100% three-year disease-free survival in head and neck cancer
Transgene and NEC Corporation have reported sustained 100% three-year disease-free survival (DFS) in patients treated with TG4050 in the Phase I part of a randomised Phase I/II trial.
TG4050 is the first individualised neoantigen therapeutic vaccine (INTV) based on the myvac platform.
It is being tested in patients with resected, locally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC).
Three-year follow-up data from the Phase I trial continue to demonstrate durable clinical outcomes in the adjuvant setting, with all 16 TG4050-treated patients remaining disease-free, while three of 16 patients in the control arm experienced relapse after a median follow-up of 41 months.
TG4050, encoding up to 30 patient-specific neoantigens, also continues to demonstrate a favourable safety profile with no unexpected safety findings.
Together, the clinical and translational findings provide further evidence supporting TG4050 as a potential individualised immunotherapy for patients with head and neck cancer at high risk of relapse following surgery and (chemo)-radiotherapy.
The Phase I data demonstrate robust and persistent neoantigen-specific CD8+ T-cell responses consistent with the proposed vaccine’s mechanism of action. Vaccine-induced responses were detected in 73.3% of patients treated with TG4050, with a median of three responding neoantigens per responder.
These responses were maintained throughout treatment and persisted for more than one year after the last vaccination, providing evidence of durable anti-tumour immunity.
“Robust and persistent CD8+ T-cell responses against patient-specific tumour neoantigens were observed following TG4050 vaccination, supporting the vaccine’s ability to generate a targeted anti-tumour immune response. These results further reinforce the potential of TG4050 as an individualised immunotherapy for patients with head and neck cancer at risk of recurrence for whom there is a major unmet need,” commented Professor Christian Ottensmeier, University of Liverpool, La Jolla Institute for Immunology and principal investigator.