RE:RE:RE:FDA guides on how AA can be converted to full approval.The previous post on Amgen's bispecific Accelerated Approval that of those patients with objective response to Imdelltra, 59% sustained the response for a median duration of at least six months and the median progression-free survival (PFS) was 4.9 months in the 10-mg group, while overall survival was 14.3 months.
By Comparison :
In May 2023 ONCY's announced the pelareorep + paclitaxel Cohort results in the Bracelet-1 study. the ORR at 4 months (16 weeks) was 31.1% versus 20% paclitaxel control while median PFS was 9.6 months versus 6.4 months paclitaxel control. Median overal survival (mOS) for pelareorep+paclitaxel was 21 months versus 10.8 months for paclitaxel alones.
These results showing the baseline for the FDA's Accelerated Approval of Amgen's bispecific Imdelltra versus ONCY's top-line Bracelet-1 pelareorep + paclitaxel Cohort data, strongly suggests that pelareorep monotherapy ( in combination with paclitaxel) is an increasingly viable candidate for an FDA Accelerated Approval. BRACELET-1 enrolled 48 patients randomized and well-balanced across three cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel in combination with pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio®). All participants enrolled in the trial previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor.
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).
https://www.stocktitan.net/news/ONCY/oncolytics-biotech-r-announces-positive-randomized-phase-2-data-from-er8qjqqo64uz.html
https://www.newswire.ca/news-releases/oncolytics-biotech-r-announces-updated-randomized-phase-2-data-from-bracelet-1-metastatic-breast-cancer-trial-that-show-pelareorep-driving-robust-increases-in-progression-free-survival-and-confirmed-overall-response-rate-831048927.html