Merck’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA’s Approval as 1L Treatment of Advanced Renal Cell Carcinoma
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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
Click here to read full press release/ article | Ref: Merck | Image: The Conversation