ALBAN: An open label, randomized, phase III trial, evaluating efficacy of atezolizumab in addition to one year BCG (bacillus Calmette-Guerin) bladder instillation in BCG-naive patients with high-risk nonmuscle invasive bladder cancer (AFU-GETUG 37).

Abstract

TPS4589 Background: The majority of patients with bladder cancer are diagnosed with non-muscle invasive bladder cancer (NMIBC). Trans-urethral resection of bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG) therapy is the standard of care for most patients with high-risk NMIBC, although clinical outcomes remain poor. Data from preclinical and clinical studies suggest that programmed death-ligand 1 PD-L1 inhibition may enhance antitumor activity of BCG therapy. Atezolizumab, an anti–PD-L1 monoclonal antibody, is approved in the United States and the European Union as monotherapy when patients are ineligible for cisplatin or after prior platinum therapy. This approval was based on the results from phase II and III IMvigor210/211 trials. We have designed ALBAN, a phase III trial to evaluate the efficacy and safety of atezolizumab given in combination with BCG versus BCG alone in patients with high-risk NMIBC. Methods: In 30 centers in France, ALBAN (NCT03799835) is enrolling patients with histologically documented NMIBC who have not received prior BCG therapy. Eligible patients have to have high-risk features (T1 staging, high grade, or in situ carcinoma), ECOG PS 0-2, and a tissue sample for PD-L1 testing (by Ventana SP142 immunohistochemistry assay). Patients are randomized 1:1 to: (Arm A) BCG alone (six weekly instillations of BCG, followed by three weekly maintenance instillations at 3, 6, 12 months), or (Arm B) atezolizumab (1200 mg; IV; q3w for up to 1 year) combined with BCG given as in arm A. Treatment with atezolizumab and BCG are continued in the absence of unacceptable toxicity, for 1 year. The primary endpoint is recurrence-free survival in the intent-to-treat population. Secondary efficacy endpoints include overall survival, PFS, complete response, disease worsening, and quality of life. Safety, biomarkers, and other exploratory endpoints will also be evaluated. Enrollment began in December 2018 with a target of 614 pts. Clinical trial information: NCT03799835.