ONCY announces positive Phase 2 Bracelet-1 results in mBCMay 26, 2023 - " Compared to the paclitaxel monotherapy cohort, the cohort evaluating the combination of paclitaxel plus pelareorep showed 50% improvements on the trial's primary endpoint of overall response rate (ORR) at week 16 (31.3% vs. 20%) as of the ASCO abstract cut-off date (October 2022). This cohort also reported median progression-free survival (mPFS) of 9.6 months vs. 6.4 months as of the cut-off date. Overall survival data from the trial continue to mature.
Data from this study validate the results of IND-213, a prior phase 2 trial that showed a statistically significant near doubling of median overall survival in HR+/HER2- metastatic breast cancer patients treated with pelareorep combined with paclitaxel (21.0 months, n = 28) vs. those treated with paclitaxel alone (10.8 months, n = 29)."
All participants enrolled in the trial previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor. [ interpreted as heavily pre-treated (salvage patients pre-treated also with chemotherapy) which compromises the patients immune system and precluded the effective use of immune checkpoint inhibitors ]