Natera and Aveta Biomics have entered into a strategic partnership to support the latter’s AVTA 30-01, a global Phase III head and neck cancer trial assessing APG-157 in patients with locally advanced head and neck squamous cell carcinoma.
The collaboration aims to explore APG-157, an oral immunotherapy, for both immune-cold and immune-hot tumours.
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This treatment has achieved fast track and orphan drug designations from the US Food and Drug Administration for this condition.
The AVTA 30-01 study is based on prior Phase II clinical data showing positive safety, tumour control, molecular response and event-free survival for APG-157 as a monotherapy.
It will utilise Natera’s Signatera test to measure molecular residual disease (MRD) and observe treatment responses throughout the course of therapy and follow-up.
Around 826 participants will be recruited across Australia, Asia-Pacific, Europe and North America. The trial will have separate randomised groups for resectable and unresectable locally advanced cases, each with both treatment and control arms.
Signatera circulating tumour deoxyribonucleic acid (ctDNA) testing will serve as a secondary endpoint. Patient enrolment is set to commence in the second half of 2026.
Aveta Biomics founder and CEO Parag Mehta said: “Patients with locally advanced head and neck cancer continue to face substantial risks of recurrence despite aggressive treatment. We believe APG-157 has the potential to transform treatment by activating anti-tumour immunity in both immune-cold and immune-hot tumours.
“Incorporating serial Signatera testing into AVTA 30-01 will allow us to further validate the ctDNA findings observed in Phase II while generating molecular response data that will advance the understanding of treatment benefits for patients and strengthen the regulatory submission.”
The study adds to growing evidence generated around head and neck cancer following the successful Phase II SINERGY trial, which substantiated the use of Signatera MRD-guided treatment in this cancer type.
In July 2024, Natera unveiled data that showed the efficacy of its MRD test in detecting Merkel cell carcinoma, a type of aggressive skin cancer.
