Shots:
- Merck has reported the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO) vs Keytruda + PBO for 1yr. in 1,841 pts with clear cell RCC following nephrectomy
- At 28.4mos. mFU, the trial showed improved DFS (1EP), reducing the risk of disease recurrence or death by 28%, with mDFS was not reached for either arm; estimated 24mos. DFS rate was 80.7% vs 73.7%. OS (2EP) remain under evaluation
- Based on LITESPARK-022, the FDA granted priority review to sNDA of Welireg + Keytruda/Keytruda QLEX as adj. therapy in high-risk clear cell RCC post-nephrectomy, with a PDUFA date of Jun 19, 2026, & global regulatory discussions planned
Ref: Merck | Image: Merck | Press Release
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