Phase 2 Trial of OSE2101 in Advanced PDAC Meets Primary End Point

Anatomy of human body with digestive system and pancreas. 3d illustration: © Rasi - stock.adobe.com

The primary end point of 1-year overall survival (OS) rate has been met in the phase 2 TEDOPaM (GERCOR D17-01 PRODIGE 63 trial) trial of OSE2101 (Tedopi) for the treatment of patients with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC).¹

The combination of OSE2101, a neoepitope-based therapeutic cancer vaccine, and FOLFIRI (irinotecan, leucovorin, and 5‐fluorouracil) chemotherapy demonstrated a statistically significant improvement in 1-year OS with minimal toxicity. While the trial was non-comparative, the findings suggest a potential benefit of adding OSE2101 to maintenance chemotherapy.

Further follow-up and translational analyses are ongoing, with detailed results expected to be presented at upcoming medical congresses.

“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,” explained Cindy Neuzillet, MD, PhD, Curie cancer research Institute, Saint-Cloud, principal investigator of the TEDOPaM study, in a press release.

“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,” continued Neuzillet.

TEDOPaM is a phase 2, randomized, non-comparative trial designed to evaluate 2 maintenance strategies in HLA-A2 positive patients with PDAC who showed no disease progression after eight cycles of FOLFIRINOX induction chemotherapy. The study randomly assigned patients in a 1:1 fashion to receive either FOLFIRI alone (arm A) or FOLFIRI plus OSE2101 (arm B).²

The primary end point was the 1-year OS rate in arm B, with a predefined statistical hypothesis of 25% (H0) vs 50% (H1). Secondary end points of the study include progression-free survival, rate of patients with success of the strategy, objective response rate, number of patients with treatment-related adverse events (AEs) as assessed by National Cancer Institute-Common Terminology Criteria for AEs, health-related quality-of-life, and the estimated quality-adjusted time without symptoms of disease or toxicity of treatment for each patient.

The trial enrolled 107 patients with histologically or cytologically proven pancreatic ductal adenocarcinoma and an ECOG performance status of 0 or 1. Patients were required to have recurrent or advanced disease not amenable to surgery with curative intent, measurable or evaluable lesions according to RECIST v1.1 criteria, stable disease or tumor response according to RECIST v1.1 after 8 cycles of first-line FOLFIRINOX or modified FOLFIRINOX induction chemotherapy, adequate organ function, and a life expectancy ≥ 3 months.

“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 benefits 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 [OSE2101] and more broadly, these data provide more evidence for the therapeutic cancer vaccine modality,” said Nicolas Poirier, chief executive officer of OSE Immunotherapeutics, in a press release.

REFERENCES

1. OSE Immunotherapeutics and GERCOR announce positive topline phase 2 result for clinical trial TEDOPaM evaluating OSE2101 (Tedopi®) in advanced pancreatic cancer. News release. OSE Immunotherapeutics SA. March 11, 2025. Accessed March 11, 2025. https://tinyurl.com/52yrwrbx

2. Maintenance with OSE2101 plus FOLFIRI, or FOLFIRI after FOLFIRINOX-based induction therapy in locally advanced or metastatic pancreatic ductal adenocarcinoma (TEDOPAM). ClinicalTrials.gov. Updated February 27, 2023. Accessed March 11, 2025. https://clinicaltrials.gov/study/NCT03806309?cond=Pancreatic%20Adenocarcinoma&term=NCT03806309&rank=1