Bladder Cancer

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.

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.

"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 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.

In part 2 of this 4-part series, Ravi D. Chauhan, MD, FACS, and R. Jonathan Henderson, MD, examine how collaboration among urologists and pathologists, along with renewed attention to bladder mapping techniques, may improve CIS detection in NMIBC.

In this opening segment, Ravi D. Chauhan, MD, FACS, and R. Jonathan Henderson, MD, discuss how underreporting of CIS in pathology reports may limit access to guideline-supported therapies for patients with NMIBC.

Maria Carmen Mir, MD, PhD, discusses how phase 3 trials of BCG/ICI combinations are shaping the future of high-risk NMIBC management, emphasizing the need for a more selective approach to treatment intensification.

The safety profile for BCG–gem/doce was favorable, which the authors suggested may “potentially increase compliance with maintenance regimens.”

Song Jiang, MD, discusses evolving biomarker approaches that may redefine care in NMIBC.