OSE Immunotherapeutics and the FoRT Foundation have completed patient enrollment in a Phase 2 clinical trial evaluating the neoepitope-based therapeutic cancer vaccine Tedopi in combination with standard treatments for patients with metastatic non-small cell lung cancer (NSCLC). The Combi-TED study enrolled 105 HLA-A2 positive patients across sites in Italy, France, and Spain, with top-line results expected in the second half of 2026.
Trial Design and Patient Population
The Combi-TED trial (NCT04884282) is an open-label, randomized, three-arm Phase 2 study sponsored and conducted by the Italian Foundation FoRT. The study evaluates Tedopi in combination with the anti-PD1 immune checkpoint inhibitor Opdivo (nivolumab) or Tedopi plus docetaxel, compared against docetaxel alone as the reference arm.
The trial targets HLA-A2 positive patients with metastatic NSCLC who have no evidence of EGFR mutations or ALK or ROS1 rearrangements and have progressed after first-line chemo-immunotherapy. The primary endpoint is 1-year survival rate, representing a critical measure for this patient population with limited treatment options.
Clinical Significance and Expert Perspectives
Federico Cappuzzo, M.D., Ph.D., Director Medical Oncology at Cancer Institute Regina Elena in Rome and Chief Investigator of the study, emphasized the trial's importance: "We are very pleased to announce the completion of enrollment in Combi-TED, an exploratory Phase 2 evaluating a new treatment strategy with the combination of therapeutic cancer vaccine Tedopi which, by activating T lymphocytes, might efficiently optimize a checkpoint inhibitor or chemotherapy treatment."
The study addresses an unmet medical need for NSCLC patients progressing after at least three months (four cycles) of first-line chemo-immunotherapy and eligible for treatment with docetaxel. Cappuzzo noted that this population "needs new treatment options" and expressed anticipation for the 2026 results to guide next steps in developing new therapies.
Broader Development Strategy
Silvia Comis, Chief Clinical and Medical Research Officer at OSE Immunotherapeutics, highlighted how Combi-TED fits into Tedopi's broader clinical development program. Building on positive results from the ATALANTE-1 study, Tedopi is currently being investigated as monotherapy compared to docetaxel in the ARTEMIA pivotal trial for HLA-A2 positive patients with metastatic NSCLC who have secondary resistance to immune checkpoint inhibitors.
"Combi-TED will therefore provide further information on the relevance of Tedopi when administered in combination as second-line in a broader metastatic NSCLC population, including patients with more aggressive disease," Comis explained. This approach distinguishes Combi-TED from ARTEMIA, as it includes patients with more aggressive disease characteristics rather than focusing specifically on those with secondary resistance to immune checkpoint inhibitors.
Mechanism and Therapeutic Approach
Tedopi is a neoepitope-based therapeutic cancer vaccine designed to activate T lymphocytes, potentially optimizing the effectiveness of checkpoint inhibitor or chemotherapy treatments. The vaccine represents OSE Immunotherapeutics' approach to developing first-in-class therapies in immuno-oncology that address unmet patient needs.
The combination strategy being tested in Combi-TED reflects the evolving landscape of cancer immunotherapy, where therapeutic vaccines are being explored as potential enhancers of existing treatments rather than standalone therapies.
Timeline and Next Steps
The completion of enrollment marks a significant milestone in the clinical development of Tedopi for NSCLC. Results from the Combi-TED trial are expected in the second half of 2026, with findings to be presented at the ESMO conference (October 17-21, 2025) as part of the Trial in Progress session.
OSE Immunotherapeutics, a biotechnology company based between Nantes and Paris and quoted on Euronext, continues to focus on developing first-in-class assets in immuno-oncology and immuno-inflammation through partnerships with leading academic institutions and biopharmaceutical companies.
