Johnson&Johnson tso Erlead (apalutamide) + Zytiga (abiraterone acetate) + prednisone triple program saib xyuas daim ntawv thov!

Johnson& Johnson (JNJ)' s Janssen Pharmaceuticals tau tshaj tawm tsis ntev los no tias nws yuav tsis nrhiav kev tswj hwm kev siv raws li Phase 3 ACIS txoj kev kawm. Txoj kev tshawb nrhiav tau ua rau cov neeg mob nrog metastatic castration-tiv thaiv prostate cancer (mCRPC) uas yav dhau los tsis tau txais kev siv tshuaj kho mob (kev kho mob-mob hlwb) thiab tau txais androgen deprivation txoj kev kho (ADT), thiab tau soj ntsuam Erleada (npe lub npe: apalutamide) nrog Zytiga (Lub npe nquag: abiraterone acetate) thiab prednisone (prednisone) ua tau zoo thiab kev nyab xeeb.

Cov ntaub ntawv tso tawm ntawm American Society of Clinical Oncology Symposium ntawm Urogenital Cancer (ASCO-GU 2021) thaum Lub Ob Hlis 2021 pom tias qhov kev tshawb fawb tau mus txog qhov kawg: piv nrog cov placebo + Zytiga + prednisone kho pab pawg ( tswj pab pawg) Hauv Erleada + Zytiga + prednisone kho pab pawg (pawg sib koom ua ke), kev kho mob radiological-tsis muaj txoj sia nyob (rPFS) tau zoo dua, thiab kev pheej hmoo ntawm radiological zuj zus lossis kev tuag tau txo los ntawm 31% Cov. Txawm li cas los xij, piv nrog pab pawg tswj hwm, cov pab pawg sib xyaw ua ke tsis pom muaj txiaj ntsig tseem ceeb ntawm cov kev ua tiav theem ob, suav nrog tag nrho cov kev ua neej nyob (OS)

Dr. Kiran Patel, tus lwm thawj kws saib xyuas kev txhim kho rau cov qog ua pob ntawm Janssen Kev Tshawb Fawb thiab Kev Txhim Kho, hais tias: "Cov kev nyab xeeb ntawm ACIS txoj kev tshawb fawb tau zoo ib yam li yav dhau los Erleada, Zytiga + cov kev tshawb fawb ua ntej, thiab tsis muaj lub cim qhia txog kev nyab xeeb tshiab. pom. Txoj kev tshawb no kuj sim PAM50. Pab pawg neeg mob ntawm cov neeg mob cais raws li hom tawv nqaij thiab pawg neeg mob ntawm cov neeg mob nruab nrab lossis siab qog androgen receptor kev ua si (cov yam ntxwv ntawm kev paub txog kev xav ntawm cov tshuaj hormones) tau tsim cov txiaj ntsig kev tshawb fawb thiab kev pom, uas tsim nyog mus kawm ntxiv. Cov ntaub ntawv no Nws yuav muaj cov ntsiab lus tseem ceeb tseem ceeb rau peb cov dej num yav tom ntej, vim peb cia siab tias yuav tsim peb cov kev coj noj coj ua thiab kev mob siab coj kev hloov kho rau cov neeg mob mob qog nqaij hlav cancer."

ACIS yog kev ua kom muaj kev sib tw, ob qhov muag tsis pom kev, tshuaj placebo-tswj theem 3 kev tshawb fawb hauv 982 cov neeg mob tau txais ADT thiab kev kho mob-kev siv tshuaj mCRPC cov neeg mob. Hauv txoj kev tshawb no, cov neeg mob no tau raug xaiv los txais Erleada + Zytiga + prednisone regimen (pawg sib xyaw) lossis cov placebo + Zytiga + prednisone regimen (pawg tswj hwm). Lub hauv paus pib ntawm txoj kev tshawb no yog radiological qhov kev vam meej-tsis muaj sia nyob (rPFS), thiab cov theem ob kawg suav nrog tag nrho kev muaj sia nyob (OS), lub sijhawm pib opioids ntev, lub sijhawm pib cytotoxic kev kho mob, thiab lub sijhawm mob mob.

