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Bullboard - Stock Discussion Forum Oncolytics Biotech Inc T.ONC

Alternate Symbol(s):  ONCY

Oncolytics Biotech Inc. is a clinical-stage biotechnology company. The Company is focused on developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype turning cold tumors hot through innate and... see more

TSX:ONC - Post Discussion

Oncolytics Biotech Inc > 12/13 Goblet PC patients had Stage IV metastatic (M1) cancer
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Post by Noteable on Nov 13, 2022 1:13pm

12/13 Goblet PC patients had Stage IV metastatic (M1) cancer

Of the 13 Stage IV evaluable patients with pancreati cancer 93% had metastasis and 64% had metastasis to the liver.

https://d1io3yog0oux5.cloudfront.net/_f805c910eb501b2a1642f91a7ce4c0a0/oncolyticsbiotech/db/343/2602/pdf/2022+GOBLET+SITC+Final.pdf

Of the 13 late Stage IV evaluable pancreatic cancer patients in the ONCY Goblet study, 12 of these late-stage patients had metastatic cancer that was classified at M1.

M1 is cancer that has spread to another part of the body, including distant lymph nodes. Pancreatic cancer most commonly spreads to the liver, the lining of the abdominal cavity called the peritoneum, and the lungs.


https://www.cancer.net/cancer-types/pancreatic-cancer/stages

The median survival for untreated advanced pancreatic (M1) cancer is about 3 1/2 months (14 weeks).

https://pancreatica.org/pancreatic-cancer/pancreatic-cancer-prognosis/
 
Continuing on - the primary objectives of the ONCY Goblet pancretic study were:
• To evaluate Objective Response Rate (ORR) at Week 16
• To evaluate tolerability of the investigational therapy

The secondary objective remains to be reported (likly on Monday November 14, 2022) and is:
• To assess other efficacy metrics including overall ORR, progression-free survival (PFS) and overall survival (OS)


Both primary objectives were met with a 69% ORR, tolerability, and an 85% clinical response benefit (CRB)

The interim results reported at SITC 2022 were the following - Tumor responses at Week 8, 16 and 24

- Week 8   - 6 patients had PR, 5 had SD, and 2 had PD. (13 patients)
- Week 16 - 1 had CR, 7 had PR, and 1 had SD. (9 patients)
- Week 24 - 1 had CR, 3 had PR, and 2 had PD. (6 patients)

Given that this Goblet study was conducted in late-stage (Stage IV) pancreatic cancer patients the study can be deemed a significant success with 1 patient still at complete response at week 16, 7 had partal responses and 1 had stable disease.

On these findings ONCY is seeking to move towards a speedy approval process in EARLY STAGE first-line pancreatic cancer where the success rates should be even greater.

As commented on by Thomas C. Heineman, ONCY's Chief Medical Officer .....

"GOBLET's interim results indicate pelareorep may be the key to finally improving the standard-of-care for first-line treatment of pancreatic cancer, a clear need given that treatment options have not changed for many years despite their limited benefits," commented Thomas C. Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics Biotech Inc.

