Bladder Cancer

Gal Wald, MD, highlights patient-reported outcomes from a phase 2 trial of intravesical gemcitabine plus BCG for patients with BCG-exposed high-grade NMIBC.

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).

Eugene Pietzak, MD, highlights the background and design of the ongoing phase 3 GAIN trial, exploring the combination of gemcitabine and BCG in BCG-exposed NMIBC.

Siamak Daneshmand, MD, emphasizes that, at present, optimal patient selection remains unclear because resistance mechanisms and predictive biomarkers are not yet well understood.

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.

Laura Bukavina, MD, MPH, offered her thoughts on the significance of the KEYNOTE-905 data and highlighted some remaining questions surrounding the regimen.

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.

Complete response 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.

Health care providers and allied health care professionals described insertion and removal of the system as “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.