Merck KGaA and Pfizer’s Bavencio (avelumab) + Inlyta (axitinib) Receive FDA’s Approval as 1L Treatment for Advanced Renal Cell Carcinoma

Merck KGaA and Pfizer’s Bavencio (avelumab) + Inlyta (axitinib) Receive FDA’s Approval as 1L Treatment for Advanced Renal Cell Carcinoma

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  • The approval is based on P-III JAVELIN Renal 101 study (NCT02684006) results assessing bavencio (avelumab) + Inlyta (axitinib) vs sunitinib in 886 patients in a ratio (1:1) with untreated advanced RCC regardless of tumor PD-L1 expression   
  • The P-III JAVELIN Renal 101 study results: improvement in PFS (13.8 vs 8.4mos.); ORR (51.4% vs 25.7%); published in The New England Journal of Medicine
  • Bavencio (avelumab) is a PD-L1 antibody, developed under the co-development and co-commercialization deal b/w Merck KGaA & Pfizer in 2014 & Inlyta is a tyrosine kinase inhibitor indicated for advanced RCC. The combination is under regulatory review in EU & Japan

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