Eisai Lenvima (Lenvatinib) Kev Tshawb Fawb Txog Kev Tshawb Fawb: 24mg Yog Qhov Tsim Nyog Pib Tsim Rau Qhov txawv Khees Xaws Cancer (DTC)!

Eisai tsis ntev los no tshaj tawm cov tshuaj tiv thaiv qog noj ntshav Lenvima (lenvatinib) rau kev kho mob radioiodine (RAI) refractory txawv cov thyroid mob qog nqaij (DTC) Theem II soj ntsuam kawm ntawm European Society of Medical Oncology (ESMO) 2020 Asia Virtual Conference. Kawm 211 (NCT02702388) cov txiaj ntsig.

Lenvima yog qhov ncauj ntau-receptor tyrosine kinase inhibitor. Txoj kev tshawb no piv cov kev ua tau zoo thiab kev nyab xeeb ntawm Lenvima nrog ob txoj kev pib noj (18mg vs 24mg, ib hnub ib zaug). Cov txiaj ntsig tau pom tias hauv cov neeg mob nrog RAI refractory DTC, siv lub hom phiaj ntsuas qhov ntsuas (ORR) kev tshuaj ntsuam thaum 24 lub lim tiam ntawm kev kho mob, piv nrog Asmeskas FDA pom zoo pib siv tshuaj (24mg), qhov qis qis pib noj (18mg) tsis ncav cuag kev pib ntawm qhov tsis muaj qhov ua tsis tau zoo. Cov ntaub ntawv ntawm cov kev kawm no txhawb kev xaiv 24 mg yog qhov pib tsim nyog rau cov neeg mob nrog RAI refractory DTC.

Tom qab Lenvima tau txais kev tso cai rov saib xyuas dua thiab tau pom zoo rau kev kho mob hauv zos rov qab los yog kev ua kom zoo, kev nthuav dav ntawm RAI-refractory DTC cov neeg mob, Kev Kawm 211 tau kawm raws li kev tshuaj xyuas ntawm Asmeskas Cov Khoom Noj thiab Tshuaj (FDA), European Tshuaj Noj Tshuaj (EMA) thiab lwm thaj tsam Ib qho kev tso npe tom qab tau cog lus los ntawm lub koom haum tswj txoj cai tau pib ua.

Lub hom phiaj tseem ceeb ntawm qhov kev xaiv no, pom ob lub qhov muag, ntau lub chaw Phase II yog txiav txim siab seb qhov pib ntawm 18 mg ib zaug ib hnub twg Lenvima tuaj yeem muab qhov kev ua tau zoo dua li piv nrog rau 24 mg ib zaug ib hnub pib noj tshuaj (raws li 24 Lub Lis Piam Ib Hlis Ntuj ORR [ORRWK24] kev ntsuas) thiab txhim kho kev nyab xeeb (raws li qhov tsis zoo [TEAE] kev tshuaj ntsuam txog kev kho ≥ qib 3).

Hauv kev txheeb xyuas kev ua tau zoo, ORRWK24 yog 57.3% (95% CI: 46.1-68.5) hauv pab pawg 24 mg thiab 40.3% (95% CI: 29.3-51.2) hauv 18 mg koob pawg. Raws li cov txiaj ntsig ntawm ORRWK24, qhov kev ua tau zoo ntawm 18 mg koob pawg tsis pom tias tsis muaj qhov tsis zoo tshaj li ntawm 24 mg koob pawg pawg (HR=0.50 [95% CI: 0.26-0.96]). Tag nrho ORR ntawm 24 mg koob pawg yog 64.0% (95% CI: 53.1-74.9), thiab 18 koob tshuaj pawg yog 46.8% (95% CI: 35.6-57.9).

Hauv kev txheeb xyuas qhov tseem ceeb ntawm kev nyab xeeb, pawg 24 mg koob tshuaj thiab 18 mg koob pawg tau muaj tus nqi zoo sib xws ntawm Qib 3 TEAE hauv 24 lub lis piam ntawm kev kho mob, thiab tsis muaj cov cim qhia tshiab txog kev nyab xeeb.

Dr. Takashi Owa, Tus Thawj Fwm Saib Xyuas Tshuaj R& D thiab Tus Thawj Fwm Saib Xyuas Haujlwm ntawm Eisai Oncology Pawg Lag Luam, tau hais tias:" Cov ntaub ntawv tshawb fawb no rov qhia dua tias qhov kev pom zoo pom zoo ntawm Lenvima (24mg, ib hnub ib zaug) muab cov txiaj ntsig zoo thiab kev sib luag rau RAI cov neeg mob nrog refractory DTC. Kev Nyab Xeeb. Los ntawm cov kev tshawb fawb no, peb tuaj yeem txhim kho kev nkag siab ntawm peb cov tshuaj los ntawm cov kws kho mob, uas pab lawv ua haujlwm zoo dua los kho cov mob qog nqaij hlav tsis zoo no."

