📬 GU Oncology Intelligence Digest — Week 2026-W30

FDA approves perioperative EV plus pembrolizumab for all cystectomy-eligible MIBC; JCOG1403 confirms single intravesical pirarubicin cuts recurrence after nephroureterectomy; long-term OMNIVORE, TRAVERSE CAR-T and adjuvant penpulimab add to the RCC conversation.

⚡ TL;DR

📄 Publications

Single, early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403): a multicentre, open-label, randomised, phase 3 trial. — 3-year relapse-free survival 60.0% vs 47.0% with pirarubicin, HR 0.67, p=0.0066

🐦 Twitter / 🦋 Bluesky

FDA approves perioperative enfortumab vedotin plus pembrolizumab for all cystectomy-eligible MIBC (KEYNOTE-B15/EV-304) — FDA approved perioperative EV plus pembrolizumab for all cystectomy-eligible MIBC regardless of cisplatin eligibility, with EFS HR 0.53 and OS HR 0.65
NICE 2026 kidney cancer guideline highlights incidental early detection — 87% of stage 1a RCC in the UK is diagnosed incidentally
FGFR3 alterations and morphology in urothelial carcinoma — FGFR3 alterations found in 17% of urothelial carcinomas, and 76% of FGFR3-altered tumors showed variant histology
Review of the genomic landscape of aggressive-variant prostate cancer — Review covers the genomic landscape of prostate cancer from targetable alterations to lineage plasticity
TRAVERSE: allogeneic CD70-directed CAR T-cell therapy in advanced RCC — ALLO-316 objective response rate 17.4% overall and 31.3% in phase Ib patients with CD70 TPS >=50%

Full details below ↓

📄 What's Being Published

Manuscripts:

Single, early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403): a multicentre, open-label, randomised, phase 3 trial. — Ito Akihiro et al., Lancet Oncol

In this phase 3 trial, 3-year relapse-free survival was 60.0% (95% CI 51.7–67.3) in the pirarubicin group versus 47.0% (38.7–54.9) in the observation group (HR 0.67 [90.96% CI 0.50–0.88]; p=0.0066). The most common grade 3–4 adverse event was haematuria, which occurred in four (3%) patients receiving pirarubicin and none in the observation group.

Clinical bottom line: A single postoperative intravesical pirarubicin instillation after radical nephroureterectomy reduces bladder recurrence with minimal added toxicity.

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EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer. Part II-2026 Update: Treatment of Relapsing and Metastatic Prostate Cancer. — Tilki Derya et al., Eur Urol

The 2026 update documents a broadened treatment landscape for metastatic prostate cancer, encompassing androgen receptor pathway inhibitors (ARPI), metastasis-directed therapy, PARP inhibitors and their combinations, and PSMA-based therapy. The guidelines consolidate evidence across relapsing and metastatic disease settings.

Clinical bottom line: The 2026 EAU prostate cancer guidelines consolidate a broadened set of options for relapsing and metastatic disease, from ARPIs to PSMA-based therapy.

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Targeted Radionuclide Therapy: Current Landscape and Combination Approaches to Improve Oncology Outcomes. — Nonnekens Julie et al., Clin Cancer Res

The review notes that most patients eventually relapse following targeted radionuclide therapy (TRT) monotherapy, leaving room to further improve patient outcomes. This limitation motivates the evaluation of combination strategies to build on the established role of TRT in prostate cancer.

Clinical bottom line: Targeted radionuclide therapy is established in prostate cancer, and combination regimens are the next frontier to overcome monotherapy relapse.

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Adjuvant penpulimab in very-high risk clear cell renal cell carcinoma: a prospective, non-randomized, controlled phase II trial with integrated plasma multi-omics analyses. — Wang Yaohui et al., J Immunother Cancer

Adjuvant penpulimab was associated with improved DFS compared with surveillance (HR 0.37; 95% CI 0.16 to 0.89; p=0.026), with 1-year DFS rates of 94.25% versus 80.46% and 2-year DFS rates of 88.68% versus 75.38% favoring the penpulimab group (log-rank p=0.026); OS data remained immature. The trial was conducted in patients with very-high risk clear cell RCC following nephrectomy.

Clinical bottom line: Adjuvant penpulimab improved disease-free survival with a manageable safety profile in very-high risk ccRCC after nephrectomy.

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Comprehensive clinical cancer analysis of homologous recombination deficiency biomarkers in an academic molecular profiling program. — Domènech Heura et al., NPJ Precis Oncol

HRD was more frequent in high-grade ovarian cancer (HGOC; 52%) than in metastatic breast (mBC; 12%) or prostate cancer (mPC; 20%). Longitudinal ctDNA sequencing revealed BRCA1/BRCA2 reversion mutations in more than 30% of post-PARPi mBC samples, which were associated with poor response to subsequent platinum therapy.

Clinical bottom line: Complementary HRD biomarkers in tissue and liquid biopsy, including RAD51 and genomic instability scoring, extend PARP inhibitor patient selection beyond mutation testing.

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Application of a translational research platform to unveil efficacy signals and mechanisms of resistance of FGFR inhibitors in multiple FGFR-altered solid tumors. — Hierro Cinta et al., Clin Cancer Res

Exploratory proteomic analysis of archival tumor samples showed FGFR1–4 protein expression in 78% of FGFR1/2-amplified tumors detected by FISH. Among patients harboring FGFR mutations, only one bladder cancer with a FGFR3-mut S249C derived benefit.

Clinical bottom line: FGFR mRNA expression may better reflect FGFR dependency than genomic alterations alone, refining patient selection for FGFR-targeted therapy.

