Epizyme epigenetics tshuaj Tazverik tau txais kev pom zoo los ntawm Tsoom Fwv Teb Chaws Asmeskas FDA kom pom qhov tshiab: follicular lymphoma (FL)!

Epizyme yog lub tuam txhab biopharmaceutical rau kev tsim kho tshuaj epigenetic tshiab. Tsis ntev los no, lub tuam txhab tshaj tawm tias Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA) tau pom zoo rau cov tshuaj epigenetic Tazverik (tazemetostat) rau 2 yam sib txawv hauv qab no rau follicular lymphoma (FL):

(1) Cov neeg mob rov huam lossis rov huam dua qub (R / R) FL cov neeg laus cov neeg mob uas cov qog tau lees tias yog qhov zoo rau kev hloov pauv ntawm EZH2 los ntawm FDA pom zoo ntsuas cov qauv thiab yav tas los tau txais tsawg kawg 2 kev kho mob;

(2) Cov neeg laus uas muaj R / R FL tsis muaj kev xaiv lwm txoj kev kho mob. Cov ntsiab lus saum toj no yog kev pom zoo los ntawm cov txheej txheem kev tso cai nrawm thiab cov txheej txheem txheeb xyuas qhov tseem ceeb. Kev pom zoo raug txiav txim siab raws li cov ntaub ntawv los ntawm tus nqi teb tag nrho (ORR) thiab lub sijhawm teb (DOR) ntawm cov neeg mob EZH2 hloov thiab hom EZH2 nyob rau hauv pawg FL ntawm ntu II.

Tazverik yog qhov ncauj, ua ntej-hauv chav EZH2 inhibitor. Thaum Lub Ib Hlis 2020, Tazverik tau txais kev pom zoo nrawm los ntawm Asmeskas FDA rau kev kho mob ntawm cov menyuam yaus thiab cov neeg laus uas muaj mob metastatic lossis hauv zos qib siab epithelioid sarcoma (ES) uas muaj hnub nyoog ≥16 xyoo thiab tsis tau raws li cov kev mob rau kev rov ua kom tiav.

Nws tsim nyog teev tias Tazverik yog thawj EZH2 inhibitor pom zoo los ntawm Asmeskas FDA thiab thawj qhov kev kho mob tau pom zoo los ntawm lub koom haum tshwj xeeb rau cov neeg mob ES. Tam sim no, FL tseem yog ib qho kab mob uas tsis tuaj yeem hloov kho. Qhov kev pom zoo kawg no yuav muab cov kev xaiv tseem ceeb tshiab rau cov neeg mob cov neeg laus uas muaj mob rov qab los lossis refractory FL. Cov kev zam ntev ntev thiab kev nyab xeeb zoo uas tau pom hauv kev tshawb fawb soj ntsuam txhawb lub peev xwm ntawm Tazverik kom nqa cov ntsiab lus hloov mus rau hom neeg mob FL.

tazemetostat cov qauv qog qauv (duab qhov chaw: Wikipedia)

Tazverik' s cov tshuaj ua kua tshuaj yog tazemetostat, uas yog qhov ncauj, muaj zog, thawj zaug, thiab EZH2 inhibitor. EZH2 yog keeb kwm methyltransferase. Yog tias nws qhib lub zog tsis ua haujlwm, nws yuav ua rau cov noob tsis muaj kev tswj hwm uas tswj cov kab mob ntawm tes, uas tuaj yeem ua rau tsis muaj kev txwv tsis pub muaj kev loj hlob sai ntawm qhov tsis yog Hodgkin' s lymphoma (NHL) thiab ntau lwm cov qog ua pob. Tazemetostat tuaj yeem tawm tsam cov qog cuam tshuam los ntawm qhov kev txwv EZH2 kev ua haujlwm enzyme. Hauv kev tshawb fawb hauv chav kho mob, tazemetostat tau qhia tias muaj peev xwm ntsws thiab txawm tias tshem tawm cov qog ua kom nyab xeeb thiab muaj txiaj ntsig thaum ntxov ntawm kev kho.

Tam sim no, tazemetostat tseem tab tom tsim rau ntau yam hematological malignancies (tsis-Hodgkin' s lymphoma: rov mob lossis refractory diffuse loj B-cell lymphoma [DLBCL], follicular lymphoma [FL]) Thiab cov hlav ua cov qog ntshav tawv (epithelial sarcoma) , synovial sarcoma, INI1-cov qog tsis zoo, mob qog-resistant prostate cancer, platinum-resistant khoom qog, thiab lwm yam).

Kev pom zoo ntawm qhov ntsuas kab mob FL tshiab tshiab yog saib raws cov ntaub ntawv los ntawm txoj kev qhib-daim ntawv lo, ib txhais caj npab, multicenter Ntu II kawm (Kev Kawm E7438-G000-101, NCT01897571). Txoj kev kawm tshawb sau npe rau cov neeg mob FL uas muaj EZH2 kev hloov pauv (n=45) thiab cov neeg mob FL uas muaj hom EZH2 (n=54).

Raws li kev soj ntsuam kev soj ntsuam ntawm Pawg Neeg Saib Xyuas Kev Nyab Xeeb (IRC): (1) Hauv cov neeg mob EZH2 hloov pauv, tag nrho cov lus teb (ORR) ntawm Tazverik kev kho yog 69%, tus nqi teb tag (CR) yog 12%, thiab ib feem ntawm tus lej teb (PR) Ntawm 57%, qhov nruab nrab ntawm kev ncua sijhawm (DOR) yog 10.9 hli. (2) Ntawm cov neeg mob hom EZH2 tsiaj qus, ORR yog 34%, CR yog 4%, PR yog 30%, thiab nruab nrab DOR yog 13.0 hli. Hauv txoj kev tshawb no, Tazverik tau muaj kev nyab xeeb thiab zoo rau lub siab.

Txhawm rau pab txhawb Tazverik pom zoo tag nrho ntawm FL qhov ntsuas, Epizyme tab tom ua kev soj ntsuam thoob ntiaj teb, xaiv ib qho, yoog raws kev ntsuam xyuas los soj ntsuam Tazverik thiab "R2 regimen" (Revlimid [lenalidomide] + Rituxan [rituximab]], R2 yog kev pom zoo rau tshuaj kho mob -free immunotherapy regimen) siv nrog kev sib txuas ua ob-kab lossis ntau txoj kab kev kho mob ntawm tus neeg mob FL. Txoj kev tshawb no yuav tsum nrhiav kwv yees li 500 tus neeg mob FL, stratified raws li lawv qhov kev hloov pauv ntawm EZH2. Qhov kev nyab xeeb xeem ntawv ntawm qhov kev tshawb fawb tau ua tiav. Tsis tas li ntawd, Epizyme yuav ua rau cov kev cog lus tom qab kev lag luam, suav nrog nthuav cov theem II cov chaw kuaj mob mus kuaj nrog cov neeg mob EZH2 FL cov neeg mob uas tau txais tsawg kawg ib qho kev kho mob los txhawb rau cov peev xwm tom ntej yuav nthuav dav hauv kab thib ob thiab cov chaw ua kom zoo nkauj.