Febhuwari 2023: I-Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) inikezwe imvume ye-FDA yokwelapha iziguli ezikhulile ezinomdlavuza ophindaphindayo noma othuthukile we-endometrial oye wathuthuka phakathi noma ngemva kohlobo lwangaphambilini oluqukethe i-platinum kunoma isiphi isimo futhi ezingezona ukhetho lokuhlinzwa okwelapha noma ngemisebe, njengoba kunqunywa Ukuhlolwa okugunyazwe yi-FDA.
I-Dostarlimab-gxly ithole ukugunyazwa okusheshisiwe ngo-Ephreli 2021 ezigulini ezikhulile ezinomdlavuza we-dMMR ophindelelayo noma othuthukile we-endometrial oqhubeke ngesikhathi noma ngemva kokwelashwa okuqukethe i-platinum, njengoba kunqunywa ukuhlolwa okugunyazwe yi-FDA.
I-GARNET (NCT02715284), ukuhlolwa kwe-multicenter, multicohort, ilebula evulekile okwenziwa ezigulini ezinamathumba aqinile athuthukile, kuhlolwe ukusebenza kahle ukuze kugunyazwe okujwayelekile. Iqembu leziguli eziyi-141 ezinomdlavuza we-dMMR ophindelelayo noma othuthukile we-endometrial ezazithuthuke ngesikhathi noma ngemva kokuthola ukwelashwa okune-platinum lenza inani labantu abaphumelelayo. Iziguli ezazisanda kuthola imithi ye-systemic immunosuppressant yokuphazamiseka kwe-autoimmune noma ezazithole ngaphambilini amasosha omzimba e-PD-1/PD-LI-blocking noma amanye ama-immune checkpoint inhibitors azifakwanga.
Isilinganiso sokuphendula sisonke (ORR) kanye nobude besikhathi sokuphendula (DOR), njengoba kunqunywe isibuyekezo esizimele esiphuphuthekile ngokuvumelana ne-RECIST v1.1, bekuyizinyathelo ezibalulekile zemiphumela yokusebenza ngempumelelo. I-ORR eqinisekisiwe ibingu-45.4% (95% CI: 37.0, 54.0), kanti u-15.6% wabaphenduli baphendule ngokugcwele bese u-29.8% bephendula kancane. Njengoba u-85.9% weziguli ezinezikhathi ezingaphansi kwezinyanga eziyi-12 kanye nama-54.7% anesikhathi esingaphezu kwezinyanga ezingama-24 (ububanzi: 1.2+, 52.8+), i-DOR emaphakathi ayizange ihlangatshezwe.
Imiphumela emibi evame kakhulu (20%) kwakuyi-asthenia/ukukhathala, i-anemia, ukuqubuka, isicanucanu, isifo sohudo, nokuhlanza. I-pneumonia, i-colitis, isifo sokusha kwesibindi, i-endocrinopathies, i-nephritis enokuhluleka kwezinso, kanye nokusabela okungekuhle kwesikhumba kuyizibonelo zokusabela okubi okubangelwa amasosha omzimba okungenzeka.
Imithamo engu-1 kuye ku-4 ye-dostarlimab-gxly kufanele inikezwe ngethamo kanye nohlelo lwama-500 mg njalo emavikini amathathu. Umthamo olandelayo ngu-1,000 mg njalo emavikini angu-6 aqala amaviki angu-3 ngemva komthamo we-4, uqhubeke kuze kube yilapho isifo siqhubeka noma kukhona ukulimala okungenakubekezelelwa. I-Dostarlimab-gxly kufanele inikezwe ngomthambo phakathi nemizuzu engama-30.
Buka imininingwane egcwele ye-Jemperli.
