Bladder Cancer

Gopa Iyer, MD, reviews early NEXUS-01 data evaluating the investigational anti–Nectin-4 ADC LY4052031, highlighting the importance of CYP2D6-guided dosing to optimize safety.

"Ultimately, integrating robust, disease-specific PROs into routine bladder cancer care represents a key step toward more truly patient-centered management," write the authors.

The NCCN recommends that clinicians consider using ctDNA-MRD testing to stratify risk and guide the use of adjuvant immunotherapy in patients who have not previously received an immune checkpoint inhibitor.

This decision marks the first approval of a PD-1 inhibitor plus antibody-drug conjugate regimen in the EU.

Eugene Pietzak, MD, highlights results from a phase 2 study of pembrolizumab plus BCG for patients with very high-risk, BCG-naive high-grade T1 NMIBC who declined upfront radical cystectomy.

Sandip Prasad, MD, discusses 3-year data from the phase 3 ENVISION trial evaluating mitomycin for intravesical solution for recurrent low-grade intermediate-risk non–muscle-invasive bladder cancer.

In this episode of The UroOnc Minute, Carissa Chu, MD, discusses the prevalence, biology, prognostic significance, and emerging molecular targets of variant histologies in bladder cancer.

Abigail Keller shares findings showing that nadofaragene firadenovec is associated with increased urine production during instillation compared with gemcitabine/docetaxel.

The primary end point—12-month DFS rate—was 80% (40/50 evaluable patients; 95% CI, 0.67-0.89), with 2 patients pending assessment and 3 not evaluable.

"Together with the efficacy and safety results, these PRO findings support the overall benefit-risk profile of perioperative EV plus [pembrolizumab] as the new standard of care in this patient population," said Peter H. O'Donnell, MD.

Study investigator Gopa Iyer, MD, concluded that LY4052031 represents a promising next-generation Nectin-4 ADC with a distinct payload mechanism that may overcome EV resistance in mUC.

"These data help inform patient decision-making regarding adjuvant therapy and also point to a possible need for supportive services to help survivors after treatment," said Ronald C. Chen, MD, MPH, FASCO, FASTRO.

At a median follow-up of 42.8 months, median OS was 33.6 months (95% CI, 26.6–39.8) with EV+P (240 events/442 patients) vs 15.9 months (95% CI, 13.6–18.3) with chemotherapy (329 events/444 patients).

"Twenty-seven of 40 patients achieved a pCR amounting to a rate of 68%. Therefore, the null hypothesis could be rejected," said Richard Cathomas, MD.

Christof Vulsteke, MD, PhD, shares in-depth insights on the 3.5-year analysis of the EV-302 trial, evaluating enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma.

The approval is supported by data from the phase 3 POTOMAC trial.

The application is supported by data from the phase 3 KEYNOTE-905/EV-303 trial.

Mark D. Tyson II, MD, MPH, discusses findings from the phse 3b PATAPSCO study, evaluating durvalumab plus BCG for patients with BCG-naïve, high-risk NMIBC.

Vesta Bladder Risk Stratify Dx applies AI foundation models to H&E pathology slides obtained during routine clinical care to generate prognostic risk assessments.

The agency issued a PDUFA target action date of January 6, 2027.

The phase 1/2 ResQ133A-NMIBC trial (NCT06800963) is evaluating intravesical recombinant BCG in patients with BCG-naïve high-risk NMIBC across US sites, with safety as the primary end point and complete response and disease-free survival as secondary end points, building on European data showing 50% response rates and no dose-limiting toxicities in BCG-unresponsive disease.

Chad A. Reichard, MD, highlights real-world data presented at AUA 2026 on re-induction with nadofaragene firadenovec in patients with BCG-unresponsive non–muscle-invasive bladder cancer.

Adam B. Weiner, MD, is joined by Mary Beth Westerman, MD, FACS, to discuss the landmark CISTO trial—a large pragmatic study examining patient-reported outcomes among individuals with high-risk non–muscle invasive bladder cancer who underwent either bladder-sparing therapy or radical cystectomy.