Bladder Cancer

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

Abigail Keller, MD, 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.

"I think these data clearly support one year of durvalumab in combination with induction maintenance BCG as a potential new treatment for patients with BCG high-risk NMIBC with the appropriate shared decision-making conversation," said Neal D. Shore, MD, FACS.

The agency simultaneously approved the Signatera CDx as a companion diagnostic to identify patients with ctDNA MRD who are eligible for treatment.

A comprehensive guide to the practice-changing, paradigm-shifting studies across urologic oncology.

In the final installment of this 4-part series, Ravi D. Chauhan, MD, FACS, and R. Jonathan Henderson, MD, discuss the clinical value of enhanced cystoscopic imaging technologies and the operational barriers that may limit broader adoption in NMIBC care.

In part 3 of this 4-part series, Ravi D. Chauhan, MD, FACS, and R. Jonathan Henderson, MD, discuss practical strategies for communicating with pathologists when CIS is not clearly addressed in NMIBC pathology reports.