# AVENGER 500

Source: https://onco.cc/trials/avenger-500/  
OnCo record `avenger-500` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding the metabolism drug devimistat to FOLFIRINOX did not help people with metastatic pancreatic cancer live longer.

## Summary

AVENGER 500 was an open-label phase 3 trial in previously untreated metastatic pancreatic adenocarcinoma comparing modified FOLFIRINOX with devimistat against modified FOLFIRINOX alone. The primary endpoint was overall survival. The trial did not show a survival benefit, and response rates were similar between arms, closing the pancreatic programme for devimistat.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-17
- Registry id: NCT03504423
- Phase: 3
- Setting: Untreated metastatic pancreatic adenocarcinoma: modified FOLFIRINOX with or without devimistat
- Sponsor: Rafael Pharmaceuticals (Cornerstone)
- Result: No overall survival benefit from adding devimistat to modified FOLFIRINOX.
- Outcomes: Overall survival: Devimistat + modified FOLFIRINOX 11.1 months vs FOLFIRINOX 11.73 months, HR 0.95; Progression-free survival: Devimistat + modified FOLFIRINOX 7.8 months vs FOLFIRINOX 8 months, HR 0.99

## Sources

- ClinicalTrials.gov NCT03504423: https://clinicaltrials.gov/study/NCT03504423
- Philip et al., Journal of Clinical Oncology 2024: devimistat with modified FOLFIRINOX versus FOLFIRINOX (AVENGER 500): https://doi.org/10.1200/JCO.23.02659

## Connected records

- cancers: [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Devimistat](https://onco.cc/drugs/devimistat/), [FOLFIRINOX / mFOLFIRINOX](https://onco.cc/drugs/folfirinox/)
- companies: [Cornerstone Pharmaceuticals (formerly Rafael Pharmaceuticals)](https://onco.cc/companies/cornerstone-pharmaceuticals/)
- key papers: [Devimistat (CPI-613) With Modified Fluorouarcil, Oxaliplatin, Irinotecan, and Leucovorin (FFX) Versus FFX for Patients With Metastatic Adenocarcinoma of the Pancreas: The Phase III AVENGER 500 Study](https://onco.cc/key-papers/paper-philip-j-clin-oncol/)
- terms: [Pancreatic cancer: the failed and stopped programmes and why](https://onco.cc/terms/pancreatic-failed-programmes/)

---
JSON: https://onco.cc/api/v1/entities/avenger-500.json