OSE Immunotherapeutics and FoRT Foundation Complete Enrollment in Combi-TED Clinical Trial Evaluating Tedopi in Combination with Nivolumab or Docetaxel for Non-Small Cell Lung Cancer

Strategic Insights -

The phase 2 clinical trial, Combi-TED, has successfully completed the enrollment of 105 HLA-A2 positive patients with non-small cell lung cancer (NSCLC) to evaluate the efficacy of Tedopi, a neoepitope-based therapeutic cancer vaccine, in combination with either nivolumab or docetaxel. This trial is an open-label, randomized, three-arm study assessing the combination of Tedopi with the anti-PD1 immune checkpoint inhibitor Opdivo (nivolumab) or Tedopi plus docetaxel or docetaxel alone as a second-line treatment for patients with metastatic NSCLC. The primary endpoint is 1-year survival rate. Top-line results are expected in the second half of 2026.

Key Takeaways:

  • The Combi-TED study is a phase 2 clinical trial evaluating Tedopi in combination with nivolumab or docetaxel for the treatment of non-small cell lung cancer (NSCLC) in HLA-A2 positive patients.
  • One hundred five patients were enrolled in the trial, which is an open-label, randomized, three-arm study assessing the combination of Tedopi with the anti-PD1 immune checkpoint inhibitor Opdivo (nivolumab) or Tedopi plus docetaxel or docetaxel alone.
  • The primary endpoint of the study is the 1-year survival rate.
  • The trial is sponsored and conducted by the Italian Foundation FoRT across sites in Italy, France, and Spain.
  • Federico Cappuzzo, M.D., Ph.D., Director Medical Oncology at Cancer Institute Regina Elena, Roma, Italy, and Chief Investigator of the Combi-TED study, comments on the completion of enrollment, highlighting the potential of Tedopi to optimize checkpoint inhibitor or chemotherapy treatment.
  • Silvia Comis, Chief Clinical and Medical Research Officer, emphasizes the significance of the Combi-TED trial in evaluating innovative second-line combinations of Tedopi with either an immuno-therapeutic agent or chemotherapy for NSCLC patients.

Statistics:

  • 105 patients were enrolled in the Combi-TED study.
  • The study is expected to provide top-line results in the second half of 2026.

Sources:

  • OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE)
  • The FoRT Foundation (Fondazione Ricerca Traslazionale)
  • Combi-TED clinical trial (EudraCT number: pending)
  • ATALANTE-1 study
  • ARTEMIA pivotal trial
  • Opdivo (nivolumab)
  • Docetaxel
  • Non-Small Cell Lung Cancer (NSCLC)
  • HLA-A2 positive patients
  • First-line chemo-immunotherapy
  • Anti-PD1 immune checkpoint inhibitor
  • Immuno-therapeutic agent
  • Chemotherapy
  • Second-line treatment
  • 1-year survival rate