https://www.biospace.com/article/releases/oncolytics-biotech-presents-updated-clinical-data-at-sitc-annual-meeting-showing-a-69-percent-objective-response-rate-and-confirmed-complete-response-in-goblet-study-s-pancreatic-cancer-cohort/
Comment by Noteable on Nov 13, 2022 1:20pm
Objective response rate (ORR) and clinical benefit rate (CBR) in GOBLET's PDAC cohort (n=13) were 69% and 85%, respectively, as of the SITC poster's data cutoff date (October 12, 2022). Additional data and conclusions presented in the poster are summarized below.   One of thirteen evaluable patients achieved a confirmed CR Eight of thirteen evaluable patients achieved ...more  
Comment by inthno on Nov 13, 2022 1:25pm
OK Noteable, not that it matters to you but I am even going to give you a thumbs up for a post that applies to onc and is relevant. Well done and looking for the update and good things on Monday at the KOL meeting.
Comment by Noteable on Dec 06, 2022 1:30pm
https://www.linkedin.com/posts/houraloghmani_oncolytics-biotech-achieves-success-criteria-activity-6949909865708343296-lG8Z/?trk=public_profile_like_view&originalSubdomain=ir
Comment by Noteable on Dec 06, 2022 1:47pm
Repost: Of the 13 Stage IV evaluable patients with pancreati cancer 93% had metastasis and 64% had metastasis to the liver. https://d1io3yog0oux5.cloudfront.net/_f805c910eb501b2a1642f91a7ce4c0a0/oncolyticsbiotech/db/343/2602/pdf/2022+GOBLET+SITC+Final.pdf Of the 13 late Stage IV evaluable pancreatic cancer patients in the ONCY Goblet study, 12 of these late-stage ...more  
Comment by jimsenior on Dec 06, 2022 2:31pm
Great Post For another possible piece to this complex puzzle  -  Search FDA approves Roche immunotherapy cocktail in liver cancer. To digress to your earlier post today Noteable. In layman's terms, can it be said that the complete response was found in an extremely ill patient. TIA
Comment by jimsenior on Dec 06, 2022 2:38pm
Apologies Noteable. I did not realize all patients were Stage IV. I knew they were all metastatic, and the results were incredible. If they were all Stage IV, I cannot think of a word.  
Comment by jimsenior on Dec 06, 2022 2:58pm
Sorry. I get it know. GOBLET To be Stage IV, it has to have gone to another organ not just outside which would be Stage 3. 93 per cent metastatic, and most,  63 per cent I think to  the liver. Roche seems to know the liver. There must be several firms looking at this. Just stand bag and think big.
Comment by jimsenior on Dec 06, 2022 3:10pm
Correction. Too much coffee today. Just stand back and think big.
Comment by SundayMovies on Dec 06, 2022 3:28pm
The press releases are too technical.  They should dum it up a bit by explaining what metastatic stage IV and all that nerdy stuff means so people can appreciate the info or not.  All that can fit in the note section with legal caviats.  Anyway, these people are very close to the end and somehow we got a complete response. I think it's actually the second instance here. ...more  
Comment by jimsenior on Dec 06, 2022 3:42pm
GOBLET There appears to have been one patient that was not Stage IV. That is to say I think ,that one patient was not metastatic. Said patient did not have a spread to another organ. So we have 12 patients that were metastatic, many but not all to the liver. The question remains; can we ascertain if the complete response was in the one non Stage IV, or in the STAGE IV group. From my lay ...more  
Comment by Buckhenry on Dec 06, 2022 3:47pm
you folks are dissecting this like you worked for one of the pharmaceutical companies doing due diligence... sit back and relax... nothing said on here has any bearing 
Comment by Noteable on Dec 06, 2022 4:29pm
SundayMovies - You say you need to have already dumbed down press releases further dumbed down to understand what you say you are invested in? From my perspective most of the barking dogs on this message board appear to fall into this same category as that you want. I believe that what you really need instead is a good understanding of the breaking and straightforward science and medicine that is ...more  
Comment by Noteable on Dec 06, 2022 3:44pm
It couldn't have been clearer:  Of the 13 Stage IV evaluable patients with pancreatic cancer 93% had metastasis and 64% had metastasis to the liver.  Of those 13 evaluable late-stage pancreatic cancer patients, 12 had metastatic cancer that was classified at M1. 1 patient had no metastasis and no cancer spread from the body of the pancreas ...more  
Comment by Noteable on Dec 06, 2022 3:59pm
The patient that demonstrated a CR at week 40 (end-of-trial) was patient #C1-002 a 54 year old male who had his cancer spread to his pertonieum. The others had experienced partial responses (PR) to their cancer. Best responses for the 13 evaluable patients at cut-off date: CR=1, PR=8, SD=2 and PD=2. Of the 9 patients with CR or PR, 7 responses were confirmed by a subsequent scan. ORR and ...more  
Comment by SundayMovies on Dec 06, 2022 4:04pm
You all have a good one! Resutls tomorrow. Let the data speak for itself!!!! All the best !!! Maybe this reovirus can also duke it out with the coronavirus!!! lololololol!!! or even make you younger... To AstraZeneca,  Low ball offer would work. Go for it!!!
Comment by fox7mf on Dec 06, 2022 4:47pm
If a lowball offer is $7b, well, sign me up...anything less than $4b usd...no deal BP!!!
Comment by jimsenior on Dec 06, 2022 4:18pm
Thank you Noteable. Got a bit confused as the non-metatstatic patient should not be classified as Stage IV. I could very well be wrong in that. Nevertheless we have a metastatic pancreatic cancer patient with a CR. I was trying to winnow out of the essence of GOBLET. A metastatic pancreatic cancer patient with a CR. Cheers
Comment by Noteable on Dec 06, 2022 4:37pm
As my subject line stated --- 12 patients out of 13 patients had Stage IV metastatic (M1) cancer ... while one patient did not (inferred by12/13).  
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