Kev ntsuam xyuas kev ua tau zoo ua ntej tshaj tawm ntawm ASCO-GU 2021 lub rooj sib tham qhia pom tias piv nrog pab pawg tswj hwm, qhov nruab nrab rPFS ntawm pab pawg sib xyaw tau txuas ntxiv 6 lub hlis (22.6 vs 16.6 lub hlis; HR=0.69 [95% CI: 0.58-0.83] ; p< 0.0001).="" lub="" hr="" rau="" radiological="" kev="" nce="" qib="" lossis="" kev="" tuag="" ntsuam="" xyuas="" los="" ntawm="" qhov="" muag="" tsis="" pom="" kev="" sab="" nraud="" nruab="" nrab="" (bicr)="" yog="" 0.="" 864="" [95%="" ci:="" 0.718–1.040].="" raws="" li="" kev="" soj="" ntsuam="" tshiab="" tshaj="" plaws="" nrog="" kev="" soj="" ntsuam="" nruab="" nrab="" ntawm="" 54.8="" lub="" hlis,="" piv="" nrog="" pab="" pawg="" tswj="" hwm,="" qhov="" kev="" pheej="" hmoo="" ntawm="" radiological="" nce="" lossis="" tuag="" hauv="" pawg="" sib="" koom="" ua="" ke="" tau="" txo="" los="" ntawm="" 30%="" (nruab="" nrab="" rpfs:="" 24="" hlis="" vs="" 16.6="" lub="" hlis;="" hr="0.70" [95%="" ci:="" 0.60-0.83]).="" hais="" txog="" kev="" ua="" tiav="" theem="" ob="" (suav="" tag="" nrho="" kev="" ciaj="" sia="" [os],="" lub="" sijhawm="" pib="" cytotoxic="" kev="" kho="" mob,="" lub="" sijhawm="" pib="" siv="" tshuaj="" opioids="" mus="" ntev,="" thiab="" lub="" sijhawm="" ua="" rau="" mob="" mob),="" tsis="" muaj="" qhov="" sib="" txawv="" ntawm="" cov="" pawg="" sib="" xyaw="" thiab="" pawg="" tswj="" hwm.="">

ACIS cov neeg kawm tag nrho yog cov kev hloov pauv ntawm androgen receptor (AR) tsis kam thiab cov cim rhiab. Cov ntaub ntawv los ntawm kev soj ntsuam ua ntej qhia tau tias cov neeg mob visceral metastasis, kev kuaj PAM50 ntawm lumen hom, thiab AR kev ua haujlwm ntawm qhov nruab nrab lossis siab (cov yam ntxwv ntawm cov tshuaj tiv thaiv kev hnov ​​mob) yuav yog los ntawm Erleada + Zytiga + preny Cov txiaj ntsig kev kho mob ntawm kev sib xyaw ua ke ntawm cov ntoo thuv muaj raws li pom los ntawm cov txiaj ntsig ntawm rPFS thiab OS hauv cov pawg neeg mob ntawm cov neeg mob.

Kev nyab xeeb kev tsom xam yog ua tau nrog Erleada' kev tshawb fawb yav dhau los, thiab tsis muaj lub cim qhia txog kev nyab xeeb tshiab. 63.3% ntawm cov pawg ua ke thiab 56.2% ntawm pawg tswj tau muaj cov xwm txheej tsis zoo (TEAEs) uas tau tshwm sim rau qib kev kho mob 3/4. Qeb 3/4 TEAE uas tshwm sim ntau dua nyob rau hauv pawg sib koom ua ke thiab pawg tswj hwm suav nrog kev qaug zog (4.7% vs 3.9%), kub siab (20.6% vs 12.5%), ntog (3.3% vs 0.6%), thiab pob (4.5%) vs. 0.4%), mob plawv (9% vs 5.7%), pob txha lov thiab pob txha tawg (4.1% vs 1.4%), thiab qaug dab peg (0.2% vs 0%). Raws li kev tshuaj ntsuam txog kab mob qog nqaij hlav cancer-kev ntsuam xyuas prostate (FACT-P Total), lub neej muaj txiaj ntsig zoo ntawm cov pab pawg ua ke thiab pawg kho mob sib piv.

