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<p>Salmonella-IL2 is an attenuated Salmonella Typhimurium strain carrying the human gene for IL-2. When&#xa0;orally administered in preclinical trials, the&#xa0;bacterium&#xa0;colonizes tumors and locally releases IL-2, triggering immunologically-mediated tumor cell killing without untoward&#xa0;side effects. A non-randomized, phase 2&#xa0;study evaluated the combination of Salmonella-IL2 with standard of care (SOC) chemotherapy where patients&#xa0;received Salmonella-IL2 plus FOLFIRINOX (FFX). Overall survival (OS), progression-free survival (PFS), safety, and biomarker data&#xa0;in each arm were studied. In total,&#xa0;34 patients (30 in the trial, 4 via EAP) were enrolled: 26 received Salmonella-IL2 with FOLFIRINOX. Those patients who received more than five doses of Salmonella-IL2 with FOLFIRINOX (n = 20)&#xa0;had&#xa0;a mPFS of 15&#xa0;months while the&#xa0;mOS was 20.3&#xa0;months. Even though there were no complete responses, the partial response rate and the overall response rate was 70.0%. In addition,&#xa0;41 serious adverse events were noted and attributed to SOC chemotherapy agents but none to Salmonella-IL2. 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.&#xa0;A multicenter, randomized, phase 3 trial is warranted. ClinicalTrials.gov identifier: NCT04589234.</p>

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A phase 2 study of orally administered live biotherapeutic salmonella-IL2 with FOLFIRINOX for stage IV pancreatic cancer

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月27日

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  • Gerald Batist,
  • Petr Kavan,
  • Lance Augustin,
  • Janet Schottel,
  • Jordan Moradian,
  • James T. Lee,
  • Daniel Saltzman

摘要

Salmonella-IL2 is an attenuated Salmonella Typhimurium strain carrying the human gene for IL-2. When orally administered in preclinical trials, the bacterium colonizes tumors and locally releases IL-2, triggering immunologically-mediated tumor cell killing without untoward side effects. A non-randomized, phase 2 study evaluated the combination of Salmonella-IL2 with standard of care (SOC) chemotherapy where patients received Salmonella-IL2 plus FOLFIRINOX (FFX). Overall survival (OS), progression-free survival (PFS), safety, and biomarker data in each arm were studied. In total, 34 patients (30 in the trial, 4 via EAP) were enrolled: 26 received Salmonella-IL2 with FOLFIRINOX. Those patients who received more than five doses of Salmonella-IL2 with FOLFIRINOX (n = 20) had a mPFS of 15 months while the mOS was 20.3 months. Even though there were no complete responses, the partial response rate and the overall response rate was 70.0%. In addition, 41 serious adverse events were noted and attributed to SOC chemotherapy agents but none to Salmonella-IL2. 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.