Bayer Nubeqa (darolutamide) Phase 3 kev soj ntsuam kuaj: Ntxiv lub sijhawm ntawm kev phais thawj zaug cuam tshuam txog kev mob qog nqaij hlav prostate!---1/2

Bayer tsis ntev los no tshaj tawm ntawm 116th American Urological Association (AUA) Lub Rooj Sib Tham Txhua Xyoo thaum kawg ntawm 2021 qhov kev ntsuam xyuas tom qab ntawm tus tshiab prostate cancer tshuaj Nubeqa (darolutamide) Theem 3 ARAMIS mus sib hais: cov ntaub ntawv ntxiv dag zog rau Nubeqa' s non-metastatic castration Ib qho kev kho mob profile ntawm cov neeg mob uas muaj resistant prostate cancer (nmCRPC).

Nubqa (darolutamide) tau tsim los ntawm Bayer hauv kev koom tes nrog Finnish kws tshuaj Orion thiab tau txais kev pom zoo hauv Tebchaws Meskas, European Union thiab ntau lub tebchaws rau kev kho cov txiv neej cov neeg mob nrog nmCRPC. Cov tshuaj yog ib qho tshuaj uas tsis yog-steroidal androgen receptor (AR) inhibitor nrog cov qauv tshuaj tshwj xeeb uas khi rau cov receptor nrog kev sib raug zoo siab thiab nthuav tawm muaj zog antagonistic ua haujlwm, yog li inhibiting kev ua haujlwm ntawm receptor thiab kev loj hlob ntawm prostate cancer hlwb. Tsis zoo li lwm cov kev kho mob nmCRPC uas twb muaj lawm, Nubeqa tsis hla cov hlab ntshav-hlwb, yog li muaj tsawg dua cov tshuaj sib cuam tshuam thiab cov kev mob tshwm sim hauv nruab nrab (xws li qaug dab peg, ntog, thiab kev paub tsis meej).

Kev tshuaj xyuas tau nthuav tawm hauv lub rooj sib tham pom tias piv nrog androgen deprivation therapy (ADT), Nubeqa+ADT ncua sij hawm mus rau kev phais thawj zaug cuam tshuam txog kev mob qog noj ntshav prostate, uas yog qhov kawg ntawm kev tshawb nrhiav (4.7% vs 9.6%; HR=0.416; 95% CI: 0.279-0.620).

Hauv kev ntsuam xyuas tom qab kev tshwm sim: Piv nrog ADT, Nubeqa+ADT ncua lub neej zoo hauv 2 ntawm 6 subscales ntawm European Cancer Research and Treatment Center Quality Life Questionnaire (EORTC-QLQ-PR25) (QoL) Sijhawm ua rau mob hnyav: Cov tsos mob tso zis (25.8 lub hlis vs 14.8 lub hlis; HR=0.64; 95% CI: 0.54-0.76) thiab cov tsos mob plab (18.4 lub hlis vs 11.5 lub hlis; HR=0.78; 95% CI: 0.66-0.92).

Nyob rau hauv qhov kev ntsuam xyuas tseem ceeb ntawm Theem 3 ARAMIS mus sib hais, qhov tshwm sim tsis zoo uas tshwm sim hauv ≥1% ntawm cov neeg mob kho nrog Nubeqa (darolutamide) suav nrog: tso zis, mob ntsws, thiab hematuria.

Neal Shore, Tus Thawj Saib Xyuas Kev Kho Mob ntawm CPI ntawm Carolina Urological Analysis Center, tau hais tias:" Cov cim hauv zos ntawm prostate thiab cov ntaub so ntswg ib puag ncig muaj kev phom sij heev rau tus neeg mob' lub neej zoo. Nyob rau hauv thawj nmCRPC kev kho mob kev sib tham ntawm tus neeg mob thiab tus kws kho mob, qhov tshwm sim ntawm tej yam tshwm sim thiab qhov kev phais invasive yog ib qho tseem ceeb. Lub neej zoo thiab cov txiaj ntsig ntawm kev phais phais txhawb nqa Nubeqa' tus nqi hauv nmCRPC."

ARAMIS yog ib qho randomized, multicenter, ob-dig muag, placebo-tswj theem III sim uas tau tso npe rau 1509 nmCRPC txiv neej cov neeg mob uas tau txais androgen deprivation therapy (ADT) thiab muaj qhov tshwm sim ntawm cov kab mob metastatic. pheej hmoo. Txoj kev tshawb no tau ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm qhov ncauj Nubeqa thiab placebo. Hauv txoj kev tshawb no, cov neeg mob tau muab tso rau ntawm qhov sib piv 2: 1 thiab tau txais 600 mg ntawm Nubeqa (darolutamide) lossis placebo hais lus ob zaug hauv ib hnub, thaum tau txais ADT. Cov neeg mob uas muaj keeb kwm ntawm qaug dab peg raug tso cai koom nrog kev kho mob hauv txoj kev tshawb no.