OSE2101 vaccine shows ‘promising benefit’ in pancreatic cancer trial
Phase 2 study enrolled 107 people with advanced pancreatic cancer
Treatment with the experimental cancer vaccine OSE2101, given in combination with standard chemotherapy, led to positive early results in a Phase 2 clinical trial that enrolled people with advanced pancreatic cancer.
That’s according to findings announced by Ose Immunotherapeutics, the company developing OSE2101, and Gercor, a nonprofit group of oncology experts that sponsored the study.
“The initial results provide a glimmer of hope in the fight against advanced or metastatic pancreatic cancer,” Nicolas Poirier, PhD, CEO of Ose, said in a press release. “This disease is notoriously difficult to treat, and the need for effective therapies is urgent.”
The Phase 2 study, called TEDOPaM (NCT03806309), enrolled 107 people with advanced pancreatic ductal adenocarcinoma, the most common type of pancreatic cancer. All of the patients had initially undergone treatment with a chemotherapy regimen called FOLFIRINOX (folinic acid, fluorouracil, irinotecan, and oxaliplatin).
After the FOLFIRINOX induction therapy, all of the patients continued treatment with the chemo regimen FOLFIRI (folinic acid, fluorouracil, and irinotecan). Half of the patients received only FOLFIRI, while the other half were also treated with OSE2101.
Vaccine designed to trigger attack of molecular targets expressed by cancer cells
OSE2101, also known as Tedopi, is a vaccine designed to trigger the immune system to attack a collection of molecular targets that are expressed by cancer cells. It is given by injection under the skin. In the trial, patients received the first two doses two weeks apart, followed by six doses administered every four weeks. Subsequent doses were given every eight weeks for up to one year, and then every 12 weeks through the second year.
The study’s main goal was to see if adding OSE2101 to the chemo regimen would improve overall survival after one year. According to Ose and Gercor, the study met its main goal, with safety data suggesting OSE2101 was generally well tolerated. More details on the results were not disclosed. Ose noted further analyses are still ongoing, and detailed results will be presented at future medical meetings.
“These early results show potential promising benefit in some subsets of patients; further research and analysis are needed to confirm their impact,” Poirier said. “These additional positive results in a randomized clinical trial represent another step forward for the development of Tedopi and more broadly, these data provide more evidence for the therapeutic cancer vaccine modality.”
Cindy Neuzillet, MD, PhD, principal investigator of the TEDOPAM study at the Curie cancer research institute, said: “These are positive results in a non-comparative trial. That said, we need to better understand the contribution of Tedopi in the context of this combination. A large translational program on tumor tissue, blood, and imaging is ongoing. Additional analysis at a longer time point will also be necessary for more mature survival data. … Every step we take brings us closer to making a meaningful impact in the fight against this challenging disease.”
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