Novemba 2022: Ezigulini ezikhulile ezike zaba nemithi yokwelashwa ehleliwe eyodwa kuya kwezintathu futhi ezine-folate receptor alpha (FR) positive, i-epithelial ovarian engamelana ne-platinum, ishubhu le-fallopian, noma umdlavuza we-peritoneal oyinhloko, i-Food and Drug Administration inikeze imvume esheshayo ku-mirvetuximab soravtansine- i-gynx (Elahere, ImmunoGen, Inc.). I-microtubule inhibitor kanye ne-folate receptor alpha antibody eqondiswe kuhlanganiswe ku-mirvetuximab soravtansine-gynx. Ukuhlolwa okugunyazwe yi-FDA kusetshenziselwa ukunquma ukuthi yiziphi iziguli ezizothola ukwelashwa.
I-VENTANA FOLR1 (FOLR-2.1) RxDx Assay (Ventana Medical Systems, Inc.) isanda kunikezwa imvume ye-FDA njengethuluzi lokuxilonga elingumngane lenkomba eshiwo ngenhla.
I-Study 0417 (NCT04296890), uhlolo lwengalo eyodwa olubandakanya iziguli ezingu-106 ezine-FR-positive, i-platinum-resistant epithelial ovarian, fallopian tube, noma umdlavuza oyinhloko we-peritoneal, kuhlolwe ukusebenza ngempumelelo kokwelashwa. Kuze kube yimigqa emithathu eyandulele yokwelashwa kwe-systemic evunyelwe ezigulini. I-Bevacizumab yayiyisidingo sazo zonke iziguli. Iziguli izimila zazo ezihlolwe ukuthi zine-positive ye-FR expression zisebenzisa i-assay eshiwo ngenhla zifakiwe ocwaningweni. Iziguli zazingafaneleki uma zinesifo samaphaphu esingatheleleki, iBanga > 1 i-peripheral neuropathy, izinkinga ze-cornea, noma izifo zamehlo ezidinga ukunakekelwa okuqhubekayo.
Iziguli zithole ukujova ngomthambo i-mirvetuximab soravtansine-gynx 6 mg/kg (ngokusekelwe esisindweni esilungile esilungisiwe) njalo emavikini amathathu kuze kube yilapho isimo sazo sithuthuka noma imiphumela emibi ingabekezeleleki. Njalo emavikini ayisithupha emasontweni okuqala angama-36, bese kuthi njalo emavikini ayi-12 ngemva kwalokho, kuhlolwe impendulo yesimila.
Isilinganiso sokuphendula sisonke (ORR) kanye nobude besikhathi sokuphendula (DOR) njengoba kunqunywe umphenyi futhi kukalwa ngokuvumelana nenguqulo ye-RECIST 1.1 kwakuyizilinganiso zomphumela eziyinhloko zokusebenza ngempumelelo. I-ORR eqinisekisiwe yayingu-31.7% (95% CI: 22.9, 41.6) kanti i-DOR emaphakathi yayiyizinyanga ezingu-6.9 (95% CI: 5.6, 9.7) kusampula esilinganisiwe sokuphumelela kweziguli ezazine-platinum ukumelana, ukugula okungalinganiswa futhi zithole okungenani eyodwa. umthamo (iziguli eziyi-104).
Ukuphazamiseka kokubona, ukukhathala, ukwanda kwe-aspartate aminotransferase, isicanucanu, ukwanda kwe-alanine aminotransferase, keratopathy, ubuhlungu besisu, ukuncipha kwama-lymphocyte, i-peripheral neuropathy, isifo sohudo, ukwehla kwe-albumin, ukuqunjelwa, ukwanda kwe-alkaline phosphatase, iso elomile, ukuncipha kwe-magnesium, ukuncipha kwe-leukocytes, ukuncipha kwe-leukocytes. ukwehla kwe-hemoglobin kwakuyizimo ezingezinhle ezivame kakhulu (20%), okuhlanganisa nokungajwayelekile kwaselabhorethri. Kunesexwayiso esisebhokisini sobuthi bamehlo kulebula yomkhiqizo.
Umthamo ophakanyisiwe we-mirvetuximab soravtansine-gynx ungu-6 mg/kg wesisindo somzimba esihle esilungisiwe (AIBW), unikezwa ngomthambo kanye njalo ezinsukwini ezingama-21 (umjikelezo) kuze kube yilapho isifo siqhubeka noma ubuthi obungabekezeleleki.
Buka imininingwane egcwele ye-Elahere.
