RE:RE:RE:RE:RE:RE:Type C Meeting TimingsONCY must be have some "compelling" long-term surrogate endpoint and biomarker data from the Phase 2 Bracelet-1 metastatic breast cancer and AWARE-1 studies to request a FDA meeting.
In June and December 2023 ONCY reported: Pelareorep-paclitaxel combination reduced risk of disease progression by 71% (hazard ratio of 0.29) compared to paclitaxel monotherapy
37.5% confirmed overall response rate with pelareorep-paclitaxel vs. 13.3% with paclitaxel monotherapy
12-month progression-free survival rate of 32.8% for pelareorep-paclitaxel compared to 0% for paclitaxel monotherapy and 0% for pelareorep-paclitaxel-avelumab
Pelareorep induced prominent expansion of pre-existing Tumor Infiltrating Lymphocytes (TILs) in the blood and new TILs in the tumor
Data highlights the association between the expansion of existing TILs in the blood and decreased tumor size
Results affirm pelareorep’s role as an immunotherapy
https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-and-solti-present-positive-translational-data-at-sabcs/
https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-announces-updated-randomized-phase-2-data-from-bracelet-1-metastatic-breast-cancer-trial-that-show-pelareorep-driving-robust-increases-in-progression-free-survival-and-confirm/