Qhov Ncauj GnRH Receptor Antagonist Prostate Cancer Theem III Nrog Kev Ntsuam Xyuas Zoo Ntxiv

Tsis ntev los no, Myovant Sciences tau tshaj tawm cov txiaj ntsig ntxiv ntawm ib zaug-txhua hnub qhov ncauj tshuaj relugolix hauv kev kho mob qib siab prostate cancer theem III HERO kawm (NCT 03085095). Cov ntaub ntawv no txuas ntxiv qhov kev tshawb pom thaum ntxov ntawm HERO txoj kev tshawb nrhiav thiab paub meej tias relugolix qhia tau zoo dua ntawm ntau qhov kawg piv rau leuprolide acetate thiab muaj kev pheej hmoo tsawg dua ntawm qhov tshwm sim mob plawv loj (MACE). Cov txiaj ntsig tau qhia txog qhov ncauj ntawm ASCO hauv 2020 thiab luam tawm ib txhij hauv New England Journal of Medicine (NEJM).

HERO yog randomized, qhib-daim ntawv lo, cov pab pawg sib law liag, ntau lub teb chaws theem III kawm tsim los ntsuas kev nyab xeeb thiab ua haujlwm ntawm relugolix hauv cov txiv neej cov neeg mob androgen-nkag siab txog kev mob qog nqaij hlav cancer uas xav tau tsawg kawg ib xyoos ntawm kev kho mob androgen deprivation txuas ntxiv (ADT ) Poj niam txiv neej. Hauv txoj kev tshawb nrhiav, cov neeg mob tau muab faib rau hauv 2: 1 piv txwv, tau txais ib qhov ncauj qhov ntau ntawm 360 mg thauj ntawm relugolix, tom qab ntawv noj tshuaj ib hnub ntawm {{6} } mg, lossis tau txais leuprolide acetate kev ncua kev kawm (ib zaug hauv lub Peb Hlis). Cov.

Cov txiaj ntsig tau pom tias relugolix tau mus txog lub ntsiab lus kawg thiab pom qhov zoo dua rau leuprolide acetate ntawm 6 qhov tseem ceeb kawg kev ua kom tiav. Hauv qhov tshuaj xyuas qhov kawg ntawm qhov kev ntsuam xyuas, 96. 7% ntawm cov neeg mob hauv cov pab pawg relugolix tau ua tiav cov tshuaj testosterone tiv thaiv ntawm qib kev tawm tsam (GG lt; 50 ng / dL) thaum {{4 }} lub lis piam ntawm kev kho mob, piv nrog rau 88. 8% hauv leuprolide acetate pawg.

Cov ntaub ntawv ntxaws ntxig ntxaws ntxig cov ntaub ntawv tso tawm lub sijhawm no tau qhia tias muaj qhov sib txawv ntawm qhov kev tshem tawm sai sai thiab sib sib zog nqus ntawm testosterone, PSA teb, thiab testosterone rov qab los tom qab kho tau nres. Qhov feem ntawm cov neeg mob uas tau nce mus txog qib kev faib tawm ntawm kev sib tw ntawm hnub 4 ntawm kev kho mob hauv pawg Relugolix yog {{1}}. 0% thiab nce mus rau 98. {{{{ 13}}}}% nyob rau 15 hnub. Cov pab pawg leuprolide acetate muaj 0.0% nyob rau hnub 4 hnub thiab 12 hnub. 1% nyob rau hnub 15 hnub. Tsis tas li ntawd, {{{{13 {}}}} {{2 4}}. 4% ntawm cov txiv neej nyob hauv pawg relugolix tau txais kev sib zog testosterone sib zog txaus hauv qab no {{1 4}} ng / dL ntawm hnub 15, piv nrog rau 1 .0% nyob hauv pawg leuprolide acetate. Qhov feem pua ​​siab dua ntawm cov neeg mob hauv cov pab pawg Relugolix tau txais PSA teb rau hnub 15 (PSA qib kev txo qis> 50%) thiab tau lees paub rau hnub 29 ({{{{13 }}}} 9. 9. 4% vs 1 9.. {{2 4}}%). Tom qab 90 hnub ntawm kev tsis ua tiav ntawm kev kho, 5 4% ntawm cov neeg mob hauv cov pab pawg rov qab tau ua tiav cov testosterone theem ({2 {{2 4}} 0ng / dL) thiab ib qho testosterone nruab nrab theem 2 {{2 4}} {{2 4}. {{13)} ng / dL. Qhov feem ntawm leuprolide acetate pawg tsuas yog 3% thiab qhov nruab nrab testosterone yog 5 {{2 4}}. 6 %. Lwm qhov tseem ceeb kawg qhov kawg ntawm txoj kev tshawb no yog lub sijhawm tiv thaiv kev tawm tsam, thiab cov txiaj ntsig tau cia siab nyob rau lub quarter thib peb ntawm lub xyoo no.

