Shots:
- The P-III (KEYNOTE-689) trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (× 15 cycles) + SoC radiotherapy (RT) ± cisplatin vs adj. SoC RT without cisplatin in treatment-naïve pts (n=714) with stage III/IVA resected LA-HNSCC; sBLA under the FDA’s review (PDUFA: Jun 23, 2025)
- At 38.3 mos. mFU, trial showed EFS risk reductions by 34% in CPS ≥10 pts (mEFS: 59.7 vs 26.9mos), 30% in CPS ≥1 pts (mEFS: 59.7 vs 29.6mos.), & 27% in ITT population (mEFS: 51.8 vs 30.4mos.)
- Trial showed improved mPR in ITT population & a 13.7% increase in pts with CPS ≥10; OS showed favorable trend but did not reach statistical significance at interim analysis & is under evaluation. Data to be presented at AACR 2025
Ref: Merck | Image: Merck
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