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Atezolizumab plus chemotherapy versus placebo plus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis results from a randomised, controlled, phase 3 study by Enrique Grande; José Á Arranz; Maria De Santis; Aristotelis Bamias; Eiji Kikuchi; Xavier Garcia del Muro; Se Hoon Park; Ugo De Giorgi; Boris Alekseev; Marina Mencinger; Kouji Izumi; Fabio A Schutz; Javier Puente; Jian-Ri Li; Peter H O'Donnell; Arash Rezazadeh Kalebasty; Dingwei Ye; Sanjeev Mariathasan; FabioIa Bene-Tchaleu; Sandrine Bernhard; Chooi Lee; Ian D Davis; Matthew D Galsky is a Medicine article available to read on EtoBox.

What is Atezolizumab plus chemotherapy versus placebo plus chemotherapy in untreated locally advanced or metastatic urothelial carcinoma (IMvigor130): final overall survival analysis results from a randomised, controlled, phase 3 study about?

Background IMvigor130 demonstrated statistically significant investigator-assessed progression-free survival benefit with first-line atezolizumab plus platinum-based chemotherapy (group A) versus placebo plus platinum-based chemotherapy (group C) in patients with locally advanced or metastatic urothelial carcinoma. Overall survival was not improved in interim analyses. Here we report the final overall analysis for group A versus group C. Methods In this global, partially blinded, randomised, controlled, phase 3 study, patients (aged ≥18 years) with previously untreated locally advanced or metastatic urothelial cancer and who had an Eastern Cooperative Oncology Group performance status of 0-2 were enrolled at 221 hospitals and oncology centres in 35 countries. Patients were randomly assigned (1:1:1), with a permuted block method (block size of six) and an interactive voice and web response system, stratified by PD-L1 status, Bajorin risk factor score, and investigator's choice of platinum-based chemotherapy, to receive atezolizumab plus platinum-based chemotherapy (group A), atezolizumab monotherapy (group B), or placebo plus platinum-based chemotherapy (group C). Sponsors, investig

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Author

Enrique Grande; José Á Arranz; Maria De Santis; Aristotelis Bamias; Eiji Kikuchi; Xavier Garcia del Muro; Se Hoon Park; Ugo De Giorgi; Boris Alekseev; Marina Mencinger; Kouji Izumi; Fabio A Schutz; Javier Puente; Jian-Ri Li; Peter H O'Donnell; Arash Rezazadeh Kalebasty; Dingwei Ye; Sanjeev Mariathasan; FabioIa Bene-Tchaleu; Sandrine Bernhard; Chooi Lee; Ian D Davis; Matthew D Galsky

Publisher

Elsevier BV

Published

2024

Language

EN

Field

Medicine (Health Sciences)