Nofeembar 2022: Bukaannada qaangaarka ah ee lahaa hal ilaa saddex hab daaweyn oo hore oo leh folate receptor alpha (FR) togan, ugxan-sidaha epithelial ee platinum u adkaysta, tuubada fallopian, ama kansarka mindhicirka aasaasiga ah, Maamulka Cuntada iyo Dawooyinka ayaa siisay oggolaan degdeg ah mirvetuximab soravtansine- gynx (Elahere, ImmunoGen, Inc.). Xakameeyaha microtubule iyo folate receptor alpha-direct antibody ayaa lagu daray mirvetuximab soravtansine-gynx. Tijaabo ay ogolaatay FDA ayaa loo isticmaalaa si loo go'aamiyo bukaanada heli doona daaweynta.
VENTANA FOLR1 (FOLR-2.1) RxDx Assay (Ventana Medical Systems, Inc.) ayaa kaliya la siiyay oggolaanshaha FDA oo ah qalab ogaanshaha saaxiibka ah ee tilmaanta aan soo sheegnay.
Daraasada 0417 (NCT04296890), tijaabo hal gacan ah oo ay ku lug leeyihiin 106 bukaan oo qaba FR-positive, platinum u adkaysta epithelial ugxansidaha, tuubada ugxan-sidaha, ama kansarka mindhicirka hoose, ayaa qiimeeyay waxtarka daaweynta. Ilaa saddex xariiq oo hore oo daawaynta habaysan ayaa loo oggolaaday bukaanka. Bevacizumab waxay ahayd baahi loo qabo dhammaan bukaannada. Bukaannada burooyinkooda ay tijaabiyeen togan ee muujinta FR iyagoo isticmaalaya qiimeynta aan soo sheegnay ayaa lagu soo daray daraasadda. Bukaan-socodka waa laga saaray haddii ay qabaan cudurka sambabada interstitial interstitial, Fasalka>1 neuropathy peripheral neuropathy, dhibaatooyinka lafaha, ama jirrooyinka indhaha ee u baahan daryeel joogto ah.
Bukaan-socodka ayaa helay faleebo xididka ah oo ah mirvetuximab soravtansine-gynx 6 mg/kg (oo ku salaysan miisaanka jidhka oo la hagaajiyay) saddexdii toddobaadba mar ilaa ay xaaladdoodu ka sii korodho ama waxyeellooyinku noqdeen kuwo aan loo dulqaadan karin. Lixdii toddobaadba 36-kii toddobaad ee ugu horreeyay, ka dibna 12-kii toddobaadba ka dib, qiimaynta jawaabta burada ayaa la sameeyay.
Heerka jawaabta guud (ORR) iyo muddada jawaabta (DOR) sida uu go'aamiyay baaruhu oo lagu cabbiray si waafaqsan nooca RECIST 1.1 ayaa ahaa cabbirada natiijada waxtarka aasaasiga ah. ORR-ga la xaqiijiyay wuxuu ahaa 31.7% (95% CI: 22.9, 41.6) iyo dhexdhexaadka DOR wuxuu ahaa 6.9 bilood (95% CI: 5.6, 9.7) ee muunadda la qiimeeyo waxtarka leh ee bukaannada qaba platina u adkaysta, jirro la qiyaasi karo oo helay ugu yaraan hal. qiyaasta (104 bukaan).
Aragga oo daciifa, daal, aminotransferase aspartate oo kordhay, lallabbo, alanine aminotransferase oo kordhay, keratopathy, calool xanuun, lymphocytes oo yaraaday, neuropathy peripheral, shuban, albumin oo yaraada, calool-istaagga, fosfatase alkaline kordhay, isha qalalan, magnesium hoos u dhacay, hoos u leukocytes, hoos u nutrophils, Hemoglobin-ka hoos u dhacay ayaa ah kuwa ugu badan (20%) dareen-celinta xun, oo ay ku jiraan cilladaha shaybaarka. Waxaa jira digniin sanduuq ah oo ku saabsan sunta indhaha oo ku taal calaamadda alaabta.
Qiyaasta la soo jeediyay ee mirvetuximab soravtansine-gynx waa 6 mg/kg oo la hagaajiyay miisaanka jidhka ku habboon (AIBW), oo xididka la siiyo hal mar 21 maalmood (wareeg) ilaa cudurku ka sii socdo ama sunta aan loo dulqaadan karin.
Eeg xogta buuxda ee Elahere.
