Natera, Aveta Biomics launch late-stage head and neck cancer trial
Natera and Aveta Biomics launched a 826-patient Phase 3 trial pairing APG-157 with Signatera blood testing in hard-to-track head and neck cancer.
Natera and Aveta Biomics launched AVTA 30-01, a global Phase 3 registrational trial in locally advanced head and neck squamous cell carcinoma that will enroll about 826 patients across North America, Europe, Asia-Pacific and Australia. The study will use Signatera to measure molecular response before, during and after treatment.
Signatera will be used in the neoadjuvant, induction and adjuvant settings, with the assay serving as a secondary endpoint. AVTA 30-01 also includes separate randomized cohorts for resectable and unresectable locally advanced disease, each with treatment and control arms. APG-157 has already received FDA Fast Track and Orphan Drug designations for this indication.
Natera puts global annual incidence of head and neck cancer at about 950,000 cases, and recurrence remains a major cause of mortality despite surgery, radiation therapy and immunotherapy. Circulating tumor DNA detects minimal residual disease and recurrence earlier than conventional imaging, offering a way to track disease course without relying only on scans or invasive procedures.
Earlier-stage data showed favorable safety, tumor control, deep molecular responses and encouraging event-free survival outcomes. The company's ongoing Phase 2 study, AVTA 20-01, is active but not recruiting, with an estimated enrollment of 24 and an estimated completion date of December 2026. In that study, APG-157 is given as an oral pastille three times a day.
Aveta’s April 2026 AACR presentation included Phase 2A subpopulation data showing reduced HPV16 expression in tumor tissue and saliva in HPV-positive patients, along with systemic immune activation across the broader population. Those early findings involved researchers from the VA Greater Los Angeles Healthcare System and UCLA, where Marilene Wang described the drug as promising for head and neck cancers that respond poorly to existing chemotherapy and immunotherapy options.
Natera's recent prospective Phase 2 SINERGY trial provides support for Signatera MRD-guided treatment in this cancer type.
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