Mob qog noj ntshav yog cov muaj feem ntau ntawm cov qog nqaij hlav endocrine malignant hlav, thiab cov ntaub ntawv thoob ntiaj teb qhia tau tias nws tshwm sim ntawm qhov nce. Nws kwv yees tias thaum xyoo 2020, yuav muaj 52,890 tus neeg mob qog mob cancer hauv lub tebchaws United States, thiab poj niam muaj peb zaug ntxiv yuav muaj mob qog noj ntshav ntau dua li txiv neej. Cov hom mob uas muaj ntau tshaj plaws ntawm cov thyroid mob cancer, papillary cancer thiab mob hlav hlav (nrog rau Hürthle hlwb) tau faib ua DTC, suav txog kwv yees li 90% ntawm tag nrho cov mob. Txawm hais tias feem ntau cov neeg mob nrog DTC tuaj yeem kho nrog kev phais mob thiab siv tshuaj kho hluav taws xob iodine (RAI), cov uas muaj mob qog lossis rov ua dua muaj mob tsis zoo.

Lenvima yog lub zog kinase inhibitor nrhiav thiab tsim los ntawm Eisai. Cov tshuaj yog qhov ncauj ntau-receptor tyrosine kinase (RTK) inhibitor uas tuaj yeem tiv thaiv vascular endothelial kev loj hlob yam receptors VEGFR1 (FLT1) thiab VEGFR2 (KDR) Thiab kinase kev ua si ntawm VEGFR3 (FLT4). Ntxiv nrog rau kev ua kom cov cell ua haujlwm tsis zoo, Lenvima kuj tseem tuaj yeem txwv lwm cov kinases ntsig txog pathogenic angiogenesis, kev mob qog thiab mob qog nqaij hlav, nrog rau fibroblast growth factor (FGF) receptor FGFR1-4, platelet-derived growth factor receptor α (PDGFRα), KIT thiab RET, Lenvima tuaj yeem txo qis qog mob macrophages thiab nce ua haujlwm cytotoxic T cell.

Txog tam sim no, Lenvima' s kev pom zoo muaj xws li: kev mob qog ua cancer, hepatocellular carcinoma (HCC), ua ke nrog everolimus rau lub raum cell carcinoma (kho kab mob thib ob), ua ke nrog Keytruda (PD-1 qog tshuaj tiv thaiv) kho cov tshuaj endometrial mob cancer. Hauv Tebchaws Europe, lenvatinib rau mob raum cell carcinoma yog ua lag luam nyob hauv qab hom npe Kisplyx.

Eisai thiab Merck tau mus txog txoj kev koom tes sib koom ua ke nyob rau lub Peb Hlis 2018 tsim thiab ua lag luam Lenvima ntawm lub ntiaj teb. Thaum lub Peb Hlis thiab Lub Yim Hli 2018, Lenvima tau pom zoo los ntawm Nyij Pooj, Tebchaws Asmeskas thiab European Union ua tiav, los ua thawj cov tshuaj kho kab mob tshiab thawj zaug pom zoo thoob ntiaj teb rau kev tshaj lij lossis tsis muaj kev tiv thaiv hepatocellular carcinoma (HCC) hauv cov kev lag luam no 10 xyoo dhau los Cov. Lub Yim Hli ntawm lub xyoo no, ob tog neeg xa daim ntawv thov sau npe tshiab rau Lenvima hauv Nyij Pooj rau kev kho mob qog nqaij hlav tsis tuaj yeem tiv thaiv qog. Nyob rau lub Rau Hli 2020, Lenvima tau tso cai me nyuam ntsuag tsim los kho kev kho mob tsis tuaj yeem tiv thaiv qog nqaij hlav hauv Nyij Pooj.

Hauv Suav teb, Lenvima tau pom zoo rau lub Cuaj Hlis 2018 yog kev kho kab mob rau cov kev kho mob thawj zaug ntawm cov neeg mob tsis tuaj yeem kho tus mob hepatocellular carcinoma (HCC) uas tsis tau txais kev kho mob yav dhau los. Tuam Tshoj yog lub teb chaws muaj cov neeg mob siab mob cancer siab tshaj plaws nyob hauv lub ntiaj teb. Thaum Lub Kaum Ib Hlis 2018, Lenvima tau tsim tawm hauv Suav teb, cim Suav Tuam Tshoj' s thawj cov kev kho kab mob tshiab rau kev kho mob thawj zaug ntawm kev kho mob tsis txaus ntseeg hepatocellular carcinoma (HCC) 10 xyoo dhau los.

Thaum Lub Kaum Ob Hlis 2019, Lenvima' s tshiab qhia txog kev kho mob qog nqaij hlav cancer sib txawv (DTC) tau pom zoo, uas tseem yog qhov ntsuas thib ob rau cov tshuaj pom zoo hauv Suav teb.