Roche says data from a Phase II trial of its PD-L1 inhibitor atezolizumab showed that the therapy shrank tumours in patients with a particular type of bladder cancer, thereby meeting its primary goal.
The IMvigor 210 study evaluated the safety and efficacy of the monoclonal antibody in people with locally advanced or metastatic urothelial bladder cancer, regardless of PD-L1 expression, whose disease had progressed despite prior treatment.
While specifics are still being kept under wraps, the drug giant said patients expressing the highest level of PD-L1 exhibited the greatest response to its treatment, which picked up a breakthrough designation in the US last year.
Roche is “encouraged by the number of people who responded to atezolizumab and maintained their response during the study because minimal progress has been made in advanced bladder cancer for nearly 30 years,” said chief medical office Sandra Horning, and she noted that results will be presented at an upcoming medical meeting and discussed with health authorities “to bring a new treatment option to patients as soon as possible”.
The Swiss drugmaker has is also currently running a randomised Phase III study, IMvigor 211, pitting atezolizumab against standard-of-care chemotherapy in people who have relapsed UBC, and a planned Phase III study, IMvigor 010, will evaluate the drug 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). All studies include the evaluation of a companion test developed by Roche Diagnostics to determine PD-L1 status.
All-in-all there are 11 ongoing or planned Phase III studies of atezolizumab across certain kinds of lung, kidney, breast and bladder cancer.