Nubeqa (darolutamide) Phase 3 kev kho mob ua tiav: Ua kom muaj sia nyob tag nrho (OS)!

Bayer tsis ntev los no tshaj tawm tias Theem 3 ARASENS sim ntsuas qhov ncauj tom ntej - tiam androgen receptor inhibitor (ARi) Nubeqa (darolutamide) rau kev kho mob ntawm metastatic hormone - rhiab prostate cancer (mHSPC) tau mus txog nws lub ntsiab kawg.

Qhov no yog randomized, multicenter, muab ob npaug rau - dig muag theem 3 mus sib hais nrog rau yav tom ntej tsim los soj ntsuam kev ua tau zoo thiab kev nyab xeeb ntawm Nubeqa ua ke nrog docetaxel thiab androgen deprivation therapy (ADT) hauv kev kho mob ntawm mHSPC cov neeg mob.

Cov txiaj ntsig tau pom tias piv nrog cov qauv kev saib xyuas kev noj qab haus huv docetaxel + ADT, Nubeqa + docetaxel + ADT ua rau lub sijhawm muaj sia nyob tag nrho (OS). Hais txog kev nyab xeeb, tag nrho cov xwm txheej ntawm cov xwm txheej tsis zoo tau tshaj tawm ntawm cov pab pawg kho mob zoo sib xws.

Cov ntsiab lus ntxaws ntxaws ntawm txoj kev tshawb fawb yuav raug tshaj tawm ntawm lub rooj sib tham kho mob yav tom ntej. Bayer npaj los tham txog cov ntaub ntawv los ntawm ARASENS mus sib hais nrog cov koom haum tswj hwm thoob ntiaj teb thiab xa Nubeqa' daim ntawv thov kev lag luam rau mHSPC indications.

Dr. Scott Z. Fields, Senior Vice President thiab Head of Oncology Development, Bayer Pharmaceuticals, tau hais tias: "Rau cov neeg mob mHSPC, tseem xav tau cov kev kho tshiab tshiab los txhim kho cov txiaj ntsig kev kho mob. Cov kev tsim yav tom ntej ntawm ARASENS kev sim tsom mus kawm Nubeqa thiab docetaxel. thiab seb qhov kev sib xyaw ua ke ntawm ADT tuaj yeem txhim kho tag nrho kev ciaj sia ntawm cov neeg mob mHSPC.Peb zoo siab tshwj xeeb rau cov neeg mob thiab cov kws tshawb fawb tau koom nrog qhov kev sim no tseem ceeb, thiab tos ntsoov yuav tshaj tawm tag nrho cov txiaj ntsig ntawm lub rooj sib tham tom ntej."

darolutamidemolecular qauv

Thoob plaws ntiaj teb, mob qog noj ntshav prostate yog tus mob qog nqaij hlav thib ob thiab thib tsib feem ntau ua rau tuag los ntawm cov txiv neej. Nws feem ntau cuam tshuam rau cov txiv neej hnub nyoog tshaj 50 xyoo, thiab qhov kev pheej hmoo yuav nce ntxiv nrog rau hnub nyoog. Xyoo 2020, kwv yees li 1.4 lab tus txiv neej thoob ntiaj teb yuav raug kuaj mob qog noj ntshav thiab kwv yees li 375,000 yuav tuag. Thaum lub sijhawm kuaj mob, cov txiv neej feem ntau muaj mob qog noj ntshav hauv zos, uas txhais tau hais tias lawv cov qog nqaij hlav tsuas yog rau cov qog nqaij hlav prostate thiab tuaj yeem kho nrog kev phais lossis kev kho hluav taws xob. Thaum qhov rov tshwm sim yog metastasized lossis kis tau, androgen deprivation therapy (ADT) yog cov kev kho mob yooj yim rau kev kho mob ntawm cov tshuaj no - rhiab kab mob.

Kwv yees li 5% ntawm cov txiv neej muaj mob qog noj ntshav prostate nrog cov metastases nyob deb ntawm thawj qhov kev kuaj mob. Cov txiv neej cov neeg mob uas muaj cov tshuaj metastatic hormone - rhiab prostate cancer (mHSPC) yuav pib kho cov tshuaj hormones, xws li ADT, androgen receptor inhibitor (ARi) + ADT, docetaxel + ADT, thiab lwm yam. Txawm hais tias hom kev kho mob no, feem ntau cov txiv neej cov neeg mob nrog mHSPC yuav kawg. castration - resistant prostate cancer (CRPC), ib tug kab mob uas muaj lub sij hawm ciaj sia tsawg.

Nubeqa tau tsim los ntawm Bayer hauv kev koom tes nrog Finnish kws tshuaj Orion thiab tau pom zoo nyob rau hauv ntau lub khw thoob ntiaj teb, suav nrog Tebchaws Meskas, European Union, Tuam Tshoj, thiab Nyij Pooj, rau kev kho cov txiv neej cov neeg mob uas tsis yog - metastatic castration - resistant prostate cancer (nmCRPC). Nubeqa muab kev kho mob tseem ceeb rau cov txiv neej cov neeg mob nrog nmCRPC uas tuaj yeem ua kom ntev metastasis - dawb ciaj sia (MFS) thiab tag nrho cov ciaj sia taus (OS). Nws muaj qhov zoo ntev - lub sij hawm kev nyab xeeb thiab pab cov neeg mob tau txais kev kho mob txuas ntxiv thiab ua tiav cov hom phiaj.

Nubeqa yog ib tiam tshiab ntawm qhov ncauj tsis yog - steroidal androgen receptor (AR) inhibitors. Nws muaj cov qauv tshuaj tshwj xeeb uas khi rau cov receptor nrog kev sib raug zoo siab thiab nthuav tawm cov haujlwm muaj zog antagonistic, yog li inhibiting receptor function thiab prostate cancer cell loj hlob. Loj hlob. Tsis zoo li lwm cov kev kho mob nmCRPC uas twb muaj lawm, Nubeqa tsis hla cov ntshav - lub paj hlwb teeb meem, yog li muaj kev cuam tshuam cov tshuaj tsawg dua thiab cov kev mob tshwm sim hauv nruab nrab ntawm lub paj hlwb (xws li qaug dab peg, ntog, thiab kev paub tsis meej).

Tam sim no, Bayer thiab Orion tseem tab tom tsim Nubeqa los kho mHSPC. Ntxiv rau qhov kev sim ARASENS, lwm theem 3 mus sib hais (ARANOTE) ntsuas qhov Nubeqa + ADT kev tswj hwm hauv kev kho mob ntawm mHSPC txuas ntxiv mus.