Agasti 2021: I-Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) ithole ukugunyazwa okusheshisiwe okuvela ku-Food and Drug Administration ezigulini ezikhulile ezinomdlavuza ophindaphindayo noma othuthukisiwe we-endometrial (dMMR), njengoba kunqunywa ukuhlolwa okugunyazwe i-FDA, eziqhubeke noma ngemva kohlobo lwangaphambili oluqukethe i-platinum.
Esivivinyweni se-GARNET (NCT02715284), ukuhlolwa kwe-multicenter, multicohort, ilebula evulekile ezigulini ezinamathumba aqinile athuthukile, ukusebenza kahle kwahlolwa kuye ngeqoqo (A1). Iziguli ezingama-71 ezinomdlavuza we-dMMR ophindelelayo noma othuthukisiwe we-endometrial owaqhubeka noma ngemva kokwelashwa okuqukethe iplatinamu zafakwa enanini elisebenzayo. Iziguli zanikezwa u-500 mg we-dostarlimab-gxly ngokufakwa emithanjeni njalo emavikini amathathu ngemithamo emine, bese kuba ngu-1,000 mg emithanjeni njalo emavikini ayisithupha.
Isilinganiso sokuphendula sisonke (ORR) kanye nobude besikhathi sokuphendula (DOR) kube yimiphumela eyinhloko yokusebenza ngempumelelo, njengoba kunqunywa isibuyekezo esizimele esiphuphuthekisiwe (i-BICR) ngokuvumelana ne-RECIST 1.1. I-ORR iqinisekisiwe ukuthi ingamaphesenti angu-42.3 (amaphesenti angu-95 CI: amaphesenti angu-30.6, amaphesenti angu-54.6). Izinga lokuphendula libe ngamaphesenti angu-12.7 ezimpendulo eziphelele kanye namaphesenti angu-29.6 ezimpendulo ezingaphelele. Ngamaphesenti angu-93.3 eziguli ezinezikhathi ezingaphansi kwezinyanga eziyisithupha, i-DOR emaphakathi ayizange ihlangane (ububanzi: 2.6 kuya ezinyangeni ze-22.4, okuqhubekayo ekuhlolweni kokugcina).
Kumaphesenti angu-34 abantu abathole i-dostarlimab-gxly, imiphumela emibi kakhulu yenzekile. I-Sepsis, ukulimala okukhulu kwezinso, ukutheleleka komgudu womchamo, ukungakhululeki kwesisu, kanye ne-pyrexia kwakuphakathi kwezimpendulo ezimbi kakhulu ezitholwa ngaphezu kwe-2% yeziguli. Ukukhathala/i-asthenia, isicanucanu, isifo sohudo, i-anemia, nokuqunjelwa kwakuyimiphumela engemihle evame kakhulu (20%). I-anemia kanye nama-transaminase aphakeme kwakuyizehlakalo ezimbi kakhulu zebanga lesi-3 noma lesi-4 (2%). I-pneumonia, i-colitis, i-hepatitis, i-endocrinopathies, kanye ne-nephritis yizo zonke izimpendulo ezimbi ezibangelwa amasosha omzimba ezingase zenzeke.
Ungahle uthande ukufunda: Ukwelapha umdlavuza eNdiya
I-Dostarlimab-gxly 500 mg njalo emavikini angu-3 umthamo kanye neshejuli enconyiwe (imithamo 1 kuye ku-4). Kusukela emasontweni amathathu emva komthamo we-4, umthamo ukhuphuka ube ngu-1,000 mg njalo emavikini ayisithupha kuze kube yilapho ukugula kuqhubeka noma ubuthi obungabekezeleleki. I-Dostarlimab-gxly kufanele ilethwe njengokufakwa emthanjeni kwemizuzu engama-30.
Inkomba: https://www.fda.gov/
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