Natera and Aveta Biomics Partner on Global Phase 3 Trial of Oral Immunotherapy APG-157 in Head and Neck Cancer
Key Insights
Natera and Aveta Biomics announced a strategic partnership to support AVTA 30-01, a global Phase 3 registrational trial evaluating APG-157 in locally advanced head and neck squamous cell carcinoma (search).
APG-157 is a first-in-class oral immunotherapy designed to activate anti-tumor immunity in both immune-cold and immune-hot tumors, with FDA Fast Track and Orphan Drug Designations.
The trial will enroll approximately 826 patients across North America, Europe, Asia-Pacific, and Australia, with enrollment expected to begin in the second half of 2026.
Natera, Inc. and Aveta Biomics, Inc. have entered a strategic partnership to support AVTA 30-01, a global Phase 3 registrational clinical trial evaluating APG-157 in patients with locally advanced head and neck squamous cell carcinoma (search) (LA-HNSCC). Under the agreement, Natera's Signatera (search) circulating tumor DNA (ctDNA) assay will be used to evaluate molecular response to APG-157 across neoadjuvant, induction, and adjuvant treatment settings.
APG-157 is Aveta's first-in-class oral immunotherapy intended to expand the benefits of immunotherapy to both immune-cold and immune-hot tumors in patients with LA-HNSCC. The candidate has received FDA Fast Track and Orphan Drug Designations for this indication, underscoring the significant unmet need in this patient population.
Trial Design and Scope
AVTA 30-01 (NCT07667296) builds upon previously reported Phase 2 clinical data of APG-157 monotherapy, which demonstrated favorable safety, evidence of tumor control, deep molecular responses, and encouraging event-free survival outcomes. Approximately 826 patients are expected to be enrolled across North America, Europe, Asia-Pacific, and Australia. The study includes separate randomized cohorts for resectable and unresectable locally advanced disease, each with treatment and control arms. Signatera (search) will serve as a secondary endpoint, with enrollment anticipated to begin in the second half of 2026.
The trial will incorporate serial Signatera (search) testing to assess molecular residual disease (MRD) and treatment response throughout therapy and follow-up. As noted in the announcement, ctDNA has emerged as one of the most promising approaches for detecting MRD and identifying recurrence earlier than conventional imaging alone.
Clinical Context and Unmet Need
The global annual incidence of head and neck cancer is approximately 950,000, and disease recurrence remains a major cause of mortality despite advances in surgery, radiation therapy, and immunotherapy.
"Patients with locally advanced head and neck cancer continue to face substantial risks of recurrence despite aggressive treatment," said Parag Mehta, Ph.D., founder and chief executive officer of Aveta Biomics. "We believe APG-157 has the potential to transform treatment by activating anti-tumor immunity in both immune-cold and immune-hot tumors. Incorporating serial Signatera (search) testing into AVTA 30-01 will allow us to further validate the ctDNA findings observed in Phase 2 while generating molecular response data that will advance the understanding of treatment benefits for patients and strengthen the regulatory submission."
Building Evidence in Head and Neck Cancer
This study adds to the body of evidence Natera continues to generate in head and neck cancer. The company recently announced a successful readout of the prospective Phase 2 SINERGY trial, supporting Signatera (search) MRD-guided treatment in this histology.
"Growing evidence continues to demonstrate the value of Signatera (search) MRD detection in head and neck cancer," said Eric Matthews, general manager, biopharma, Natera. "We're pleased to partner with Aveta on AVTA 30-01 to demonstrate how Signatera has the potential to advance the field and improve care for patients."
The partnership represents a convergence of Aveta's novel oral immunotherapy approach and Natera's precision medicine capabilities, with the goal of generating robust molecular response data to support a future regulatory submission for APG-157 in LA-HNSCC.