Oncolytics Biotech Inc T.ONC

AA and mBC

[westcoast1000]

If I recall correctly, paxlitaxol is now generic, or at least under a sowewhat different patent regime than initially.

If that is the case, I would think there are not many obstacles to ONCY applying directly to the FDA for the pax'pelo combo for mBC for accelerated approval.

Hence that might be the most direct path to AA. Or we could apply for AA for pela on its own, which has virtually the same pfs results as Trodelvey, an ADC that is beign prasied on the NYT front page today. We have far less side effects than Tro and would likely cost a lot less also. 

With the panc results, the combo is with Tecentriq which Roche owns, so it seems that it would be harder if not impossible for us to apply to the FDA for AA without Roche.

[Noteable]

Correct.  However should the GOBLET-1 study continue to prove effective, any Big Pharma could acquire ONCY, then file for Accelerated Approval of pelareorep + paclitaxel in HR+/Her2 - metastatic breast cancer, and then run their own immune checkpoint inhibitor in a supplemental trial.

[westcoast1000]

Thx Noteable.   Would we not expect that ONCY would have more leverage with big pharma if they applied for mBC as an AA on their own? What are the obstacles to doing that at present? Any thoughts?

[Noteable]

No significant obstacles since a two-arm confirmatory trial with a pelareorep + paclitaxel arm versus a paclitaxel control arm, that follows and validates an accelerated approval, would be able to be easily conducted at a reasonably inexpensive cost. Similar to Gilead's Trodelvy Phase 3 study which gained FDA approval.

[inthno]

Noteable - (6/18/2023 7:13:23 PM) RE:RE:RE:AA and mBC No significant obstacles since a two-arm confirmatory trial with a pelareorep + paclitaxel arm versus a paclitaxel control arm, that follows and validates an accelerated approval, would be able to be easily conducted at a reasonably inexpensive cost. Similar to Gilead's Trodelvy Phase 3 study which gained FDA approval.

[westcoast1000]

I am profuoundly sick of hearing this second guessing: ______ I agree that moving forward that this should be a simple trial with a reasonable cost, BUT the frustration that a few might be having is that we will now be running the same trial that we were approved for back in 2017 with fast track and a spa. _____ Those frustrated should have soldinstead of biatching now. Far far far more is

[Noteable]

No .. an ONCY Phase 3 trial will be run against the SOC treatment which is paclitaxel- just as Heineman described and just as Gilead did with Trodelvy's Phase 3 that led to approval. 

[Capitalista]

Noteable, in which subset of HR+ HER- mBC treatment situations are you saying paclitaxel is the SOC?  My research shows nowadays it's used mainly when patients have progressed after CDK4/6 inhibitor treatment, or in the 20% of patients who don't respond to CDK4/6.  This would imply that CDK4/6 is the SOC.   As I recall, the BRACELET-1 PFS numbers reported at ASCO were

[Noteable]

Simple due diligence on your part would have answered your question. "All participants enrolled in the trial had previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor. "  https://www.oncolyticsbiotech.com/press-releases/detail/601/oncolytics-biotech-announces-updated-randomized-phase-2

[Noteable]

The SOC in the treatment of HR+/Her2- mBC is the chemotherapy. In the Bracelet-1 trial the chemotherapy evauated against was paclitaxel. 2nd line therapy is CDK4/6 therapy.

[Noteable]

For example - in Immunomedics/Gilead's Phase 3 TROPiCS-02 study that gained FDA approval for HR+/Her2 - mBC patients, Trodelvy was trialed against a comparator single-agent chemotherapy (treatment of physician’s choice) which was considered as the SOC. nothwithstanding that the enrolled patients had previouly received endocrine-based therapy and at least two additional systemic

[westcoast1000]

What  puzzles me is the requirement for a two arm trial when there must have been many hundreds of trials that use paxlitaxol as one arm. Why not use those aggregated results as the control?  Why replicate something that has been done hundreds of times. I know that is not the "gold standard" for clinicial trials, but following the so called gold standard for drug approval has