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news.Swiss drugmaker Roche has reported positive results from a Phase II trial (IMvigor 210 study) of its investigational cancer immunotherapy atezolizumab in people with a specific type of bladder cancer.
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The trial showed that atezolizumab shrank tumors in people with locally advanced or metastatic urothelial bladder cancer (UBC) who had progressed on initial treatment.
High amounts of Programmed Death Ligand-1 (PD-L1) expression by a person’s cancer correlated with increased response to the medicine.
The company noted that adverse events were consistent with what has been previously observed for atezolizumab.
The open-label, multicenter, single-arm Phase II trial evaluated the safety and efficacy of atezolizumab in people with locally advanced or metastatic UBC, regardless of PD-L1 expression.
Patients in the trial were enrolled into one of two cohorts, with the cohort one included people who had received no prior therapies for locally advanced or metastatic UBC, but who were ineligible for first-line cisplatin-based therapy; results from this cohort are not yet mature.
The trial’s second cohort included people whose disease progressed during or following previous treatment with a platinum-based chemotherapy regimen.
During the trial, people received a 1200mg intravenous dose of atezolizumab on day one of 21-day cycles until progressive disease (Cohort one) or loss of clinical benefit (Cohort two).
Secondary endpoints included duration of response (DoR), overall survival (OS), progression-free survival (PFS) and safety. PD-L1 expression was assessed using an investigational immunohistochemistry (IHC) test being developed by Roche Diagnostics.
In 2014, the US Food and Drug Administration (FDA) had granted breakthrough therapy designation for atezolizumab in people whose metastatic bladder cancer expressed PD-L1.
The company is also conducting a randomized Phase III trial (IMvigor 211) which compares atezolizumab with standard-of-care chemotherapy in people who have relapsed UBC.
Additionally, a planned Phase III trial, IMvigor 010, is being carried out to evaluate atezolizumab compared with observation in people with early-stage muscle-invasive bladder cancer who are selected for PD-L1 expression and are at risk for recurrence (adjuvant).