Durvalumab in Combination With Bacillus Calmette-Guerin For Bacillus Calmette-Guerin-Naive High-Risk Non-Muscle-Invasive Bladder Cancer: Primary Results From a US-Based, Phase IIIb, Open-Label, Single-Arm, Multicenter Study (PATAPSCO)

Document Type

Conference Proceeding

Publication Date

5-2026

Publication Title

Journal of Urology

Abstract

INTRODUCTION AND OBJECTIVES: The standard of care for bacillus Calmette-Guerin (BCG)-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC) has been transurethral resection of bladder tumor (TURBT) followed by BCG induction and maintenance (IþM) therapy. Recently, the results of the phase III POTOMAC trial inpatients (pts) with BCG-naïve, high-risk NMIBC demonstrated a statistically significant and clinically meaningful improvement in disease-free survival with 1 year of durvalumab (D) in combination with BCG (IþM) vs BCG (IþM) alone. We report the results from aUS-based phase IIIb safety study of D plus BCG (IþM) in pts with BCG-naïve, high-risk NMIBC.METHODS: Pts were ≥18 years of age with BCG-naïve, local histologically confirmed high-risk NMIBC who had undergone complete resection of Ta/T1 papillary disease with TURBT (pts with residual carcinoma in situ were eligible). Pts received D (1500 mg Q4W for 13cycles for a maximum of 12 months [mo]) plus BCG (I+M; weekly  × 6 weeks [I] and 3 weekly doses for up to 24 mo [M]). The primary endpoint was the incidence of grade 3 or 4 adverse events (AEs)possibly related to treatment that occurred within 6 mo of study treatment initiation. RESULTS: At a median safety follow-up of 10.8 mo (data cutoff on June 16, 2025), enrollment was complete with 99 pts having received any of the 2 study treatments. Median age was 70.0 years and most pts were male (85.9%); 43 (43.4%) pts had papillary tumor stage Ta and 48 (48.5%) had T1. Twelve pts (12.1%; 95% CI,6.4e20.2) had a grade 3 or 4 AE that was possibly related to any study treatment (investigator assessed) and occurred within 6 mo of treatment initiation. 18 (18.2%) pts discontinued treatment due to an AE possibly related to D, and 4 (4.0%) discontinued treatment due to an AE possibly related to BCG. Overall safety data are summarized in the table. One pt had a serious AE (myocardial infarction)unrelated to study treatment that led to death. CONCLUSIONS: In pts with BCG-naïve, high-risk NMIBC, 1year of D in combination with BCG (IþM) showed a manageable safety profile consistent with that of the individual therapies. No new safety signals were identified

Volume

215

Issue

5S

First Page

e497

Last Page

e498

Comments

American Urological Association Annual Meeting, May 15-18, 2026, Washington, DC

DOI

10.1097/01.JU.0001191408.90885.ae.07

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