Roche’s combination therapy of atezolizumab (Tecentriq) plus chemotherapy improved progression-free survival (PFS) in patients with previously-untreated advanced bladder cancer, according to new data from a phase 3 study.
 
Urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 80% of cases, with 30% considered advanced based on muscle-invasive or metastatic disease, according to Roche. 
 
The study, IMvigor130, is the first to assess the combination therapy in this patient population. There are currently 4 ongoing phase 3 clinical trials evaluating atezolizumab alone and in combination with other medications in early and advanced bladder cancer.
 
In the IMvigor130 trial, 1213 patients with previously-untreated, locally advanced or metastatic urothelial carcinoma (mUC) were randomized to receive either atezolizumab plus platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin), atezolizumab alone, or platinum-based chemotherapy plus a placebo. The study evaluated the efficacy and safety of atezolizumab in combination with chemotherapy or alone versus chemotherapy, with co-primary endpoints of overall survival (OS) and PFS.
 
At this interim analysis, the combination of atezolizumab plus chemotherapy showed a statistically significant reduction in the risk of disease worsening or death compared with chemotherapy alone. Additionally, encouraging OS results were observed, but the data are not yet mature, according to the study.
 
The safety of the combination therapy appeared consistent with the known safety profiles of the individual medicines and no new safety signals were identified.
 
“IMvigor130 is the first positive phase 3 study of a cancer immunotherapy combination in previously untreated advanced bladder cancer, an aggressive disease with high unmet need,” Sandra Horning, MD, chief medical officer and head of global product development at Roche, said in a statement. “These results support our broad clinical development program 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.”
 
Atezolizumab is currently approved, either alone or in combination with other therapies, in various forms of non-small cell and small cell lung cancer, certain types of mUC, and in PD-L1 positive triple-negative breast cancer.
 
References
 
Roche’s Tecentriq plus platinum-based chemotherapy reduced the risk of disease worsening or death in people with previously untreated advanced bladder cancer [news release]. Roche. https://www.roche.com/media/releases/med-cor-2019-08-05.htm. Accessed August 5, 2019.