30May

Another missed trial of the ASCO 2020 as Adjuvant treatment with the PD-L1 inhibitor did not significantly improve disease-free survival (DFS) in patients with muscle-invasive bladder cancer

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


Results:

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.


Conclusion:

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.


Commentary:

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.


Refer to Urothelial Carcinoma Market report for detailed Insights.