Oncolytics Biotech Inc T.ONC

Keytruda+Chemo neoadjuvant in early ER+/HER2- breast cancer

[Noteable]

October 20, 2023 - KEYTRUDA plus chemotherapy before surgery met one of its dual primary endpoints of pathological complete response (pCR), demonstrating a statistically significant improvement in pCR rate compared to placebo plus chemotherapy. 

The pCR rate increased from 15.6% in patients treated with neoadjuvant chemotherapy alone (n=100/643) to 24.3% in patients treated with neoadjuvant KEYTRUDA plus chemotherapy (n=154/635), an estimated increase of 8.5 percentage points (p=0.00005).

These results support the potential of a KEYTRUDA-based regimen for patients with early-stage breast cancer

[ Opens the door for ONCY + CPI in 2L ER+/HER2- breast cancer ]

https://www.biospace.com/article/releases/merck-s-keytruda-pembrolizumab-plus-chemotherapy-showed-statistically-significant-improvement-in-pathological-complete-response-pcr-rate-/

[Noteable]

Of all breast cancer patients, about 70% will be diagnosed with hormone receptor-positive, HER2-negative disease. The global Breast Cancer Market size is expected to be worth around USD 49.2 Bn by 2032 from USD 19.8 Bn in 2022   And with the potential use of pelareorep in combination with a checkpoint and CDK4/6 or PARP inhibitor,  in 2L HR+/HER2

[Noteable]

Specific terms and phrases are defined as follows: • The phrase early-stage breast cancer refers to invasive breast cancer without distant metastases • The phrase high-risk refers to patients with early-stage breast cancer who continue to have a high risk of distant disease recurrence and death despite use of optimal modern local and systemic adjuvant therapy • The terms neoadjuvant and

[Quentin30]

ONCY are pursuing a standard approval process... show me where MATT has stated they will apply for accelerated approval. It doesn't exist.

[Azzak34]

It's a good point Quentin! ONCY, nor Pancan, nor Roche will want to get this done too quickly. We should take as long as we can to get this to market. All those dying of Pancreatic cancer can just hold their horses. It's a strong argument you make! 

[Quentin30]

perhaps Roche will wait until the patent expires in a couple of years... and then run the trial all on their lonesome...  2027 isn't it..? Of course if ONCY can get an approval before then, then they have 13 years exclusive marketing rights... (not sure about China and SE Asia - didn't they sell those for 5 million...). Yah, but fiorst they need to run a phase III... lol... yeah

[Azzak34]

That sounds a lot like making predictions and engaging in conjecture? Isn't that what you accuse others of? Tut tut Quento.  Let's lock in that call and we'll revisit it when it goes horrendously and laughably wrong. 

[Quentin30]

Dammit, you made me laugh out loud again Azzak..!! no-one knows what's gonna happen with this stock... nor the market...  But with wars both hot and cold ongoing, collapsing housing markets, highest bond yields in 16 years and talk of debt implosion, you could say that we're at peak despair... But, like when making a cake, add the required amount, and sprinkle for good measure... so

[Azzak34]

Gotta let the past go Quentin, it can be hard but we had those beautiful times. Must move forward.  Pancan logo is on the clinical trials portion of the ONCY website for Goblet. That's a done deal and will be announced any day. If you know anything about business, adding a partners logo to your website signifies signed and sealed. So let's stop with the phase 3 not happening, let it

[Noteable]

Communicated planned Accelerated Approval discussions in mBC with the FDA https://stockhouse.com/companies/bullboard/t.onc/oncolytics-biotech-ord-shs?postid=35694705

[Noteable]

Second-line (2L) therapy for hormone receptor-positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer is yet to be established. ONCYs pelareorep 2L combination therapy would be the first.

[Noteable]

The global Breast Cancer Market size is expected to be worth around USD $49.2 Bn by 2032 from USD $19.8 Bn in 2022 Of all breast cancer patients, about 70% will be diagnosed with hormone receptor-positive (ER+) / HER2-negative disease.