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 rationale of the IMvigor130 trial in urothelial cancer.

Urothelial cancer has a high mutational burden and the more mutations a tumor has, the more the tumor releases tumor antigens, explains Grande. Therefore, according to Grande, the stimulation of the immune system will be better with atezolizumab (Tecentriq) as the checkpoint inhibitor.

The purpose of the IMvigor130 trial is to examine the synergy between chemotherapy plus immunotherapy, says Grande. Chemotherapy is used to release more neoantigens into the microenvironment of the tumor, which may enhance the activity of the immune system in addition to the action of the atezolizumab, concludes Grande.

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Enrique Grande, MD, discusses the rationale of the IMvigor130 trial in urothelial cancer.

Dr. Grande on the Rationale of the IMvigor130 Trial in 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.

Enrique Grande, MD, discusses the design of the phase III IMvigor130 trial, which compared atezolizumab plus chemotherapy versus atezolizumab monotherapy (arm B) versus standard chemotherapy plus placebo in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

Enrique Grande, MD

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Dr. Grande on the Rationale of the IMvigor130 Trial in Urothelial Cancer

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