March 2024: I-Food and Drug Administration inikeze imvume yokuthi i-mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc. [manje eseyingxenye ye-AbbVie]) okufanele isetshenziswe ezigulini ezikhulile ezine-FRα positive, i-platinum-resistant epithelial ovarian, fallopian tube, noma umdlavuza oyinhloko we-peritoneal. Lokhu kugunyazwa kuqondene ngqo neziguli eziye zathola uhlobo olulodwa kuya kwezintathu zokwelashwa okuhleliwe kwangaphambilini. Ukuhlolwa okuthole imvume ye-FDA kusebenza njengesisekelo sokukhetha iziguli. I-Mirvetuximab soravtansine-gynx ngaphambilini yanikezwa imvume esheshisiwe kulesi sibonakaliso esithile.
The ukuphumelela kokwelashwa kwahlolwa Ocwaningweni 0416 (MIRASOL, NCT04209855), okwakuyisivivinyo esaqhutshwa ezikhungweni eziningi. Ukuhlolwa bekunelebula elivulekile, okusho ukuthi kokubili iziguli nabacwaningi babazi ukuthi yikuphi ukwelashwa okunikezwayo. Iphinde yalawulwa ngokusebenzayo, okusho ukuthi bekuneqembu lokuqhathanisa elithola ukwelashwa okuhlukile. Ukuhlolwa kwakungahleliwe, okusho ukuthi iziguli zabelwa emaqenjini okwelapha ngokungahleliwe. Ukuhlolwa kwakuhlanganisa iziguli ezingu-453 ezine-platinum-resistant epithelial ovarian, fallopian tube, noma umdlavuza oyinhloko we-peritoneal. Iziguli zavunyelwa ukuba zithole izifundo ezidlule ezintathu zokwelashwa kwesistimu. Ukuhlolwa kwakuhlanganisa iziguli ezinezimila ezine-FRα enhle, njengoba kuhlolwe i-VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Abahlanganyeli babelwa ngokungahleliwe ngesilinganiso esingu-1:1 ukuze bathole i-mirvetuximab soravtansine-gynx ngedosi engu-6 mg/kg (elungiswe ukuze kube nesisindo somzimba esifanele) njengokufakwa emthanjeni njalo emavikini angu-3, noma bathole ukwelashwa ngamakhemikhali okukhethwe umphenyi (paclitaxel). , i-pegylated liposomal doxorubicin, noma i-topotecan) kuze kube yilapho isifo sabo siba sibi kakhulu noma behlangabezana nokungamukeleki okuqhamuka uma udla imishanguzo. The imiphumela yesilingo ukuhlangabezana nombandela wokumaketha wangemva kokumaketha we-mirvetuximab soravtansine-gynx, njengoba kushiwo ukugunyazwa okusheshisiwe kwangaphambilini.
Izinyathelo eziyinhloko zokusebenza kwaba ukusinda kukonke (i-OS), ukusinda kwe-progression-free (PFS) njengoba kunqunywe umphenyi, kanye nezinga lokuphendula eliqinisekisiwe (ORR) ngokusho kokuhlola komseshi. Ukuhlolwa kwe-procession-free survival (PFS) kanye nezinga lokuphendula eliphelele (ORR) kwenziwe ngokuvumelana Nemibandela Yokuhlola Izimpendulo ku- Izimila eziqinile (RECIST), inguqulo 1.1. Ukusinda kukonke okumaphakathi (OS) kwakuyizinyanga eziyi-16.5 (isikhawu sokuzethemba esingu-95% [CI]: 14.5, 24.6) engalweni ye-mirvetuximab soravtansine-gynx kanye nezinyanga eziyi-12.7 (95% CI: 10.9, 14.4) engalweni ye-chemotherapy. Isilinganiso sengozi (HR) ye-OS sasingu-0.67 (95% CI: 0.50, 0.88) enenani lika-p elingu-0.0046. Ukusinda kwe-median progression-free survival (PFS) kwakuyizinyanga ezingu-5.6 (isikhawu sokuzethemba esingu-95% [CI]: 4.3, 5.9) nezinyanga ezingu-4.0 (95% CI: 2.9, 4.5) emaqenjini ahlukene okwelapha. Isilinganiso sengozi (HR) sasingu-0.65 (95% CI: 0.52, 0.81) enenani lika-p elingaphansi kuka-0.0001. Isilinganiso sokuphendula esiphelele (ORR) sasingu-42% (95% isikhawu sokuzithemba [CI]: 36, 49), futhi izinga lokuphendula leqembu lesibili lalingu-16% (95% CI: 12, 22) (p-value <0.0001 ).
Imiyalelo ihlanganisa isexwayiso esisebhokisini sokulimala kwamehlo, kanye nezixwayiso nezinyathelo zokuphepha ze-pneumonia, i-peripheral neuropathy, nokulimala kwe-embryo-fetal. Imiphumela emibi evame kakhulu (≥ 20%) kuhlanganise nemiphumela engavamile yaselabhorethri, kwaba ukuphakama aspartate aminotransferase, ukukhathala, ephakeme alanine aminotransferase, ukubona lufifi, isicanucanu, ephakeme alkaline phosphatase, isifo sohudo, ubuhlungu besisu, keratopathy, peripheral lymphocykeletal pain, i-peripheral lymphoma , amaplatelet ancishisiwe, i-magnesium encishisiwe, i-hemoglobin eyancipha, iso elomile, ukuqothulwa, ukunciphisa ama-leukocyte, ukuhlanza, ukunciphisa i-albhamuin, ukunciphisa ukudla, nokunciphisa ama-neutrophils.
Umthamo ophakanyisiwe we-mirvetuximab soravtansine-gynx ungu-6 mg/kg wesisindo somzimba esilungisiwe esinikezwa ngomthambo wokujova njalo emavikini ama-3 (umjikelezo wezinsuku ezingama-21) kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki.
