Bladder Cancer

Nogapendekin alfa inbakicept was approved in combination with BCG in the US in April 2024.

"If 2025 showed us anything, it is the power of combining scientific progress with public engagement," writes Michael S. Cookson, MD, MMHC, FACS.

The FDA has selected detalimogene voraplasmid to participate in the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program.

The investigators reported a high-grade CR rate at any time of 72.4% (21 of 29 patients).

DFS rate was 85.3% at 6 months (95% CI, 71.6-92.7), 74.3% at 12 months (95% CI, 59.2-84.6), and 69.2% at 18 months (95% CI, 53.4-80.6).

In patients with high-grade T1 disease, high-grade EFS was 100% and 3 months and at 6 months and 87.5% at 9 months.

The overall CR rate was 83.7% (95% CI, 70.3-92.7).

Michael S. Cookson, MD, MMHC, FACS, shares his thoughts on the most exciting recent advances in bladder cancer treatment.

Joshua J. Meeks, MD, PhD, discussed the emerging role of ctDNA in guiding adjuvant and neoadjuvant strategies in patients with bladder cancer.

Forty-one of the 85 patients experienced disease persistence, progression, or recurrence.

The group agreed that the future of NMIBC treatment depends on biomarkers that can direct patients toward the therapy most likely to work.

CR at any time was 92% (23/25 patients), 84% (21/25) at 3 months, 87% (20/23) at 6 months, and 85% (17/20) at 9 months.

INVITE is a 2-part clinical trial designed to evaluate the safety, feasibility, and patient experience of administering intravesical bladder cancer therapies in the home.

The HCPs and AHCPs described insertion and removal of the system to be “straightforward” and done in less than 5 minutes.

At a median follow-up of 25.8 months, the CR rate at any time was 75.5%.

At a median follow-up of 18.8 months, the confirmed ORR was 31%.

Félix Guerrero-Ramos, MD, PhD, FEBU, discusses key findings from the phase 3 POTOMAC trial and other studies of BCG/ICI combinations in high-risk NMIBC.

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

At the 2025 LUGPA Annual Meeting, Joshua J. Meeks, MD, PhD, outlined the rapidly evolving treatment landscape in MIBC.

Schmidt notes that differences in response rates between disease subtypes largely reflect inherent tumor biology.

The data, presented at ESMO, support a role for gemcitabine intravesical system plus cetrelimab in MIBC.

The authors suggested that a greater treatment effect may be observed with a more antigenic vaccine.

AVZO-103 is a Nectin-4/TROP2 biospecific antibody-drug conjugate for adult patients with urothelial carcinoma whose tumors have progressed on enfortumab vedotin.

A key finding was that 86% of patients required no additional therapy after receiving nadofaragene.

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