Oncolytics Biotech Inc T.ONC

ONCY's Bracelet-1 was in HR+/HER2 negative breast cancer

[Noteable]

To undersstand the significance of ONCY's Phase 2 Bracelet-1 study in Hormone receptor-Positive (HR+)/HER2 negative breast cancer, clinical evidence shows that the addition of an PD-(L)1 immune checkpoint inhibitor  (pembrolizumab) to chemotherapy (eribulin) for metastatic hormone receptor-positive breast cancer patients who pretreated with 0 to 2 lines of salvage chemotherapy did not improve ORR, PFS, or OS (immature) compared with chemotherapy (eribulin) alone.

 Tolaney SM, Barroso-Sousa R, Keenan T, Li T, Trippa L, Vaz-Luis I, et al. Effect of Eribulin With or Without Pembrolizumab on Progression-Free Survival for Patients With Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: A Randomized Clinical Trial. JAMA Oncol (2020) 6:1598–605. doi: 10.1001/jamaoncol.2020.3524

Consequently, early data from the ASCO clinical trial abstract demonstrates that:

 "BRACELET-1 substantially de-risks our HR+/HER2- breast cancer program by providing a second randomized dataset showing pelareorep plus paclitaxel outperforming paclitaxel alone," said Dr. Matt Coffey, President and Chief Executive Officer. "Importantly, evidence of pelareorep's ability to synergistically enhance paclitaxel's efficacy has now been seen consistently across multiple clinical efficacy endpoints of overall survival, progression-free survival, and ORR. With these data, our program is phase 3-ready, and efforts to expeditiously advance to a two-arm registrational study of pelareorep-paclitaxel combination therapy are well underway."

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).

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[Noteable]

Should read:  Tolaney SM et al. JAMA Oncol (2020) showed that the addition of an PD-1 immune checkpoint inhibitor  (pembrolizumab) to chemotherapy (eribulin) for metastatic hormone receptor-positive breast cancer patients who pretreated with 0 to 2 lines of salvage chemotherapy did not improve ORR, PFS, or OS (immature) compared with chemotherapy (eribulin) alone

[Noteable]

What we’ve learned about checkpoint blockade is that the earlier on you apply PD-(L)1 inhibition strategies in the course of disease, the more likely they are to be effective. Bracelet-1 enrolled heavily pre-treated (salvage) patients who had failed at least one hormone based therapy plus a CDK 4/6 inhibitor and thus had progressed before enrollment into the Bracelet-1 study. Consequently, the

[Noteable]

The combination of the oncolytic reovirus pelareorep and paclitaxel generated responses in patients with metastatic hormone receptor (HR)–positive/HER2-negative breast cancer, according to data from the phase 2 BRACELET-1 trial (NCT04215146) presented at the 2023 ASCO Annual Meeting.1,2 Notably, findings also showed that the addition of avelumab (Bavencio) to pelareorep and paclitaxel increased

[Noteable]

A primary endpoint for ONCY'S  Phase 2 metastatic breast cancer (Bracelet-1)  of overall survival (OS) has been maturing and the 2 year data timeline was reached at the end of May- early June 2024. Now that the important and statistically significant FDA 2 year OS milestone has been met,  I think that ONCY may have decided to lengthen the OS time period by extending the data

[Noteable]

This notwithstanding ONCY has committed to releasing the mature OS mBC data in H2 2024 ... which can be anytime now. - making reference in the release perhaos, that OS is still maturing but that the current 2 year + OS data has met the mature survival timeline sufficient for the FDA to grant an Accelerated Approval for pelareorep in mBC.

[Noteable]

A primary endpoint for ONCY'S  Phase 2 metastatic breast cancer (Bracelet-1)  of overall survival (OS) has been maturing and the 2 year data timeline was reached at the end of May- early June 2024. Now that the important and statistically significant FDA 2 year OS milestone has been met,  I think that ONCY may have decided to lengthen the OS time period by extending the data

[Noteable]

Quentin30 Koffey doesnt appear to read what had been posted  so here is a reminder for him .... and he should pay particular attention to the bolded section that speaks to ORR, PFS,, and MBC. "A primary endpoint for ONCY'S Phase 2 metastatic breast cancer (Bracelet-1) of overall survival (OS) has been maturing and the 2 year data timeline was reached at the end of May- early June

[Noteable]