Zytiga (abiraterone acetate) yog ib qho tshuaj noj hauv qhov ncauj uas tau hloov pauv mus ua abiraterone hauv lub cev, uas yog androgen biosynthesis inhibitor uas txwv CYP17-mediated androgen ntau lawm hauv testis, cov qog adrenal thiab cov qog nqaij hlav prostate. Androgens tuaj yeem txhawb kev loj hlob ntawm cov hlwb qog nqaij hlav prostate. Zytiga tau pom zoo los ntawm Asmeskas FDA rau lub Plaub Hlis 2011 thiab European Commission (EC) thaum Lub Cuaj Hli 2011, ua ke nrog prednisone rau kev kho mob ntawm cov neeg mob nrog metastatic castration-resistant prostate cancer (mCRPC). Ib qho ntxiv, Zytiga tau pom zoo los ntawm EC thaum lub Kaum Ib Hlis 2017 thiab FDA thaum Lub Ob Hlis 2018 rau kev kho mob ntawm cov neeg mob uas muaj kev phom sij ua rau mob ua rau mob prostate-sensitive prostate cancer (mCSPC). Txij li nws tau pom zoo ua ntej xyoo 2011, cov tshuaj tau pom zoo hauv ntau dua 100 lub teb chaws thoob ntiaj teb, thiab ntau dua 500,000 tus neeg mob tau kho nrog Zytiga thoob ntiaj teb.

Hauv Suav teb, Zytiga (abiraterone acetate) tau pom zoo rau xyoo 2015 thiab 2018, thiab siv los ua ke nrog prednisone lossis prednisolone los kho: (1) metastatic castration-resistant prostate cancer (mCRPC); (2) Kev Tshuaj Ntsuam tshiab uas muaj kev pheej hmoo siab metastatic endocrine kev kho-rwj prostate cancer (mHSPC), suav nrog tsis tau txais cov tshuaj endocrine lossis tau txais kev kho mob rau endocrine ntau kawg yog 3 lub hlis.

Erleada (apalutamide) yog lub cim tshiab ntawm androgen receptor (AR) cov tshuaj tiv thaiv kab mob uas tuaj yeem pab thaiv kev ua haujlwm ntawm cov txiv neej cov tshuaj hormones (xws li cov tshuaj hormones testosterone) thiab ncua kev loj hlob ntawm tus kab mob. Hauv Tebchaws Meskas, Erleada tau pom zoo thawj zaug pom zoo los ntawm FDA rau lub Ob Hlis 2018 rau kev kho mob rau cov neeg mob laus uas tsis muaj kev tiv thaiv mob ua rau mob qog nqaij hlav cancer (nmCRPC) ntawm kev pheej hmoo siab ntawm metastasis. Qhov kev pom zoo no ua rau Erleada ntiaj teb' s thawj cov tshuaj rau kev kho mob ntawm nmCRPC. Thaum lub Cuaj Hlis 2019, FDA tau pom zoo tshiab rau Erleada rau kev kho mob ntawm cov neeg mob nrog metastatic castration-sensitive prostate cancer (mCSPC).

Hauv Suav Teb, Erleada (apalutamide) tau txais kev pom zoo sai sai rau lub Cuaj Hlis 2019 rau kev kho mob ntawm qhov tsis-metastatic castration-resistant prostate cancer (nmCRPC) cov neeg mob laus uas muaj qhov mob siab, thiab tau txais kev pom zoo rau kev kho kab mob thaum lub Yim Hli 2020 nrog endocrine kev kho-rhiab tus mob prostate (mHSPC). Nws tsim nyog teev tias ob qhov ntsuas no tau pom zoo kev soj ntsuam kev muaj peev xwm ua ntej.