Vitrakvi Tau Pom Zoo Hauv Tebchaws Askiv Rau Kev Kho Mob ntawm NTRK Fusion Cov Pob Qij Tawv

Lub chaw muag tshuaj German loj tshaj Bayer (Bayer) qhov tseeb oncology tshuaj Vitrakvi (larotrectinib) tau tsis ntev los no tau txais xov xwm zoo nyob hauv UK. Lub koom haum National Health of Clinical Optimization (NICE) tau tshaj tawm cov lus pom zoo kom pom zoo rau Vitrakvi siv rau hauv National Health Service (NHS) ntawm tebchaws Askiv, rau cov qog tawv uas muaj cov neurotrophic receptor tyrosine kinase (NTRK) cov noob fusion hauv qog cov menyuam. thiab cov neeg mob cov laus, tshwj xeeb: cov neeg mob uas muaj NTRK gene fusion, hauv kev tshaj lij hauv zos, kev kho mob lossis phais mob ntxiv yuav ua rau muaj mob hnyav, thiab tsis muaj kev xaiv txaus rau txoj kev kho mob. Nws tsim nyog teev tias Vitrakvi yog thawj" cov kabmob kheesxaws tsis muaj kev txwv (tsis txheeb rau keeb kwm)" tshuaj muab los ntawm UK los ntawm Cancer Cancer Fund (CDF) rau cov neeg mob NHS.

Vitrakvi yog lub qhov ncauj tshaj tawm TRK inhibitor, uas yog keeb kwm kev ywj pheej kev kho mob, tshwj xeeb yog tsim kho kev mob qog nqa NTRK gene fusion, tsis hais qhov twg cov qog yug hauv lub cev. TRK fusion-driven hlav tuaj yeem tshwm sim nyob rau ntau qhov chaw ntawm lub cev, feem ntau hauv cov qog tsis tshua muaj, thiab kev xaiv cov kev kho mob yooj yim (xws li kev phais mob, kho mob, kho hluav taws xob, thiab lwm yam) yuav tsis txaus siab. Vitrakvi muaj cov kev ua tau zoo hauv cov menyuam yaus thiab cov neeg laus nrog TRK fusion hlav, suav nrog cov qog ua haujlwm hauv nruab nrab (CNS) cov qog ntshav thiab lub hlwb metastases, uas tuaj yeem muab tus nqi kho mob siab thiab cov kev tshem tawm ntev.

Thaum lub Kaum Ib Hlis 2018, Vitrakvi tau txais lub ntiaj teb' s thawj pawg hauv Tebchaws Meskas, los ua thawj lub qhov ncauj TRK inhibitor pom zoo hauv keeb kwm thiab thawj" cov kabmob mob cancer tsis muaj sia, dav-spectrum" tshuaj los tiv thaiv tus mob cancer tsis cuam tshuam rau cov qog ntshav, qhib lub sijhawm tshiab ntawm" qog agnostic" kev kho mob. Tam sim no, Vitrakvi tau txais kev pom zoo hauv ntau lub teb chaws thiab cheeb tsam thoob ntiaj teb, suav nrog European Union.

NICE qhov kev txiav txim siab hauv tebchaws Askiv tau txiav txim los ntawm cov ntaub ntawv sau los ntawm tag nrho ntawm 102 tus neeg mob los ntawm Ntu I kawm txog tus neeg mob cov neeg laus, Theem II NAVIGATE txoj kev tshawb ntawm cov neeg laus thiab cov menyuam mob, thiab Phase I / II SCOUT txoj kev tshawb nrhiav cov menyuam muaj mob, ntawm cov neeg mob 93 leej yog los ntawm pab pawg tsom xam tseem ceeb thiab 9 lwm tus Cov neeg mob lub hauv paus loj ntawm cov leeg (CNS) hlav. Cov txiaj ntsig pom tau hais tias kev kho Vitrakvi qhia tau muaj kev sib zam zoo, kev tiv thaiv kav ntev thiab kho tau sai. Cov ntaub ntawv tshwj xeeb yog: Cov kev ntsuas tseem ceeb tau qhia tias tag nrho cov lus teb tau dhau los (ORR) yog 72% (95% CI: 62,81), ntawm cov lus teb tiav (CR) yog 16% thiab tus lej feem teb (PR) ) yog 55%. Hauv kev txheeb xyuas ntxiv, suav nrog cov neeg mob nrog CNS thawj, ORR yog 67% (95% CI: 57,76), nrog CR ntawm 15% thiab PR ntawm 51%.

