Katy Beckermann

FDA approved talazoparib plus enzalutamide for HRR-mutated mHSPC/APMN based on TALAPRO-3. 📜 Combination vs enzalutamide: rPFS HR 0.48, 36-month rPFS 77% vs 56% 🧬 BRCA1/2 HR 0.37 and non-BRCA HRR HR 0.57, post hoc, with wide intervals, so no BRCA-specific claim ⚠️ Grade 3 or 4 events 79% vs 41% 🔍 OS is immature, interim HR 0.77 with a CI crossing 1 👉 https://t.co/hbbsFhNCuz #ProstateCancer #ProstateCA #GUonc

Day 2 of #ASCO26 in GU oncology covered all three diseases, and the through-line was personalization: who needs more, who needs less, and who needs testing first. Prostate 🎯 TALAPRO-3: TALA + ENZA cut progression risk 52% in HRR-altered mCSPC (rPFS HR 0.481), benefit beyond BRCA 🎯 ZZFIRST: EZ + TALA, 73% PSA <0.2 in high-volume mHSPC, with on-treatment biopsies showing the adaptive biology 🎯 ARACOG: first US randomized head-to-head on cognition, enza declined more than daro at 24 wks 🎯 A-DREAM: 41% of exceptional responders stayed treatment-free 18 mo after stopping ADT + ARPI Bladder 🎯 RAD-IO: single arm feasibility, durvalumab + chemoRT, bladder-preserving, with strong early DFS in MIBC Kidney 🎯 RAMPART: adjuvant durvalumab ± tremelimumab in RCC, both IO arms moved the same direction, durva mono signal did not reach significance More tomorrow. #ProstateCA #BladderCancer #RCC #GUonc #ASCO26 @OncoAlert

TALAPRO-3 met its primary endpoint: talazoparib + enzalutamide cut the risk of progression or death by 52% vs enzalutamide alone in HRR gene-altered mCSPC (rPFS HR 0.481, 95% CI 0.357 to 0.647, p<0.0001). Phase 3, 599 pts, first-line HRR-altered mCSPC, randomized 1:1 to TALA + ENZA vs placebo + ENZA. Median follow-up ~38 mo. 🎯 Median rPFS: NR vs 45.8 mo (HR 0.481, p<0.0001) 📊 BRCAm subgroup HR 0.37, non-BRCAm HR 0.57. The benefit was consistent, not BRCA-driven 📊 Interim OS trend favors the combination (HR 0.767, 95% CI 0.564 to 1.044, p=0.09), still immature 📊 No clinically meaningful PRO decline vs ENZA alone, despite the added drug 🔍 Toxicity is the trade. Anemia 71% (24% G≥3), 60% needed a TALA dose reduction, and AEs of special interest included 3 MDS and 2 AML in the combination arm. The mCSPC space is getting crowded. #⃣The number that should change practice today is upstream: you cannot offer this without HRR testing, and early molecular testing in prostate cancer is still the rate-limiting step. Congrats to the team. @neerajaiims NEJM 👉https://t.co/y1kTHe6fne #ProstateCA #mCSPC #GUonc @OncoAlert

CAPItello-281 OS at 42% maturity: median 57.4 vs 46.5 months with capivasertib + abiraterone, HR 0.82, p=0.044. Descriptive, with a CI upper bound of 0.99, supports the primary rPFS result The outcomes from control arm emphasizes clinical need and aggressive biology 46.5 months median OS on abiraterone alone in PTEN-deficient mHSPC. #ProstateCancer #mHSPC #GUonc #ESMO26

