Lenvima + Keytruda (lenvatinib + pembrolizumab) montre yon Efe fo!

Denyeman, Eisai a oral milti-récepteurs tyrosine kinaz inibite Lenvima (lenvatinib) ak Merck anti-PD-1 terapi Keytruda (pembrolizumab) te evalye pou tretman an nan selil ren kasinom (RCC) faz 1b/2 etid klinik (etid 111/KEYNOTE)-146) rezilta yo te pibliye nan "istouri la la nan atik la se: Lenvatinib plis pembrolizumab nan pasyan ki gen swa tretman-nayif oswa deja trete metastatic selil ren kasinom (etid 111/KEYNOTE-146): yon faz 1b/2 etid.

Rezilta yo montre ke nan pasyan ki gen metastatik RCC ki pa te deja resevwa tretman (tretman inisyal) epi yo te resevwa tretman (tretman, ki gen ladan iminite tipos inibite [ICI]), "vize + iminite" plan tretman Lenvima + Keytruda montre ankouraje aktivite anti-Time ak sekirite kontwole.

Koulye a, siplemante aplikasyon an Dwog nouvo (sNDA) ak siplemante aplikasyon lisans pwodwi Byolojik (SBLA) nan Lenvima + Keytruda konbinezon traitement pou tretman an premye-liy nan RCC avanse yo sibi revizyon priyorite pa FDA a US. Dat yo sib pou lwa sou preskripsyon itilizate dwog (PDUFA) yo 2021, respektivman. Out 25th ak 26th. Rezilta yo soti nan faz kle a 3 KLE etid (etid 307/KEYNOTE-581) montre ke: nan tretman an premye-liy nan pasyan ak RCC avanse, konpare ak gwoup tretman sunitinib, Lenvima + Keytruda gwoup tretman te nan endpoint prensipal la (pa gen okenn siviv pwogresif, medyan PFS: 23,9 mwa vs mwa 9,2; $ = 0,39, p<0.001), overall="" survival="" for="" key="" secondary="" endpoints="" (median="" os:="" not="" reached="" vs="" not="" reached;="" hr="0.66;" p="0.005" )="" and="" the="" objective="" response="" rate="" (orr:="" 71.0%="" vs="" 36.1%;=""><0.001) both="" have="" statistically="" significant="" and="" clinically="" significant="">