NEW YORK – Persephone Biosciences on Monday announced the launch of an observational study to assess the microbiome's effect on cancer patients' immune function and response to treatment.
The longitudinal, prospective trial, dubbed ARGONAUT, will involve roughly 4,000 patients with advanced non-small cell lung cancer, triple-negative breast cancer, colorectal cancer, and pancreatic cancer. The NSCLC patients will be treated with immune checkpoint inhibitors they haven't previously received, while others can receive any type of treatment they've not had prior exposure to. In all cases, patients in ARGONAUT will have to access these standard-of-care or investigational treatments by joining another trial that permits co-enrollment.
Patients will submit two blood and two stool samples over a six-month period for microbiome analysis, and will be monitored for up to two years. Researchers will conduct whole-genome sequencing and metabolomics analysis on these samples to assess whether patients' microbiome composition can predict the progression-free survival they experience on treatments they receive within parallel studies.
Researchers are also interested in whether microbiome composition can predict patients' overall survival, and whether there is any correlation between the microbiome composition and immune markers identified in the patients' blood samples. Persephone will save patient samples for future studies to develop precision microbiome treatments and identify companion diagnostics to guide treatment.
According to a statement from Persephone CEO Stephanie Culler, the longitudinal ARGONAUT study will be the largest of its kind to date in the US, and will generate data that she hopes will facilitate partnerships with drug companies interested in using the microbiome to bolster the benefit of their therapies.
Persephone has also committed to improving diversity within ARGONAUT, and study investigators are aiming for even representation of the sexes among study participants. They are also aiming for a cohort comprising 20 percent African American patients, 10 percent Hispanic patients, and 10 percent Asian patients.
"Significant cancer health disparities currently exist," Sandip Patel of the University of California, San Diego, a clinical advisor to Persephone, said in a statement. "But with this nationwide study that includes tumor types, like TNBC, that are more prevalent in at-risk demographics, we believe we can address these disparities and develop equitable precision medicine, thereby potentially increasing survival rates and quality of life."