Transgene and NEC Corporation announced compelling 24.1-month median follow-up data from their Phase I trial of TG4050, an individualized neoantigen cancer vaccine, in patients with head and neck cancers. The data, presented at the Society for ImmunoTherapy of Cancer (SITC) 2024 Annual Meeting, demonstrated that all patients treated with TG4050 after completing adjuvant standard of care remained disease-free.
Sustained Disease-Free Survival
The trial results showed that none of the 16 patients who received TG4050 as adjuvant immunotherapy experienced relapse after a median follow-up of 24.1 months. In contrast, 3 out of 16 patients in the control observation arm relapsed. This is particularly significant given that approximately 30% of head and neck cancer patients are expected to relapse within 24 months after standard surgery and adjuvant chemoradiotherapy.
Robust Immune Response
Researchers observed immune responses targeting selected neoantigens in 100% of patients who received TG4050, indicating the vaccine's strong ability to stimulate the immune system. The responses included both de novo and amplified immune reactions, and analysis over seven months showed sustained immune activity during the induction and boost periods.
Clinical Significance
Pr. Le Tourneau, MD, PhD, Head of the Department of Drug Development and Innovation (D3i) at Institut Curie, and Principal Investigator, emphasized the unmet medical need in the adjuvant setting for head and neck cancer patients. "It is therefore highly encouraging to see confirmation of TG4050’s clinical and immune response data after a median follow-up of 24.1-months," he stated. "TG4050 has demonstrated its potential to prime an adaptive immune response against tumor antigens and prevent relapse in patients with locally advanced resected head and neck squamous cell carcinoma (HNSCC)."
Ongoing Phase I/II Trial
Building on these positive findings, the Phase I trial has been expanded into a randomized Phase I/II trial (NCT04183166) in the adjuvant setting for head and neck cancer. The Phase II part of the trial is currently enrolling patients internationally.
About TG4050
TG4050 is an individualized immunotherapy developed for solid tumors, utilizing Transgene’s myvac® platform and NEC’s AI capabilities for antigen selection. The vaccine is designed to stimulate the patient’s immune system to recognize and destroy tumors using their own cancer-specific genetic mutations. It encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System.
Safety Profile
All treatment-related adverse events observed in the trial remained mild to moderate, suggesting a favorable safety profile for TG4050.
