AstraZeneca / Mersk's Lynparza (olaparib) Nyiv tau txais 3 qhov kev pom zoo: mob qog qe menyuam, mob qog ntshav, thiab mob qog ntshav!

AstraZeneca thiab Merck& Co tau tshaj tawm tsis ntev los no tias Lynparza (olaparib), lub hom phiaj tshuaj anticancer, tau pom zoo hauv Nyij Pooj rau kev kho mob ntawm peb hom mob qog nqaij hlav siab tshaj: zes qe menyuam, mob qog nqaij hlav cancer, thiab mob qog nqaij hlav cancer.

Cov kev taw qhia tshwj xeeb yog: (1) Lynparza ua ke nrog bevacizumab, raws li thawj txoj kab kev saib xyuas kev kho mob, siv rau kev kho mob homologous recombination kho mob (HRD)-kev ua kom zoo tshaj ntawm zes qe menyuam mob qog neeg laus uas tau txais kev kho mob ua ntej. (2) Lynparza yog siv los kho cov mob castration-resistant prostate cancer (mCRPC) cov neeg mob uas muaj cov kabmob metastases thiab cov BRCA noob hloov pauv (BRCAm). (3) Lynparza yog siv los ua thawj kab kev tu xyuas los kho cov neeg mob uas tsis muaj kev tiv thaiv BRCAm mob qog nqaij hlav mob qog nqaij hlav uas tsis tuaj yeem tau txais tom qab tau txais kev kho mob thawj zaug.

Nws tsim nyog teev tias Lynparza yog thawj zaug thiab tsuas yog PARP inhibitor pom zoo los kho mCRPC thiab mob qog nqaij hlav hauv Nyij Pooj. Qhov 3 qhia tau pom zoo rau lub sijhawm no yog ua raws cov qhabnias ntawm kev kawm 3 ntawm PAOLA-1, PROfound thiab POLO. Cov txiaj ntsig ntawm txoj kev tshawb nrhiav no tau tshaj tawm nyob rau hauv New England Journal of Medicine (NEJM).

—— Cov mob qog nqaij hlav zes qe menyuam, raws li biomarker pawg neeg (n=387) tshuaj xyuas cov ntaub ntawv ntawm cov neeg mob HRD-cov qog nqaij hlav zoo nyob rau theem 3 PAOLA-1: hauv cov neeg mob HRD-zoo siab ntawm zes qe menyuam mob qog nqaij hlav, bevacizumab zoo li ib leeg. tus neeg sawv cev Piv nrog kev kho mob, Lynparza ua ke nrog kev kho kev kho mob bevacizumab txo qis kev pheej hmoo ntawm tus kab mob kev tuag lossis tuag los ntawm 67% (HR=0.33 [95% CI: 0.25-0.45]), thiab ua rau muaj kev vam meej ncua ntev-tsis muaj txoj sia nyob (piv txwv li PFS: 37.2) Lub hlis vs 17.7 lub hlis).

-Qhov kev qhia txog kabmob kheesxaws, raws li pawg neeg tshuaj ntsuam xyuas tau los ntawm Theem 3 PROfound sim: Hauv cov neeg mob BRCA1 / 2 hloov pauv hauv mCRPC, tus qauv kev saib xyuas tshuaj Xtandi (enzalutamide, enzalutamide) lossis Zytiga (abiraterone acetate, abirate Long), Lynparza ho txhim kho hluav taws xob hloov zuj zus-tsis muaj sia nyob (nruab nrab rPFS: 9.8 lub hlis vs 3.0 lub hlis) thiab tag nrho cov muaj sia nyob (nruab nrab OS: 20.1 lub hlis vs 14.4 lub hlis), kev mob tus kab mob lossis kev pheej hmoo tuag tau txo qis los ntawm 78% (HR=0.22, p< 0.0001),="" thiab="" kev="" pheej="" hmoo="" tuag="" tau="" txo="" los="" ntawm="" 37%="" (hr="">

-Pancreatic cancer qhia, raws li cov txiaj ntsig ntawm Theem 3 POLO kev sim: piv nrog cov placebo, Lynparza, ua thawj kab kev kho mob, ze li ntawm ob zaug kev vam meej-tsis muaj sia nyob ntawm cov neeg mob BRCAm metastatic pancreatic cancer (nruab nrab PFS: 7.4 Hlis) vs. 3.8 lub hlis), qhov pheej hmoo ntawm tus kab mob zuj zus lossis kev tuag tau txo qis txog 47%.

Lynparza yog thawj-ntawm-zoo, qhov ncauj poly-ADP ribose polymerase (PARP) inhibitor uas tuaj yeem ua kom zoo dua ntawm qhov tsis xws luag hauv lub qog DNA ua kev puas tsuaj kho (DDR) txoj hauv kev mus rau qhov tshwj xeeb tua cov qog nqaij hlav cancer. Qhov kev ua no muab Lynparza kev kho mob rau DNA kev puas tsuaj kho tsis xws li Lub luag haujlwm rau ntau hom qog ntshav.

Lynparza yog lub ntiaj teb' s thawj PARP inhibitor thiab tau pom zoo thawj zaug los ntawm Asmeskas FDA rau lub Kaum Ob Hlis 2014. Txog tam sim no, Lynparza tau pom zoo rau 7 kev kho mob, ntawm cov uas muaj 4 ntawm zes qe menyuam thiab 2 yog thawj zaug kev kho mob rau mob zes qe menyuam. Tshwj xeeb: (1) Kev kho thib ib-kab kev kho mob rau cov neeg laus uas muaj BRCAm siab mob zes qe menyuam; (2) Kev saib xyuas thawj zaug kev kho mob rau cov neeg laus uas muaj HRD-kev paub zoo ntawm zes qe menyuam mob ua ke nrog bevacizumab; (3) Kho kev kho mob rau cov neeg laus uas muaj mob hlav zes qe menyuam; (4) Cov neeg mob loj hauv cov neeg muaj mob gBRCAm qog ntawm zes qe menyuam; (5) Kev kho mob gBRCAm, HER2-tsis zoo (HER2-) cov neeg laus uas muaj mob cancer mis; (6) Kho thawj zaug kab kev kho rau cov neeg laus nrog gBRCAm metastatic pancreatic cancer; (7) Kev kho mob ntawm mCRPC nrog cov kev hloov kho tshwj xeeb ntawm tus neeg mob.