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Early ctDNA clearance predicts better survival in HPV-negative head and neck cancer. Patients with HPV-negative head and neck squamous cell carcinoma (HNSCC) who cleared circulating tumor DNA (ctDNA) early during pembrolizumab plus chemoradiotherapy had dramatically better 5-year survival rates than those who didn't. The findings, from the phase 3 KEYNOTE-412 trial, suggest ctDNA could serve as a powerful predictive biomarker for this hard-to-treat cancer.
A new analysis of the phase 3 KEYNOTE-412 trial reveals that early clearance of circulating tumor DNA (ctDNA) — a blood-based cancer biomarker — is strongly linked to long-term survival in patients with HPV-negative locally advanced head and neck squamous cell carcinoma (HNSCC) receiving pembrolizumab plus chemoradiotherapy. The findings were presented at the 2026 ESMO Congress.
Among HPV-negative patients treated with pembrolizumab plus chemoradiotherapy, those who cleared ctDNA by cycle 3 had a 5-year overall survival (OS) rate of 72.9%, compared to just 38.9% for those who did not. Importantly, this predictive value held up regardless of other common prognostic markers like tumor size, disease stage, and PD-L1 status — suggesting ctDNA clearance is an independent signal of treatment benefit.
By the Numbers:
Why it matters: For HPV-negative HNSCC — a subgroup with historically poor outcomes — identifying who will benefit from pembrolizumab is critical. ctDNA clearance could become a practical, real-time tool to guide treatment decisions and personalize care.
