Bayer Cov Hom Phiaj Los Tiv Thaiv Kab Mob Cancer Vitrakvi Tau Ua Rau Ua Lag Luam Hauv Nyij Pooj

Bayer tsis ntev los no tau tshaj tawm tias nws tau xa daim ntawv thov kev lag luam tshuaj tshiab (NDA) rau nws qhov tseeb oncology tshuaj Vitrakvi (larotrectinib) rau Ministry of Health, Labour thiab Welfare (MHLW). Vitrakvi yog qhov ncauj TRK inhibitor tsim tshwj xeeb rau kev kho mob rau menyuam yaus thiab cov neeg laus nrog lub siab lossis metastatic cov qog uas cov qog muaj cov neurotrophic tyrosine receptor kinase (NTRK) fusion fusion. Tam sim no, Vitrakvi tau txais kev pom zoo hauv ntau lub teb chaws thiab cheeb tsam thoob ntiaj teb, suav nrog Asmeskas, Brazil, Canada, thiab EU lub teb chaws. Cov ntawv thov nyob hauv lwm cov cheeb tsam tseem tab tom ua tiav lossis npaj tseg.

Scott Z. Liaj teb, MD, tus lwm thawj coj tus thawj coj thiab thawj coj ntawm kev loj hlob oncology ntawm Bayer Pharmaceuticals, tau hais tias:" Nrog qhov kev xa tawm no, peb tau muab cov neeg mob thiab cov kws kho mob hauv Nyij Pooj muaj qhov siab rau xaiv tshwj xeeb uas tau tsim tshwj xeeb rau cov neeg laus thiab kho tsiaj hauv TRK fusion cancer. Kev kho mob yog ib kauj ruam ze dua thiab muaj lub peev xwm los txhim kho txoj kev kho mob tsis hais hom mob qog lossis hnub nyoog ntawm tus neeg mob. Yav dhau los, cov tshuaj anticancer yog siv rau kev mob qog nqaij hlav hauv qee qhov chaw hauv lub cev, thiab Vitrakvi tau tsim tshwj xeeb los kho cov neeg mob TRK fusion mob cancer, tsis hais qhov twg cov qog tawm hauv lub cev. Vitrakvi yog ib qho tseem ceeb ua ntej tiv thaiv tus kabmob tsis tshua muaj no vim tias nws yuav hloov cov kev kho mob uas kim tshaj plaws uas tsis tsom tshwj xeeb rau hom mob cancer no thiab tsis tau muaj pov thawj zoo thiab muaj kev nyab xeeb rau pawg neeg mob no."

Hauv Nyij Pooj, kev xa ntawm Vitrakvi NDA yog suav raws li cov ntaub ntawv sib sau los ntawm tag nrho ntawm 102 tus neeg mob hauv kev sim I ntawm cov neeg laus, Phase II NAVIGATE kev sim rau cov neeg laus thiab cov neeg mob, thiab The Phase I / II SCOUT mus sib hais rau cov neeg mob hlwb Cov. Hauv cov kev sim no, Vitrakvi tau tshawb nrhiav ntau dua 20 lub qog ua haujlwm nrog cov keeb kwm sib txawv, suav nrog kev mob qog nqaij hlav cancer, mob qog nqaij hlav cancer, melanoma, mob plab hnyuv hlav, mob plab hnyuv, cholangiocarcinoma, nqaij mos sarcoma, salivary adenocarcinoma thiab me nyuam mos Fibrosarcoma, thiab lwm yam.

Ntawm 102 tus neeg mob, 93 yog los ntawm pab pawg tsom xam tseem ceeb, thiab 9 yog cov neeg mob thawj lub qog ua haujlwm (CNS) hlav. Cov txiaj ntsig pom tau hais tias kev kho Vitrakvi qhia tau muaj kev kho siab, 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), ntawm uas CR yog 15% thiab PR yog 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 tau txiav kev kho 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 xwm txheej tsis zoo. 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 nqaij hlav tau ua rau muaj kev txhim kho hauv cov neeg mob 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 ntawm PedsQL cov qhab nia.

TRK fusion cancer feem ntau tsis tshua muaj, tuaj yeem cuam tshuam rau cov menyuam yaus thiab cov neeg laus, thiab tshwm sim ntawm ntau zaus muaj ntau hom qog. Thaum ib qho NTRK gene nrog fuse nrog lwm lub noob uas tsis sib txheeb los tsim cov protein uas hloov pauv, TRK fusion cancer yuav tshwm sim. Cov hloov ua kom muaj protein, lossis TRK fusion protein, hloov ua lub cev lossis ua haujlwm ntau dhau, ua rau kev ua haujlwm ntawm cov teeb liab ua ke ntawm cov hlwb. Cov TRK fusion protein, raws li tsav ntawm oncogenes, tuaj yeem txhawb qog kis thiab loj hlob tsis hais qhov twg los ntawm cov qog los.

Vitrakvi yog lub xub ntiag qhov ncauj TRK inhibitor. Nws cov tshuaj ua kom nquag plias, larotrectinib, yog lub zog, qhov ncauj, thiab xaiv tropomyosin receptor kinase (TRKs) inhibitor tsim kom ncaj qha rau TRK (suav nrog TRKB, TRKB, Thiab TRKC), kaw lub teeb liab uas ua rau TRK fusion qog nce. TRK fusion-ua cov qog yuav tshwm sim nyob rau ntau qhov chaw ntawm lub cev, thiab kev kho kom zoo li qub (xws li kev phais mob, kev kho mob, kho hluav taws xob, thiab lwm yam) feem ntau tsis tuaj yeem ua tiav cov txiaj ntsig kho tau.

Vitrakvi yog ib txoj kev kho mob histology-ywj siab, tshwj xeeb yog tsim los kho cov qog uas nqa NTRK gene fusion, tsis hais qhov twg cov qog yug hauv lub cev. Hauv cov menyuam yaus thiab cov neeg laus nrog TRK fusion hlav, Vitrakvi muaj cov kev ua tau zoo, suav nrog rau cov kabmob hauv nruab nrab ntawm cov leeg hlwb (CNS) hlav thiab lub hlwb metastases, ob qho tib si muab cov kev kho mob siab thiab cov chaw nyob ntev, tsis hais tus neeg mob lub hnub nyoog thiab cov keeb kwm mob.

Thaum lub Kaum Ib Hlis 2018, Vitrakvi tau txais lub ntiaj teb' s thawj pawg nyob hauv Tebchaws Meskas, los ua thawj qhov ncauj TRK inhibitor pom zoo hauv keeb kwm thiab thawj" cov kab mob cancer tsis muaj kev txwv, dav-spectrum" tsom tshuaj anticancer uas tsis cuam tshuam nrog cov qog ntshav. Tam sim no, Vitrakvi tau txais kev pom zoo hauv ntau lub teb chaws thiab cheeb tsam thoob ntiaj teb, suav nrog European Union.