Oncolytics Biotech Inc ONCY

Trodelvy improved PFS by 34% in heavily pre-treated patients

[Noteable]

For comparison purposes - Gilead's Phase 3 TROPiCS-02 study of Trodelvy® (sacituzumab govitecan-hziy) versus physicians’ choice of chemotherapy (TPC) in heavily pre-treated HR+/HER2- metastatic breast cancer patients who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy improved 12 month PFS by 34% and was approved by the FDA for the treatment of HR+/HER2 - metastatic breast cancer on this result.

The study met its primary endpoint of progression-free survival (PFS) with a statistically significant and clinically meaningful 34% reduction in the risk of disease progression or death (median PFS 5.5 vs. 4 months; HR: 0.66; 95% CI: 0.53-0.83; P<0.0003)  at 12 months versus physician's choice of chemotherapy.

https://www.gilead.com/news-and-press/press-room/press-releases/2022/6/trodelvy-improved-progressionfree-survival-by-34-in-heavily-pretreated-hrher2-metastatic-breast-cancer-patients


Similarly ONCY's Phase 2 Bracelet-1 study demonstrated that pelareorep as a single agent improved met the surrogate endpoint of PFS with a clinically meaningful reduction in the risk of diseae progression or death by 32.8%. (HR: 0.29; 95% CI: 0.11.7-0.924) in the same heavily pre-treated patient groups as Trodelvy, namely patients who received prior endocrine therapy, CDK4/6 inhibitors and at least two lines of chemotherapy.

Consequently it would appear that ONCY's pelareorep as a single agent would adequately meet the FDA's Accelerated Approvable requirements, given their earlier decision to approve Gilead's Trodolvey in the same groups of patients.

https://www.oncolyticsbiotech.com/press-releases/detail/601/oncolytics-biotech-announces-updated-randomized-phase-2

The result was Trodely's approval by the FDA based on this 34% improvement in PFS at 12 months.

[Noteable]

Should read: " ... in the same group of heavily pre-treated patients as were enrolled in ONCY's Phase 2 Bracelet-1 study with pelareorep in the treatment of HR+/HER- metastatic breast cancer."

[Noteable]

Gilead Sciences acquired Immunomedics for US$21 Billion and the deal's crown jewel was Trodelvy  https://www.gilead.com/news-and-press/press-room/press-releases/2020/9/gilead-sciences-to-acquire-immunomedics

[Noteable]

https://www.bloomberg.com/press-releases/2023-02-03/u-s-fda-approves-trodelvy-in-pre-treated-hr-her2-metastatic-breast-cancer

[westcoast1000]

Thanks, Noteable. It seems it was approved as a phase 3 drug, meaning no AA.

[Noteable]

westcoast - you're wrong, meaning yes AA.  And an AA must be requested by the sponsor pursuant to a Phase 3 filing.The FDA's criteria for granting an Accelerated Approval under the new requirements under the passage of the Inflation Reduction Act (IRA) has been fully explained in previous postings, so I won't waste anyone's time going through them again for you.

[Noteable]

Simply put - Gilead didn't apply for or request an AA during their Phase 3 submission. Which is good for ONCY or ONCY's acquirer, IMO.

[Noteable]

westcoast - you're right in that Gilead didn't request an AA for Trodelvy in HR+/HER- mBC - for reasons we don't know but can speculate on, that perhaps having to do with Trodely's side effect profile and QoL in this indication.

[Noteable]

Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea, and is a serious consideration in the the FDA's decisions involving the granting an Accelerated Approval. In contrast, ONCY's pelareorep has not such warnings and has demonstrated a minimal side effect profile in over 1000 patients who've been treated with the drug. In otherwords pelareorep is

[Noteable]

ONCY's pelareorep is considered a new class of treatment for this and other indications and would appear a much better side effect and QoL profile than Trodelvy as determined by the 5 point ESMO-MCBS scoring guidelines of decision making in clinical practice. https://www.esmo.org/guidelines/esmo-mcbs/about-the-esmo-mcbs TRODELVY side effects include decreased white blood cell (leukocyte and

[Noteable]

The FDA's Accelerated Approval is intended to be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies, which includes taking into consideration the product's side effect profile and QoL considerations. ONCY's pelareorep appears to have such an appreciable therapeutic benefit over Trodelvy.

[westcoast1000]

Again, this is a very significant post and should provide a direct and favorable comparison to straight pela on its own.

[westcoast1000]

Any naysayer, doubter or basher can read these posts, see the approval of the Gilead drug, see the side effects, and see how much was paid for Immunometics. This is convincing information. 

