Verzenio (abemaciclib): Thawj CDK4/6 Inhibitor Rau Kev Kho Mob Ntawm HR+/HER2-high-risk Early Breast Cancer!--2/2

Qhov kev pom zoo no yog los ntawm cov txiaj ntsig ntawm kev txheeb xyuas kev ua tau zoo ntawm pawg sub pawg saum toj no thiab ntxiv kev soj ntsuam tom qab qhov tshwm sim. Hauv qhov kev tshuaj ntsuam no, Verzenio ua ke nrog ET txuas ntxiv qhia cov txiaj ntsig tseem ceeb hauv kev kho mob: Rau cov neeg mob uas muaj kev pheej hmoo siab kho mob thiab cov kab mob pathological thiab Ki-67 tau qhab nia ≥20%, Verzenio+ET piv nrog tus qauv adjuvant ET yuav ua rau lub mis. mob qog noj ntshav rov qab los yog qhov kev pheej hmoo ntawm kev tuag raug txo los ntawm 37% (HR=0.626; 95% CI: 0.49-0.80), thiab qhov txiaj ntsig zoo ntawm IDFS qhov xwm txheej hauv 3 xyoos yog 7.1%. Hauv qhov kev tshuaj ntsuam no, tus naj npawb ntawm IDFS qhov xwm txheej hauv Verzenio+T pab pawg ET yog 104, thaum nyob hauv pawg ET yog 158. Cov ntaub ntawv muaj sia nyob tag nrho (OS) tseem tsis tau paub tab, thiab kev soj ntsuam txuas ntxiv txuas ntxiv mus. . Hauv qhov kev sim no, qhov tsis zoo tshwm sim tau ua raws li kev paub txog kev nyab xeeb ntawm Verzenio.

Sara M. Tolany, tus kws tshawb fawb ntawm huab tais E sim thiab tus kws kho mob ntawm Harvard Medical School, tau hais tias:" Cov qauv tsim thiab cov txiaj ntsig ntawm kev tshawb fawb huab tais tau hloov pauv kev coj ua thiab sawv cev rau thawj qhov kev nce qib hauv kev kho mob ntawm HR. +HER2- mob qog noj ntshav hauv lub mis ntev. FDA pom zoo Kev sib xyaw ntawm Verzenio thiab endocrine kev kho mob rau kev mob qog noj ntshav thaum ntxov muaj peev xwm los ua tus qauv tshiab ntawm kev saib xyuas rau cov pej xeem no. Peb tau txais kev txhawb nqa los ntawm kev txo qis hauv kev pheej hmoo ntawm cov neeg mob rov qab los tom qab 2 xyoos kev kho mob, thiab peb zoo siab heev uas tuaj yeem muab cov neeg mob nrog cov kev kho mob tshiab no."

Mob qog noj ntshav mis yog mob qog noj ntshav ntau tshaj plaws ntawm cov poj niam thoob ntiaj teb. Nws kwv yees tias 90% ntawm cov qog nqaij hlav hauv lub mis raug kuaj pom thaum ntxov. Kwv yees li 70% ntawm cov qog nqaij hlav mis yog HR+/HER2-, uas yog hom kab mob ntau tshaj plaws. Txawm nyob rau hauv HR+/HER2- subtype, mob qog noj ntshav mis yog ib yam kab mob nyuaj, thiab ntau yam-xws li seb tus mob qog noj ntshav tau kis mus rau cov qog nqaij hlav, cov yam ntxwv ntawm cov qog-yuav ua rau muaj kev pheej hmoo ntawm kev rov tshwm sim dua. .

