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Trial result
Pancreatic cancer

Oral Salmonella-IL2 bacteria + systemic FOLFIRINOX triples median PFS to 15 mo in stage IV pancreatic cancer

Trial ID
NCT04589234 on ClinicalTrials.gov
Cancer type
Pancreatic Cancer
Published in
New in Oncology - June 16, 2025

Salmonella-IL2, an attenuated S. Typhimurium engineered to secrete human IL-2 and colonize tumors, was administered orally alongside bi-weekly FOLFIRINOX in a non-randomized Phase II study (NCT04589234). 20 metastatic PDAC patients in Canada received ≥5 doses, the mPFS reached 15 months versus 5.8 months in 37 site-matched FOLFIRINOX controls (HR 0.30, p<0.0001). The mOS was 20.3 vs 11.5 months (HR 0.59, p=0.07). Grade ≥3 toxicities were driven by chemotherapy (anemia 45%, rash 14%); no serious events were linked to the live microbe. Historically, first-line FOLFIRINOX alone delivers ~6 mo PFS and 11–12 mo OS, underscoring the sizable survival improvement observed in this small, non‑randomised study.

Take home

If a planned phase III trial confirms these gains without new safety issues, oral tumor-tropic IL-2–expressing salmonella could become a novel immune-chemo backbone for an otherwise intractable disease (and perhaps it will work for other ‘cold’ GI cancers too). Fascinating!

Source: Read the original publication

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