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Highlights from the 2026 ASCO Genitourinary Cancers Symposium
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| Neoadjuvant and Adjuvant Enfortumab Vedotin + Pembrolizumab for Participants with MIBC Who Are Eligible for Cisplatin: Randomized, Open-Label, Phase 3 KEYNOTE-B15 Study
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| Matthew Galsky, MD
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| KEYNOTE-B15 showed that perioperative enfortumab vedotin plus pembrolizumab significantly improved event-free survival, overall survival, and pathologic complete response compared with standard neoadjuvant gemcitabine/cisplatin followed by cystectomy in cisplatin-eligible MIBC, with median EFS not reached versus 48.5 months and pCR 55.8% versus 32.5%.
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| A Phase 2 Study of Disitamab Vedotin in HER2-Expressing Previously Treated Advanced Urothelial Carcinoma
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| Thomas Powles, MBBS, MRCP
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| The phase 2 RC48G001 trial showed that disitamab vedotin monotherapy produced high objective response rates and complete response rates in both HER2-positive and HER2-low, previously treated locally advanced/metastatic urothelial carcinoma, with median overall survival of 20.0 and 17.0 months, respectively.
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| ctDNA to Guide Response-Adapted Bladder Preservation in MIBC: Integrated Analysis of the RETAIN Trials
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| Pooja Ghatalia, MD
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| Pooja Ghatalia presented an integrated analysis of RETAIN-1/2 showing that a biomarker-driven, response-adapted strategy (using accelerated MVAC ± nivolumab plus mutational selection) allowed a subset of MIBC patients to pursue active surveillance with bladder preservation, achieving 70% 2‑year metastasis-free survival and non‑inferiority to cystectomy-based management.
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| A Phase II Study Evaluating the Efficacy and Safety of Perioperative EV + Toripalimab Combined with Endoscope-Based Kidney-Sparing Surgery for Patients with High-Risk UTUC (WUTSUP-04EV-JS001)
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| Yige Bao, MD, PhD
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| This phase II single-center WUTSUP-04EV-JS001 trial is testing whether perioperative enfortumab vedotin plus toripalimab can enable endoscopic kidney-sparing surgery in patients with high-risk, non-metastatic UTUC who have clinical indications or strong preference for nephron preservation. Patients receive induction EV + toripalimab, endoscopic tumor ablation, then further EV + toripalimab followed by toripalimab maintenance, with the primary endpoint of conversion-free survival and secondary endpoints including response, survival, renal function, and safety.
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| LUNAR: Safety and Efficacy Evaluation of Nadofaragene Firadenovec Instilled into the Renal Pelvis in Subjects with Low-Grade UTUC: A Single-Arm, Open-Label Phase 1/2 Trial
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| Seth Lerner, MD, FACS
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| The LUNAR phase 1/2 trial is evaluating nadofaragene firadenovec, a quarterly gene therapy instilled into the renal pelvis, as a kidney-sparing, non-surgical treatment for patients with low-grade UTUC who currently face high recurrence rates after endoscopic management and limitations with mitomycin gel. It will enroll 20 patients in the US and Europe, with primary endpoints of complete response at 3 or 6 months and safety through 30 months, and results expected in 2029.
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| Patient Experiences with UGN-102 for Recurrence LG-IR-NMIBC: Insights for Shared Decision Making
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| Ruchika Talwar, MD
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| Ruchika Talwar reported that in patients with recurrent low-grade, intermediate-risk NMIBC, six weekly instillations of UGN-102 maintained stable quality-of-life scores and were generally experienced as less invasive, less painful, and less disruptive than repeat TURBT. Most interviewed patients preferred UGN-102 over surgery, though a minority favored TURBT for its one-day convenience, underscoring the need for individualized, shared decision-making.
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| SWOG-2427: Single Arm Phase II Study of Bladder Preservation with Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients with MIBC (BRIGHT)
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| Leslie Ballas, MD, FASTRO
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| SWOG S2427 (BRIGHT) is a single-arm phase II trial testing whether patients with MIBC who achieve ≤T1 disease after guideline-concordant neoadjuvant therapy can preserve their bladder using consolidative radiotherapy plus one year of pembrolizumab instead of radical cystectomy. The study, activated in September 2025 with a planned enrollment of 111 patients, aims to demonstrate a 3-year bladder-intact event-free survival of at least 70%, with secondary endpoints including local control, metastasis-free and overall survival, salvage cystectomy rates, and toxicity.
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| Trastuzumab Deruxtecan in Pretreated Patients with HER2-Expressing Bladder Cancer: Final Results from the Bladder Cancer Cohort in Part 1 of DESTINY-PanTumor02
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| Kyung Hae Jung, MD
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| In the DESTINY-PanTumor02 bladder cancer cohort, trastuzumab deruxtecan produced a 41.5% objective response rate in 41 pretreated patients with HER2-expressing urothelial carcinoma, with higher responses in IHC 3+ tumors but meaningful activity also in IHC 2+ disease, alongside a median progression-free survival of 7.0 months and overall survival of 12.8 months.
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| Avelumab in Combination with Other Anticancer Agents as 1L Maintenance Treatment of Advanced UC: Primary Analysis from the JAVELIN Bladder Medley Phase 2 Trial
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| Jeannie Hoffman-Censits, MD
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| In the phase 2 JAVELIN Bladder Medley trial, first-line maintenance avelumab plus sacituzumab govitecan significantly prolonged progression-free survival versus avelumab alone, while combinations with M6223 or NKTR-255 did not show clear PFS benefit over monotherapy. Overall survival data are still immature but trend in favor of all avelumab-based combinations, with higher but manageable rates of treatment-related adverse events compared with avelumab alone.
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| ECOG ACRIN EA8291 Cohort C: A Phase II Trial of Neoadjuvant Gemcitabine/Durvalumab in Patients with High Grade UTUC Ineligible for Cisplatin-Based Chemotherapy
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| Jeannie Hoffman-Censits, MD
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| This phase II ECOG ACRIN EA8291 Cohort C study tested neoadjuvant gemcitabine plus durvalumab in cisplatin-ineligible patients with localized high-grade UTUC undergoing planned radical nephroureterectomy. Among 30 treated patients, the regimen was feasible and generally tolerable, achieving a 10% pathologic complete response rate and 33% downstaging to <ypT2N0/x, with an estimated 1-year event-free survival of 65.5% and no unexpected safety signals.
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| A Phase II Clinical Trial of Neoadjuvant Sasanlimab and Stereotactic Body Radiation Therapy as an in Situ Vaccine for Cisplatin-Ineligible MIBC: The RAD VACCINE MIBC Clinical Trial
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| Raj Satkunasivam, MD, MS, FRCSC
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| This phase II RAD VACCINE MIBC trial tested neoadjuvant sasanlimab plus SBRT as an in situ vaccine in cisplatin-ineligible cT2–4aN0M0 MIBC before cystectomy. The regimen was feasible and well tolerated, achieving a 44.8% pathologic complete response rate and 75.9% downstaging to ≤pT1, with two-year metastasis-free survival of 92.3% in patients with pCR versus 56.3% without, supporting further evaluation of this chemo-free neoadjuvant strategy.
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