Addition of Salmonella-IL2 to FOLFIRINOX for metastatic stage 4 pancreatic cancer nearly doubles median survival

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Published: 20 Apr 2023
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Prof Daniel Saltzman - University of Minnesota, Minneapolis, USA

Prof Daniel Saltzman speaks to ecancer about a phase II trial studying the addition of Salmonella-IL2 to standard of care chemotherapy for stage 4 metastatic pancreatic cancer. 

Prof Saltzman talks about the study design and results. 

The trial found that the addition of Salmonella-IL2 to FOLFIRINOX for stage 4 metastatic pancreatic cancer results in almost doubling of the median survival when compared to historical and site-specific controls receiving FOLFIRNOX only. 

Prof Saltzman concludes by discussing the future of this study.

We looked at adding our lead compound, Saltikva, which is an attenuated salmonella containing the human gene for interleukin-2, to standard of care in a phase II trial with patients with stage 4 metastatic pancreatic cancer. As you know, this disease is extraordinarily deadly and with standard of care we basically see about an 11-month median survival with the standard of care FOLFIRINOX regimen and then either around seven months with gemcitabine/abraxane-based regimen as standards of care for this disease.

What was the study design?

It was a two-arm study basically adding our lead compound, Saltikva, to standard of care for patients with stage 4 metastatic pancreatic cancer. We followed them and it’s given every two weeks; it’s an orally administered drug.

What were the results?

What we found was, the bottom line is when you’re looking at cancer studies, all the biomarkers and the radiology response are great and they’re supportive but the bottom line is it’s all about your overall survival and your median survival. What we’ve shown, that by adding Saltikva orally every two weeks to standard of care FOLFIRINOX we can nearly double median survival to up to 24 months. Our longest surviving patient is now on 44 months but the trial is still going and we’re still following patients. 

How do you think these results can impact future research and treatment?

The main thing that we have also shown in our study is that there have been no adverse events attributed to our drug. There are side effects to standard of care chemotherapy, of course, but nothing else over and above what we see with our drug. So this is highly encouraging. Salspera is now pivoting itself to perform a pivotal phase III multicentre randomised controlled trial which will then lead us to look for approval in the United States, Europe and Japan and some parts of the Middle East.