Merck’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA’s Approval as 1L Treatment of Advanced Renal Cell Carcinoma

August 12, 2021 Auto Bot Advanced Renal Cell Carcinoma, approval, FDA, KEYTRUDA, Lenvima, Merck, pembrolizumab, regulatory 0

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

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