Shots:
- The US FDA has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC based on P-III (KEYNOTE-689) trial
- Trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ± cisplatin vs adj. SoC RT without cisplatin in above pts (n=714), which showed EFS risk reduction by 30% in CPS ≥1 pts (mEFS: 59.7 vs 26.9mos.) at first interim analysis; data was shared at AACR 2025
- Approval was reviewed under Project Orbis, allowing parallel regulatory review across partner countries, with MAA under review in Israel, Canada, Australia, Singapore, Brazil & Switzerland. Regulatory review is ongoing globally, incl. EU & Japan
Ref: Merck | Image: Merck | Press Release
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