RE:12/13 Goblet PC patients had Stage IV metastatic (M1) cancerRepost:
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/