On May 24, 2023 OSE reported completion of patient enrollment in the Phase 2 clinical trial TEDOPaM sponsored and conducted by the GERCOR Group and evaluating Tedopi in advanced or metastatic pancreatic ductal adenocarcinoma (Press release, OSE Immunotherapeutics, MAY 24, 2023, View Source [SID1234632027]).

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This randomized, non-comparative Phase 2 trial is designed to evaluate Tedopi plus FOLFIRI* chemotherapy versus FOLFIRI as maintenance treatment in patients (HLA-A2 genotype) with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with no progression after 8 cycles of FOLFIRINOX induction chemotherapy**. The primary endpoint of the trial is the one-year overall survival (OS) rate (Fleming- futility analysis; null hypothesis ≤25%; alternative hypothesis ≥ 50%), and the key secondary endpoint is the progression-free survival [TEDOPaM GERCOR D17-01 PRODIGE 63 study: Maintenance With OSE2101 Plus FOLFIRI, or FOLFIRI After FOLFIRINOX-based Induction Therapy in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma NCT03806309].

Prof. Cindy Neuzillet, MD PhD (Curie cancer research Institute, Paris), Principal Investigator of the TEDOPaM study, comments: "Completing enrollment of this Phase 2 trial represents a major milestone in evaluating an innovative activating immunotherapy-based maintenance strategy for patients with pancreatic cancer. Tumor-associated antigens selected for Tedopi are found overexpressed in pancreatic tumor, thus giving a rationale for testing this cancer vaccine in a very hard to treat patient population. We now look forward to advancing on the patients’ follow-up period and to reporting the research main findings, including survival and predictive biomarkers. We are very grateful to the patients involved and their families, and to the clinical investigators and centers for their trust and participation in this important development program."

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, concludes: "We are very pleased with the progress of the TEDOPaM clinical study and are now expecting the final results in Q3 next year as additional source of clinical value of Tedopi beyond non-small lung cancer, further to the first encouraging interim results shared at the 2022 ASCO (Free ASCO Whitepaper) meeting. We warmly thank the GERCOR academic group, sponsor of the trial, and the PRODIGE Intergroup, for this important milestone in Tedopi’s development program in pancreatic cancer. This step brings us closer to delivering potential evidence to assess the use of Tedopi as a potentially maintenance treatment in an aggressive disease with a generally poor prognosis, demanding for novel therapeutic approaches and representing significant unmet medical need."

The interim results from the TEDOPaM Phase 2 trial presented at the 2022 ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) meeting referred to the first 29 randomized HLA-A2 positive patients with no progression after 8 cycles of FOLFIRINOX: 9 patients included in standard arm A (FOLFIRI) with a 1-year OS rate of 44% and one partial response (11%); 10 patients in experimental arm B (Tedopi monotherapy) with a similar 1-year OS rate of 40% and one partial response (10%); and 10 patients in experimental arm C (nivolumab + Tedopi) with a 1-year OS rate of 30% and no partial response.

Tedopi as maintenance monotherapy showed a favorable safety profile and encouraging time to strategy failure warranting further evaluation. Nivolumab + Tedopi was associated with poorer outcomes leading to the closing of this arm. Following an Independent Data Monitoring Committee (IDMC) recommendation, the study continued with an amended protocol comparing a maintenance treatment Tedopi in combination with FOLFIRI versus FOLFIRI chemotherapy after treatment with FOLFIRINOX. A total of 107 patients were enrolled in this second part.

* FOLFIRI: A combination chemotherapy with folinic acid, fluorouracil and irinotecan
**FOLFIRINOX: A combination chemotherapy with folinic acid, fluorouracil, irinotecan and oxaliplatin

PDAC is the most common type of pancreatic cancer with approximately 60,000 patients diagnosed in the U.S. each year and nearly 500,000 new cases per year globally1,2. Due to lack of initial symptoms at early stage and high invasive potential, PDAC diagnosis is made at an advanced stage in 80% of cases, when patients already have metastases (50%) or locoregional extension (30%) precluding surgical treatment3, 4, 5. Advanced PDAC remains a challenging, non-curable disease6,7. Currently, fewer than half of patients diagnosed with metastatic PDAC and treated with FOLFIRINOX8 survive longer than one year and overall, pancreatic cancer has the lowest 5-year OS rate of all cancer types globally and in the U.S, not exceeding 10%1,2. The global pancreatic cancer treatment market size was estimated at USD 2.527 billion in 2022 and is projected to reach USD 6.859 billion by 2030.