Roche Group member Genentech has reported positive results from the Phase III IMvigor130 combination trial of Tecentriq (Atezolizumab) and platinum-based chemotherapy.
The trial of the cancer immunotherapy combination reduced the risk of disease worsening or death in people with previously untreated locally advanced or metastatic urothelial carcinoma (mUC) compared to chemotherapy alone.
The multi-centre, partially blinded, randomised Phase III IMvigor130 trial evaluated the efficacy and safety of Tecentriq in combination with chemotherapy or versus chemotherapy alone for people with mUC.
A total of 1,213 subjects were enrolled and randomised to receive Tecentriq plus platinum-based chemotherapy, Tecentriq alone, or platinum-based chemotherapy alone.
The study met its co-primary endpoint of investigator-assessed progression-free survival (PFS).
Genentech observed encouraging overall survival (OS) results from this interim analysis, however this data is yet to be matured and follow-up will continue until the next planned analysis.
Genentech Global Product Development chief medical officer and head 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.”
Four Phase III trials are currently evaluating monoclonal antibody Tecentriq alone and in combination with other medicines in early and advanced bladder cancer.
The co-primary endpoints in the Tecentriq combination arm are OS and PFS as assessed by investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Tecentriq binds with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells and blocks its interactions with both PD-1 and B7.1 receptors.
The antibody may enable the re-activation of T cells by inhibiting PD-L1.