Built from each patient's tumor mutations, the vaccine kept every head and neck cancer patient in the small Phase 1 arm disease free at three years, while 3 of 16 in the control arm relapsed.
A personalized cancer vaccine built from each patient's own tumor mutations kept all 16 head-and-neck cancer patients disease-free for three years in a small Phase 1 study, while 3 of 16 patients in the same trial's randomized control arm relapsed after a median 41 months of follow-up, according to results published Wednesday in Nature Communications.
The trial enrolled patients with resected, locally advanced HPV-negative head-and-neck squamous cell carcinoma, a cancer that recurs in a large share of patients even after surgery and chemoradiotherapy. TG4050, the vaccine in question, encodes up to 30 patient-specific neoantigens, the abnormal peptides that sit on the surface of each person's tumor cells, delivered through Transgene's myvac viral vector platform.
The treated arm reported durable neoantigen-specific T cell responses and no unexpected safety findings. The control-arm relapse count was small enough that the 16-of-16 versus 3-of-16 comparison cannot be read as a verdict. The team behind the trial calls this a signal that justifies a larger, broader randomized Phase 2 portion, which is already underway, rather than a result that changes practice.
The publication is the first peer-reviewed, long-term readout of a randomized individualized neoantigen vaccine trial in this indication, after earlier data had been shared on the medRxiv preprint server.