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

Tsis ntev los no, Myovant Science tau tshaj tawm cov txiaj ntsig ntxiv ntawm ib zaug-txhua hnub qhov ncauj tshuaj relugolix hauv kev kho mob ntawm qib siab prostate cancer theem III HERO kawm (NCT03085095). 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 tshaj tawm cov lus hais ntawm ASCO hauv 2020 thiab luam tawm tib lub sijhawm 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 rau 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 androgen deprivation txuas ntxiv (ADT ) Poj niam txiv neej. Hauv txoj kev tshawb nrhiav, cov neeg mob tau muab faib rau 2: 1 piv, tau txais ib zaug ntawm qhov ncauj ntawm 360 mg thauj ntawm relugolix, tom qab ntawd noj tshuaj txhua hnub ntawm 120 mg, lossis tau txais leuprolide acetate ncua kev kawm ntawv (ib zaug hauv lub Peb Hlis). Cov.

Cov txiaj ntsig tau pom tias relugolix tau mus txog rau qhov chaw pib thiab pom qhov zoo dua rau leuprolide acetate ntawm 6 qhov tseem ceeb theem ob kawg. Hauv qhov tshuaj ntsuam teb lub sijhawm kawg teb, 96.7% ntawm cov neeg mob hauv cov pab pawg relugolix tau ua tiav kev tiv thaiv qib testosterone ntawm kev tiv thaiv qib (GG lt; 50ng / dL) thaum 48 lub lim tiam ntawm kev kho mob, piv nrog 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 rau hnub 4 ntawm kev kho mob hauv pab pawg Relugolix yog 56.0% thiab nce ntxiv rau 98.7% rau hnub 15. Cov leuprolide acetate pawg muaj 0.0% nyob rau hnub 4 thiab 12.1% rau hnub 15. Ntxiv rau, 78.4% ntawm cov txiv neej hauv cov pab pawg relugolix ua tiav kev sib sib zog nqus tshuaj testosterone qis dua 20 ng / dL hnub 15, piv nrog 1.0% hauv leuprolide acetate pawg. Qhov feem pua ​​ntau dua ntawm cov neeg mob hauv pab pawg Relugolix tau txais PSA teb rau hnub 15 (PSA qib txo> 50%) thiab tau lees tias hnub 29 (79.4% vs 19.8%). Tom qab 90 hnub ntawm kev tsis ua tiav ntawm kev kho, 54% ntawm cov neeg mob hauv pawg pab pawg tau ua tiav testosterone qib (testosterone280ng / dL) thiab qhov nruab nrab testosterone theem ntawm 288.4ng / dL. Qhov feem ntawm leuprolide acetate pawg tsuas yog 3% thiab qhov nruab nrab testosterone nce yog 58.6%. 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.

Hais txog kev nyab xeeb, kev pheej hmoo ntawm MACE hauv kev thim rov qab pab pawg tau txo los ntawm 54% (2.9% vs 6.2%; HR=0.46; 95% CI: 0.24-088).

Ntxiv rau, ntawm cov neeg mob uas muaj keeb kwm ntawm MACE, qhov kev pheej hmoo ntawm MACE nyob rau hauv pawg thim rov qab tau raug txo los ntawm 80% (3.6% vs 17.8%). Hauv HERO txoj kev tshawb nrhiav, ntau dua 90% ntawm cov neeg mob muaj tsawg kawg yog ib qho kev pheej hmoo ntawm cov hlab 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 ntshav siab, thiab keeb kwm yav dhau los ntawm MACE.

Raws li tau hais dhau los, qhov tshwm sim ntawm qhov tshwm sim tsis zoo hauv HERO txoj kev tshawb nrhiav tau sib piv ntawm pawg relugolix thiab pawg leuprolide acetate (92.9% vs 93.5%). Cov xwm txheej uas nquag pom tshwm sim tsawg kawg 10% ntawm cov txiv neej hauv pawg relugolix yog kub kub, nkees, cem quav, mob me me mus rau mob raws plab, thiab mob sib koom tes.

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 cov tshuaj GnRH agonist siv tshuaj, kev kho lub qhov ncauj muaj qhov muaj zog thiab tseem txo kev pheej hmoo ntawm cov kab mob plawv, uas yuav yog qhov tseem ceeb rau cov txiv neej cov txiv neej muaj mob qog nqaij hlav cancer.

Raws li cov ntsiab lus 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 prostate, thiab yuav rov txiav txim siab saib xyuas cov neeg mob. Thaum Lub Plaub Hlis Ntuj xyoo no, Myovant xa Daim Ntawv Thov 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 (relugolix 40 mg / estradiol 1.0 mg / norethisterone acetate 0.5 mg), Siv los kho tshuaj uterine. fibroids thiab endometrial cancer. 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.