Dr. Grande on the IMvigor130 Trial in Metastatic Urothelial Cancer

Enrique Grande, MD, head of the Medical Oncology Service, head of Clinical Research of the MD Anderson Foundation Spain, MD Anderson Cancer Centre Madrid, Spain, discusses the design of the phase III IMvigor130 trial, which compared atezolizumab plus chemotherapy (arm A) versus atezolizumab (Tecentriq) monotherapy (arm B) versus standard chemotherapy plus placebo (arm C) in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

In the IMvigor130 trial, 1213 patients were randomized to 1 of the 3 arms and stratified according to PD-L1 expression, explains Grande. The co-primary endpoints of the trial were progression-free survival and overall survival (OS) in arm A versus arm C, and OS in arm B versus arm C with a hierarchical approach, says Grande.

At the interim analysis of the study, median overall survival was 16.0 months in the atezolizumab/chemotherapy arm and 13.4 months in the placebo/chemotherapy arm (HR, 0.83; 95% CI, 0.69-1.00; one-sided P = .027). These results were clinically meaningful but did not cross the prespecified interim efficacy boundary for significance.