Oncolytics Biotech Inc T.ONC

ONCY announces positive Phase 2 Bracelet-1 results in mBC

[Noteable]

May 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 ]

[Noteable]

Combination Therapy: Combination regimens are difficult to assess without comparing with individual components. [ONCY's Bracelet-1 Phase 2 study compared pelareorep as a single agent and pelareorep in combination with an immune checkpoint inhibitor demonstrating PFS improvements at 6 months in both treatment arms] https://www.targetedonc.com/view/fda-draft-guidance-supports-randomized

[Quentin30]

Why is it that Matt and Co have never used the words 'accelerated approval' noteable...? is it because this is just your dream..?

[Noteable]

Since ther paths to FDA approval are many, ONCY's Big Pharma acquirer will use the term accelerated approval to your heart's content.

[Noteable]

Looks like some on this message board who identify themselves as watching movies should stick to watching movies. It is evident that these same movie watchers have a very limited understanding of the cancer domain and instead are "glued" to just the SP, which a BP acquirer considers irrelevant. It has been observed many times over that BP wants to acquire late-stage scientifically sound

[Noteable]

" Notebook has been posting for years, 10 billion buyout, it's coming folks.." Other than "for years" .. the rest sounds about to me.

[Noteable]

....  the rest sounds about right to me....

[Azzak34]

If you're do confident, short the stock on Friday. You got no balls!