IMvigor010: Primary analysis from a phase III randomized study of adjuvant atezolizumab (atezo) versus observation (obs) in high-risk muscle-invasive urothelial carcinoma (MIUC)
Abstract No : 5000
Abstract Type : Oral Abstract Session
Indication : high-risk muscle-invasive urothelial carcinoma (MIUC)
Intervention : Atezolizumab
Company : Roche
Technology : Monoclonal antibody
The ITT population included 809 pts (median follow-up, 21.9 mo). In the atezo and obs arms, respectively, 48% and 47% had NAC; 7% and 6% had UTUC as primary disease; 48% each had LN+ disease. DFS and OS are in Table. Baseline prognostic/clinical factors did not influence DFS tx benefit; stratified HR was 0.81 (95% CI: 0.63, 1.05) in IC0/1 pts (PD-L1 , 5%; n = 417) and 1.01 (0.75, 1.35) in IC2/3 pts (PD-L1 $ 5%; n = 392). 16% of atezo-treated pts had a txrelated G3-4 AE. Skin and gastrointestinal toxicities most commonly led to tx discontinuation.
IMvigor010, the first phase 3 adjuvant study of a checkpoint inhibitor in MIUC, did not meet its primary EP of DFS. More tx discontinuation due to AEs was seen vs mUC studies. Safety was generally consistent with previous studies.
Adjuvant treatment with the PD-L1 inhibitor did not significantly improve disease-free survival (DFS) versus observation in patients with muscle-invasive bladder cancer, and missed the trial’s primary end point.