Salmonella-IL2 may improve upon standard care in patients with stage IV pancreatic cancer, according to research presented at the AACR Annual Meeting 2023.
Patients who received Salmonella-IL2 plus folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) had roughly double the median overall survival as control individuals who received FOLFIRINOX alone, researchers found.
Salmonella-IL2 is based on an attenuated strain of salmonella genetically engineered to carry the human gene for interleukin-2 (IL-2), explained study presenter Daniel A. Saltzman, MD, PhD, a professor at the University of Minnesota in Minneapolis and chief medical officer of Salspera, the company developing Salmonella-IL2.
Dr Saltzman and colleagues evaluated Salmonella-IL2 in combination with standard care in a phase 2 study of patients with stage IV pancreatic cancer (ClinicalTrials.gov Identifier: NCT04589234).
In the first arm of the trial, patients received Salmonella-IL2 plus FOLFIRINOX every 2 weeks. In the second arm, patients received Salmonella-IL2 plus gemcitabine and nab-paclitaxel every 2-3 weeks. Efficacy results were not presented for the second arm.
The researchers compared results for 20 patients treated with Salmonella-IL2 and FOLFIRINOX to results for 37 patients in a trial site-specific control group who received FOLFIRINOX alone, as well as to historical control individuals who received FOLFIRINOX alone.
The median overall survival was 24 months in patients treated with Salmonella-IL2 and FOLFIRINOX, 13.1 months in the site-specific control group, and 11.1 months in the historical control group.
A total of 37 serious adverse events were reported in 20 patients — 12 patients in the FOLFIRINOX-Salmonella-IL2 arm and 8 patients in the arm receiving Salmonella-IL2 with gemcitabine and nab-paclitaxel. No serious adverse events were attributed to Salmonella-IL2 treatment.
Based on these results, the researchers are planning a phase 3 trial of Salmonella-IL2.
Disclosures: This research was supported by Salspera LLC. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Kavan P, Saltzman DA, Muegge J, Moradian J, Batist G. Addition of Salmonella-IL2 to FOLFIRINOX for metastatic stage 4 pancreatic cancer nearly doubles median survival. AACR 2023. April 14-29, 2023. Abstract CT035.