Bladder Cancer

The study is assessing FL115 in combination with BCG in patients with non-muscle invasive 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.

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.

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

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.

“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.

“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.

The addition of radiation after surgery improved clinical outcomes while not increasing severe late toxicity in this setting.

The review summarizes results from the OPTIMA II, ATLAS, and ENVISION trials.

Here’s a look back at notable news between July and September 2025.

We recap notable headlines from last month in the urologic oncology space.

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

Chad A. Reichard, MD, outlines key findings from the CREST trial, evaluating the combination of sasanlimab plus BCG in patients with high-risk BCG-naïve NMIBC.