All 16 patients treated with an individualized cancer vaccine after surgery for locally advanced head and neck cancer remained disease-free after a median follow-up of 41 months, according to updated results from a small randomized trial.
Conversely, three of the 16 patients assigned to the control group experienced disease recurrence. The findings were reported by Transgene and NEC following publication of the trial’s earlier results in Nature Communications.
The phase I portion of the trial enrolled patients with resected, human papillomavirus-negative head and neck squamous cell carcinoma. Around one-third of patients with this form of cancer experience recurrence despite surgery and postoperative treatment.
Patients were randomly assigned to receive the investigational vaccine, TG4050, following standard adjuvant therapy or to undergo watchful waiting. Those in the control group could receive the vaccine if their cancer returned.
TG4050 is manufactured separately for each patient. Tumor and normal tissue samples are sequenced to identify cancer-specific mutations, and an artificial intelligence system selects up to 30 predicted neoantigens – abnormal proteins that could be recognized by the immune system. Genetic sequences encoding those targets are incorporated into a modified vaccinia Ankara viral vector.
At the peer-reviewed study’s primary cutoff, none of the 16 evaluable patients in the immediate-treatment group had relapsed after a median follow-up of 30 months, compared with three of 16 controls. The subsequent company update extended the median follow-up to 41 months without additional recurrences in the treatment group.
The vaccine produced detectable T-cell responses against selected neoantigens in 73.3 percent of evaluated patients. Responding patients recognized a median of three vaccine targets, and responses could still be detected more than a year after the final dose.
Analysis showed that the vaccine induced new immune responses while also expanding T-cell populations already present in some tumors. Vaccine-reactive CD8-positive T cells displayed markers associated with cytotoxic activity and tissue residency.
Long-term follow-up identified no unexpected safety findings, supporting the tolerability observations in the published study.
A larger randomized phase II study is underway to evaluate immune responses and disease-free survival more rigorously.
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