Hauv kev hais txog kev nyab xeeb, kev pheej hmoo ntawm MACE hauv kev thim rov qab pab pawg tau raug txo los ntawm 54% (2. {{{2}}% vs 6. {{1} }%; HR=0. 46; {{2}} 5% CI: 0. 2 4-088).

Ntxiv rau, ntawm cov neeg mob uas muaj keeb kwm ntawm MACE, qhov kev pheej hmoo ntawm MACE nyob rau hauv pawg relugolix tau txo los ntawm 80% (3. 6% vs 17. { {4}}%). Hauv HERO txoj kev tshawb nrhiav, ntau dua li 90% ntawm cov neeg mob tau muaj tsawg kawg yog ib qho kev pheej hmoo mob plawv, suav nrog kev txaus ntshai ntawm kev ua neej xws li kev haus luam yeeb thiab kev rog, comorbidities xws li ntshav qab zib thiab kub siab, thiab yav dhau los ntawm MACE.

Raws li tau hais ua ntej, qhov tshwm sim ntawm qhov tsis zoo nyob rau hauv HERO txoj kev tshawb fawb tau sib piv ntawm cov pab pawg relugolix thiab cov pab pawg leuprolide acetate (92. 9% vs 9 3. 5 %). Cov xwm txheej uas nquag pom tshwm sim tsawg kawg ntawm 10% ntawm cov txiv neej hauv pawg relugolix yog kub kub, nkees, cem quav, mob plab me me mus rau mob raws plab, thiab mob tej pob txha.

Hauv cov neeg mob uas muaj mob qog nqaij hlav prostate, txo qis testosterone ntau dua sai thiab rov qab testosterone ntau dua sai sai tom qab txiav kev kho yog qhov tseem ceeb, uas tuaj yeem ua kom lub neej zoo dua ntawm cov neeg mob. Ob qho kev tshawb pom yuav muaj lub txiaj ntsig zoo rau kev kho mob ntawm cov neeg mob uas muaj kev mob qog nqaij hlav prostate. Ntxiv rau, kab mob plawv yog qhov ua rau ploj tuag hauv cov neeg mob uas muaj mob qog nqaij hlav cancer. Piv nrog rau cov tshuaj GnRH agonist siv tshuaj, kev kho qhov ncauj muaj qhov muaj zog thiab tseem yuav txo cov kev mob plawv, uas yuav yog qhov tseem ceeb rau cov txiv neej mob ntshav siab prostate.

Raws li cov txiaj ntsig saum toj no, relugolix muaj lub peev xwm los ua qhov kev xaiv tseem ceeb tshiab rau kev kho mob txiv neej muaj mob qog nqaij hlav cancer prostate, thiab yuav rov txiav txim siab saib xyuas cov neeg mob. Lub Plaub Hlis xyoo no, Myovant xa Daim Ntawv Thov Tshuaj Yeeb Tshuaj Tshiab (NDA) rau Asmeskas FDA. Yog tias tau txais kev pom zoo, relugolix yuav yog thawj qhov ncauj gonadotropin-tso cov tshuaj hormone (GnRH) receptor antagonist tshuaj siv los kho cov neeg mob uas muaj mob qog nqaij hlav cancer.

Tam sim no, Myovant tab tom tab tom txhim kho relugolix ua ib ntsiav tshuaj rau kev kho mob qog nqaij hlav qog nqaij hlav (120 mg txhua hnub), thiab tseem tab tom tsim cov tshuaj tiv thaiv kab mob sib xyaw ua ke (relugolix 40 mg / estradiol 1 .0 mg / norethisterone Acetate 0. 5 mg), Siv los kho kev mob uterine fibroids thiab mob qog nqaij hlav endometrial. Lub hli tas los, lub tuam txhab tau tshaj tawm cov txiaj ntsig zoo ntawm thawj theem III kev tshawb fawb ntawm tus kab mob endometriosis, thiab lwm txoj kev kawm qib III vam tias yuav tshaj tawm tom qab lub hlis no.