Oncolytics Biotech Inc T.ONC

New Press Release - Oncolytics Biotech® Announces Productive FDA Type C Meeting on its Metastatic Breast Cancer Program

Clear path forward on key elements of the planned potential registration-enabling trial in HR+/HER2- metastatic breast cancerOn track to report overall survival results from the randomized HR+/HER2- metastatic breast cancer BRACELET-1 trial in H2 2024SAN DIEGO and CALGARY, AB, June 27, 2024...read article.

[Azzak34]

PFS as the primary is what I was hoping for.

[Noteable]

As Matt Coffey previously stated .. " The Company's proposed study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy " .. which is an unmet need since ADCs result in T cell exhaustion and have significant "black box" adverse side effects (including grade 5 patient deaths). ONCY's

[Noteable]

Wayne Pisano, Interim CEO and Chair of the Board of Oncolytics, commented, "We are appreciative of the thoughtful dialog with the FDA and are pleased to have reached an important regulatory milestone that provides a clear path forward for pelareorep's advancement towards registration in HR+/HER2- mBC. Looking ahead, initiating a registration-enabling trial has become a major corporate

[Journeytc]

Its great ONC recieved feedback from the Type C meeting.  They can now prepare a phase three filing. I looked specifically for one clarification by the agency.     Whats the target therapeutic popularion?   Cause that determines size of opporrunity.   The press release stated...    "recieved delivery of no more than one ADC treatment"

[Journeytc]

Todays announcement is a huge win.  In last post I gave thoughts on target therapeutic popularion ONC always intended to partner entering into a phase 3.  If thats still the case, we have a partnership to look forward to in the near term before a phase 3 mBC is launched.    Acceptance of PFS as a  primary trial outcome over OS is also a big win.    It

[Noteable]

As ONCY stated in today's press release .. " We are now well-positioned to deliver on our mission of making pelareorep available to breast cancer patients in need of better treatment options."

[13X2413]

Sure hope "now" wasn't another typo and it wasn't actually "not". 

[Noteable]

" .. now well-positioned ..."  not only in breast cancer but also in metastatic pancreatic, anal, colorectal and other GI cancers. 

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- Clear path forward on key elements of the planned potential registration-enabling trial in HR+/HER2- metastatic breast cancer - The FDA supports progression-free survival as the primary endpoint of the study, with overall survival as a key secondary endpoint  - Metastatic breast cancer overall survival (OS) results to be released this H2'24 

[Noteable]

The BRACELET-1 results reported a 12-month progression-free survival (PFS) rate of 32.8% for pelareorep-paclitaxel compared to 0% for paclitaxel monotherapy. 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/

[Quentin30]

so, IF as ONCY claims they have a clear path forward... there is no need to wait for the OS results to be relesed later in the year. They should start authoring the CTA NOW. and what a surprise, NO accelerated approval for mBC. This would suggest that FDA has not approved a surrogate end point based on ONCY's potential biomarkers..  the pps tells you everything you need to know... 

[Azzak34]

Don't be bursting in here with your fantastical nonsense just because your portfolio is on fire.... again!!!  Calm down and don't get so emotional. 

[CaseyL]

It's Pfizer's exclusivity. It's Pfizer's data. ONCY can't course anybody. However, they have until END H2 to release that data. Every puzzle that gets put down needs collaborating. ONCY, FDA, Pharma, Lawyers, Product Managers etc. Constant progress mounting to something. And it's not a stupid reverse split. 

[Noteable]

Quentin30 - as usual you're wrong again on many things including on Accelerated Approval and biomarkers/surrogate endpoints, since these markers apply to pelareorep in combination with immune checkpoint inhibitors, like anti - PD-(L)1. The FDA has agreed to the breast cancer registration study to be designed on PFS as the primary endpoint, which ONCY has already already showed a 32.8

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Correction: Earlier ONCY reported that the confirmed overall response rate (ORR) at 1 year was 37.5% for the pelareorep-paclitaxel doublet vs. 13.3% with paclitaxel monotherapy. In June 2023 ONCY reported " “BRACELET-1’s positive results complement prior phase 2 data showing a statistically significant increase in overall survival when pelareorep was combined with paclitaxel by

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ONCY's proposed registration study will enroll patients who have failed hormonal therapy and have received no more than one line of antibody-drug conjugate (ADC) therapy.

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Last year ONCY showed that ORR improved over time with pelareorep therapy, further confirming that immunotherapy requires some lag-time before showing significantly improved effectiveness - which is how the body normally responses to an exogenous stimulus.

[Noteable]

That said ... PFS  is considered by the FDA to be a "validated" surrogate endpoint that  can also lead times an Accelerated Approval. CelTil is a novel biomarker/surrogate endpoint that applies breast, pancreatic,  CRC and anal caner which can lead to  Accelerated Approval particularly involving pelareorep in combination with ICIs, such as Tecentriq.

[Noteable]

Should read : PFS  is considered by the FDA to be a "validated" surrogate endpoint that can lead to shorter approval times through an Accelerated Approval ....