The study has achieved its co-primary endpoint of investigator-assessed progression-free survival (PFS).
Roche’s combination of Tecentriq plus platinum-based chemotherapy demonstrated a statistically significant reduction in the risk of disease worsening or death (PFS) in people with previously untreated locally advanced or metastatic urothelial carcinoma (mUC) compared with chemotherapy alone.
The promising overall survival (OS) results have been observed at this interim analysis, and follow-up will continue until the next planned analysis, said the company.
The four ongoing phase III studies are assessing Tecentriq alone and in combination with other medicines in early and advanced bladder cancer.
Roche has a comprehensive development programme for Tecentriq, including various ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers.
IMvigor130 is a multicentre, partially blinded and randomised Phase III study designed to assess the efficacy and safety of Tecentriq in combination with chemotherapy or alone versus chemotherapy alone for people with mUC who have not received prior systemic therapy for metastatic disease.
Tecentriq, which was the first cancer immunotherapy approved in bladder cancer, is a monoclonal antibody that will bind to the PD-L1 protein to block its interactions with both PD-1 and B7.1 receptors.
Tecentriq may facilitate the activation of T cells by inhibiting PD-L1. It has the potential to use as a foundational combination partner with other immunotherapies targeted medicines and various chemotherapies across a range of cancers.
Roche global product development head and chief medical officer Dr Sandra Horning said: “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.
“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.”
In July this year, Roche’s flu drug Xofluza (baloxavir marboxil) has achieved primary endpoint in phase III Ministone-2 children study.