RE:RE:Breast cancer treatment: perspectives on the oncolytic virusOn April 12, 2024 ONCY announced that the company would be requesting a “Type C” meeting with the FDA , based on data from the Bracelet-1 breast cancer study.
“The data from the
randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in [patients with] HR-positive/HER2-negative metastatic breast cancer, with a nearly tripled confirmed ORR, a 50% improvement in median PFS, and a hazard ratio of 0.29 compared to the paclitaxel alone control,” Thomas Heineman, MD, PhD, chief medical officer at Oncolytics Biotech, added in the press release.
1 “Importantly, these data support the statistically significant near doubling of median OS in another randomized phase 2 study, IND-213, which also evaluated pelareorep and paclitaxel in [patients with HR-positive/HER2-negative metastatic breast cancer.”
https://www.onclive.com/view/fda-receives-type-c-meeting-request-for-pelareorep-in-hr-her2-metastatic-breast-cancer Correspondingly – from April 02, 2024 - Study reveals immune cell levels as prognostic marker in early-stage triple-negative breast cancer (TNBC)
Immune cells, also known as tumor-infiltrating lymphocytes, or TILs, are naturally existing immune system cells that can move from the bloodstream into a tumor and can recognize and destroy cancer cells.
" This is an important finding because it highlights that the abundance of TILs in breast tissue is a prognostic biomarker in people with early-stage triple-negative breast cancer, even when chemotherapy is not administered. The study's findings may inspire future clinical trials to explore whether patients with a favorable prognosis (high TILs) can avoid intensive chemotherapy regimens." -- according to Roberto Leon-Ferre, M.D., breast medical oncologist at Mayo Clinic Comprehensive Cancer Center and first author of the study.
The results of this study could lead to a recommendation to include TILs in the pathology reports of early-stage TNBC worldwide, as it has the potential to inform clinicians and patients when they discuss treatment options," says Dr. Salgado.
Furthermore, this biomarker would only require a visual evaluation by a pathologist looking through a microscope, meaning there are no additional costs associated with identifying the presence of immune cells. This could be particularly beneficial to regions with limited resources, adds Dr. Leon-Ferre.
ONCY has identified TiLs as a biomarker and has demonstrated pelareorep's ability to enhance levels of TILS in the tumor microenvironment (TME) thus facilitating the killing of cancer cells including those in TNBC. https://www.news-medical.net/news/20240402/Study-reveals-immune-cell-levels-as-prognostic-marker-in-early-stage-triple-negative-breast-cancer.aspx