Theem 3 Ntsuam Xyuas Ntawm Merck / Eisai Kev Tiv Thaiv + Lub Hom Phiaj Sib Txuas Yog Qhov Zoo Tshaj!

Merck& Co thiab nws tus khub Eisai tsis ntev los no sib koom ua ke tshaj tawm kev tshuaj ntsuam xyuas ntawm kev tiv thaiv PD-1 Keytruda (pembrolizumab) thiab lub qhov ncauj ntau-receptor tyrosine kinase inhibitor Lenvima (lenvatinib) rau thawj kab kev kho mob ntawm kev mob raum cell carcinoma (RCC) Zoo tshaj plaws kab ntsuas cov txiaj ntsig ntawm theem tseem ceeb 3 KEYNOTE-581 / CLEAR sim (kawm 307).

Cov ntaub ntawv qhia tias piv nrog sunitinib," kev tiv thaiv + tsom" ua ke txoj kev kho mob Keytruda + Lenvima muaj cov kev txhim kho zoo heev hauv qhov kev cuam tshuam ntau kawg.

Tam sim no, Keytruda + Lenvima kev sib xyaw ua ke raug soj ntsuam rau kev kho 13 ntau hom qog, thiab tau pom tias muaj kev ua tau zoo hauv ntau hom qog!

KKEYNOTE-581 (NCT02811861) yog ib qho kev sib tw, qhib-daim ntawv lo rau lub sijhawm 3, kev sim kho mob, uas tam sim no kho cov neeg mob uas muaj mob raum cell carcinoma (RCC) nrog Keytruda + Lenvima, Lenvima + Everolimus, thiab sunitinib Cov. Qhov kev txiav txim siab tau sau npe txog 1,050 cov neeg mob uas tau muab faib rau 3 pawg kho mob thiab tau txais: (1) Lenvima (18 mg hais lus, ib hnub ib zaug) thiab everolimus (5 mg hais lus, ib hnub ib zaug); (2) Lenvima (18mg, hais lus, ib hnub ib zaug) thiab Keytruda (200mg, tso ntshav, ib zaug txhua 3 lub lis piam); (3) Sunitinib (50mg, qhov ncauj, ib zaug ib hnub, kev kho mob tso tseg rau 4 lub lis piam 2 lub lis piam). Thawj qhov kawg ntawm txoj kev kawm yog kev vam meej tsis muaj kev vam meej (PFS), thiab cov ntsiab lus tseem ceeb theem kawg suav nrog tag nrho cov kev ua neej nyob (OS), cov lus teb rau lub hom phiaj (ORR), thiab kev nyab xeeb.

Cov txiaj ntsig tau qhia tias Keytruda + Lenvima tau mus txog qhov kawg (thawj PFS) thiab qhov tseem ceeb tshaj plaws theem kawg (OS thiab ORR): nyob rau hauv lub hom phiaj-rau-kho (ITT) kawm cov pej xeem, piv nrog sunitinib hais txog PFS, OS , thiab ORR Nws muaj ib qho kev txhim kho kev pom zoo thiab thaj chaw kho mob. Tsis tas li, Lenvima + everolimus kuj tau mus txog qhov kawg endpoint (PFS) thiab qhov tseem ceeb theem nrab kawg (ORR): Hauv ITT kawm cov pej xeem, piv nrog sunitinib, nws muaj cov lus tseem ceeb thiab kev soj ntsuam tseem ceeb hauv PFS thiab ORR. Kev Txhim Kho. ITT cov pejxeem suav nrog tag nrho Sloan-Kettering Cancer Center (MSKCC) cov pab pawg muaj kev pheej hmoo (muaj kev pheej hmoo tsawg, nruab nrab-pheej hmoo, thiab muaj kev pheej hmoo). Kev nyab xeeb ntawm Keytruda + Lenvima thiab Lenvima + everolimus zoo ib yam nrog cov kev tshawb fawb qhia tas los.

Merck thiab Eisai yuav sib tham txog cov ntaub ntawv no nrog cov koom haum tswj hwm thoob ntiaj teb, thiab npaj yuav xa cov ntawv thov kev tso cai muag lag luam raws li cov txiaj ntsig no. Cov txiaj ntsig tau no yuav nthuav tawm ntawm kev sib tham txog kev kho mob.

Keytruda + Lenvima kev sib xyaw ua ke yog ib feem ntawm txoj kev sib koom tes ua ke ntawm Merck thiab Eisai Oncology. Thaum Lub Peb Hlis 2018, ob tog tau kos npe rau kev koom tes pom zoo nrog tag nrho tus nqi nce mus txog 5,8 billion nyiaj daus las los tsim ib cov tshuaj ntawm Lenvima thiab kev sib xyaw nrog Keytruda rau kev kho mob ntawm ntau hom qog.

Lenvima yog qhov ncauj ntau-receptor tyrosine kinase (RTK) inhibitor nrog cov hom tshiab khi. Ntxiv rau kev tiv thaiv qog ua hlav mob qog ua pob qij txha, kev mob qog thiab hloov kho cov qog ua lub cev tiv thaiv kab mob, lwm yam pro-angiogenic thiab oncogenic signaling pathway ntsig txog RTKs (suav nrog Ntxiv rau platelet-derived growth factor (PDGF) receptors PDGFRα, KIT thiab RET), nws kuj tseem tuaj yeem xaiv inhibit vascular endothelial kev loj hlob yam (VEGF) receptors (VEGFR1, VEGFR2, VEGFR3) thiab fibroblast kev loj hlob tau (FGF) receptors (FGFR1, FGFR2, FGFR3, FGFR4) kinase kev ua si.

Keytruda yog qhov los tiv thaiv PD-1 qog tshuaj tiv thaiv kab mob uas pab tshawb nrhiav thiab tua cov qog hlwb los ntawm kev txhim kho kev muaj peev xwm ntawm tib neeg lub cev tsis muaj zog. Keytruda yog tib neeg cov monoclonal antibody uas cuam tshuam kev cuam tshuam ntawm PD-1 thiab nws cov ligands PD-L1 thiab PD-L2, yog li ua kom T lymphocytes uas yuav cuam tshuam cov qog hlwb thiab cov hlwb noj qab haus huv.

Lub sijhawm tam sim no, Merck thiab Eisai tab tom ua haujlwm LEAP (LEnvatinib thiab Pembrolizumab) cov kev txhim kho kev soj ntsuam hauv 13 ntau hom qog nqaij hlav (endometrial cancer, hepatocellular carcinoma, melanoma, tsis mob qog nqaij hlav hauv lub ntsws, mob raum cell carcinoma, lub taub hau thiab caj dab squamous Cell carcinoma) , urothelial carcinoma, cholangiocarcinoma, mob hnyuv plab, mob plab hnyuv, glioblastoma, mob kheesxaws ntawm zes qe menyuam thiab mob qog mis triple-negative mob cancer mis) txuas ntxiv mus tshawb nrhiav Keytruda + Lenvima ua ke hauv 19 qhov kev sim tshuaj.

Cov ntaub ntawv los ntawm ob qhov kev sim ntawm LEAP qhov haujlwm tshaj tawm hauv lub Cuaj Hli xyoo no tau qhia tias kev sib xyaw ntawm Keytruda + Lenvima qhia kev ua tau zoo hauv 7 hom qog.