Erleada (apalutamide): Kev txo qis sai, sib sib zog nqus thiab kav ntev ntawm Prostate Specific Antigen (PSA)--1/2

Janssen Pharmaceuticals, ib lub koom haum ntawm Johnson& Johnson (JNJ), tsis ntev los no tau tshaj tawm cov ntaub ntawv tshiab ntawm 2021 American Urological Association Online Lub Rooj Sib Tham Txhua Xyoo (AUA2021), qhia tias: nyob rau hauv qhov chaw kho mob hauv ntiaj teb tiag tiag, qhov tsis yog-metastatic castration tsis kam ntawm Erleada (apalutamide) Kev kho mob Cov neeg mob qog nqaij hlav qog nqaij hlav (nmCRPC) tau pom tias muaj zog prostate-specific antigen (PSA) cov lus teb thiab kev ua raws li kev noj tshuaj ntau. Ib qho lus teb PSA muaj zog kuj tau pom nyob rau hauv ib qho kev soj ntsuam tom qab sib cais. Cov kev soj ntsuam tau pom tias muaj kev sib raug zoo ntawm cov lus teb sai thiab sib sib zog nqus PSA thiab ntev kev ciaj sia nyob rau hauv metastatic castration-sensitive prostate cancer (mCSPC) thiab nmCRPC. Kev sib txheeb. Kev soj ntsuam tom qab tuag kuj tseem txhawb nqa PSA raws li kev kwv yees biomarker rau kev kho mob ntawm cov neeg mob qog noj ntshav siab.

Erleada yog ib tiam tshiab ntawm androgen receptor (AR) inhibitors uas tuaj yeem pab thaiv kev ua haujlwm ntawm cov txiv neej cov tshuaj hormones (xws li testosterone hormone) thiab ncua kev loj hlob ntawm tus kab mob. Hais txog kev mob qog noj ntshav prostate, Erleada tau pom zoo rau 2 qhov kev qhia: kev kho mob ntawm non-metastatic castration-resistant prostate cancer (nmCRPC) thiab metastatic castration-sensitive prostate cancer (mCSPC). Ob qhov kev qhia no tau pom zoo hauv Suav teb.

Nyob rau ntawm lub rooj sib tham no, kev soj ntsuam tom qab ntawm Phase 3 TITAN txoj kev tshawb fawb thiab kev tshawb fawb SPARTAN tau tshuaj xyuas PSA kinetics ntawm 2259 cov neeg mob nrog mCSPC (TITAN txoj kev tshawb fawb) lossis nmCRPC (SPARTAN txoj kev tshawb fawb). Cov txiaj ntsig tau pom tias hauv cov neeg mob uas muaj mob qog noj ntshav siab kho mob nrog Erleada + androgen deprivation therapy (ADT), txawm tias mCSPC lossis nmCRPC, hauv 3 lub hlis tom qab pib kho Erleada, PSA poob sai, tob, thiab kav ntev, thiab tau siv sijhawm ntau tshaj ib xyoos.

Hauv mCSPC (TITAN txoj kev tshawb fawb), piv nrog cov neeg mob kho nrog ADT ib leeg, hauv cov neeg mob kho nrog Erleada+ADT ua ke kev kho mob, PSA qib qis dua ≥50% lossis ≥90% lossis PSA (< 0.2ng="" ml)="" yog="" undetectable="" qhov="" feem="" ntawm="" cov="" neeg="" mob="" yog="" kwv="" yees="" li="" peb="" zaug="" ntau="" dua.="" hauv="" nmcrpc="" (spartan="" txoj="" kev="" tshawb="" fawb),="" raws="" li="" qhov="" xav="" tau,="" cov="" neeg="" mob="" kho="" nrog="" adt="" ib="" leeg="" tsis="" pom="" qhov="" txo="" qis="" hauv="" psa,="" tab="" sis="" kev="" kho="" mob="" nrog="" erleada+adt="" pom="" qhov="" txo="" qis="" hauv="" psa,="" suav="" nrog="" feem="" ntau="" ntawm="" cov="" neeg="" mob="" uas="" tsis="" tuaj="" yeem="" kuaj="" pom="" psa.="" qib.="" zoo="" ib="" yam="" li="" titan="" kev="" tshawb="">

Hauv ob txoj kev tshawb fawb no, cov neeg mob uas tau ua tiav qhov PSA poob qis (txhais tias yog PSA qib poob ntawm ≥90% los ntawm cov hauv paus los yog PSA qib ntawm ≤0.2ng / mL) kuj tau pom tias PSA poob sai (ob qho tib si ntawm ob txoj kev tshawb fawb tau<3 hli);="" kev="" poob="" qis="" dua="" thiab="" tob="" dua="" psa="" cuam="" tshuam="" nrog="" kev="" muaj="" sia="" nyob="" ntev="" dua.="" tsis="" tas="" li="" ntawd,="" hauv="" cov="" neeg="" mob="" kho="" nrog="" erleada+adt,="" lub="" sijhawm="" nruab="" nrab="" ntawm="" psa="" poob="" qis="" (1.9="" lub="" hlis="" hauv="" titan="" txoj="" kev="" tshawb="" fawb="" thiab="" 2.8="" lub="" hlis="" hauv="" spartan="" txoj="" kev="" tshawb="" fawb)="" tau="" tshwm="" sim="" sai="" dua="" li="" lwm="" cov="" kev="" kho="" mob="" yav="" dhau="" los="" tau="" tshaj="">

Dr. Tracy McGowan, MD, Tus Thawj Saib Xyuas Kev Kho Mob Prostate Cancer, Janssen US Department of Medical Affairs, tau hais tias: “Cov kws kho mob urologist thiab oncologist sai sai pom cov cim qhia tias cov neeg mob tau txais txiaj ntsig los ntawm kev kho mob, lawv muaj peev xwm muab kev saib xyuas zoo tshaj plaws. Ib yam li qhov kev xav tom qab. Raws li kev soj ntsuam daim ntawv qhia, PSA yog ib qho tseem ceeb ntawm kev kwv yees ntxov ntawm cov neeg mob mCSPC lossis nmCRPC, thiab kev kho Erleada tau txhim kho qhov tob thiab ceev ntawm PSA poob."

Hauv tsab ntawv tshaj tawm cais (Cov Lus Qhia #PD05-08), Asmeskas kev tshawb fawb ntiaj teb tiag tiag ntawm 193 nmCRPC cov neeg mob uas tau txais Erleada+ADT kev kho mob rau qhov nruab nrab ntawm ib xyoos pom tau tias cov neeg mob feem ntau pom tau tias muaj kev ua raws li kev kho mob siab. Hauv cov pab pawg dub thiab tsis yog dub, ntau dua 90% ntawm cov neeg mob pheej mus kho (90.1% thiab 94.5%, feem).