(UroToday.com) The 2025 ESMO annual meeting featured a urothelial carcinoma proffered paper session and a presentation by Dr. Morgan Roupret discussing ALBAN, a phase 3, randomized, open-label, international study of IV atezolizumab and intravesical BCG versus BCG alone in BCG-naïve high-risk non muscle-invasive bladder cancer. Non muscle invasive bladder cancer represents 75% of patients with urothelial tumors, and the standard of care for high-risk non muscle-invasive bladder cancer patients is transurethral resection of the bladder tumor followed by BCG intravesical instillations. According to the EAU guidelines, BCG maintenance therapy should be given for a duration of 1 to 3 years. However, BCG therapy still fails in 30 – 40% of patients. Prior studies suggest that PD-L1 expression and alterations in immune infiltration might be associated with BCG failure. Atezolizumab, a monoclonal anti-PD-L1 antibody, has demonstrated a favorable safety profile and clinical activity in early phase studies when combined with BCG in both BCG-naïve and BCG-unresponsive high risk non muscle invasive bladder cancer patients. The ALBAN study aimed to compare the combination of atezolizumab + BCG versus BCG for BCG-naïve patients with high-risk non muscle-invasive bladder cancer.
Eligible patients with histologically confirmed non muscle-invasive bladder cancer with high-risk features, no prior BCG therapy, ECOG performance status 0-2 were randomized 1:1 to BCG (6-weekly instillations followed by 3-weekly maintenance instillations at 3, 6, 12 months [Arm A]) or atezolizumab (1200 mg IV every 3 weeks for up to 1 year) combined with BCG delivered as in Arm A (Arm B). Randomization was stratified by the presence of CIS, and the primary endpoint was event free survival. Key secondary endpoints included high-grade recurrence free survival, overall survival, and safety. The trial design for ALBAN is as follows:
Between December 2018 to October 2023, a total of 517 patients were randomized to Arm A (n = 255) or Arm B (n = 262). The mean age was 67.4 years (range: 29-91), 85.5% of patients were men, most patients had an ECOG performance status of 0 (88.6%), 39.1% were diagnosed with the presence of CIS at inclusion, including 7.0% of pure CIS, 39.5% had T1 tumor, and 21.3% had high grade Ta:
Among the 517 randomized patients, 505 (97.7%) received at least one dose of trial treatment:
At the data cut-off date of January 9, 2025, the median follow-up was 35.3 months (range: 0-60). There was no statistically significant difference in event free survival between arms (HR 0.98, 95% CI 0.71-1.36, p = 0.9106):
Event free survival results were consistent across all prespecified subgroups, including CIS population:
The high-grade recurrence free survival was similar between arms (stratified HR 1.06, 95% CI 0.73-1.55; p = 0.7658):
Overall survival in the intention to treat population was immature, with only 25 overall events (HR 1.73, 95% CI 0.76-3.92):
Grade ≥3 treatment-related adverse events occurred in 8.8% and 22.7% of patients in Arm A and Arm B:
The most common adverse events were cystitis (1.2%) in Arm A, and urinary tract disorder (2.0%) and pollakiuria (1.2%) in Arm B:
Dr. Roupret concluded his presentation discussing ALBAN with the following take home points:
- BCG + atezolizumab showed no significant improvement in event free survival versus BCG alone (HR 0.98, 95% CI: 0.71–1.36; p = 0.9106)
- The safety profile of the treatment combination was consistent with that of the individual agents
- Higher rates of treatment related adverse events and grade ≥3 treatment related adverse events were observed in the combination arm compared to BCG alone
- Future directions include:
- Biomarker-driven patient selection based on integrated molecular and spatial immune profiling
- Optimization of the timing, duration, and delivery route of checkpoint inhibitors in non muscle invasive bladder cancer
Presented by: Morgan Roupret, MD, PhD, Pitié-Salpêtrière University Hospital, Sorbonne University, AP-HP, Paris, France
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2025 European Society of Medical Oncology (ESMO) Annual Meeting, Berlin, Germany, Fri, Oct 17 – Tues, Oct 21, 2025.
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ALBAN Trial Analysis: Evaluating Atezolizumab Addition to BCG Therapy in High-Risk, Non-Muscle-Invasive Bladder - Morgan Rouprêt
ALBAN (GETUG-AFU 37): A Phase 3, Randomized, Open-Label, International Trial of Intravenous Atezolizumab and Intravesical Bacillus Calmette-Guérin (BCG) Versus BCG Alone in BCG-Naive High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC).
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ALBAN (GETUG-AFU 37): A Phase 3, Randomized, Open-Label, International Trial of Intravenous Atezolizumab and Intravesical Bacillus Calmette-Guérin (BCG) Versus BCG Alone in BCG-Naive High-Risk, Non-Muscle Invasive Bladder Cancer - Beyond the Abstract