PTEN loss is associated with worse outcomes in prostate cancer. Now there's a way to act on it in the hormone-sensitive setting. 🎯 CAPItello-281: capivasertib + abiraterone improved rPFS in PTEN-deficient mHSPC, 33.2 vs 25.7 mo, HR 0.81. FDA approved this month, PTEN by IHC. ⚠️ The AKT inhibitor adds hyperglycemia, diarrhea, and rash, including grade 3 rash. 🏥 Plan for it: check glucose at baseline and on treatment with metformin ready, antihistamine prophylaxis for rash, loperamide early for diarrhea (onset around day 9). Why this matters for your practice: 💡 The supportive care and counseling need to be set up early before the first dose. What are you recommendations for handling glucose and skin monitoring for these patients? 🩺 👉CAPItello-281 full results: https://t.co/FRpQO9hmJO #ProstateCancer #GUOnc

New FDA approval: Frontline mHSPC keeps splitting by biology. The aggressive PTEN-deficient subset, driven by PI3K/AKT signaling, now has its own combo. 🎯 CAPItello-281: capivasertib + abiraterone in de novo PTEN-deficient mHSPC 📈 Median rPFS 33.2 vs 25.7 mo (HR 0.81, p=0.034) 👥 6,003 screened to randomize 1,519, a measure of what PTEN selection takes ⚠️ Grade ≥3 AEs 67% vs 40%, mostly early rash, hyperglycemia, diarrhea; QoL maintained Why this matters for your practice: 💡 A new biomarker-defined intensification option, but we can only catch these patients if PTEN is tested at diagnosis! With docetaxel, PARP combos, and now capivasertib all as options, how are you choosing intensification in HSPC: by volume, by biomarker, or by fitness? Congrats to @Daniel_J_George and the whole team on an enormous effort. 👏 #ProstateCancer #mHSPC #GUOnc #PrecisionOncology

VOLGA: perioperative durvalumab with 3 cycles of neoadjuvant EV improved EFS and OS in cisplatin-ineligible or cisplatin-refusing MIBC, n=695. 📈 EFS HR 0.51, OS HR 0.58. 24-mo OS 78% vs 69% 📝 EV stopped at surgery. Durvalumab continued for 9 adjuvant cycles, and pCR was 45% vs 10% ⚠️ Adding tremelimumab: OS HR 0.77, p=0.12, grade 3-4 AEs 70% vs 64% Tremelimumab added toxicity without a significant OS gain at this interim, final OS pending. Congrats to the team and wonderful to see ctDNA and QoL in this presentation! @tompowles1 #BladderCancer #MIBC #GUonc #ESMO26

EV-303: EFS HR 0.40, OS HR 0.50 with 9 EV cycles. VOLGA gave 3, all neoadjuvant. future trials hopefully begin to ask what to do for component of parts adjuvant e.g. ctDNA neg no adjuvant unless converting to positive, ctDNA positive or lack of pCR switching ADC or MOA in the adjuvant setting.

✈️ En route to Madrid for #ESMO26, landing just in time for the data to start Friday morning. Most excited for: VOLGA LBA2 in bladder cancer, INTerpath-001's first phase 3 neoantigen win, LITESPARK-011 final in kidney cancer, and DASL-HiCaP in prostate. What a week ahead 🔬 #GUonc

Day 1 GU at #ASCO26. 🎯 EV-302, 3.5 years: median OS 33.6 vs 15.9 months (HR 0.53), 44% alive at 42 months. Two-thirds of CRs converted from PR with a median of 5 more EV cycles. Dose interruptions in 75.5% of patients on treatment >1 year, reductions in 65.8%. Staying on it requires active reduction and dose holds. @tompowles1 🔬 Post-EV: LY4052031 (Nectin-4, Topo-I payload, NEXUS-01) in EV-pretreated mUC (n=15): ORR 40% (6/15), DCR 80%, median DoR 7 months. EV-naive ORR 67%. No responses in prior Topo-I ADC-exposed patients. EV-signature toxicities rare. CYP2D6 genotyping required. @IyerGopa 🏥 HRQOL got a dedicated session. In the curative intent setting, how patients live through treatment is a primary endpoint. Periop cisplatin is out. Whether current PRO tools are measuring what patients actually experience remains an open question. 📊 KEYNOTE-564 ctDNA substudy: ctDNA positive at baseline = 24-mo DFS 18.3%, median 6.4 months on placebo. ctDNA negative = 72.9%, median 80.7 months. Strong prognostic signal when positive, but detectable in only 5-8% at baseline; sensitivity just 10-15%. Most relapsers are ctDNA-negative. Not ready to guide treatment selection. @DrChoueiri 🦴 RADICAL trial: radium-223 did not improve symptomatic skeletal event-free survival when added to cabozantinib in RCC with bone mets. Trial closed at interim for futility. A numerical OS trend favored the combination (32.2 vs 21.3 months) but did not reach significance. @DrRanaMcKay More to come Day 2. #BladderCancer #KidneyCancer #ASCO26 #GUonc

