Patients with early-stage breast cancer who received pelareorep demonstrated consistent data with safety run-in data and had a favorable toxicity profile, according to an cohort analysis from the window-of-opportunity study, AWARE-1 (NCT04102618).1
Safety parameters were evaluated by a committee of investigators from patients who participated in the safety run-in portion of the trial. The committee determined no safety concerns with this therapy.
“After reviewing the totality of safety data, including patients receiving pelareorep plus the standard of care and those also receiving Tecentriq, the Safety Committee for AWARE-1 confirmed no significant toxicity resulting from treatment,” said Rita Laeufle, MD, PhD, chief medical officer at Oncolytics Biotech. “The study is continuing as planned, recruiting additional patients and examining the combination of pelareorep, plus the standard of care plus Tecentriq.”
An amendment has been made to the study, reducing the dose of TECENTRIQ to be consistent with the currently approved dose of 840 mg for patients with breast cancer. Patients will continue to be enrolled on the study; cohorts 1 and 2 represent the target tumor type, hormone receptor (HR)-positive and HER2-negative. Data from these 2 cohorts will inform the design of the expected phase III study.
The trial is enrolling patients t Read More