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Allogeneic CD70-Targeted Chimeric Antigen Receptor T-Cell Therapy for Advanced Renal Cell Carcinoma: Results From the Phase I TRAVERSE Trial. — Srour Samer A et al., J Clin Oncol

The objective response rate was 17.4% overall, 25.0% in phase Ib patients, and 31.3% in phase Ib patients with CD70 tumor proportion score ≥50%. Grade ≥3 cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome occurred in 2.0%, 0%, and 6.0% of patients, respectively.

Clinical bottom line: Allogeneic CD70-directed ALLO-316 CAR T cells showed manageable safety and encouraging activity in heavily pretreated CD70-positive ccRCC, a proof of concept for CAR T in solid tumors.

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Genomic Classification to Predict Survival in Metastatic Prostate Cancer: Development of Somatic Tumor Risk Assessment for Overall Survival-Prostate. — Schoen Martin W et al., JCO Precis Oncol

Classification into intermediate and unfavorable groups was associated with increased mortality relative to the favorable group (adjusted HR 1.54 [95% CI 1.33 to 1.78] and aHR 2.37 [95% CI 1.97 to 2.485], respectively), with an average AUC of 0.83. The STRATOS-P tool was developed and validated for overall survival prediction in metastatic prostate cancer.

Clinical bottom line: The STRATOS-P genomic classification is a validated prognostic tool for overall survival in metastatic prostate cancer.

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🗣️ What People Were Discussing This Week

How these are chosen: filtered for clinical relevance, grouped by the new development discussed, then ordered by engagement (bookmarks and reposts).

FDA approves perioperative enfortumab vedotin plus pembrolizumab for all cystectomy-eligible MIBC (KEYNOTE-B15/EV-304)

The FDA approved perioperative enfortumab vedotin plus pembrolizumab for all cystectomy-eligible muscle-invasive bladder cancer regardless of cisplatin eligibility, based on a 47% reduction in the risk of recurrence, progression, or death (EFS HR 0.53) and a 35% reduction in the risk of death (OS HR 0.65). Trial data showed 2-year EFS of 79.4% versus 66.2%, 2-year OS of 86.9% versus 81.3%, and a pathologic complete response rate of 55.8% versus 32.5%. With a platinum-free perioperative regimen now established, clinicians are debating whether some patients may achieve cure without proceeding to cystectomy.

Discussed by: @neerajaiims, @OncBrothers, @nataliagandur, @OncoAlert

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NICE 2026 kidney cancer guideline highlights incidental early detection

The NICE 2026 kidney cancer guideline drew attention to the fact that 87% of stage 1a RCC in the UK is diagnosed incidentally, underscoring how challenging early detection remains in everyday clinical practice. The central question for clinicians is how risk-adapted pathways should handle detection and follow-up when the majority of early-stage diagnoses are chance findings.

Discussed by: @EladSharonMD, @Ric_Campi

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FGFR3 alterations and morphology in urothelial carcinoma

FGFR3 alterations were identified in 17% of urothelial carcinomas, with S249C and Y373C accounting for most mutations; notably, 76% of FGFR3-altered tumors exhibited variant histology, most commonly micropapillary (39%) and squamous differentiation (21%). FGFR3 alterations occur in approximately 15–20% of MIBC/mUC, and in the THOR trial erdafitinib improved OS versus chemotherapy in FGFR-altered mUC (12.1 vs 7.8 months, HR 0.64, p=0.005). The pattern of variant histology enrichment raises the practical question of whether histologic features can help identify which urothelial tumors should be prioritized for FGFR3 testing.

Discussed by: @LiangChengMD, @OncoAlert

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Review of the genomic landscape of aggressive-variant prostate cancer

A review covering the genomic landscape of prostate cancer — from targetable alterations to lineage plasticity and therapeutic strategies — prompted oncologists to consider whether the field is ready to identify and treat aggressive-variant prostate cancer beyond AR and BRCA. The debate centers on translating comprehensive genomic characterization into actionable clinical decisions for this difficult-to-treat population.

Discussed by: @OncoAlert, @neerajaiims

→ View representative tweet

TRAVERSE: allogeneic CD70-directed CAR T-cell therapy in advanced RCC

Results from the phase I TRAVERSE trial of ALLO-316 showed an objective response rate of 17.4% overall, 25.0% in phase Ib patients, and 31.3% in phase Ib patients with CD70 tumor proportion score ≥50%. Grade ≥3 cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome occurred in 2.0%, 0%, and 6.0% of patients, respectively. The central question for specialists is whether these results establish a genuine role for allogeneic CAR T-cell therapy in refractory solid tumors such as ccRCC.

Discussed by: @RielyMD, @Cancer_Buzz

Adjuvant penpulimab prolongs disease-free survival in very-high risk ccRCC

In a non-randomized phase II trial, adjuvant penpulimab significantly prolonged disease-free survival versus surveillance in very-high risk ccRCC post-nephrectomy (HR 0.37, p=0.026), with 1-year DFS of 94.3% versus 80.5%, 2-year DFS of 88.7% versus 75.4%, and grade 3–4 treatment-related adverse events in 6.9% of patients; OS data remained immature. Clinicians are weighing whether a non-randomized phase II signal is sufficient to inform adjuvant treatment decisions in this setting.

Discussed by: @CancerNetwrk, @OncoAlert

→ View representative tweet

🔥 Top Ranked Tweets

Neeraj Agarwal, MD, FASCO @neerajaiims

Just in 👉 Great news for our patients! 🎉 The @US_FDA has approved perioperative EV + pembrolizumab for all patients with MIBC who are candidates for cystectomy, regardless of cisplatin eligibility!👏 link👉https://t.co/qHiOymmjib #bladdercancer @OncoAlert https://t.co/7vsI01MAzH

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