Natera, Aveta Biomics to Incorporate MRD Testing into Phase 3 Cancer Trial
The Signatera test will serve as a secondary endpoint in a study of oral immunotherapy in locally advanced head and neck squamous cell carcinoma.
Natera and Aveta Biomics have announced a partnership to incorporate Signatera circulating tumor DNA (ctDNA) testing into Aveta’s global Phase 3 registrational trial evaluating an oral immuntherapy in patients with locally advanced head and neck squamous cell carcinoma.
Under the agreement, Aveta will use serial Signatera testing to assess molecular residual disease (MRD) and treatment response across neoadjuvant, induction, and adjuvant settings throughout the trial and follow-up period. Signatera will function as a secondary endpoint in the study.
APG-157 is an oral immunotherapy that has received FDA Fast Track and Orphan Drug Designations for the indicated disease. The Phase 3 trial builds on previously reported Phase 2 data of APG-157 monotherapy, which showed evidence of tumor control, deep molecular responses, and event-free survival outcomes.
The trial expects to enroll more than 800 patients across North America, Europe, Asia-Pacific, and Australia, beginning in the second half of 2026. Financial and other terms of the partnership were not disclosed.
Just under a million people are diagnosed with head and neck cancer around the world each year.
“Patients with locally advanced head and neck cancer continue to face substantial risks of recurrence despite aggressive treatment,” Parag Mehta, CEO and founder of Bedford, Massachusetts-based Aveta Biomics, said in a statement. Incorporating Signatera testing into its clinical trial “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.”
The partnership extends Natera’s footprint in head and neck cancer research. The company recently announced results from the prospective Phase 2 SINERGY trial, which examined Signatera MRD-guided treatment in the same tumor type in 27 patients.
“The trial demonstrated a promising response rate and survival, with roughly three-quarters of patients experiencing treatment de-escalation guided by ctDNA dynamics,” Ari Rosenberg, a researcher at the University of Chicago and presenting author of the study, said in a February statement accompanying the presentation of results at the 2026 Multidisciplinary Head and Neck Cancers Symposium. “This led to a reduction in the number of chemotherapy cycles along with lower rates of high-grade toxicity compared with historical controls. With these results, there is great potential for ctDNA dynamics to optimize treatment.”