Site Editor

Thomas Flaig, MD


ASCO 2022: Can N-803 Plus BCG Improve Outcomes in Non–Muscle-Invasive Bladder Cancer?

By: Victoria Kuhr, BA
Posted: Monday, June 13, 2022

Karim Chamie, MD, of the University of California, Los Angeles, and colleagues reported that intravesical N-803 plus bacillus Calmette-Guérin (BCG) may prove to be an effective therapeutic strategy for patients with BCG-unresponsive high-grade non–muscle-invasive bladder cancer. Additionally, with 2 years of follow-up, the bladder cancer–specific overall survival was 99% with intravesical N-803 plus BCG, and cystectomy was avoided in more than 90% of patients. These findings were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4508).

The study enrolled patients with BCG-unresponsive high-grade non–muscle-invasive bladder cancer. All patients were treated with intravesical N-803 plus BCG. The primary endpoint for cohort A (carcinoma in situ) was the incidence of complete response of carcinoma in situ at any time. The primary endpoint for cohort B (papillary) was disease-free rate at 12 months.

Of the 160 patients enrolled in the study, 83 were in cohort A and 77 were in cohort B. In the overall population, the median age was 72 years, and 81% were male. The mean number of prior transurethral resections of bladder tumor was four. The median number of prior BCG doses was 12.

Patients with carcinoma in situ had a complete response rate of 71%, with a median duration of response of 24.1 months. In patients with papillary cancer, the 12-month disease-free survival rate was 57%, the 24-month disease-free survival rate was 48%, and and 95% avoided cystectomy. The median time before cystectomy in four responders was 12.9 months compared with 7.8 months in eight nonresponders.

The most common grade 1 or 2 treatment-related adverse events were dysuria (22%), pollakiuria (19%), hematuria (18%), fatigue (16%), and urgency (12%). There were no reports of treatment-related grade 4 or 5 adverse events or immune-related adverse events.

Disclosure: For full disclosures of the study authors, visit

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.