Seattle Genetics 'HER2 Lub Hom Phiaj TKI Qhov ncauj tshuaj Tukysa Tau Pom Zoo Los Ntawm EU!

Seattle Genetics (Seagen) tau tshaj tawm tsis ntev los no hais tias European Commission (EC) tau pom zoo lub hom phiaj tshuaj anticancer Tukysa (tucatinib), ua ke nrog trastuzumab thiab capecitabine, rau kev kho mob HER2 uas yav tas los tau txais tsawg kawg yog ob qho tshuaj tiv thaiv HER2. Cov neeg laus uas muaj mob cancer mis hauv zej zog lossis paub txog mob cancer mis.

Tukysa yog qhov ncauj me me molecule tyrosine kinase inhibitor (TKI) uas tsom rau HER2, yog ib hom protein uas txhawb txoj kev loj hlob ntawm cov qog nqaij hlav cancer. Qhov kev pom zoo no siv rau txhua tus tswvcuab ntawm European Union nrog rau Norway, Liechtenstein, Iceland thiab Northern Ireland. Hauv Tebchaws Meskas, Tukysa tau pom zoo los ntawm FDA rau lub Plaub Hlis 2020 rau kev kho mob rau cov neeg mob uas muaj HER2-zoo mob cancer mis uas tsis tuaj yeem raug phais thiab tus uas yav tas los tau txais ib lossis ntau tshaj kev tiv thaiv HER2 rau tus kabmob metastatic, suav nrog lub hlwb kev loj hlob. Cov neeg mob uas tau hloov chaw lawm. Ntxiv rau, Tukysa kuj tau pom zoo hauv tebchaws Canada, Switzerland, Singapore, thiab Australia.

Kev pom zoo ntawm EU yog kev nce qib loj rau cov neeg mob nyob sab Europe. Lawv yuav tau txais cov tshuaj pom zoo thawj zaug, uas tau lees paub tias ua haujlwm zoo rau HER2-zoo metastatic cov neeg mob qog mis uas tau muaj kev vam meej tom qab tau txais ob qho qauv tiv thaiv HER2 cov kev cai. Muab cov txiaj ntsig kev ua neej. Hauv kev sim piv txwv HER2CLIMB, piv nrog trastuzumab + kev kho mob capecitabine, Tukysa + trastuzumab + capecitabine kev kho qhov tseeb tau txhim kho txoj kev muaj sia tag nrho (OS) thiab kev vam meej tsis muaj sia nyob ntawm cov neeg mob (PFS), suav nrog cov neeg mob uas ua haujlwm nquag, tsis tau kho, lossis nce siab ntxiv cov metastases uas lawv xav tau tsis meej.

Clay Siegall, CEO ntawm Seagen, hais tias: “Tukysa kev kho ua ke yog kev kho mob rau tus neeg mob HER2-zoo metastatic mob cancer mis (nrog lossis tsis muaj hlwb metastases). Tag nrho cov neeg muaj sia nyob ntawm cov neeg mob tau raug nthuav ntev. Peb zoo siab tias Tukysa tau pom zoo tam sim no nyob hauv Europe, thiab peb tos ntsoov yuav muab Tukysa rau cov neeg mob kom sai li sai tau. "

Qhov kev pom zoo no yog txiav txim siab los ntawm cov ntaub ntawv los ntawm HER2CLIMB qhov kuaj pom muaj nuj nqis. Qhov no yog ib qho kev xaiv (2: 1), ob chav dig muag, tshuaj placebo, tshuaj muaj tshuaj muaj txiaj ntsig zoo hauv cov neeg mob uas muaj kev tiv thaiv kab mob hauv cheeb tsam tsis pom lossis mob HER2-zoo mob cancer mis, sib xyaw tucatinib nrog trastuzumab thiab carbohydrate Txoj kev sib xyaw ntawm pecitabine yog piv nrog kev sib xyaw ua ke ntawm trastuzumab thiab capecitabine. Cov neeg mob uas tau cuv npe hauv txoj kev sim tau yav tas los tau txais kev kho mob trastuzumab, pertuzumab, thiab T-DM1 (ado-trastuzumab emtansine) kev kho mob, thiab 48% ntawm cov neeg mob tau mob hlwb metastases thaum lawv cuv npe kawm.

