Shots:
- The US FDA has approved MSD‘s Welireg + Keytruda/Keytruda QLEX as adj. therapy in clear cell renal cell carcinoma (ccRCC) pts at intermediate-high or high risk of recurrencepost-nephrectomy or post-nephrectomy & resection of metastatic lesions
- Approval was backed by the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO) vs Keytruda + PBO for 54wks. in 1,841 pts with ccRCC with intermediate-high or high risk of recurrence following nephrectomy
- 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 81% vs 74%. OS (2EP) remains under evaluation
Ref: Businesswire | Image: Merck |Press Release
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