OSE2101 Plus FOLFIRI Meets OS End Point in Advanced PDAC

The OSE2101 cancer vaccine plus FOLFIRI chemotherapy demonstrated positive survival data with minimal toxicities in the phase 2 TEDOPaM trial.

OSE2101 (Tedopi), an off-the-shelf neoepitope-based therapeutic cancer vaccine, plus chemotherapy has demonstrated positive overall survival (OS) efficacy in the treatment of patients with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), according to a press release from the developers, OSE Immunotherapeutics and GERCOR.¹

The phase 2 TEDOPaM trial (NCT03806309), which compared chemotherapy vs OSE2101 plus chemotherapy, met its primary end point of 1-year OS in the OSE2101 arm (Fleming 2-stage design, H0, 25%; H1, 50%; 1-sided alpha, 2.5%; power, 90%).

Additionally, the trial demonstrated minimal toxicity with the experimental treatment of OSE2101 plus chemotherapy. More detailed results are planned to be presented at future medical conferences.

“These are positive results in a non-comparative trial. That said, we need to better understand the contribution of [OSE2101] 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,” principal study investigator Cindy Neuzillet, MD, PhD, from the Curie Cancer Research Institute in Saint-Cloud, France, stated in the press release.¹ “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.”

TEDOPaM is a randomized, non-comparative study that assessed the efficacy and safety of OSE2101 alone or with nivolumab (Opdivo) followed by leucovorin calcium, fluorouracil, and irinotecan hydrochloride (FOLFIRI) chemotherapy vs FOLFIRI alone as maintenance therapy in patients with advanced PDAC.²

The trial enrolled a total of 107 patients who were randomly assigned, in a 1:1 ratio, to either study arm. Patients in the comparator arm received 400 mg/m² of folinic acid, 180 mg/m² of intravenous irinotecan, and 400 mg/m² of intravenous fluorouracil bolus and 2400 mg/m² of continuous infusion. In the experimental arm, patients received subcutaneous injection of OSE2101 on days 1 and 15 every 4 weeks for 6 doses then every 8 weeks until month 12 then every 12 weeks for the maximum treatment duration of 24 months plus the same chemotherapy regimen.

Eligible patients were 18 years or older with histologically or cytologically confirmed PDAC with HLA-A2 genotype and recurrent or advanced disease not amenable to curative surgery. Additionally, patients had an ECOG performance status of 0 or 1,

adequate organ function, measurable or evaluable lesions per RECIST v1.1 criteria, stable disease or tumor response per RECIST v1.1 guidelines after 4 months of first-line FOLFIRI plus oxaliplatin (FOLFIRIOX) induction chemotherapy, and a life expectancy of 3 months or greater.

Exclusion criteria included obstructive jaundice without adequate biliary drainage, diagnosis of second malignancy within the previous 5 years, known active central nervous system metastases, uncontrolled massive pleural effusion or massive ascites, active uncontrolled infection, radiotherapy treatment to more than 30% of bone marrow, known or suspected hypersensitivity to the OSE2101 vaccine, and treatment with any other investigational medicinal products within 28 days to study entry.

The trial’s primary end point was OS at 1 year. Secondary end points included progression-free survival by centralized review of CT-scan imaging, rate of patients with success of the strategy at 6 months, objective response rate, health-related quality of life, and number of patients to experience treatment-related adverse events.

Previously, in February 2023, the FDA vocalized support for the development of the OSE2101 cancer vaccine in patients with advanced or metastatic non–small cell lung cancer.³

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. March 11, 2025. Accessed March 12, 2025. https://tinyurl.com/3dedbbpt
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 12, 2025. https://tinyurl.com/2p9myavd
3. OSE Immunotherapeutics provides regulatory update on Tedopi®, a cancer vaccine at a late-stage clinical development in lung cancer after failure to immunotherapies. News release. OSE Immunotherapeutics. February 15, 2023. Accessed March 12, 2025. https://tinyurl.com/yck28nbd