Addition of Salmonella-IL2 to FOLFIRINOX is associated with increased mPFS and mOS when compared to previously reported outcomes with FOLFIRINOX alone in the literature. A multicenter, randomized, phase 3 trial is warranted. ClinicalTrials.gov identifier: NCT04589234.
Addition of Salmonella-IL2 to FOLFIRINOX for stage 4 metastatic pancreatic cancer results in the near doubling of median survival when compared to historical and site-specific controls receiving FOLFIRNOX only. These findings strongly indicate that a larger pivotal phase 3 multicenter trial is warranted.