you can ensure you remain at the forefront of this rapidly evolving field.

REFERENCES:

1. Pfizer’s sasanlimab in combination with BCG improves event-free survival in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer. News release. Pfizer. January 10, 2025. Accessed April 21, 2025. https://tinyurl.com/5t5a3x2h

2. Tyson M, Uchio E, Nam J, et al. Pivotal results from BOND-003: a phase 3, single-arm study of intravesical cretostimogene grenadenorepvec for the treatment of high risk, BCG-unresponsive non-muscle invasive bladder cancer. Presented at: 2024 American Urological Association Meeting; May 3-6, 2024; San Antonio, TX.

3. QUILT-3.032: a multicenter clinical trial of intravesical Bacillus Calmette-Guerin (BCG) in combination with ALT-803 (N-803) in patients with BCG unresponsive high grade non-muscle invasive bladder cancer. ClinicalTrials.gov. Updated April 13, 2025. Accessed April 21, 2025. https://clinicaltrials.gov/study/NCT03022825