NEW YORK — OSE Immunotherapeutics said Wednesday that it has randomized the first patient into its Phase II clinical trial of its neo-epitope-based vaccine Tedopi as a second-line treatment for metastatic non-small cell lung cancer.
The three-arm, randomized Phase II trial is evaluating Tedopi in combination with nivolumab (Bristol Myers Squibb's Opdivo), Tedopi in combination with chemotherapy, and chemotherapy alone as treatments for HLA-A2 positive metastatic NSCLC patients previously treated with first-line chemo-immunotherapy. The primary outcome measure is one-year survival rate.
Tedopi activates T lymphocytes and could, the trial sponsors said, optimize the performance of a PD1-targeted checkpoint inhibitor like nivolumab or chemotherapy.
The trial, which is sponsored and being conducted by Italy's Fondazione Ricerca Traslazionale (FoRT Foundation), is to enroll 105 patients.
In 2020, OSE reported that its Phase III Atalante 1 trial showed Tedopi improved, as compared to chemotherapy, the 12-month survival rate of patients with HLA-A2 positive NSCLC who failed PD-1 or PD-L1 immune checkpoint inhibitor therapy.