EV-302 updated OS data at ASCO 2026. After 3.5 years of follow-up, the separation is holding. Median OS: 33.6 vs 15.9 months. HR 0.53 (95% CI 0.45-0.63). At 42 months, 44% of EV+P patients alive vs 24.6% on chemotherapy. Outcomes: 🎯 CR rate approximately doubled: 30.4% (EV+P) vs 14.5% (chemo) 📊 Among confirmed CRs in the EV+P arm: mOS not estimable, >80% alive at 3.5 years The CR deepening story is the standout finding: 🔍 Many patients who achieved CR started as a PR, converting with a median of 5 additional EV cycles. 🔍 Dose interruptions were high in long-term patients (75.5% for EV in those on treatment >1 year), with dose reductions in 65.8%. Managing this regimen over years requires active dose titration, not a passive approach. One more point platinum-based chemo retained activity after EV+P, with an ORR of ~21% in evaluable patients. SOC control for future drug development These are the kind of long-term data that reframe how we think about functional cure in urothelial cancer. Congrats to the team. @tompowles1 #BladderCancer #UrothelialCA #ASCO26 #GUonc

EV+pembro is now first-line standard after EV-302 (updated at #ASCO26). 6 urothelial trials at ASCO 2026 are already testing what follows, 3 in Phase 3. 📈 Two TROP-2 strategies: Dato-DXd post-EV/pembro (TROPION-Uro03) + SG+pembro in ICI-resistant mUC (EA8231) Ph1: CD28×Nectin-4 costimulatory bispecific (RNDO-564) + trispecific TCE (CD3, CD2, and NKG2D ligands) both are novel T-cell strategies 🏥 ENLIGHTED: padeliporfin VTP Phase 3 for low-grade upper tract UC 🔬 novel photodynamic therapy Why this matters for your practice: 💡 TROP-2 is leading the 2L mUC charge, but the early-phase pipeline is testing a different unique MOA entirely: T-cell costimulation and multi-target engagement. What are you using 2L after EV+pembro today? 🩺 My go to: FGFR3 targeting, Her2 targeting, carbo/gem #BladderCancer #UrothelialCancer #GUOnc #ASCO26 @tompowles1 @AmandaNizamMD @PGrivasMDPhD

DASL-HiCaP: darolutamide on top of 96 weeks of ADT plus RT improved MFS in very high-risk localized prostate cancer, HR 0.42, 4-yr MFS 95% vs 88%. 📈 n=1,106, interim at 67% of events, 46 mo follow-up. OS immature 📝 Thanks to @Silke_Gillessen putting this into context STAMPEDE M0 (HR 0.53) and ENZARAD (HR 0.88): not contradictory, the ARPI benefit tracks metastatic risk 🎯 N1 is the clearest indication. N0 is less clear, and Gleason seems to matter Every patient got pelvic RT, so who needs it in N0 not yet answered. @Niazi_Dr7 #ProstateCancer #GUonc #ESMO26

