Tedopi Cancer Vaccine Meets Trial End Point For Pancreatic Cancer

The phase 2 TEDOPaM trial evaluating patients with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) met its primary end point of overall survival (OS), according to a news release from OSE Immunotherapeutics and GERCOR.

The investigation evaluated treatment with Tedopi (OSE2101), an “off-the-shelf” neoepitope-based therapeutic cancer vaccine which, according to the predefined statistical hypothesis, demonstrated responses as well as minimal toxicity with the cancer vaccine when combined with FOLFIRI chemotherapy as maintenance treatment.

“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,” Dr. Cindy Neuzillet, principal investigator of the TEDOPaM study, stated in the news release. “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. These results underscore the critical need for ongoing research and the development of more effective therapies, especially given the low long-term survival rates in pancreatic cancer. Every step we take brings us closer to making a meaningful impact in the fight against this challenging disease.”

Neuzillet serves as a professor at the Curie Cancer Research Institute, Saint-Cloud Hospital in Fance, as well as the head of the Department of Digestive Oncology.

PDAC is an aggressive malignancy that originates in the pancreatic ducts and accounts for approximately 95% of all pancreatic cancers. The global incidence of pancreatic cancer has more than doubled in recent decades, making it the sixth leading cause of cancer-related mortality worldwide, with an estimated 510,922 new cases and 467,409 deaths in 2022. The disease continues to rise annually, with projections forecasting a 95.4% increase in new cases by 2050. The overall five-year survival rate remains low at 10%, showing only minimal improvement over the past decade. In 2025, more than 67,000 Americans are expected to be diagnosed with pancreatic cancer — equivalent to 184 new cases per day. In the United States, it is the 10th most commonly diagnosed cancer, while in the European Union, it accounts for 3.5% of all new cancer cases and 7.1% of cancer-related deaths. 

Surgical resection remains the only potentially curative option for PDAC, but only 15% to 20% of patients are eligible at diagnosis due to advanced disease. Even among those who undergo surgery and neoadjuvant therapies, the prognosis remains poor, with a high risk of recurrence. These challenges highlight the urgent need for continued research and the development of more effective systemic therapies to improve survival outcomes for patients with pancreatic cancer.

To address this unmet need, investigators evaluated the chemotherapy, FOLFIRI, in Arm A of the randomized, non-comparative, phase 2 TEDOPaM trial, while the cancer vaccine, Tedopi, combined with chemotherapy was evaluated as maintenance treatment in Arm B. Investigators evaluated this treatment in patients with HLA-A2 positive PDAC who have had no progression after eight cycles of FOLFIRINOX induction chemotherapy.

The primary end point of the trial in the experimental Arm B was one-year OS rate. Additionally, the 107 participants who were enrolled were done so with a 1:1 ratio.

Nicolas Poirier, chief executive officer of OSE Immunotherapeutics concluded the press release by stating that, “The initial results provide a glimmer of hope in the fight against advanced or metastatic pancreatic cancer. This disease is notoriously difficult to treat, and the need for effective therapies is urgent. These early results show potential promising benefit in some subsets of patients; further research and analysis are needed to confirm their impact. 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.”

Detailed results are to be presented at upcoming medical congresses and further follow-up and translational analyses are ongoing, according to the news release.

Transcript has been edited for clarity and conciseness.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.