NEW YORK – Oncolytics Biotech said on Tuesday that it has dosed its first patient in a Phase II study of a pelareorep-based combination therapy in hormone receptor-positive, HER2-negative breast cancer.
Patients in the study, called BRACELET-1, will be randomized to one of three arms: pelareorep and the chemotherapy paclitaxel; pelareorep and paclitaxel along with the PD-L1 checkpoint inhibitor avelumab (Merck KGaA/Pfizer's Bavencio); or paclitaxel alone. The study will take place at 20 sites and enroll 45 patients into each cohort.
Pelareorep is derived from a reovirus containing double-stranded RNA, which can help trigger immune reactions to cancer cells.
In a Phase II study published in 2017, women with HR-positive, HER2-negative breast cancer treated with pelareorep and chemotherapy lived twice as long as those in the control arm receiving just chemotherapy. The randomized BRACELET-1 study is designed to expand upon the results of the company's earlier breast cancer studies.
The primary endpoint in BRACELET-1 is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments. Additionally, investigators are hoping to validate peripheral T cell clonality as a biomarker of pelareorep response in HR-positive, HER2-negative metastatic breast cancer, which according to the company, "may aid in future registrational trial study design and patient selection."
Amgen is also studying the effects of a virus and immune checkpoint inhibitor combination in a Phase III trial of melanoma patients.