Lub active tshuaj muaj nyob rau hauv Verzenioabemacclib, uas yog lub hom phiaj ntawm qhov ncauj CDK4/6 inhibitor uas muaj peev xwm xaiv tau inhibit cyclin-dependent kinase 4/6 (CDK4/6), rov qab tswj lub voj voog ntawm tes, thiab thaiv cov qog hlwb proliferation. Lub voj voog ntawm tes tsis tswj hwm yog ib qho tseem ceeb ntawm kev mob qog noj ntshav. CDK4/6 yog overactive nyob rau hauv ntau yam mob qog noj ntshav, ua rau lub cell proliferation uncontrolled. CDK4/6 yog tus tswj hwm lub voj voog ntawm tes, uas tuaj yeem ua rau kev hloov pauv ntawm lub voj voog ntawm tes los ntawm theem kev loj hlob (G1 theem) mus rau DNA replication theem (S1 theem). Hauv cov tshuaj estrogen receptor zoo (ER{13}}) mob qog noj ntshav mis, kev ua haujlwm dhau ntawm CDK4/6 yog nquag heev, thiab CDK4/6 yog lub hom phiaj tseem ceeb ntawm ER signaling. Cov ntaub ntawv hauv tsev kho mob qhia tau hais tias ob qhov inhibition ntawm CDK4/6 thiab ER signaling muaj kev sib koom ua ke thiab tuaj yeem cuam tshuam kev loj hlob ntawm ER+ cov qog nqaij hlav cancer mis hauv G1 theem. Cov pov thawj kho mob kuj qhia tau tiasabemacclibhla cov ntshav-hlwb barrier. Hauv cov neeg mob qog noj ntshav siab, suav nrog cov neeg mob qog noj ntshav mis, qhov concentration ntawm abemaciclib thiab nws cov metabolites nquag (M2 thiab M20) hauv cov kua cerebrospinal yog sib npaug rau qhov tsis muaj ntshav plasma concentration.

Verzenio tau txais kev pom zoo rau kev lag luam thaum Lub Kaum Hli 2017 rau kev kho mob ntawm cov neeg mob HR+/HER2- qib siab lossis mob qog nqaij hlav cancer mis. Cov tshuaj tsim nyog rau: (1) Ua ke nrog aromatase inhibitor (AI) raws li kev kho mob endocrine thawj zaug rau kev kho cov poj niam postmenopausal (2) Ua ke nrog fulvestrant rau cov poj niam uas tau nce hauv kev kho endocrine; (3) Raws li kev kho mob monotherapy, nws yog siv rau cov neeg laus laus uas tau txais kev kho mob endocrine thiab kws khomob los tswj cov kab mob metastatic tab sis tau ua tiav.

Tam sim no, muaj ntau CDK4/6 inhibitors ntawm lub khw, ntxiv rau Eli Lilly's Verzenio, Pfizer's Ibrance (palbociclib) thiab Novartis's Kisqali (ribociclib). Hauv Suav teb, Pfizer Ibrance (palbociclib) tau pom zoo thaum Lub Yim Hli 2018 thiab tau los ua thawj CDK4/6 inhibitor pom zoo hauv Suav teb. Cov tshuaj qhia yog: ua ke nrog aromatase inhibitors raws li kev kho mob endocrine thawj zaug rau HR+/HER2- Kev kho mob ntawm cov poj niam postmenopausal nrog mob qog noj ntshav hauv zos lossis mob qog noj ntshav.

Thaum Lub Kaum Ob Hlis 2020, Eli Lilly Verzenio (abemacclib) tau pom zoo thiab dhau los ua tus thib ob CDK4/6 inhibitor pom zoo hauv Suav teb. Cov tshuaj no yog siv los kho HR+/HER2- mob qog noj ntshav hauv zos lossis mob qog noj ntshav metastatic: (1) thiab aroma Kev sib xyaw ntawm cov enzyme inhibitors yog siv los ua thawj txoj kev kho endocrine rau cov poj niam tom qab yug menyuam; (2) Kev sib xyaw ua ke nrog fulvestrant yog siv rau cov neeg mob uas tau ntsib tus kab mob tom qab tau txais kev kho mob endocrine.

Thaum Lub Peb Hlis 8, 2021, Eli Lilly tau tuav lub rooj sib tham xov xwm hauv Beijing thiab Shanghai tib lub sijhawm: CDK4/6 inhibitor Verzenio (abemaciclib) tau ua tiav hauv Suav teb.