Cov txiaj ntsig tau pom tias qhov kev sim tau mus txog qhov kawg ntawm kev vam meej-tsis muaj sia nyob (PFS): piv nrog trastuzumab + capecitabine regimen, tucatinib + trastuzumab + capecitabine regimen qhia tau zoo dua, kev pheej hmoo ntawm kev muaj mob lossis tuag tau txo qis 46% (nruab nrab PFS: 7.8 hlis vs 5.6 hli; HR=0.54 [95% CI: 0.42-0.71], p< 0.00001).="" hauv="" kev="" txheeb="" xyuas="" ntu="" ib="" ntus,="" qhov="" kev="" sim="" siab="" tseem="" mus="" txog="" ob="" lub="" ntsiab="" tseem="" ceeb="" kawg.="" piv="" nrog="" trastuzumab="" +="" capecitabine="" kho="" pab="" pawg,="" qhov="" muaj="" sia="" nyob="" tag="" nrho="" (os)="" ntawm="" tucatinib="" +="" trastuzumab="" +="" kev="" kho="" mob="" capecitabine="" pab="" pawg="" zoo="" dua="" (nruab="" nrab="" os:="" 21.9="" lub="" hlis="" vs="" 17.4="" lub="" ib="" hlis),="" qhov="" kev="" pheej="" hmoo="" ntawm="" kev="" ploj="" tuag="" tau="" txo="" los="" ntawm="" 34%="" (hr="0.66" [95%="" ci:="" 0.50-0.88],="" p="0.0048)," thiab="" lub="" hom="" phiaj="" zam="" lub="" hom="" phiaj="" tau="" yuav="" luag="" ob="" npaug="" (orr:="" 40.6%="" vs="" 22.8%).="" rau="" cov="" neeg="" mob="" lub="" hlwb="" metastases="" ntawm="" lub="" hauv="" paus,="" piv="" nrog="" trastuzumab="" +="" capecitabine="" regimen,="" tucatinib="" +="" trastuzumab="" +="" capecitabine="" regimen="" kuj="" pom="" qhov="" zoo="" dua="" pfs="" cov="" ntaub="" ntawv="" (nruab="" nrab="" pfs:="" 7.6="" lub="" hlis="" thiab="" 5.4="" lub="" hlis="" ),="" qhov="" pheej="" hmoo="" ntawm="" tus="" kab="" mob="" kev="" loj="" hlob="" lossis="" tuag="" tau="" txo="" qis="" los="" ntawm="" 52%="" (hr="0.48" [95%="" ci:="" 0.34-0.69],=""><>

Hauv cov kev sim no, kev nyab xeeb ntawm tucatinib ua ke nrog trastuzumab thiab capecitabine yog qhov zoo. Feem ntau cov kev phiv tshuaj nyob hauv cov pab pawg tucatinib suav nrog zawv plab, palmoplantar hnov ​​qhov liab liab (PPE), xeev siab, qaug zog, thiab ntuav. Piv nrog pab pawg tswj hwm, cov xwm txheej tsis zoo ntawm qeb 3 lossis siab dua hauv pawg tucatinib muaj xws li mob raws plab (12.9% vs 8.6%), nce aspartate aminotransferase (AST) (4.5% vs 0.5%), alanine aminotransferase (ALT)) nce ( 5.4% vs 0.5%) thiab bilirubin ntau zog (0.7% vs 2.5%). Tsis tas yuav tsum muaj cov tshuaj tiv thaiv kev tiv thaiv kab mob. Cov xwm txheej tsis zoo uas ua rau kev txiav tawm tsis sib haum xeeb hauv pawg tucatinib thiab pawg tswj hwm (5.7% thiab 3.0%, feem).

HER2 yog ib txoj kev loj hlob tau uas yog muaj ntau yam mob qog nqaij hlav, suav nrog mob qog noj ntshav mis, mob qog nqaij hlav cancer, thiab mob cancer. HER2 mediates cell loj hlob, sib txawv thiab ciaj sia. Hauv lub mis mob cancer, txog 15-20% yog HER2 zoo. Piv nrog HER2-tsis zoo mob cancer mis, HER2-zoo mob cancer mis yog qhov ntau dua thiab rov huam dua. Txog li 50% ntawm cov neeg mob uas muaj tus kabmob HER2-zoo mob cancer mis pib lub hlwb metastases sijhawm.

Kev nquag noj tshuaj ntawm Tukysa yog tucatinib, uas yog lub qhov ncauj lom tyrosine kinase inhibitor (TKI) uas tau xaiv rau HER2 ntau thiab tsis muaj kev cuam tshuam pom tseeb ntawm EGFR. Kev txwv tsis pub ntawm EGFR yog txuam nrog kev mob lom, nrog rau cov tawv nqaij ua pob thiab zawv plab. Tucatinib tau qhia txog kev ua kom noj tshuaj zoo li ib yam tshuaj, kev kho mob ua ke thiab lwm yam tshuaj HER2 tsom (xws li trastuzumab). Cov kev tshawb fawb soj ntsuam ntawm kev sib xyaw ntawm tucatinib tau qhia txog kev ua haujlwm ntawm lub cev thiab tiv thaiv lub hlwb metastasis. Yav dhau los, tucatinib tau txais kev tso cai tshuaj xyuas chaw menyuam yaus los ntawm FDA rau kev kho mob rau cov neeg mob qog mis mob ntshav hlwb.

Ntxiv rau HER2CLIMB mus sib hais, Seattle Genetics tab tom ua lwm theem III kev soj ntsuam kuaj mob, HER2CLIMB-02, txhawm rau ntsuas kev sib xyaw ntawm tucatinib thiab T-DM1 thiab T-DM1 ib leeg-tus neeg sawv cev rau kev kho mob hauv cheeb tsam tsis muaj kev tiv thaiv lossis metastatic HER2 tus mob cancer mis zoo. Tsis tas li ntawd, lub tuam txhab tseem tab tom ua theem II kev soj ntsuam MOUNTAINEER los soj ntsuam tucatinib ua ke nrog trastuzumab hauv kev kho mob HER2-zoo, RAS tsiaj-hom, mob metastatic lossis tsis tuaj yeem tiv thaiv mob qog nqaij hlav.