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Brief Report Open Access

Suppression of New Metastases with Saltikva in a Phase II Clinical Trial: A Potential Signal of Immune Memory in Metastatic Pancreatic Ductal Adenocarcinoma

  • 1Segal Cancer Center, McGill University Center for Translational Research, McGill University, Jewish General Hospital, Montreal, Quebec, Canada
  • 2Salspera, Cambridge, MA, USA
  • 3Department of Surgery, University of Minnesota, Minneapolis, MN, USA
+ Affiliations - Affiliations

Corresponding Author

Daniel Saltzman, DSaltzman@Salspera.com; Saltz002@umn.edu

Received Date: May 11, 2026

Accepted Date: May 25, 2026

Abstract

Background: Metastatic pancreatic ductal adenocarcinoma (mPDAC) remains one of the most lethal solid tumors, with poor survival despite modern chemotherapy. Traditional efficacy metrics such as objective response rate (ORR) and RECIST-defined progression-free survival (PFS) may incompletely capture the biologic effects of immunotherapy, particularly therapies designed to induce durable systemic immune surveillance rather than immediate cytoreduction.

Observation: In patients receiving more than five doses of Saltikva (orally administered attenuated Salmonella enterica Typhimurium expressing human IL-2) in combination with FOLFIRINOX, only 4 of 20 developed new metastatic lesions, while 16 (80%) progressed through enlargement of pre-existing metastatic disease without radiographic evidence of de novo metastatic spread.

Hypothesis: This pattern suggests possible immune-mediated suppression of micrometastatic dissemination and may represent evidence of functional immune memory rather than transient immune activation.

Conclusion: Freedom from new metastatic disease may serve as a clinically meaningful endpoint for microbial immunotherapies and could represent a stronger indicator of biologic efficacy than ORR alone.

Keywords

Cancer immunology, Immunotherapy, Tumor immunology

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