Roche’s ‘breakthrough’ immunotherapy atezolizumab was shown to shrink tumours in a Phase II trial involving patients with locally advanced or metastatic non-small cell lung cancer expressing PD-L1.
The Swiss drug giant said the Phase II BIRCH study met its primary endpoint of objective response rate and showed the amount of PD-L1 expressed by a person’s cancer - as determined by an investigational immunohistochemistry test being developed by Roche Diagnostics - was linked to response to the medicine.
“We are encouraged by the number of people who responded to atezolizumab and maintained their response during the study, which is particularly meaningful for people who had received several prior treatments,” said Sandra Horning, Roche’s chief medical officer and head of Global Product Development.
Data from the trial are to be presented at an upcoming medical conference, and the firm said it would discuss the results and those from other studies assessing the monoclonal antibody in lung cancer with global health regulators “to bring this medicine to patients as quickly as possible”.
Earlier this year, the US Food and Drug Administration awarded atezolizumab a Breakthrough Therapy Designation for patients whose NSCLC expresses PD-L1 and who progressed during or after standard treatments.
There are currently 11 ongoing or planned Phase III studies of atezolizumab across certain kinds of lung, kidney, breast and bladder cancer.