OSE Immunotherapeutics and the FoRT Foundation Announce First Patient Randomized in Phase 2 Clinical Trial Evaluating Tedopi® in Combination with Opdivo® (nivolumab) in Non-Small Cell Lung Cancer

17 November 2021
  • Clinical trial sponsored and conducted by the Italian Oncology Foundation FoRT and supported by Bristol Myers Squibb and OSE Immunotherapeutics.
  • A strategy of combining Opdivo®, a PD-1 targeted checkpoint inhibitor, with Tedopi® as a second-line treatment in patients with metastatic non-small cell lung cancer after first-line chemo-immunotherapy.

OSE Immunotherapeutics SA and the FoRT Foundation (Fondazione Ricerca Traslazionale) announced today that the first patient has been randomized in the Phase 2 clinical trial evaluating Tedopi® in combination with Opdivo® or chemotherapy as second-line treatment in patients with metastatic non-small cell lung cancer (NSCLC).

This three-arm Phase 2 study will evaluate neo-epitope-based vaccine Tedopi® in combination with Bristol Myers Squibb’s Opdivo® (nivolumab), an immune checkpoint inhibitor, or Tedopi® plus chemotherapy or chemotherapy alone as second-line treatment in patients with HLA-A2 positive metastatic NSCLC after first-line chemo-immunotherapy.

Federico Cappuzzo, M.D., Ph.D., Director Medical Oncology at Cancer Institute Regina Elena, Roma, Italy, and Chief Investigator of the study, comments: “We are very pleased to announce enrollment of the first patient in this Phase 2 trial evaluating a new treatment strategy with the combination of therapeutic vaccine Tedopi® which, by activating T lymphocytes, might efficiently optimize a checkpoint inhibitor or chemotherapy treatment in patients with acquired resistance to immunotherapy. We look forward to evaluating this second-line combination of immuno-therapeutic agents in NSCLC patients with disease progression, a population who needs new treatment options.”
The clinical trial, sponsored and conducted by the Italian oncology foundation FoRT, is designed to enroll 105 patients.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, adds: “Having the first patient enrolled in an additional oncology indication marks a key milestone in broadening the scope of Tedopi®’s development. On the heels of the positive final results from the Phase 3 trial in NSCLC patients in secondary resistance to ICIs*, including promising clinical benefit and good safety profile, this Phase 2 development of Tedopi® in NSCLC will expand and enhance the product’s clinical data. We are expecting first results of Tedopi® as a potential second-line treatment of NSCLC patients after chemoimmunotherapy in 2024.”