✈️ En route to Madrid for #ESMO26, landing just in time for the data to start Friday morning. Most excited for: VOLGA LBA2 in bladder cancer, INTerpath-001's first phase 3 neoantigen win, LITESPARK-011 final in kidney cancer, and DASL-HiCaP in prostate. What a week ahead 🔬 #GUonc

KEYNOTE-B15 ctDNA analysis, cis-eligible MIBC: EV plus pembro cleared ctDNA more often than cis-gem. 📈 Presurgery ctDNA negative: pCR 72.4% vs 43.7% 📊 24-month EFS if cleared 81.1% vs 63.2%, if ctdna persistent 33.3% vs 35.3% 🔍 Presurgery ctDNA positive: pCR only in 2 of 72 across both arms ctDNA is prognostic in both arms. Persistent positivity does poorly on either regimen, and know seeing trial designs to address. #ESMO26 #BladderCancer #MIBC #ctDNA #GUonc

🔥 KEYNOTE-B15 is practice-changing and redefines perioperative management in cis-eligible MIBC. EV + pembrolizumab significantly improved: 📊 pCR: 55.8% vs 32.5% 📊 EFS: HR 0.53 📊 OS: HR 0.65 Yes, toxicity was higher (grade ≥3 AEs: 76% vs 67%), but this is the clearest signal yet that peri-op EVP can improve curative-intent outcomes and should reshape how we treat patients. 🚨 #ASCOGU26 #GU26 #BladderCancer #ClinicalTrials

✈️ En route to Madrid for #ESMO26, landing just in time for the data to start Friday morning. Most excited for: VOLGA LBA2 in bladder cancer, INTerpath-001's first phase 3 neoantigen win, LITESPARK-011 final in kidney cancer, and DASL-HiCaP in prostate. What a week ahead 🔬 #GUonc

Belzutifan + lenvatinib is now FDA approved for advanced ccRCC after PD-(L)1. The clinical impact from LITESPARK-011 is durability. ⏳ Median DOR 23.0 vs 12.3 mo with cabozantinib 📈 Still responding at 24 mo: 49.5% vs 25.5% 🎯 mPFS 14.8 vs 10.7 mo, HR 0.70. OS HR 0.85, not yet significant (final readout OS ESMO 2026) 🔍 The trial excluded anyone hypoxic or on O2 and anyone with NYHA III/IV heart failure. Belzutifan lowers Hgb by suppressing EPO, and the combo label adds a cardiac dysfunction warning. I check baseline SpO2, Hgb and LVEF. Next up 🧬 PEAK-1: casdatifan + cabo vs cabo after IO LITESPARK-033: belzutifan + zanzalintinib vs cabo after adjuvant IO LITESPARK-034: belzutifan + zanzalintinib vs belzutifan after IO and a TKI 👉 https://t.co/bF0wfFAWGg #RCC #KidneyCancer #GUonc

Fitting to see LITESPARK-022 quality-of-life data debut at a patient-advocacy-led meeting. @tompowles1 presenting at #KCRS26. Adjuvant pembro + belzutifan adds reversible grade 3+ toxicity, but the PROs are reassuring: 📊 Symptoms stable, side-effect bother "not at all/a little bit" for >78% 🔍 Physical and role functioning dipped on treatment, then recovered to match placebo 🎯 No clinically meaningful PRO change at week 84 The DFS gain does not come at a lasting quality-of-life cost. Awaiting OS data🩺 #KidneyCancer #RCC #KCRS26 @kidneycan

I wrote about where belzutifan fits across the RCC continuum in @OncJournal. Today's adjuvant approval (LITESPARK-022) sits right next to LITESPARK-011 in the post-PD-(L)1 setting, where belzutifan + lenvatinib beat cabozantinib on PFS (14.8 vs 10.7 mo, HR 0.70) and ORR (53% vs 40%) and most impactful nearly doubled duration of response. The throughline: earlier HIF-2α targeting may buy durability, but patient selection and careful monitoring of toxicity, and OS immature in both datasets 👉 https://t.co/UdmAtLjpoy