Roche’s ‘breakthrough’ immunotherapy atezolizumab is being given a priority review in the US on the back of Phase II data supporting its potential as a treatment for bladder cancer.
Atezolizumab is being developed to treat locally advanced or metastatic urothelial carcinoma (mUC) in patients with metastatic disease experiencing disease progression during or after platinum-based chemotherapy, or for those whose disease worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.
The US Food and Drug Administration is undertaking a speedy six-month review of the drug on the back of data from the IMvigor 210 study, which showed that it shrank tumours and that the majority of patients responding to treatment continued to do so after nearly a year of follow up.
Data from the Phase II IMvigor 210 trial, which assessed atezolizumab in heavily pre-treated people with locally advanced or metastatic urothelial carcinoma, showed median overall survival of 11.4 months in those with higher levels of PD-L1 expression, and 7.9 months overall.
Also, 84% of patients who responded to the drug continued to do so regardless of their PD-L1 status, when the results were assessed with longer median follow-up of 11.7 months.
“The treatment options available for advanced bladder cancer are very limited, and we are committed to working with the FDA to bring the first anti-PDL1 cancer immunotherapy to people with this disease as quickly as possible,” said Sandra Horning, chief medical officer and head of global product development at Roche.
Atezolizumab also carries breakthrough status in the US, and is also being studied in a number of other cancers.