Adding atezolizumab to BCG does not improve EFS in BCG-naïve NMIBC

Atezolizumab (Tecentriq) plus BCG did not show improved event-free survival (EFS) compared with BCG alone in patients with BCG-naïve, high-risk non–muscle invasive bladder cancer (NMIBC), according to data from the phase 3 ALBAN trial (NCT03799835) presented at the 2025 European Society for Medical Oncology Congress in Berlin, Germany.¹

“The gold-standard treatment for high-risk NMIBC consists of complete TURBT [transurethral resection of the bladder tumor] and BCG intravesical instillations, induction, and maintenance,” explained lead author Morgan Rouprêt, MD, PhD, during the presentation. “However, BCG therapy is still failing in up to 40% of cases. We all know that atezolizumab is a checkpoint inhibitor, known as a monoclonal anti-PD-L1 antibody, which has demonstrated biological activity against urothelial cancer.”

In total, the open-label study enrolled 517 patients who were randomly assigned 1:1 to receive BCG plus atezolizumab (n = 262) or BCG alone (n = 255). The median duration on treatment was 52 weeks in the combination arm and 53 weeks in the monotherapy arm. The median follow-up in each cohort was 35.35 months (range, 0.03 to 60) and 34.86 months (range, 0.13 to 60), respectively.

The primary end point for the study was EFS, which was defined as high-grade or low-grade NMIBC relapse, persistence of carcinoma in situ (CIS) after 6 months, disease progression, appearance of upper tract urothelial carcinoma, or death due to any cause. Key secondary end points included high-grade recurrence-free survival (RFS), progression-free survival, overall survival (OS), duration of response, safety, and quality of life measures.

At the time of data report, Kaplan-Meier curves showed similar EFS rates between both arms (HR, 0.98; 95% CI, 0.71 to 1.36; P = .9106). Specifically, EFS events occurred in 73 of 262 patients in the combination arm vs 73 of 255 patients in the monotherapy arm. The median EFS was not reached in either arm at the time of data report.

There was no statistically significant impact on EFS across all subgroups assessed.

The rate of RFS events, which included the reappearance of high-grade NMIBC relapse or death due to any cause, was also similar between the 2 arms (HR, 1.06; 95% CI, 0.73 to 1.55; P = .7658). Specifically, high-grade RFS events occurred in 56 of 262 patients in the combination arm vs 52 of 255 patients in the monotherapy arm.

OS data were immature at the time of data report. Based on the interim analysis, the addition of atezolizumab showed no impact on OS (HR, 1.73; 95% CI, 0.76 to 3.92; P = .1799).

The safety profile for the combination was consistent with the known safety profiles of each individual agent. Overall, adverse events (AEs) were reported in 98.8% of patients in the combination arm and 94% of patients in the BCG monotherapy arm. Grade 3 or higher treatment-related AEs occurred in 22.7% of patients in the combination arm and 8.8% of patients in the monotherapy arm.

“As a conclusion, I'd like to mention that BCG plus atezolizumab showed no significant improvement in EFS vs BCG alone with, a hazard ratio close to 1,” Rouprêt said during the presentation. “Of course, one can understand that biomarker by patient selection based on integrated molecular and spatial immune profiling could be interesting in such population to optimize the timing, the duration, and delivery route of checkpoint inhibitors in non-muscle invasive bladder cancer.”

DISCLOSURES: Roupret noted consulting/advisory associations with Johnson & Johnson, Ipsen, BMS, Astellas, Accord Healthcare, AAA, Ferring, Oncodiag, Intuitive, Medtronics, MSD, Pfizer, AstraZeneca, Bayer, Photocure, Provepharm, Thermofisher, Vitadx, Recordati, Besins Healthcare, CG Oncology, Curium, and Roche Genetech

REFERENCE

1. Roupret M, Bertaut A, Pignot G, et al. ALBAN: A phase III, randomized, open-label international study of intravenous (iv) atezolizumab and intravesical Bacillus Calmette-Guérin (BCG) vs BCG alone in BCG-naïve high-risk, non-muscle-invasive bladder cancer (NMIBC). Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. LBA110. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/LBA107.html.pdf