Roche announced that the Phase III IMvigor130 study met its co-primary endpoint of investigator-assessed progression-free survival.
The combination of Tecentriq® (atezolizumab) plus platinum-based chemotherapy showed a statistically significant reduction in the risk of disease worsening or death in people with previously untreated locally advanced or metastatic urothelial carcinoma compared with chemotherapy alone. Encouraging overall survival results were observed at this interim analysis; however, these data are not yet mature and follow-up will continue until the next planned analysis.
Safety in the Tecentriq plus chemotherapy arm appeared consistent with the known safety profiles of the individual medicines and no new safety signals were identified with the combination. Results will be presented at an upcoming medical meeting and shared with health authorities globally, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
“IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer, an aggressive disease with high unmet need,”
said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development.
“These results support our broad clinical development programme for Tecentriq in bladder cancer, as well as our approach of combining immunotherapy with chemotherapy or other medicines to improve patient outcomes, and we look forward to discussing them with health authorities.”
Tecentriq was the first cancer immunotherapy approved in bladder cancer. Currently, there are four ongoing Phase III studies evaluating Tecentriq alone and in combination with other medicines in early and advanced bladder cancer. Roche has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.