Thaum lub sij hawm ntawm lub ntsiab tsom xam, lub sij hawm nruab nrab mus rau thawj cov lus teb rau cov neeg mob tau txais Viktarvy yog 1.81 hlis. Thaum lub sijhawm tshuaj ntsuam, lub sijhawm nruab nrab ntawm kev so kom ncav tsis cuag (thaj tsam: 1.6+ txog 38.7+ hli), thiab 75% ntawm cov neeg mob tau ncua sijhawm ntawm ission12 lub hlis. Ntawm cov neeg mob uas tau txais kev kho mob, 88% (95% CI: 81,95) tseem muaj sia nyob li ib xyoos tom qab pib kho mob. Thaum lub sijhawm tshuaj xyuas, qhov nruab nrab ntawm kev vam meej-tsis muaj sia nyob (PFS) tsis tau mus txog. Kev nyab xeeb ntawm 125 cov neeg mob nrog NTRK cov noob fusion tau ntsuas. Feem ntau cov kev tshwm sim tsis zoo (AEs) yog qib 1 lossis qib 2. Tsuas yog 3% ntawm cov neeg mob yuav tsum nres kev kho mob tas mus li vim tias AEs tshwm sim thaum kho. Kaum cuaj (15%) cov neeg mob tau qhia txog kev txo qib koob tshuaj, ntawm 10 (8%) yog vim muaj cov nyom tshwm sim. Feem ntau cov kev tsis zoo uas ua rau txo koob tshuaj tau tshwm sim thaum thawj peb lub hlis ntawm kev kho mob.

Viktarvy kev kho mob ntawm TRK fusion-tsav cov laus thiab cov menyuam muaj mob qog noj ntshav tau muaj kev txhim kho hauv kev kho mob hauv lub neej zoo (QoL). Hauv ob qhov kev kuaj mob thoob ntiaj teb, 60% ntawm cov neeg mob laus tau qhia txog kev txhim kho hauv EORTC QLQ-C30 cov qhab nia noj qab haus huv thoob ntiaj teb. Rau cov mob hlwb, 76% ntawm cov neeg mob tau qhia txog kev txhim kho hauv tag nrho cov qhab nia ntawm PedsQL.

Amanda Cunnington, Bayer UK tus thawj coj ntawm cov tshuaj rau cov neeg mob, tau hais tias: "Bayer zoo siab rau NICE qhov kev pom zoo rau Viktarvy vim tias nws yuav muab sijhawm rau cov kws kho mob hauv tebchaws Askiv thawj zaug los muab cov neeg laus thiab kws kho mob nrog TRK fusion-driven cancer los tua lawv. muaj tus kab mob kev kho mob tshwj xeeb. Bayer zoo siab koom tes nrog NICE thiab UK National Service System (NHS) thoob plaws kev tshuaj ntsuam xyuas txoj kev kho mob tshiab no kom coj tau cov neeg muaj qhov ncauj tshiab rau cov neeg mob qog noj ntshav uas yog tsav los ntawm TRK fusion kev kho."

NTRK gene fusion yog qhov hloov pauv txawv txav uas muaj nyob rau ntawm cov qog loj, ua rau cov neeg tsis muaj kev sib tw hauv TRK thiab cov qog loj tuaj. Ntau thiab ntau cov pov thawj qhia tau tias cov gene NTRKs encoding TRKs protein yuav raug cuam tshuam nrog lwm cov noob, kev tsim cov cim qhia uas tuaj yeem ua rau mob qog nqaij hlav hauv ntau qhov chaw ntawm lub cev. TRK fusion cancer feem ntau tsis tshua muaj, cuam tshuam tsis ntau tshaj li ob peb txhiab tus neeg mob hauv Tebchaws Europe txhua xyoo. TRK fusion tuaj yeem cuam tshuam rau cov menyuam yaus thiab cov neeg laus thiab tshwm sim ntawm ntau zaus ntawm cov qog sib txawv.

Cov tshuaj muaj tshuaj lom neeg ntawm Vitrakvi yog larotrectinib, uas yog lub zog, qhov ncauj, xaiv tropomyosin receptor kinase (TRKs) inhibitor tsim kom ncaj qha hom phiaj rau TRK (suav nrog TRKB, TRKB, thiab TRKC), uas ua rau lub cev tsis sib haum xeeb TRK fuses cov teeb liab ntawm txoj kev mob qog Cov. TRK fusion cancer feem ntau tsis tshua muaj thiab cuam tshuam tsis ntau tshaj li ob peb txhiab tus neeg mob hauv Tebchaws Europe hauv ib lub xyoo. Tus kabmob tuaj yeem cuam tshuam rau cov menyuam yaus thiab cov neeg laus thiab tshwm sim ntawm ntau zaus sib txawv ntawm cov qog. Hauv cov kev tshawb fawb soj ntsuam, Vitrakvi tau tshawb thiab kho 29 cov qog hlav nrog cov keeb kwm sib txawv. Cov txiaj ntsig pom tau hais tias Vitrakvi muaj qhov tseem ceeb thiab ruaj khov los tiv thaiv qog ua haujlwm tiv thaiv TRK fusion hlav, suav nrog CNS cov qog thiab lub hlwb metastases, tsis hais tus neeg mob hnub nyoog thiab cov keeb kwm mob.

qhov chaw:NOOBapproves qhov ncauj tshuaj VITRAKVI (larotrectinib), thawj qhov keeb kwm-kev kho mob ywj pheej uas tau muaj nyob hauv tebchaws Askiv, rau cov menyuam yaus thiab cov neeg laus nrog TRK fusion tsav mob cancer