Ngomhla wama-30 kuJuni, i-Avistone's ezimeleyo ye-MET inhibitor Vebreltinib yafumana imvume emiselweyo kwi-National Medical Products Administration (NMPA) yaseTshayina yokunyanga izigulane ezinomhlaza wemiphunga ongengoweseli encinci (NSCLC) oqhubele phambili okanye osasazekayo kwindawo ethile. Oku kubonisa uphawu lwesithathu oluvunyiweyo lweVebreltinib eTshayina kunye nonyango lokuqala lwe-single-agent oluvunyiweyo ngokukodwa kwizigulane ze-NSCLC ezivunyiweyo ze-MET.
Ukuvunywa kweVebreltinib eTshayina kwesi sibonakaliso sitsha—ukunyanga izigulane ezinomhlaza wamaphaphu ongengoweseli encinci (i-NSCLC) ophucukileyo okanye osasazekileyo obangela ukwanda kwe-MET—kwakusekelwe kwiziphumo ezilungileyo ezivela kwiQela lesi-2 kunye neQela lesi-3 lophando lwe-KUNPENG (NCT04258033).
Iqela lesi-2 libhalise ikakhulu izigulane ezazinyangwe ngaphambili ezine-NSCLC ephuculweyo ye-MET ezazingaphumelelanga kunyango oluqhelekileyo (kuquka ne-chemotherapy esekelwe kwi-platinum), ngelixa iqela lesi-3 libandakanya izigulane ezazingenalo unyango ezine-NSCLC ephuculweyo ye-MET ezazingavumi unyango lwe-chemotherapy.
Izigulane ezingama-86 ezine-NSCLC ephucukileyo okanye eguqukileyo zabhaliswa kuzo zombini ii-cohorts (33 kwiQela lesi-2 kunye nama-53 kwiQela lesi-3). Iziphumo zophando zibonise izinga lokuphendula elijolise kuko konke (ORR) elingama-48.8%, izinga lokulawula isifo (DCR) elingama-77.9%, ixesha eliphakathi lokuphendula (DoR) leenyanga ezili-12.1, ixesha eliphakathi lokusinda ngaphandle kokuqhubela phambili (PFS) leenyanga ezi-7.4, kunye nexesha eliphakathi lokusinda (OS) leenyanga ezili-13.9.
KwiQela lesi-2 (abaguli abangama-33 ababenyangwe ngaphambili), i-ORR yayiyi-48.5%, i-DCR yayiyi-78.8%, i-DoR ephakathi yayiyi-11.0 iinyanga, i-PFS ephakathi yayiyi-6.2 iinyanga, kwaye i-OS ephakathi yayiyi-11.7 iinyanga.
KwiQela lesi-3 (izigulane ezingama-53 ezingafumani nyango), i-ORR yayiyi-49.1%, i-DCR yayiyi-77.4%, i-DoR ephakathi yayiyi-12.1 iinyanga, i-PFS ephakathi yayiyi-8.3 iinyanga, kwaye i-OS ephakathi yayiyi-15.5 iinyanga.
Kwisifundo se-KUNPENG, izigulane ezingama-21 ezine-baseline brain metastases zahlolwa yi-Independent Review Committee (IRC). Phakathi kwezi, ezili-10 zifumene iimpendulo ezingaphelelanga eziqinisekisiweyo (PR), nto leyo ebangele i-ORR engama-47.6%, i-DCR engama-85.7%, kunye ne-median DoR engama-11.0. Ukongeza, i-median PFS kunye ne-OS beziziinyanga eziyi-8.3 kunye neenyanga ezili-14.7, ngokulandelelana.
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.
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Ixesha leposi: Julayi-08-2025