New Indication: Periop Pembrolizumab for Head and Neck Cancer

Phase 3, open-label, randomized, multicenter trial [KEYNOTE-689]

Locally advanced resectable head and neck squamous-cell carcinoma (HNSCC)

Neoadjuvant and adjuvant pembrolizumab plus standard care vs. standard care alone

Event-free survival at 36 mos: 59.8% vs 45.9% (HR 0.66 [0.49 – 0.88]) in CPS-10 population

Event-free survival at 36 mos: 58.2% vs 44.9% (HR 0.70 [0.55 – 0.89]) in CPS-1 population

Event-free survival at 36 mos: 57.6% vs 46.4% (HR 0.73 [0.58 – 0.92]) in total population

Overall survival at 3 yrs: 68.2% vs 59.2% (HR 0.72 [0.52 – 0.98]) in CPS-10 population

Overall survival at 3 yrs: 69.0% vs 60.2% (HR 0.72 [0.56 – 0.94]) in CPS-1 population

Overall survival at 3 yrs: 68.4% vs 61.1% (HR 0.76 [0.59 – 0.98]) in total population

Grade ≥3 AE: 44.6% vs 42.9%

Serious AEs: 19.1% vs 10.5%

Treatment-related deaths: 1.1% vs 0.3%

Immune-mediated AEs Grade ≥3: 10.0% vs 0.6%

Reviewed by Elvin Chalabiyev, MD on Sep 3, 2025