Adding Pembrolizumab to Standard Care Ups Event-Free Survival in Head, Neck Cancer
FRIDAY, June 27, 2025 -- For patients with locally advanced head and neck squamous cell carcinoma (HNSCC), the addition of neoadjuvant and adjuvant pembrolizumab to standard care significantly improves event-free survival, according to a study published online June 18 in the New England Journal of Medicine.
Ravindra Uppaluri, M.D., Ph.D., from Brigham and Women's Hospital in Boston, and colleagues conducted a phase-3, open-label trial involving patients with locally advanced HNSCC who were randomly assigned to receive two cycles of neoadjuvant pembrolizumab and 15 cycles of adjuvant pembrolizumab in addition to standard care (pembrolizumab group) or standard care alone, comprising surgery and adjuvant radiotherapy with or without concomitant cisplatin (control group; 363 and 351 patients, respectively).
In each group, surgery was completed in approximately 88 percent of the participants. The median follow-up was 38.3 months at the first interim analysis. The researchers found that event-free survival at 36 months was 59.8 and 45.9 percent in the pembrolizumab and control groups (hazard ratio [HR] for progression, recurrence, or death, 0.66) among participants whose tumors expressed programmed death ligand 1 (PD-L1) with a combined positive score (CPS) of 10 or more; 58.2 and 44.9 percent, respectively (HR, 0.70) for participants whose tumors expressed PD-L1 with a CPS of 1 or more; and 57.6 and 46.4 percent, respectively (HR, 0.73) among all participants. Grade-3 or higher treatment-related adverse events occurred in 44.6 and 42.9 percent of participants in the pembrolizumab and control groups, respectively.
"Results for overall survival were not mature at the first prespecified interim analysis; additional follow-up is ongoing," the authors write.
The study was funded by Merck, the manufacturer of pembrolizumab.
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