AUA 2026 preview: Practice-changing trials in urologic oncology

Urologists will soon gather in Washington, DC, for the 2026 Annual Meeting of the American Urological Association, set to showcase a wealth of advances across the specialty. The meeting will kick off with the Friday morning plenary session, which will feature several notable trials across urologic oncology.

Bladder cancer will take center stage with updated results from the phase 3 POTOMAC trial (NCT03528694) evaluating durvalumab (Imfinzi) plus BCG in high-risk NMIBC, interim findings from the LEGEND study (NCT04752722) of intravesical gene therapy with detalimogene voraplasmid, and additional data exploring pembrolizumab (Keytuda) combined with BCG in “very high-risk” T1 disease.

Meanwhile, prostate cancer presentations will include new findings from the phase 2 ARASEC trial (NCT05059236) of darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive disease, long-term randomized data comparing extended vs limited pelvic lymph node dissection during radical prostatectomy, and extended follow-up from the phase 3 CAN-2409 program in localized prostate cancer. Collectively, the presentations underscore a common theme likely to resonate throughout AUA 2026: Clinicians are increasingly refining, not replacing, existing treatment strategies through more personalized, combination-based, and evidence-driven approaches.

Notable data presentations in urologic oncology

Abstract: Durvalumab with bacillus Calmette–Guérin therapy for high-risk non-muscle-invasive bladder cancer: expanded efficacy and safety analyses from POTOMAC

Presenter: Neal D. Shore, MD, FACS

Summary: Neal D. Shore, MD, FACS, will present updated results from the phase 3 POTOMAC trial, which are expected to further clarify the role for immune checkpoint inhibitors in combination with BCG for patients with high-risk, BCG-naïve non–muscle invasive bladder cancer (NMIBC). POTOMAC previously demonstrated that 1 year of druvalumab in combination with BCG induction plus maintenance significantly improved disease-free survival vs BCG induction plus maintenance alone (HR, 0.68; 95% CI, 0.50 to 0.93; P = .015).¹ Grade 3 to 4 treatment-related adverse events were reported in 21% of patients in the treatment arm vs 4% of patients in the comparison arm.

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Abstract: A non-viral intravesical gene therapy for BCG-unresponsive NMIBC with CIS, with or without papillary disease: pivotal phase 2 interim results of detalimogene voraplasmid

Presenter: Ashish M. Kamat, MD, MBBS

Summary: Interim results from the phase 2 LEGEND trial of detalimogene voraplasmid in BCG-unresponsive NMIBC will be shared by Ashish Kamat, MD, MBBS. According to the company, the agent led to a 54% complete response (CR) rate at any time point (67 of 124), with a 43% CR rate at 6 months. Treatment-related adverse events occurred in 55% of patients.²

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Abstract: Intravenous Pembrolizumab Combined with Intravesical Bacillus Calmette–Guérin (BCG) for Patients with BCG-Naïve “Very High-Risk” T1 Non-Muscle Invasive Bladder Cancer

Presenter: Eugene Pietzak, MD

Summary: Eugene Pietzak, MD, will report on a phase 2 trial (NCT03504163) looking at pembrolizumab plus BCG vs BCG alone for patients with BCG-naïve “very high risk” T1 NMIBC. According to a recent publication on combination strategies in NMIBC, “Additional data for BCG + [immune checkpoint blockade] is needed in patients with ‘very high-risk’ T1 NMIBC where AUA and NCCN guidelines currently recommend immediate radical cystectomy over attempting BCG.”³

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Abstract: Darolutamide plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC): ARASEC – US prospective, open-label phase 2 study with an external control

Presenter: Rana R, McKay, MD, FASCO

Summary: Rana McKay, MD, FASCO, will then share results from the phase 2 ARASEC trial, which is evaluating darolutamide plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The trial follows positive findings from the phase 3 ARAMIS (NCT02200614), ARASENS (NCT02799602), and ARANOTE (NCT04736199) studies. Because ADT alone is no longer considered an acceptable comparator in the US, investigators used a propensity score–matched external control arm derived from patients treated with ADT alone in the CHAARTED trial (NCT00309985) to assess progression-free survival, overall survival, and other clinical outcomes.⁴

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Abstract: Long-Term Oncological Outcomes of Extended Versus Limited Pelvic Lymph Node Dissection During Radical Prostatectomy for Intermediate- and High-Risk Prostate Cancer: Phase 3 Randomized Controlled Trial

Presenter: Jean F.P. Lestingi

Summary: Jean F.P. Lestingi will share long-term results from a phase 3 trial of extended (EPLND) vs limited (LPLND) pelvis lymph node dissection during radical prostatectomy in patients with intermediate- and high-risk disease. Early results from the trial showed that EPLND provided better pathological staging, though there were not observed differences in early oncological outcomes. A subgroup analysis suggested a potential benefit in biochemical-recurrence-free survival among patients with ISUP grade 3–5 who were allocated to EPLND (HR, 0.33; 95% CI, 0.14 to 0.74, interaction P = .007).

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Abstract: Extended follow-up shows accumulating benefit for patients treated with CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) in men with localized prostate cancer

Presenter: Mark Garzotto, MD

Summary: Mark Garzotto, MD, will conclude the Friday morning plenary session with extended follow-up results from a phase 3 trial (NCT01436968) of aglatimagene besadenovec (CAN-2409) vs placebo plus valacyclovir (prodrug) and EBRT in localized prostate cancer. Previous data from the trial, presented at the 2025 Annual Meeting of the American Society for Radiation Oncology, showed that the addition of aglatimagene besadenovec to standard-of-care led to a 30% improvement in disease-free survival (HR, 0.7; P = .0155) and a 38% improvement in prostate cancer-specific disease-free survival (HR, 0.62; P = .0046).⁶

REFERENCES

1. De Santis M, Palou-Redorta J, Nishiyama H, et al. Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial. Lancet. 2025;406(10516):2221-2234. doi:10.1016/S0140-6736(25)01897-5

2. enGene announces updated interim results from LEGEND pivotal cohort. News release. enGene. May 7, 2026. Accessed May 12, 2026. https://engene.com/engene-announces-updated-interim-results-from-legend-pivotal-cohort/

3. Wald G, Lang J, Alkazemi H, et al. Combination strategies to enhance Bacillus Calmette-Guérin efficacy for nonmuscle-invasive bladder cancer. J Urol. 2026;215(3):264-275. doi:10.1097/JU.0000000000004848

4. Darolutamide plus androgen-deprivation therapy (ADT) versus ADT in metastatic hormone-sensitive prostate cancer: Open-label single-arm study with an external control arm (ARASEC). J Clin Oncol. 2023;41(6). doi:10.1200/JCO.2023.41.6_suppl.TPS29

5. Lestingi JFP, Guglielmetti GB, Trinh QD, et al. Extended versus limited pelvic lymph node dissection during radical prostatectomy for intermediate- and high-risk prostate cancer: Early oncological outcomes from a randomized phase 3 Trial. Eur Urol. 2021;79(5):595-604. doi:10.1016/j.eururo.2020.11.040

6. Candel Therapeutics presents phase 3 clinical trial of CAN-2409 in localized prostate cancer at ASTRO 2025. News release. Candel Therapeutics. September 29, 2025. Accessed May 12, 2026. https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-presents-phase-3-clinical-trial-can-2409