In September 2023 Ose Immunotherapeutics announced the publication of new data supporting its cancer vaccine, Tedopi, in HLA-A2 positive patients with advanced or metastatic non-small cell lung cancer (NSCLC). The results, shared in Annals of Oncology, detail the randomised Phase III clinical trial and suggest that the novel cancer vaccine “improves overall survival” with a better safety and quality of life profile in monotherapy than chemotherapy. Tedopi is a T-cell epitope-based cancer vaccine that targets five tumour-associated antigens. It is an activating and differentiated off-the-shelf immunotherapy.
A need for better approaches and OSE2101
The paper states that the therapeutic strategy of treatment-naïve patients with advanced NSCLC lacking oncogenic drivers has been “revolutionised” by the approval of immune checkpoint blockers (ICBs). However, the “majority of patients will relapse”, will resistance to chemotherapy (CT)-ICB representing an unmet medical need. CT remains the standard of care.
OSE2101 is a T-specific immunotherapy that is designed to induce cytotoxic T lymphocytes (CTLs) against five tumour-associated antigens that are frequently overexpressed in NSCLC. This vaccine comprises nine synthetic peptides from the tumour-associated antigens that are presented in lung cancer cells by the human leukocyte antigen (HLA)-A2 phenotype.
The trial demonstrates a “significant therapeutic benefit” in patients with secondary resistance to immune checkpoint inhibitors, defined as patients with failure to platinum-based chemotherapy followed by a minimum of 12 weeks ICI treatment. The vaccine demonstrated a “favourable benefit/risk ratio” against the standard of care.
Professor Benjamin Besse, Director of Clinical Research at Gustave Roussy Institute and Principal Investigator of the trial commented that the vaccine is the “first cancer vaccine to demonstrate positive results on survival in a randomised Phase III trial in advanced and metastatic NSCLC cancer patients in 3rd line”.
“A significant reduction of the risk of death by 41% was achieved with a better safety profile and a maintained quality of life.”
Professor Besse calls for “clearly warranted” further evaluation to “potentially make this cancer vaccine available to hard-to-treat patients in failure and with high medical needs”. Nicolas Poirier, CEO of OSE Immunotherapeutics, agreed that Tedopi is the “most advanced cancer vaccine in clinical development”. He praised the “major achievement for all involved”.
“The clinical value of our results, re-activating specifically the anti-tumour immune responses, is particularly interesting in patients showing immune escape from checkpoint inhibitors.”