The Phase 2 TEDOPaM trial evaluating OSE2101 (Tedopi) in combination with chemotherapy has met its primary endpoint of one-year overall survival (OS) rate in patients with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), according to a joint announcement from OSE Immunotherapeutics and the French GERCOR Oncology Clinician Group.
The randomized, non-comparative trial demonstrated that the combination of OSE2101, a neoepitope-based therapeutic cancer vaccine, with FOLFIRI (irinotecan, leucovorin, and 5‐fluorouracil) chemotherapy achieved a statistically significant improvement in one-year OS with minimal toxicity compared to the predefined statistical hypothesis.
"These are positive results in a non-comparative trial," said Professor Cindy Neuzillet, MD, PhD, from the Curie cancer research Institute in Saint-Cloud and Principal Investigator of the TEDOPaM study. "That said, we need to better understand the contribution of Tedopi in the context of this combination."
Trial Design and Patient Population
The TEDOPaM study (GERCOR D17-01 PRODIGE 63 trial) enrolled 107 HLA-A2 positive patients with advanced or metastatic PDAC who showed no disease progression after eight cycles of FOLFIRINOX induction chemotherapy. Patients were randomized in a 1:1 ratio to receive either:
- Arm A: FOLFIRI chemotherapy alone
- Arm B: FOLFIRI plus OSE2101 (Tedopi)
The primary endpoint was the one-year OS rate in the experimental Arm B, with a predefined statistical hypothesis of 25% (H0) versus 50% (H1). Secondary endpoints included progression-free survival, objective response rate, treatment-related adverse events, and quality-of-life measures.
Eligible patients had histologically or cytologically proven PDAC with an ECOG performance status of 0 or 1, recurrent or advanced disease not amenable to curative surgery, and measurable or evaluable lesions according to RECIST v1.1 criteria.
Significance in Pancreatic Cancer Treatment
Pancreatic cancer represents a significant unmet medical need with dismal survival statistics. It is currently the sixth leading cause of cancer-related death worldwide, with an estimated 510,922 new cases and 467,409 deaths in 2022. The global burden has more than doubled in recent decades, with projections indicating a 95.4% increase in new cases by 2050.
The overall five-year survival rate for pancreatic cancer remains at approximately 10% worldwide, showing only modest improvement over the past decade. Surgical resection, the only potentially curative treatment, is feasible for only 15-20% of patients at diagnosis due to the advanced stage of the disease at presentation.
"The initial results provide a glimmer of hope in the fight against advanced or metastatic pancreatic cancer," said Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics. "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."
Mechanism of Action and Future Directions
OSE2101 (Tedopi) is described as an 'off-the-shelf' neoepitope-based therapeutic cancer vaccine. This approach represents an emerging modality in cancer immunotherapy, designed to stimulate the patient's immune system to recognize and attack cancer cells.
A comprehensive translational research program is ongoing, examining tumor tissue, blood samples, and imaging data to better understand the mechanisms behind the observed clinical benefit. The researchers note that additional analysis at longer time points will be necessary to obtain more mature survival data.
"A large translational program on tumor tissue, blood, and imaging is ongoing," explained Dr. Neuzillet. "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."
Detailed results from the TEDOPaM trial are expected to be presented at upcoming medical congresses, providing the oncology community with a more comprehensive understanding of this potential new treatment approach for one of the most lethal malignancies.
About OSE Immunotherapeutics
OSE Immunotherapeutics is a biotech company focused on developing first-in-class assets in immuno-oncology and immuno-inflammation. The company partners with leading academic institutions and biopharmaceutical companies to develop and bring to market transformative medicines for patients with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris, France, and is quoted on Euronext.
