Johnson&Johnson / AbbVie Imbruvica (ibrutinib) ib leeg-tus neeg sawv cev kho mob thawj zaug rau 7 xyoo qhia tau hais tias muaj kev pab lub neej ntev mus!

Janssen Cov Chaw Ua Tshuaj, ib lub chaw tsim khoom ntawm Johnson& Johnson (JNJ), tsis ntev los no tau tshaj tawm qhia lub hom phiaj tshuaj anticancer Imbruvica(ibrutinib)raws li kev kho mob rau txoj kev kho thawj zaug ntawm kev mob ntsws lymphocytic rau cov ntshav (CLL) Theem 3 RESONATE-2 (PCYC-1115/1116) kawm txog qhov ua tau zoo kawg rau qhov kev vam meej-tsis muaj sia nyob ntu 3 (PFS) thiab tag nrho kev muaj sia nyob (OS) ntev txog 7 xyoo. Qhov no yog qib ntev tshaj plaws 3 cov ntaub ntawv taug qab rau BTK inhibitors kom deb li deb, uas ntxiv dag zog rau Imbruvica cov kev pab cuam muaj sia nyob ntev thiab paub tseeb txog kev nyab xeeb hauv kev kho mob ntawm CLL pw ua ke.

Imbruvica yog qhov ncauj BTK inhibitor, tsim thiab ua lag luam los ntawm Johnson& Johnson thiab AbbVie. Hauv Suav teb, Imbruvica tau pom zoo rau kev kho mob: kab mob ntsws lymphocytic ntau npaum li cas / mob me lymphocytic lymphoma (CLL / SLL), mantle cell lymphoma (MCL), Waldenstrom' s macroglobulinemia (WM). Cov ntaub ntawv muaj feem xyuam tuaj yeem nrhiav tau ntawm tus nom lub vev xaib ntawm Xi' ib qho Janssen Tshuaj.

Lub 7-xyoo cov txiaj ntsig ntawm RESONATE-2 txoj kev tshawb fawb ntxiv txhawb cov txiaj ntsig ntev ntev ntawm Imbruvica monotherapy hauv thawj-kab CLL. Qhov dav thiab kev loj hlob ntawm nws cov ntaub ntawv txuas ntxiv nce ntxiv los pab txhawb cov txheej txheem kev saib xyuas no thiab nws cov txiaj ntsig ntawm kev vam meej tsis muaj kev vam meej thiab kev ciaj sia tag nrho Cov txiaj ntsig zoo ntawm qhov no.

Kev Tshawb Xyuas RESONATE-2 tau soj ntsuam 269 tus neeg mob CLL ≥65 xyoo uas tsis muaj 17p kev tshem tawm (del17p). Cov neeg mob no tau raug xaiv thiab txuas ntxiv kom tau txais kev kho mob Imbruvica kom txog thaum muaj mob ntxiv lossis tsis tuaj yeem siv tshuaj lom, lossis tau txais kev kho mob chlorambucil txog li 12 chav kawm

Thaum lub 7-xyoo rov qab ua tiav, Imbruvica monotherapy qhia pom tseeb PFS tau txais txiaj ntsig, txhim kho kab mob lossis txo kev pheej hmoo ntawm 90% (HR=0.160; 95% CI: 0.111-0.230). Nyob rau ntawm 6,5 xyoo, cov tshuaj nruab nrab PFS hauv Imbruvica kho pab pawg tseem tsis tau txog, 61% ntawm cov neeg mob tseem muaj sia thiab tsis muaj kabmob, thiab 9% hauv chlorambucil kho pawg. Cov txiaj ntsig PFS ntawm kev kho mob Imbruvica tau pom nyob hauv txhua pawg neeg, suav nrog cov phom sij ntawm cov xeeb ceem nrog TP53 hloov pauv, tsis siv neeg IGHV, lossis 11q tshem tawm (HR=0.091; 95% CI: 0.054-0.152).

Tsis tas li ntawd, nyob rau ntawm 6,5 xyoo, 78% ntawm cov neeg mob hauv pawg Imbruvica kho mob tseem muaj sia nyob. Sij hawm dhau los, qhov kev teb tiav (CR) ntawm Kev Siv Tshuaj Imbruvica tau nce mus txog 34%. Thaum lub sijhawm rov qab taug qab txog 7 xyoo, ze li ib nrab ntawm cov neeg mob tseem tau txais kev kho mob Imbruvica.

