RE:RE:RE:ONCY January 2024 slide deck - over 120 panc pts studiedFebruary 02, 2024 - The long-acting human interleukin-7, efineptakin alfa (NT-17), has received an orphan drug designation (ODD) from the FDA for use as a potential therapeutic option in patients with pancreatic cancer.
The safety and efficacy of efineptakin alfa paired with pembrolizumab (Keytruda) is under investigation in patients with advanced solid tumors, including pancreatic cancer, as part of an ongoing phase 1/2 study (NCT04332653).
Efficacy data from the study showed that in patients with pancreatic ductal adenocarcinoma (PDAC; n = 26), at a median follow-up of 3.53 months,
- the objective response rate (ORR) by RECIST v1.1 criteria was 3.8%,
- the disease control rate (DCR) was 30.8%,
- the median duration of response was 8.7 months
- the median time to response (TTR) was 2.8 months.
By iRECIST v1.1 criteria,
- the ORR was 7.7%,
- the DCR was 34.6%,
- the median DOR was 6.1 months, and
- the median TTR was 3.4 months
- median progression-free survival (PFS) was 6.0 months.
By comparision ONCY's Phase 2 Goblet study PDAC cohort involving pelareorep with atezolizumab resulted in the following data:
- Objective Response Rate (ORR) of 62% (54% confirmed by two or more scans)
- A Disease Control Rate (DCR) of 85%
Survival data: Evaluated based on 4 parameters including:
- Median duration of response was 5.7 months
- Median progression-free survival (PFS) was 7.2 months
- Interim 12-month survival rate was 46%
- Interim median overall survival (OS) was 10.6 months
This move by the FDA demonstrates that the Agency views pancreatic cancer as a significant (rare) disease with an unmet treatment need which appears responsive to checkpoint inhibitor therapy in combination with an immune stimulator.
https://oncolyticsbiotech.com/press_releases/oncolytics-presents-positive-updated-pancreatic-cancer-data-from-goblet-phase-1-2-study-at-esmo/