Kukadzi 2023: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) yakapihwa mvumo yeFDA yekurapa varwere vakura vane kusawirirana kwekugadzirisa dambudziko (dMMR) inodzokororwa kana yakakwira endometrial cancer iyo yakawedzera panguva kana mushure mekutanga-ine platinamu regimen mune chero marongero uye vasiri kugadzirira kuvhiyiwa kurapa kana radiation, sekutsanangurwa kwazvinoitwa ne FDA-yakatenderwa bvunzo.
Dostarlimab-gxly yakawana kukurumidza kubvumidzwa muna Kubvumbi 2021 kuvarwere vakuru vane dMMR yadzokororwa kana yakakwira endometrial cancer iyo yakawedzera panguva kana mushure mekutanga kurapa-ine platinamu, sekutsanangurwa kwebvunzo yakatenderwa neFDA.
GARNET (NCT02715284), multicenter, multicohort, yakavhurika-label kuyedza inoitwa muvarwere vane mamota akasimba, yakaongororwa kushanda kwemvumo yakajairwa. Boka revarwere zana nemakumi mana nevaviri vane dMMR inodzokororwa kana yepamberi endometrial cancer vaive vafambira mberi panguva kana mushure mekugamuchira kurapwa-ine platinamu vakagadzira huwandu hwekuita. Varwere vakanga vachangobva kugamuchira mishonga yekudzivirira zvirwere zve autoimmune disorders kana avo vakambogamuchira PD-141/PD-LI-blocking antibodies kana mamwe immune checkpoint inhibitors havana kubatanidzwa.
Yese mhinduro mwero (ORR) uye nguva yekupindura (DOR), sezvakatsanangurwa neyakapofumadzwa yakazvimirira yepakati wongororo maererano neRECIST v1.1, ndiyo yaive yakakosha mhedzisiro matanho. Verified ORR yaiva 45.4% (95% CI: 37.0, 54.0), ne15.6% yevakapindura vachipindura zvizere uye 29.8% vachipindura zvishoma. Ne 85.9% yevarwere vane nguva pasi pemwedzi ye12 uye 54.7% vane nguva yakareba kupfuura mwedzi ye24 (range: 1.2+, 52.8+), DOR yepakati haina kusangana.
Izvo zvinowanzoitika zvakashata (20%) zvaive asthenia / kuneta, kupererwa neropa, kuputika, kusvotwa, manyoka, uye kurutsa. Pneumonitis, colitis, hepatitis, endocrinopathies, nephritis nekutadza kushanda kwetsvo, uye kushata kweganda mienzaniso yekusagadzikana kwe immune-mediated kunogona kuitika.
Dozi 1 kusvika ku4 yedostarlimab-gxly inofanirwa kupihwa pachiyero uye chirongwa che500 mg masvondo matatu ega ega. Nhamba inotevera ndeye 1,000 mg masvondo ose e6 kutanga mavhiki e3 mushure memushonga 4, ichienderera mberi kusvikira chirwere ichi chichiwedzera kana pane kukuvadza kusingagoneki. Dostarlimab-gxly inofanirwa kupihwa intravenously mukati mekufamba kwemaminetsi makumi matatu.
Wona ruzivo rwakazara rwekurayira Jemperli.