Imbruvica monotherapy zoo zam rau ntev, thiab tsis muaj lub cim tshiab txog kev nyab xeeb. Cov xwm txheej pheej tshwm sim ntawm qib 3 lossis tshaj saud cov kev mob tsis zoo tseem muaj qis: kev kub siab (lub sijhawm 5-6 xyoo: n=20; 6-7 xyoo: n=15) thiab atrial fibrillation (thaum 5-6 xyoo: n=7; lub sijhawm lub xyoo 6-7: n=5). Tsis tas li ntawd, tsis muaj ntshav tawm ntawm qeb 3 lossis siab dua tau tshwm sim thaum 5-7 xyoo. Hauv lub sijhawm 5-6 xyoo, txhua qib ntawm cov kev tsis zoo uas ua rau muaj kev cuam tshuam tau tshwm sim hauv 3% ntawm tus neeg mob (n=2); lub sijhawm 6-7 xyoo, tsis muaj ib tus neeg mob hauv Imbruvica kho pab pawg tau ntsib kev tu ncua los ntawm qhov xwm txheej tsis zoo.

Imbruvica(ibrutinib)yog lub ntiaj teb' s ua ntej pom zoo BTK inhibitor, sib koom tsim thiab ua lag luam los ntawm Johnson& Johnson' s Janssen Biotechnology Tuam Txhab thiab AbbVie' s Tsev Muag Khoom Imbruvica ua txoj haujlwm los tiv thaiv qog noj ntshav los ntawm kev thaiv BTK, uas yog qhov yuav tsum muaj mob qog nqaij hlav cancer loj hlob thiab metastasis. BTK yog lub teeb meem tseem ceeb tshaj tawm hauv B cell receptor signaling complex, thiab nws ua lub luag haujlwm tseem ceeb hauv kev muaj sia nyob thiab metastasis ntawm malignant B cell thiab lwm yam kab mob hnyav. Imbruvica tuaj yeem thaiv cov kev taw qhia uas daws cov kev tswj tsis tau thiab nthuav tawm ntawm cov hlwb B, pab tua thiab txo qis cov qog nqaij hlav cancer, thiab ncua kev mob qog nqaij hlav cancer. Hauv kev sim tshuaj, kev siv tshuaj ib leeg thiab kev sib txuas ua ke tau pom muaj zog muaj zog tiv thaiv ntau yam kev mob ntshav tawm.

Txij li nws tau pom zoo rau kev lag luam thaum lub Kaum Ib Hlis 2013, Imbruvica tau txais 11 US FDA pom zoo nyob rau hauv tag nrho ntawm 6 kab mob xws li 5 kab mob B-cell thiab mob qog nqaij hlav thiab tiv thaiv tus kab mob (cGVHD): nrog lossis tsis muaj 17p kev tshem tawm (Del17p ) mob qog mob ntshav qog ntshav ntshav (CLL), mob lymphocytic lymphoma me me (SLL) nrog lossis tsis muaj 17p ua kom loog hloov (del17p), Waldenstrom macroglobulinemia (WM), yav tas los kho tus mob mantle cell lymphoma Tumor (MCL), uas yuav tsum tau kho tus mob qog nqaij hlav lymphoma (MZL). thiab tau txais tsawg kawg ib qho tshuaj tiv thaiv CD20, thiab kev kho mob ntsig-ncua ntev-tiv thaiv tus kab mob (cGVHD) uas tau ua tsis tiav ib lossis ntau cov kev kho mob hauv lub cev.

Hauv Suav Teb, Imbruvica(ibrutinib)tau txais kev pom zoo thaum lub Yim Hli 2017 los ua kev kho kab mob rau kev kho mob ntawm: (1) Mob ntsws lymphocytic rau cov neeg mob / cov mob lymphocytic ntau dua cov neeg mob qog ntshav (CLL / SLL); (2) Mantle cell lymphoma (MCL) cov neeg mob uas tau txais tsawg kawg ib yam kev kho mob yav dhau los. Thaum Lub Kaum Ib Hlis 2018, Imbruvica tau pom zoo rau cov cim tshiab: (1) Raws li kev kho mob monotherapy, nws yog siv rau cov neeg mob nrog Waldenstrom' s macroglobulinemia (WM) uas tau txais tsawg kawg ib yam kev kho mob yav dhau los, lossis cov neeg mob uas tsis haum rau kev siv chemoimmunotherapy (2) Ua ke nrog rituximab rau kev kho mob ntawm WM cov neeg mob. Hauv kev sib tham txog kev tuav pov hwm kev kho mob 2018, Imbruvica tau nkag mus hauv cov ntawv kho mob cov ntawv kho mob los ntawm tus nqi pheej yig.

Tam sim no, AbbVie thiab Johnson& Johnson tau nce qib rau Imbruvica ua cov kabmob loj hlob rau kev kho mob. Raws li daim ntawv tshaj tawm txhua xyoo tso tawm los ntawm ob tog, Imbruvica' s thoob ntiaj teb kev muag khoom hauv 2020 tau txog 9.442 billion Asmeskas las. Qee cov kws tshuaj ntsuam kwv yees hais tias Imbruvica' s kev muag khoom yuav nce mus txog $ 11.9 nphom hauv 2025.