Cemiplimab + platinum-docetaxel/cetuximab delivers 31% pCR, 97% 1-yr OS in resectable HNSCC

Cemiplimab, an anti-PD-1 IgG4, was added to cisplatin / carboplatin-docetaxel and EGFR-blocker cetuximab in a single-arm pilot (NCT04722523) of 30 locally advanced head-and-neck SCC patients slated for surgery and adjuvant radiotherapy. After three 21-day neoadjuvant cycles, 66% (19/29) achieved major pathologic response and 31% (9/29) pathologic CR; 62% skipped postoperative RT, yet 1-year EFS/OS still remained 92.7%/96.9% overall and 98.3%/100% when RT was omitted. Grade ≥3 immune AEs were limited to 10%, the pCR edges the 29% seen with neoadjuvant durvalumab-chemo, and 1-yr OS surpasses historical surgery + RT outcomes (~88%).