{"entity":{"id":"avenger-500","kind":"trial","name":"AVENGER 500","aka":[],"tldr":"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.","status":"negative","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03504423","url":"https://clinicaltrials.gov/study/NCT03504423"},{"label":"Philip et al., Journal of Clinical Oncology 2024: devimistat with modified FOLFIRINOX versus FOLFIRINOX (AVENGER 500)","url":"https://doi.org/10.1200/JCO.23.02659"}],"tags":[],"related":[],"cancers":["pancreatic"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["devimistat","folfirinox"],"companies":["cornerstone-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-philip-j-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"nct":"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.","started":"2018-11-09","startedType":"actual","yearReported":2024,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Devimistat + modified FOLFIRINOX","n":266,"value":11.1},{"name":"FOLFIRINOX","n":262,"value":11.73}],"hr":0.95,"ci":[0.77,1.18],"p":"0.655","source":"https://doi.org/10.1200/JCO.23.02659"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Devimistat + modified FOLFIRINOX","value":7.8},{"name":"FOLFIRINOX","value":8}],"hr":0.99,"ci":[0.76,1.29],"p":"0.94","source":"https://doi.org/10.1200/JCO.23.02659"}]},"route":"/trials/avenger-500/","neighbours":{"cancer":[{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"devimistat","kind":"drug","name":"Devimistat","route":"/drugs/devimistat/"},{"id":"folfirinox","kind":"drug","name":"FOLFIRINOX / mFOLFIRINOX","route":"/drugs/folfirinox/"}],"company":[{"id":"cornerstone-pharmaceuticals","kind":"company","name":"Cornerstone Pharmaceuticals (formerly Rafael Pharmaceuticals)","route":"/companies/cornerstone-pharmaceuticals/"}],"paper":[{"id":"paper-philip-j-clin-oncol","kind":"paper","name":"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","route":"/key-papers/paper-philip-j-clin-oncol/"}],"term":[{"id":"pancreatic-failed-programmes","kind":"term","name":"Pancreatic cancer: the failed and stopped programmes and why","route":"/terms/pancreatic-failed-programmes/"}]}}