Ngomhla wesi-8 kweyoMqungu ngo-2025, i-9MW2821 yanikwa iBreakthrough Therapy Designation (BTD) yiZiko loVavanyo lwaMayeza (CDE) le-National Medical Products Administration (NMPA) eTshayina. I-9MW2821 inikwa kunye ne-toripalimab, i-antibody ye-monoclonal anti-PD-1, yonyango olungenakususwa, oluphambili okanye olusasazekayo lwe-urothelial carcinoma (la/mUC).
Malunga ne-9MW2821
I-9MW2821 yi-ADC yokuqala entsha ejoliswe kwindawo ethile edityanisiweyo neNectin-4 eyenziwe nguMabwell esebenzisa iqonga le-ADC kunye neqonga lokufumanisa ii-antibody molecular discovery elizenzekelayo, kwaye liyeza lokuqala ukungena kuphando lwezonyango phakathi kwe-ADCs ezijolise kwiNectin-4 eziphuhliswe ziinkampani zaseTshayina, kunye neyeza lokuqala lonyango elijolise kwiNectin-4 kwihlabathi liphela ukutyhila idatha yokusebenza kakuhle kwezonyango zomhlaza wesibeleko, umhlaza wesibeleko kunye nomhlaza webele. I-9MW2821 inikwe iFast Track Designation (FTD) yonyango lwe-advanced, recurrent, okanye metastatic esophageal squamous cell carcinoma ngoFebruwari 2024, kwaye ikwanikwe i-Orphan Drug Designation (ODD) kunye ne-FTD yonyango lomhlaza wesibeleko kunye nomhlaza wesibeleko ophindaphindayo okanye ophindaphindayo oqhubekekayo okanye emva konyango lwangaphambili nge-chemotherapy regimen esekwe kwiplatinum ngoMeyi 2024.
Iziphumo zophando lweklinikhi lwesigaba soku-1/sesibini olusebenzisa i-9MW2821 kwiithumba ezininzi eziqinileyo eziphucukileyo zixelwe kwiNtlanganiso yoNyaka ye-American Society of Clinical Oncology (ASCO) ka-2024.
Ukusukela nge-1 ka-Epreli, 2024, phakathi kwezigulane ezingama-240 kwiqela ledosi ye-1.25 mg/kg kuvavanyo lweklinikhi lweSigaba sesiBini:
Umhlaza we-Urothelial (UC)
Kwizigulane ezingama-37 ezivavanyiweyo ukuze kuhlolwe ukusebenza kakuhle, izinga lokuphendula ngendlela echanekileyo (ORR) kunye nezinga lokulawula isifo (DCR) zaziyi-62.2% kunye ne-91.9%, ngokulandelelana, kunye nokusinda okuphakathi okungenankqubela phambili (mPFS) yayiziinyanga eziyi-8.8 kwaye ukusinda okuphakathi (mOS) yayiziinyanga ezili-14.2.
Umhlaza woMlomo (CC)
Kwizigulane ezingama-53 ezivavanyiweyo ukuze kuhlolwe ukusebenza kakuhle, ama-51% aye anyangwa ngaphambili nge-platinum-based doublet chemotherapy kunye ne-bevacizumab, kwaye ama-58% afumene i-platinum-based doublet chemotherapy kunye ne-immune checkpoint inhibitor, kunye ne-ORR kunye ne-DCR zaziyi-35.8% kunye ne-81.1%, ngokulandelelana. I-mPFS yayiziinyanga eziyi-3.9, kwaye i-mOS ayifikelelwanga. Kwizigulane ezine-Nectin-4 tumor cell staining intensity 3+, i-ORR yayiyi-43.6% phakathi kwezigulane ezingama-39 ezivavanyiweyo.
Umhlaza womqala (EC)
Kwizigulane ezingama-39 ezivavanyiweyo ukuze zivavanywe ngempumelelo, i-ORR kunye ne-DCR zaziyi-23.1% kunye ne-69.2%, ngokulandelelana, kunye ne-mPFS yeenyanga ezi-3.9 kunye ne-mOS yeenyanga ezi-8.2; ezingama-37 kuzo zanyangwa nge-chemotherapy esekelwe kwi-platinum kunye ne-immunotherapy ngaphambili.
Umhlaza Webele Ongenazo Iintlobo Ezintathu (TNBC)
Kwizigulane ezingama-20 ezinomhlaza webele ophucukileyo okanye osasazekayo kwaye zivavanywa ukuze kuhlolwe ukusebenza kakuhle, i-ORR kunye ne-DCR zaziyi-50.0% kunye ne-80.0% ngokulandelelana. I-mPFS yayiziinyanga ezi-5.9, kwaye i-mOS yayingekafikelelwa, isigulane esinye sifumene impendulo epheleleyo (CR) kwaye besikwi-CR kangangeenyanga ezingama-20 kwaye okwangoku siqinisekisiwe ukuba sikwi-CR.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
Email：myimmnet@163.com
Iireferensi
1. https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.UMabwell – Hlola Ubomi, Zuza Impilo
Ixesha leposi: Jan-15-2025