The 2026 ASCO Genitourinary Cancers Symposium showcased pivotal advances across renal, prostate and bladder cancers. Key late-breaking trials across kidney, prostate and bladder cancer highlighted promising combinations, novel targeted therapies and innovative radioligand approaches, demonstrating improved disease control, progression-free survival and tolerability. These findings could reshape standards of care and offer new options for high-risk genitourinary patients. Below, we break down the key presentations, take-home messages and data not to miss.
Renal cell carcinomaLITESPARK-022: Promising DFS with pembrolizumab + belzutifan in ccRCC
Presented by: Toni Choueiri (Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA)
The late-breaking phase III LITESPARK-022 (LBA418) trial tested adjuvant pembrolizumab + belzutifan versus pembrolizumab + placebo in 1,841 high-risk ccRCC patients post-nephrectomy. After 28.4 months median follow-up, disease-free survival (DFS) improved with the combination (HR 0.72, 95% CI 0.59–0.87; P=0.0003); 24-month DFS was 80.7% vs 73.7%. Overall survival (OS) was immature. Grade ≥3 adverse events were more frequent with the combination (52.1% vs 30.2%). These important findings support DFS benefit and a potential new standard of care.
LITESPARK-011: PFS and ORR benefit of belzutifan + lenvatinib in RCC
Presented by: Robert Motzer (Memorial Sloan Kettering Cancer Center, New York, NY, USA)
The late-breaking phase III LITESPARK-011 trial (LBA417) randomized 747 advanced ccRCC patients progressing after anti–PD-(L)1 therapy to belzutifan 120 mg + lenvatinib 20 mg daily versus cabozantinib 60 mg. Bel + lenva improved progression-free survival (PFS) at both interim analyses and overall response rate (ORR) at IA1, with median duration of response (DOR) 23.0 months vs 12.3 months. Grade ≥3 adverse events occurred in 84.1% vs 82.7%. OS favoured bel + lenva but did not reach statistical significance.
AVION: Safety and efficacy of avelumab + axitinib in advanced renal cell carcinoma
Presented by: Axel Merseburger (Department of Urology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany)
The AVION study (Abstract 438) shows first-line avelumab plus axitinib (Ave + Axi) is effective and tolerable in real-world advanced RCC. Among 104 patients in Germany, Greece, Belgium and Russia, median OS was not reached (12-/24-month OS: 81.8%/69.2%), median PFS 11.1 months, ORR 48.4%, and disease control 80.2%. Treatment-related adverse events (TRAEs) occurred in 68.3% (grade ≥3: 19.2%; diarrhea 27.9%), with health-related quality of life (HRQoL) stable throughout treatment.
Prostate cancerFirst results of the PEACE-2 randomized phase III trial
Presented by: Karim Fizazi (Centre Oscar Lambret, University of Paris Saclay, Lille, France)
In the late-breaking phase III PEACE-2 trial (NCT01952223/LBA307), adding cabazitaxel to standard ADT plus radiotherapy in very-high-risk localized prostate cancer did not improve outcomes. Among 761 patients, cabazitaxel (n=381) vs no cabazitaxel (n=380) showed similar 6-year cPFS (67.2% vs 71.4%; HR 1.11) and OS >85%. Grade ≥3 toxicity was higher with cabazitaxel (65% vs 47%). Investigators conclude it should not be added in this setting.
PAnTHa: Promising early-phase results for novel alpha-emitter 225Ac-PSMA-Trillium
Presented by: Fred Saad (Urologic Oncology, University of Montreal Hospital Centre (CHUM), Montreal, QC, Canada)
In the phase I PAnTHa trial (Abstract 19/NCT06217822), 225Ac-PSMA-Trillium showed promising activity and manageable safety in metastatic castration-resistant prostate cancer. Fifty patients received 75–150 kBq/kg every 6 weeks (≤4 doses). No dose-limiting toxicities or treatment-related deaths occurred. Grade ≥3 TEAEs occurred in 38% (lymphopenia 20%). Among 24 evaluable patients, ORR was 46%, DCR 83%, with PSA50/PSA90 rates of 58%/36% overall and 83%/58% at 125 kBq/kg.
PSMAddition improves rPFS without clinically meaningful HRQoL deterioration
Presented by: Michael Morris (Memorial Sloan Kettering Cancer Center, New York, NY)
The phase III PSMAddition trial (NCT04720157) showed that adding [177Lu]Lu-PSMA-617 (7.4 GBq q6w ×6) to ADT plus ARPI significantly improved rPFS in PSMA-positive metastatic hormone-sensitive prostate cancer (HR 0.72; 95% CI 0.58–0.90; p = 0.002) without meaningful HRQoL decline. Among 1,144 patients, grade ≥3 AEs were 50.7% versus 43.0%. Time to worsening of HRQoL and pain had HRs >1.0 but <1.2, 95% CIs including 1.0.
MEVPRO-3: Mevrometostat Plus Enzalutamide in ARPI-Naïve Prostate Cancer
MEVPRO-3 (Abstract TPS284) is a global, double-blind, phase III trial evaluating mevrometostat, a selective EZH2 inhibitor, plus enzalutamide versus placebo plus enzalutamide in ~1,000 ARPI-naïve patients with metastatic castration-sensitive prostate cancer. The primary endpoint is radiographic progression-free survival (rPFS). Phase I data showed rPFS 14.3 vs 6.2 months (HR 0.51). Secondary endpoints include overall survival, PSA progression, CRPC onset and patient-reported outcomes, testing whether EZH2 inhibition delays resistance and improves outcomes.
Bladder cancerKEYNOTE-B15: EV + Pembrolizumab Boosts Survival in Muscle-Invasive Bladder Cancer
Presented by: Matthew Galsky (Mount Sinai Tisch Cancer Center, New York, NY, USA)
The late-breaking phase III KEYNOTE-B15 trial (LBA630) evaluated neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) versus cisplatin/gemcitabine in 808 cisplatin-eligible muscle-invasive bladder cancer patients. After 33.6 months, EV + pembro improved event-free survival (NR vs 48.5 mo; HR 0.53; 24-mo 79.4% vs 66.2%), overall survival (HR 0.65; 24-mo 86.9% vs 81.3%), and pathological complete response (55.8% vs 32.5%). Grade ≥3 skin reactions were most common. Results support EV + pembro as an effective perioperative option.
RC48G001: Disitamab Vedotin Shows High Response in HER2-Expressing Advanced UC
Presented by: Thomas Powles (Barts Cancer Centre, Queen Mary University of London, Royal Free NHS Service Trust, London, UK)
The late-breaking RC48G001 (LBA631) trial assessed disitamab vedotin (DV), a HER2-targeted ADC, in previously treated advanced urothelial carcinoma. In this global phase II trial, 73 HER2-positive (Cohort A) and 78 HER2-low (Cohort B) patients received 1.5 mg/kg every 2 weeks. Confirmed ORRs were 54.9% (CR 16.9%) and 52.6% (CR 18.4%), with median PFS 5.7 months and OS 20.0 vs 17.0 months. Grade ≥3 TRAEs occurred in 41.1%, mostly fatigue. DV showed strong efficacy with manageable toxicity.
Citation: ASCO GU26: What’s new and what you need to know. touchONCOLOGY. 5th March, 2026.
Disclosure: This article was created by the touchONCOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
Editor: Sophie Nickelson (Editorial Director).
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