An experimental vaccine aimed at preventing pancreatic cancer showed signs of immune activity and appeared safe in a small phase 1 trial at Johns Hopkins School of Medicine in Baltimore, according to a study published in Cancer Discovery.
The trial tested mKRAS-VAX in 20 people with an inherited risk of pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer, and an abnormality found on imaging, usually a pancreatic cyst. None had been diagnosed with pancreatic cancer.
Participants received four injections during weeks 1, 3, and 5, with a booster at week 13. The vaccine targeted six common KRAS mutations, which researchers said drive more than 90% of pancreatic ductal adenocarcinomas.
Researchers reported that 18 of 20 participants, or 90%, developed a mutant KRAS-targeted immune response. On average, immune activity increased about 18-fold, though responses varied. Half of participants responded to all six KRAS mutations included in the vaccine.
The study also found the vaccine generated two types of T cells, one to attack abnormal cells and one associated with longer-term immune memory.
Researchers said the vaccine appeared safe. Reported side effects were limited to injection-site reactions and temporary flu-like symptoms.
The phase 1 trial was designed primarily to evaluate safety, not effectiveness. After about 16.5 months of follow-up, no participants had developed pancreatic cancer. Researchers also reported that 37.5% of vaccinated participants had shrinkage or disappearance of the pancreatic cysts linked to increased risk.
“In addition, the vaccine was safe and well-tolerated, supporting its use in larger cancer interception studies,” study co-author Dr. Neeha Zaidi, an associate professor of oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, said in a press release. “Overall, this study represents the first proof of concept for the use of vaccines for interception of pancreatic cancer in human patients.”