Bladder Cancer

A recap of the FDA submissions and regulatory decisions in urology from October 2025.

Explore the evolving landscape of non-muscle invasive bladder cancer treatments, focusing on the promising gene therapy detalimogene voraplasmid and its trial results.

Petros Grivas, MD, PhD, touches on the signficance of KEYNOTE-905 data, which were presented at ESMO 2025.

Christof Vulsteke, MD, PhD, discusses results from the KEYNOTE-905 trial, evaluating perioperative EV/pembrolizumab in cisplatin-ineligible MIBC.

According to the authors, immune-mediated adverse events were manageable and consistent with the known profiles for ICIs.

Preliminary data from the study are promising.

The code, J9282, will be effective on January 1, 2026.

Three cycles of chemotherapy was shown to improve patient-reported outcomes vs six cycles, with no detriment to overall survival.

The findings revealed that patients prioritized improvements in overall survival and reductions in cancer recurrence at 5 years over all other treatment factors

The PDUFA target action date for the application is April 7, 2026.

Chan shares how her passion for research and desire to impact patients on a broader scale led her from academia to industry.

In patients who were ctDNA positive, median DFS was 9.9 months (95% CI: 7.2-12.7) in the atezolizumab group vs 4.8 months (95% CI: 4.1-8.3) in the placebo group.

Enrique Grande, MD, shares key findings from the DISCUS trial, exploring 3 vs 6 cycles of platinum-based chemotherapy for advanced urothelial carcinoma.

“This is the first trial to show an overall survival benefit in this population,” Christof Vulsteke, MD, PhD, noted.

Andrea Necchi, MD, reported a pCR rate of 38% (95% CI: 28-49) for cohort 1 vs 28% (95% Ci: 16-44) for cohort 2.

“POTOMAC met its primary end point of disease-free survival in the ITT [intent-to-treat] population," said Maria De Santis, MD.

The data continue to support adjuvant nivolumab as a standard of care for patients with high-risk muscle-invasive urothelial carcinoma.

“With 5 years of follow-up, median overall survival is longer with nivolumab vs placebo on interim analysis," said Matthew D. Galsky, MD.

"The addition of perioperative durvalumab to neoadjuvant chemotherapy significantly improved event-free survival and overall survival without adversely affecting patient-reported outcomes,” said Michiel van der Heijden, MD, PhD.

Data from the phase 3 ALBAN trial showed that atezolizumab plus BCG did not improve EFS compared with BCG alone.

Andrea Necchi, MD, shares key findings from the phase 2 GDFather-NEO trial, presented at ESMO 2025.

Apolo highlighted the positive topline results from the phase 3 EV-303 trial (NCT03924895) evaluating EV plus pembrolizumab in cisplatin-ineligible patients with muscle-invasive bladder cancer.

"My pragmatic takeaway is that for patients who experience spasm or leak despite anticholinergics, this is a great thing to consider," says Mark D. Tyson II, MD, MPH.