[westcoast1000]

should have added:  ..and compare that information to pela's PFS results and safetry proflie,

[westcoast1000]

Moreover, Trodelvey is an ADC. While I know nothing about ADC's, my guess is that it may not be relevant for other indications than triple neg mBC. On the other hand, pela shows well in an array of indications, and is a top performer (so far) on panc. So while Immunometics had a variety of drugs (ADCs, I guess) when it was aquired for $11 bil, we have only one, but it works in a wide array

[Noteable]

Immunomedics was a company with a single antibody-drug conjugate (ADC) technology platform that centers on using a novel linker and was acquired by Gilead for US$21 Billion. Like Immunomedics, ONCY has a platform technology in pelareorep and can be viewed as valued between US$11 Billion and US$ 15 Billion.

[Noteable]

Immunomedics was an I/O company with a single antibody-drug conjugate (ADC) technology platform that centers on using a novel linker and was acquired by Gilead for US$21 Billion. Like Immunomedics, ONCY has a platform technology in pelareorep and can be viewed as valued between US$11 Billion and US$ 15 Billion

[Noteable]

Catalyst

[westcoast1000]

I thought the same thing, Noteable. If that story on Trodelvy is new, and its readers can actually understand what it means relative to our last results, then they certainly should be buying this stock.

[inthno]

I  do believe that our results are good and that the market will wake up but trial design will be most important and it is good that onc will hopefully be proceeding with dual primary endpoints as pfs did not come through in indication 213 as per the press release. Consistent with REOLYSIN® acting as an immune therapy agent, there was no meaningful improvement in either progression free

[Noteable]

Already stated to be a two arm study which Bracelet-1 has proved to be effective.

[Noteable]

This is the what .. when .. and how ...!!

[westcoast1000]

Noteable, Thank you very much for this significant post. Here are a few questions: -did Gilead get accelerated approval? -what type of treatment is trodelvey? Chemo, i/O? -I would guess (with no information) that the side effect of trodelvey are more far concerning than pela. Finally I am very dismayed that the FDA pays so little attention to balancing risk and benefit. pela has no risk and

[Noteable]

Trodelvy's approval based on a 34% improvement in PFS at 12 months in heavily pre-treated patients sets the way for ONCY's approval for the same indication of HR+/HER2 - metastatic breast cancer, as this thread describes.

[fasttrack5]

Ok let's get it done:)

[Noteable]

Trodelvy's approval by the FDA was based on a 34% improvement in PFS at 12 months in heavily pre-treated patients sets the way for ONCY's approval for the same indication of HR+/HER2 - metastatic breast cancer, given ONCY's similar comparables in heavily pre-treated patients, as this thread describes.

[westcoast1000]

Noteable, here is a question. Trodelvy was approved on its 12 month pfs. How many months of pfs data do we have now? Thanks

[Noteable]

Bracelet-1 reported 12 month results. Same as Gilead's Trodelvy.

[westcoast1000]

And already Trodelvy is now marketed and heralded in the NYT as part of the breakthrough underway. I do not think we will be lanquishing and waiting for a long time before we see progress on the regulatory front, on the partnership front, and then on the share price.  Our time is coming fast. 

[Angler101]

WC....I think last week's unexpected increased volume on no news is an encouraging indicator of how close we are to a positive event of some nature

[Angler101]

And I'm guessing that this week will prove to be just as encouraging

[Noteable]

As a reminder ... "ONCY's Phase 2 Bracelet-1 study demonstrated that pelareorep as a single agent improved met the surrogate endpoint of PFS with a clinically meaningful reduction in the risk of diseae progression or death by 32.8%. (HR: 0.29; 95% CI: 0.11.7-0.924) in the same heavily pre-treated patient groups as Trodelvy, namely patients who received prior

[fox7mf]

And yet we wait on the FDA approval & partnership or buyout news. Something big better come before the fall.

[Noteable]

The antibody-drug conjugateTroldolvy entered Gilead’s fold in 2020 with the company’s $21 billion purchase of Immunomedics. Trodely was approval by the FDA based on 34% improvement in PFS at 12 months in HR+/ HER2- metastatic breast cancer patients. ONCY's Phase 2 Bracelet-1 study demonstrated that pelareorep as a single agent improved met the surrogate endpoint

[Noteable]

Should read: Trodelvy

[westcoast1000]

They could buy ONCY for half that and already get about the same PFS clinical impact, while also reaping our panc, CRC, CAR-T and other opportunities.  Let it be. 

[Buckhenry]

I get so all gitty inside when I here from canadafan talking about Matt's fireside chat...  Expect stock to plummet.