Shots:
- The EC has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) across all 30 EEA states
- Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ± cisplatin vs adj. SoC RT ± cisplatin in above pts (n=714)
- Trial showed EFS risk reduction by 30%, with mEFS of 59.7 vs 29.6mos. at first interim analysis
Ref: Merck | Image: Merck | Press Release
Related News:- Merck Reports the P-III (LITESPARK-022) Trial Data on Welireg + Keytruda to Treat Clear Cell Renal Cell Carcinoma (RCC)
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