Natera, Inc. reported that its Phase 2 SINERGY trial, a prospective study of Signatera‑guided therapy in recurrent or metastatic head and neck squamous cell carcinoma, achieved a 63% objective response rate and demonstrated that ctDNA dynamics could safely reduce chemotherapy exposure in 74% of patients.
The 27‑patient trial enrolled individuals receiving either immunotherapy alone or in combination with chemotherapy. ctDNA levels measured by Signatera during treatment guided escalation or de‑escalation of chemotherapy, resulting in a median of only two chemotherapy cycles and a reduction in high‑grade toxicity compared with historical controls. The study’s design and outcomes were presented in an oral plenary at the 2026 Multidisciplinary Head and Neck Cancers Symposium in Palm Desert, California, which ran from February 19‑21, 2026.
"This trial was designed to address an urgent need for treatment personalization that mitigates unnecessary toxicity while improving survival for patients with recurrent or metastatic head and neck cancer. We saw remarkable results that Signatera can inform therapeutic decision‑making in real‑time for this aggressive and difficult‑to‑treat cancer, laying the groundwork for changes in the standard of care," said Alexey Aleshin, M.D., General Manager of Oncology and Corporate Chief Medical Officer at Natera. "The SINERGY trial is unique in that it adapted chemo‑immunotherapy treatment guided by ctDNA dynamics. The trial demonstrated a promising response rate and survival, with roughly three‑quarters of patients experiencing treatment de‑escalation guided by ctDNA dynamics," added Ari J. Rosenberg, M.D., Associate Professor of Medicine at the University of Chicago and presenting author.
The results reinforce Natera’s strategy to position Signatera as a real‑time biomarker that can personalize therapy and reduce unnecessary chemotherapy. A 63% response rate in a small, early‑stage trial signals strong clinical potential, while the 74% de‑escalation rate highlights a tangible benefit in toxicity reduction. These findings could accelerate adoption of Signatera in head and neck oncology, strengthen Natera’s competitive advantage over other ctDNA and diagnostic companies, and open new revenue opportunities as payers and clinicians seek precision tools to improve patient outcomes.
The announcement was made on February 24, 2026, following the symposium presentation. The trial’s success is a milestone for Natera’s oncology diagnostics portfolio and may influence future clinical development plans and market positioning in the precision medicine space.
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