Shots:

• The approval is based on P-III CLEAR /KEYNOTE-581 trial that evaluates Keytruda (200 mg- IV- q3w) + Lenvima (20 mg- PO- qd) or Lenvima (18mg) + everolimus (5mg- PO- qd) vs sunitinib (50 mg- q4w) in a ratio (1:1:1) in 1-069 patients with advanced RCC
• The results demonstrated an improvement in PFS with a 61% reduction in the risk of disease progression or death- mPFS (23.9 vs 9.2mos.); OS (34% reduction in risk of death)- ORR (71% vs 36%); CR (16% vs 4%); PR (55% vs 32%); median duration of exposure to the combination therapy was 17mos.
• Additionally- permanent discontinuation due to an AEs occurred in 37% of patients. The approval was reviewed under the FDA’s RTOR pilot program

  Ref: Merck | Image: Merck