Natera and Aveta Biomics partner on phase 3 head and neck cancer trial

Natera, Inc. (NASDAQ: NTRA) and Aveta Biomics, Inc. have announced a 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 (LA-HNSCC).

Under the agreement, Natera's Signatera test will be used to assess molecular residual disease (MRD) and treatment response throughout the trial and follow-up period, serving as a secondary endpoint. Signatera uses circulating tumor DNA (ctDNA) to detect MRD and identify recurrence.

APG-157 is Aveta's oral immunotherapy candidate, which has received FDA Fast Track and Orphan Drug Designations for head and neck squamous cell carcinoma. The Phase 3 trial builds on previously reported Phase 2 data that showed evidence of tumor control, molecular responses, and event-free survival outcomes with APG-157 monotherapy.

The trial is expected to enroll approximately 826 patients across North America, Europe, Asia-Pacific, and Australia, with enrollment anticipated to begin in the second half of 2026. The study includes separate randomized cohorts for resectable and unresectable locally advanced disease, each with treatment and control arms.

"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. "Incorporating serial Signatera 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."

Global annual incidence of head and neck cancer is approximately 950,000, according to a 2025 study published in Frontiers in Oncology. Natera separately announced a successful readout of the prospective Phase 2 SINERGY trial, which the company said supports Signatera MRD-guided treatment in head and neck cancer.

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