Tecentriq Plus BCG Does Not Improve Outcomes in Some With Bladder Cancer

Combining Tecentriq (atezolizumab) with Bacillus Calmette-Guérin (BCG) therapy did not lead to better outcomes compared with BCG alone for patients with high-risk, non–muscle-invasive bladder cancer (NMIBC) who had not previously received BCG treatment. These findings, shared at the 2025 European Society for Medical Oncology (ESMO) Congress, showed that the addition of Tecentriq did not significantly improve the time patients lived without their cancer returning or worsening.

The findings, presented by Dr. Morgan Roupret, professor of urology at Sorbonne University in Paris, France, and simultaneously published in the Annals of Oncology, reported 73 events of 262 patients in the experimental combination arm versus 72 of 255 patients in the single-agent BCG arm. Events were defined as high-grade or low-grade NMIBC relapse, persistence of carcinoma in situ (CIS) after 6 months, progression of disease, appearance of upper tract urothelial carcinoma, or death of any cause.

“You don’t have to be a statistician to see the [Kaplan-Meier] curves are very close to one another,” Roupret said during the presentation.

Regarding the secondary end point of high-grade recurrence-free survival (RFS), defined as reappearance of high-grade NMIBC or death of any cause, there was also no improvement in the experimental arm. Data were not yet mature for an analysis of overall survival (OS), but there was no impact on the median survival with the addition of Tecentriq.

Side Effects Associated With Tecentriq and BCG Combination

Any-grade treatment-related side effects were reported in 94% (240 patients) and 76% (189 patients) of patients in the experimental and control arms, respectively. Grade 3 or higher and serious side effects occurred in 23% (58 patients) of those receiving Tecentriq and 9% (22 patients) of those receiving BCG only, and in 24% (60 patients) and 8% (21 patients) of patients, respectively.

Side effects leading to dose interruption occurred in 18% (47 patients) of the experimental arm versus 8% (9 patients) of the control arm. Treatment withdrawal due to side effects occurred in 29% (73 patients) and 9% (22 patients) of patients, respectively. In the experimental arm, 13% (32 patients) withdrew from BCG only, 16% (41 patients) withdrew from Tecentriq only, and 3% (8 patients) withdrew from both.

“Side effects such as rash and pruritus were common and consistent with previously published data. There was no particular surprise,” Roupret said.

How the ALBAN Trial Evaluated Tecentriq Plus BCG in High-Risk Bladder Cancer

The ALBAN study enrolled 517 patients who were BCG-naive with high-risk NMIBC after first- and second-look transurethral resection of bladder tumor (TURBT). High risk was defined as the presence of any high-grade or grade 3 Ta or T1 tumors and/or CIS. Patients were also required to have no metastatic disease in the pelvis, abdomen, or chest and an ECOG performance status of 0 to 2.

Patients were randomized 1:1 to receive BCG once a week for 6 weeks during the induction phase and once a week for 3 weeks at 3, 6, and 12 months during the maintenance phase, with or without Tecentriq, which was administered at 1200 mg intravenously every 3 weeks for up to 1 year.

The primary end point was EFS, and key secondary end points included high-grade RFS, progression-free survival, OS, duration of response, safety, and quality of life.

Understanding the ALBAN Study Population in High-Risk NMIBC

Patient characteristics were balanced between the treatment arms. The median age was 68 years in the combination arm versus 67 years in the control arm. Male patients comprised 84% (221 patients) of the experimental arm and 87% (221 patients) of the control arm.

Roupret noted that the only notable discrepancy between arms was smoking history. In the experimental arm, 66% (173 patients) identified as former smokers and 19% (50 patients) as current smokers. In the control arm, 62% (157 patients) were former smokers and 15% (38 patients) were current smokers.

What’s Next for NMIBC Treatment After the ALBAN Trial?

Roupret concluded that future research will focus on biomarker-driven patient selection based on integrated molecular and spatial immune profiling. He also emphasized the need to optimize the timing, duration, and delivery route of checkpoint inhibitors in NMIBC.

References:

1. "ALBAN: A phase 3, 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)," by Dr. Morgan Roupret. Presented at: ESMO 2025 Congress; Oct. 17–20, 2025; Berlin, Germany. Abstract LBA107.
2. "ALBAN (GETUG-AFU 27): A phase 3, randomized, open-label, international trial of intravenous atezolizumab and intravesical Bacillus Calmette-Guérin (BCG) versus BCG alone in BCG-naïve high-risk, non-muscle invasive bladder cancer (NMIBC)," by Dr. Morgan Roupret. Annals of Oncology.