ONCY has demonstrated that PFS was 38.2% better in the pelareorep + paclitaxel treatment arm of Bracelet-1 vs the control arm of paclitaxel alone and reproduced a near doubling (2X) median overal survival seen in IND-213 - which is the clinical benefit that the FDA is seeking. Consequently ONCY's 180-200 patient Phasew2b->Phase3->Confirmatory trial will have PFS as the primary

[Noteable]

Once again the major determinant of clinical benefit for the FDA is overall survival (OS) which was statistically significantly improved in both of ONCY's IND-213 and Bracelet-1 mBC Phase 2 clinical trials with a near doubling of OS between the treatment and control arms of pelareorep (monotherapy) + paclitaxel vs paclitaxel alone, respectively.  The 38.2% improvement of PFS in ONCY'

[Quentin30]

and yet they need a third phase II trial... that's three phase II trials... to show something that in the majoraity of cases is approved for AA with just one... Puts ONCY in the minority.. Originally the target market size fior ONCY was 154,000 patients per year, now that is reduced by 2/3 to 55,000 so presumably, the analysts need to reassess their future valuations..?

[Noteable]

You don't seem to understand much. ONCY's 180-200 patient Phase2b->Phase3->Confirmatory trial is an adaptive designed trial that can seemlessly move from one Phase to the next Phase without much effort. Thi ha already been fully discussed in earlier posts. Take the time to keep up. Furthermore, a growing number of Acceleratred Approvals are being granted on Phase 2 data. And

[Noteable]

Quentin30 while IND-213 as a study wasn't powered for statistical significance, because of the low number pf patients enrolled, the trial's results were statistically evaluated showing a statistically significant overall survival improvement and clinical benefit in the treatment arm with pelareorep (montherapy) + paclitaxel vs paclitaxel (alone) .

[Noteable]

Furthermore Accelerated Approvals are becoming more frequently granted by the FDA on Phase 2 data with as little as 30 patients (not powered for statistical significance) - and thee AAs are also granted based on lesser endpoints than progressive free survival (PFS). The FDA is seeking to bring effective treatments for oprphan, rare, and diseases with unment needs more quickly than ever before, and

[Quentin30]

and Matt and Prof Heineken already told us that Bracelet-1 was not powered for statisical significance. How many patients were in each arm? lets just remind the boys and girls shall we... Bracelet-1 Cohort-1 (n=15) Pax Cohort 2 (n=15)  Pax + Pela Primary endpoint for this trial was ORR, which was almost 3 times better than Pax alone. and exploratory endpoint PFS was better in Pela + Pax vs

[Quentin30]

and Matt and Prof Heineken already told us that Bracelet-1 was not powered for statisical significance. How many patients were in each arm? lets just remind the boys and girls shall we.. Bracelet-1 Cohort-1 (n=15) Pax Cohort 2 (n=15) Pax + Pela Primary endpoint for this trial was ORR, which was almost 3 times better than Pax alone.and exploratory endpoint PFS was better in Pela + Pax vs Pax by

[canadafan]

For some reason mr. Qu30, keeps stating " they have the data" Unless, he/ she is part if the trial clinics & evaluating teams, there is 100% no way to prove or unproven " they have the data". Most importantly along that line, the trial is not run by Onc. There are multiple recording, collecting & analysts of data required. Seeing on the fda page the trial is over on xx

[inthno]

Wow cf and one to talk especially after telling everyone that Matt had exercised 350k options and said that all was good and would not retract that statement. As for the trial cutoff. Kirk clearly stated that they chose the end of May as the 2 year cutoff so that is now 3.5 months so IMO they do know up to that point who is alive in the trial Bottom line is we can spec all we want but onc holds

[Buckhenry]

Ole unnoteable is so hung up on himself he has to repost his garbage... why get hung up on things we don't know about how the company will do things... it's like listening to all the goofballs trying to figure if we get a 25 or 50 interest rate cut.  Just shut up and wait. 

[Noteable]

Reposts are necessary for the "goofballs" that you have referenced.

[Noteable]

 "BRACELET-1 substantially de-risks our HR+/HER2- breast cancer program by providing a second randomized dataset showing pelareorep plus paclitaxel outperforming paclitaxel alone," said Dr. Matt Coffey, President and Chief Executive Officer. "Importantly, evidence of pelareorep's ability to synergistically enhance paclitaxel's efficacy has now been seen

[Noteable]

October 18, 2024 – Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Kisqali® (ribociclib) for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2