Oncolytics Biotech Inc T.ONC

RE:RE:RE:RE:RE:"The reality is the boats are shaking"

[Noteable]

As previously posted the FDA had granted Ipen's NALIRIFOX treatment regimen a PDU date of February 14, 2024  whereby the FDA will review of Ipsen’s sNDA application for the company's Onivyde regimen (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen) - as a first-line combination treatment for mPDAC. 

Onivyde is currently approved in most major markets including the U.S., the E.U. and Asia in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with mPDAC after disease progression following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of patients with mPDAC.

NALIRIFOX is a treatment regimen that combines 50 mg/m2 of Onivyde with 2,400 mg/m2 5-fluorouracil, 400 mg/m2 leucovorin and 60 mg/m2 oxaliplatin.  

NALIRIFOX improved overall survival by 17% relative to standard of care, an effect that proved to be statistically significant. 

These findings were presented in a late-breaking abstract session at the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium in January 2023. 

A Tough Disease to Treat 

The biopharma industry has seen limited success with PDAC, with few clinical studies demonstrating efficacy in recent decades, Ipen's Mayer said. Still, there has been some progress as of late. 

One example came in November, when Oncolytics (ONCY)  reported promising performance from its candidate pelareorep, in combination with atezolizumab, gemcitabine and nab-paclitaxel, in the Phase I/II GOBLET study. 

Patients treated with the investigational drug achieved a 69% objective response rate, nearly three times as high as in historical control trials.


https://www.biospace.com/article/ipsen-becomes-first-to-beat-standard-of-care-in-metastatic-pdac/