Oncolytics Biotech and SOLTI Achieve Primary Endpoint in AWARE-1 Study
- Pelareorep and atezolizumab synergize the anti-cancer immune response in HR+/HER2- breast cancer patients
- Pelareorep alone and with checkpoint blockade converts tumors to PD-L1 positive classification
- Oncolytics validates that pelareorep significantly improves immunotherapies
- Company management hosting a KOL event today at 2:00 pm ET
SAN DIEGO and CALGARY, Alberta, April 12, 2021 /PRNewswire/ -- Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), together with SOLTI, recently announced new clinical data from the AWARE-1 window-of-opportunity breast cancer study showing patients receiving pelareorep plus checkpoint blockade therapy met the trial's primary endpoint. These data are featured in an electronic poster at the American Association for Cancer Research (AACR) Annual Meeting 2021 during Week 1, which is taking place virtually from April 10-15, 2021.
In the poster, data from the twenty HR+/HER2- early-stage breast cancer patients included in AWARE-1's first two cohorts are presented. These patients were treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) the PD-L1 inhibitor atezolizumab (Tecentriq) prior to surgery. Evaluation of cohorts 1 and 2 is the core objective of AWARE-1, as HR+/HER2- is the breast cancer subtype Oncolytics intends to examine in a future registrational study.
Pelareorep treatment in cohort 1 upregulated tumor PD-L1 expression, induced the generation and expansion of T cell clones, promoted tumor infiltration of CD8+ T cells, and increased the CelTIL score, a measure of tumor cellularity and inflammation associated with favorable clinical outcomes. These desired outcomes were further enhanced in cohort 2 patients, demonstrating pelareorep and atezolizumab synergistically combine to generate an anti-cancer immune response in the tumor and peripheral blood. Notably, cohort 2 met the pre-specified success criteria for the study's primary endpoint (50% of patients with ≥ 30% increase in CelTIL score), with six of ten patients achieving at least a 30% increase in CelTIL score following treatment.