Transgene and NEC Corporation announced positive 24.1-month median follow-up data from their ongoing randomized Phase I trial of TG4050 in the adjuvant treatment of head and neck cancers. The data, presented at the Society for ImmunoTherapy of Cancer (SITC) 2024 Annual Meeting, highlights the potential of this individualized immunotherapy to prevent relapse in high-risk patients.
Sustained Disease-Free Survival
After a median follow-up of 24.1 months, all 16 patients who received TG4050 as adjuvant immunotherapy following standard of care remained disease-free. In contrast, 3 out of 16 patients in the control observation arm experienced relapse. 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, underscoring the high unmet medical need in this population.
Robust Immune Response
Notably, immune responses targeting selected neoantigens were identified in 100% of patients treated with TG4050, demonstrating the vaccine's strong immunogenicity. The analysis also indicated that these immune responses are sustained during both the induction and boost periods over a 7-month observation window. All treatment-related adverse events remained mild to moderate.
Expert Commentary
Pr. Le Tourneau, head of the department of drug development and innovation (D3i) at Institut Curie and the trial's Principal Investigator, stated, "It is highly encouraging to see confirmation of TG4050’s clinical and immune response data after a median follow-up of 24.1-months... TG4050 has demonstrated its potential to prime an adaptive immune response against tumour antigens and prevent relapse in patients with locally advanced resected head and neck squamous cell carcinoma."
Dr. Emmanuelle Dochy, chief medical officer of Transgene, added, "We are very encouraged to observe that all the patients treated with our neoantigen cancer vaccine TG4050 remain disease-free after a median follow-up of 24.1 months... A phase II part of our trial is currently enrolling patients internationally, with the aim of further confirming these promising findings."
About TG4050
TG4050 is an individualized immunotherapy developed for solid tumors, combining Transgene’s myvac platform with NEC’s AI capabilities to optimize antigen selection. The therapy is designed to stimulate the patient’s immune system to recognize and destroy tumors using their own cancer-specific genetic mutations. This individualized treatment is created for each patient after surgery and during adjuvant therapy.
The ongoing Phase I/II trial (NCT04183166) is evaluating TG4050 in patients with HPV-negative head and neck cancers. The Phase II part of the trial is currently enrolling patients internationally to further assess the treatment's benefits in those at risk of relapse.
