Oncolytics Biotech Inc T.ONC

eyes on the prize

[Geneman2004]

The ASCO results will update the BRILLIANT results by 6m and what are the potential outcomes? 

The updated data on Arm 2 (Pela/Pacl) will almost certainly show improvement in the already good results. Better 16 week response rate and extended PFS (secondary endpoint). We will see good data on the T cell responses and other surrogate markers. Importantly, the safety question should be answered by the KOL session, I bet. This is already baked into the story and great results are expected - good enough to move to a registration trial.  The elephant in the room - who pays???

The second body of information comes from the Avelumab arm and the absence of information is deafening. I think we may have to expect a miss for this arm of the study - not surprising considering Avelumab's record. May not be the right checkpoint inhibitor for this specific indication. Kind of a lock and key thing but Avelumab may not be the right key.  The checkpoint inhibitors chosen for the GI trials look like they have activity so partnerships with Immunotherapy companies are still on the menu.

Looking at the big picture, 2 independent randomized trials totalling 87 patients with advanced ER+ Her2- breast cancer (43 Pela/Pacl treated; 44 Pacl control) suggests a clinical benefit in a cohort of breast cancer patients with few treatment options. About 60,000 woman are recognized as having metastatic breast cancer in North America each year (incidence) and about 200,000 women are currently living with metastatic breast cancer (prevalence). About 80% of these patients will have ER+ Her2- disease. Demonstrating safety and a clinically significant survival advantage for these women would cement regulatory approval for Pela in this setting. This is a very large treatment population and positive survival results and a tolerable safety profile would result in a landmark change in modern treatment of breast cancer in the advanced/metastatic setting.

What is left?  Importantly, survival data. Surrogate markers like 16 week response, PFS, disease control, T cell markers are not close to perfect in predicting survival. It could become obvious though. If the PFS data are sufficiently robust - ie: PFS data approaching the median survival in the control group (~12 months?? - my guess), it would be impossible for the OS to miss in Arm 2. We will know in a week, I guess. 

It is my opinion that there will be no regulatory approval without a + survival endpoint derived from a well designed Ph III trial - the design could have an early look with a small alpha spend but no nod from the FDA for a paradigm shift without very good OS results. It would be great to see an option for earlier approval but the statistical price could be too high. Difficult negotiations with risky consequences if things go sideways.

The current data support a registration trial and the company now has to figure out a design with the regulatory agencies, figure out who enrolls the patients and figure out how to fund it.  They have the typical options of financing (dilutive or non-dilutive), partnering or selling ONCY.  I have no clue on these issues.....they are 20+ years into this and all options should be on the table.

The BRILLIANT results and the various interpretations are stealing all of the immediate attention. Looming is a better understanding of the Panc results and potential roads forward.  There are more data maturing in the GI world and the CAR-T story has it's own life. Lots of information to chew on for the next year.......there has been little to consider for a long time but the rubber is meeting the road now!!

cheers, Geneman

[fox7mf]

The ONLY viable way fwd is partnering or selling...no more dilution svp.

[Noteable]

We all know that the reults were "Brilliant" but the results were from the "Bracelet".  And surrogate endpoints do not have to be "perfect" to predict OS outcome - but the FDA has found them good enough of a predictor in multiple Phase 2 studies and will now increase importance of Phase 2 surrogate endpoints to grant accelerated approval, given that the FDA has

[Noteable]

In general, the association between ORR and PFS, and that between PFS and OS, are stronger than the association between ORR and OS, which may indicate a pass-on effect of ORR to PFS to OS. The fine surrogacy of ORR for PFS to some extent comes from the definition of those two indices. Notably, it seems that ORR works better as surrogacy for PFS in both immunotherapy and targeted therapy than that

[inthno]

Interesting conversation all around regarding the first set of results from the Bracelet Trial. It will be hard to determine the trial design other than that onc has stated that it will be a 2 arm trial but the endpoints will be most interesting. Also of note is that the original mbc 213 trial did not meet its clinical endpoint of pfs so even though Bracelet is showing that intitially will onc and

[YegJeeber]

From what I've seen, and I admit it hasn't been great in depth research, is that biotechs are seemingly bought out prior to initiation of P3s, probably so the BP buyer can control and run the trial themselves. When Gilead bought Forty Seven for their product Macrolimab (??) for 4.9 billion, the trial was in Phase 1B if I am not mistaken. Thoughts? 

[Noteable]

That's exactly what Big Pharma wants to do, since having full control over a Phase 3's trial design and implementation, further allows for selection of trial sites, timely patient enrollment, efficient trial data collection, and relatively unrestricted communications with the FDA which ultimately provides for the quicker filing of a BLA, review and the issuance of a potential accelerated

[Geneman2004]

there is an amazing range of things that happen with biotech companies and, recently, not too many of them good!  Quite uncommon for a big player to buy out a 20y old company with a franchise value of $100-150M.  The Gilead purchase was an outlier, for sure. Particularly after Gilead's experience with Kite. None of the top 10 biotech purchases in the last year or so have been

[Noteable]

20+ year old single product company Immunomedics was purchased by Gilead for US$21 Billion 2 years ago. Multibillion dollar acquisitions are becoming the standard in a current environment where Big Pharma has US$1.5 Trillion in firepower, a looming patent cliff, and a dwindling product  pipeline that requires replenishment with biological products over small molecules. I am getting the

[fox7mf]

Gotta love the soft bash, lol. The very best of luck this week ladies & gents. This is what we've been waiting for. Go ONCY!!

[Lesalpes29]

It's in the hands of management and BP now! Not in the hands of soft or heavy bashers. GL

[Buckhenry]

As we can see unnoteable  bashes ANYONE  that does not totally agree  with  his narrative. He posts many things that are not pertinent to oncy and takes things out of context when he needs to. Unnoteable  reminds me of an Ole wise proverb.... when you're up to ur neck in alligators.... it's hard to remember  ur initial  objective was to drain the swamp. I

[Azzak34]

No one cares what you think!