Merck’s Keytruda (pembrolizumab) + Inlyta (axitinib) Receive FDA’s Approval as 1L Treatment for Advanced Renal Cell Carcinoma

Merck’s Keytruda (pembrolizumab) + Inlyta (axitinib) Receive FDA’s Approval as 1L Treatment for Advanced Renal Cell Carcinoma

Shots:

  • The approval is based on P-III KEYNOTE-426 study assessing Keytruda (pembrolizumab, 200mg, q3w up to 24mos.) + Inlyta (axitinib,5mg, bid) vs sunitinib (50mg, qd for 4wks.)  in 861 patients in ratio (1:1) who had not received systemic therapy for advanced RCC
  • The P-III KEYNOTE-426 & median 12.8mos. follow up studies result:  47% reduction in risk of death; 31% reduction in PFS; ORR (59% vs 36%); OS (90% vs 78%); m-PFS (15.1 vs 11.1 mos.); CRR (6% vs  2%); PRR (53% vs 34%)
  • Keytruda (pembrolizumab, IV, 100mg) is a mAb blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2 and activating the T lymphocytes. Inlyta (axitinib) is a tyrosine kinase inhibitor and is prescribed to treat advanced kidney cancer

Click here to read full press release/ article | Ref: Merck | Image: Pinterest