Hu rau:Errol Zhou (Mr.)
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Eisai tsis ntev los no tau tshaj tawm tias Japanese Ministry of Health, Labour thiab Welfare (MHLW) tau tso cai rau lub qhov ncauj ntau-tus kabmob tyrosine kinase inhibitor Lenvima (lenvatinib) chaw muag tshuaj muaj xim rau kev kho mob hauv uterine lub cev mob.
Hauv Nyij Pooj, muaj txog 30,000 leej neeg muaj mob cancer rau lub cev. Nws kwv yees tias yuav muaj 17,000 tus mob tshiab thiab 3,000 tuag nyob rau xyoo 2020. Nws ntseeg tau tias ntau tshaj 90% ntawm kev mob qog nqaij hlav hauv lub cev tau tshwm sim hauv endometrium. Cov neeg mob uas muaj mob cancer endometrial mus ntsib tus neeg tuag coob thiab cov kev kho tom qab tau pib kho dua.
Tsis ntev los no, ntawm 52th American Society ntawm Gynecological Oncology (SGO) Cov Poj Niam Kawv Xeeb Rooj Sib Tham Txhua Xyoo hauv 2021, Eisai thiab nws tus khub Merck& Co tshaj tawm thawj zaug rau theem tseem ceeb 3 KEYNOTE-775 / Txoj Kev Kawm 309 kev sim (NCT03517449) cov ntaub ntawv kawm. Kev sim tau soj ntsuam los kho kev tiv thaiv PD-1 Keytruda (pembrolizumab, pembrolizumab) thiab Lenvima hauv kev kho mob rau cov neeg mob uas muaj txuj ci siab, mob siab lossis rov ua mob qog nqaij hlav endometrial uas tau txais platinum-muaj tshuaj kho. Kev ua tau zoo thiab kev nyab xeeb.
Nws tsim nyog teev tias cov txiaj ntsig tau tshaj tawm ntawm lub rooj sib tham yog thawj qhov kev soj ntsuam ntawm qib 3 kev soj ntsuam ntawm kev sib koom ua ke nrog kev kho mob nrog rau kev kho mob rau kev mob qog nqaij hlav endometrial: Tau piv nrog kev siv tshuaj kho mob, Keytruda + Lenvima regimen muaj kev ciaj sia tag nrho. (OS), kev vam meej-tsis muaj txoj sia nyob (PFS), thiab tus lej teb tag nrho (ORR) tau zoo tuaj.
Cov ntaub ntawv tshwj xeeb yog: hauv tag nrho cov tib neeg tshawb fawb, piv nrog kev siv tshuaj kho mob, Keytruda + Lenvima program: (1) Txo txoj kev pheej hmoo ntawm kev tuag los ntawm 38% thiab txo lub sijhawm ntev tag nrho cov kev muaj sia nyob (qhov nruab nrab OS: 18.3 lub hlis vs. 11.4 hlis), Tsis hais cov xwm txheej ntawm kev kho tsis zoo; (2) Txo kev pheej hmoo ntawm kab mob kev loj hlob lossis tuag los ntawm 44% thiab kev ncua kev muaj mob ntxiv mus tsis muaj txoj sia nyob (piv txwv li PFS: 7.2 lub hlis vs. 3.8 lub hlis); (3) Txo qhov kev txhim kho tag nrho tus nqi (ORR: 31.9% vs 13.7%).
Raws li cov ntaub ntawv tshawb fawb saum toj no, Eisai thiab Merck tab tom npaj xa cov ntawv thov rau cov cim tshiab ntawm Keytruda + Lenvima rau kev kho mob cancer endometrial hauv cov teb chaws thoob ntiaj teb, suav nrog Nyiv.
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 sib koom ua ke tag nrho US $ 5.8 billion 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) kev txhim kho kev soj ntsuam hauv 13 ntau hom qog nqaij hlav (endometrial cancer, hepatocellular carcinoma, melanoma, tsis mob qog nqaij hlav rau lub ntsws mob ntsws, mob raum cell carcinoma, lub taub hau thiab caj dab squamous Cell carcinoma) , urothelial carcinoma, cholangiocarcinoma, mob hnyuv taum, mob plab, mob plab, glioblastoma, mob cancer ntawm zes qe menyuam thiab mob qog mis triple-negative mob cancer mis) txuas ntxiv mus tshawb nrhiav Keytruda + Lenvima kev sib xyaw hauv 20 kev soj ntsuam, nrog rau kev kho mob siab kawg endometrium The Pha 3 sim LEAP-001 rau kev ntsuam xyuas kab thib ib hauv cov neeg mob cancer. Cov ntaub ntawv los ntawm cov phiaj xwm no qhia tau hais tias kev sib xyaw ntawm Keytruda + Lenvima tau qhia tau lub zog zoo hauv ntau hom qog!