TG4050 neoantigen vaccine as adjuvant treatment in head and neck cancer: no relapses among 16 vaccinated patients in a randomised phase 1 trial

In a randomised phase 1 trial (NCT04183166), patients with completely resected head and neck squamous cell carcinoma received TG4050, an individually designed vaccine on a Modified Vaccinia Ankara viral vector encoding up to 30 predicted patient-specific neoantigens. In the arm vaccinated immediately after adjuvant therapy, none of the 16 evaluable patients relapsed at a median follow-up of 30 months, whereas 3 of 16 relapsed in the control arm, where vaccination was deferred until recurrence. The vaccine was well tolerated. This is a small phase 1 study designed primarily around safety and immunogenicity — the difference in relapses must not be read as proof of efficacy, and a larger, later-phase trial is required to settle the question.