Mark Tyson, MD, highlights additional safety data on durvalumab plus BCG in BCG-naive NMIBC

In the following interview, conducted at the 2026 American Urological Association Annual Meeting in Washington, DC, Mark D. Tyson II, MD, MPH, discussed findings from the phase 3b PATAPSCO study (NCT05943106) evaluating durvalumab (Imfinzi) in combination with induction and maintenance BCG in patients with BCG-naïve, high-risk non–muscle-invasive bladder cancer (NMIBC).¹ Tyson is a urologic oncologist at Mayo Clinic in Phoenix, Arizona.

PATAPSCO was designed as a US-based follow-on study to the global phase 3 POTOMAC trial (NCT03528694), which previously demonstrated a disease-free survival benefit with the addition of durvalumab to BCG induction and maintenance therapy in high-risk NMIBC. Tyson explained that whereas POTOMAC enrolled patients entirely outside the United States, PATAPSCO was intended to evaluate the safety and feasibility of the regimen specifically in a US population treated with TICE BCG.

The single-arm, open-label phase 3b study enrolled 99 patients with BCG-naïve, high-risk NMIBC following complete TURBT. Approximately half (48.5%) of participants had T1 disease, and 43.4% had papillary tumor stage Ta. Patients received durvalumab 1500 mg every 4 weeks for up to 13 cycles over 1 year in combination with BCG induction followed by maintenance therapy for up to 24 months. The primary end point was the incidence of treatment-related grade 3 or 4 adverse events occurring within 6 months of treatment initiation, with secondary analyses evaluating immune-mediated adverse events and efficacy outcomes.

At a median safety follow-up of 10.8 months, 12.1% of patients experienced a treatment-related grade 3 or 4 adverse event possibly related to treatment within the primary 6-month assessment window. Immune-mediated adverse events occurred in about 20% of patients, with 5% experiencing grade 3 or higher events. Most immune-related toxicities were thyroid-related and were generally manageable with corticosteroids, dose interruption, or discontinuation. Treatment discontinuation due to adverse events occurred in 18.2% of patients for durvalumab-related toxicity and 4.0% for BCG-related toxicity.

REFERENCE

1. Jayram G, Shore ND, Tyson M, et al. DURVALUMAB IN COMBINATION WITH BACILLUS CALMETTE-GUéRIN FOR BACILLUS CALMETTE-GUéRIN-NAÏVE, HIGH-RISK NON-MUSCLE-INVASIVE BLADDER CANCER: PRIMARY RESULTS FROM A US-BASED, PHASE IIIB, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY (PATAPSCO). J Urol. 2026;215(5S):e497. doi:10.1097/01.JU.0001191408.90885.ae.07