Ngomhlaka-30 Juni, i-Avistone's inhibitor ye-MET ethuthukiswe ngokuzimela i-Vebreltinib yathola imvume enemibandela evela ku-National Medical Products Administration (NMPA) yaseShayina yokwelapha iziguli ezinomdlavuza wamaphaphu ongeyona encane (i-NSCLC) othuthuke endaweni noma osakazeke endaweni ethile one-MET amplification. Lokhu kuphawula isibonakaliso sesithathu esivunyelwe se-Vebreltinib eShayina kanye nokwelashwa kokuqala komhlaba okune-single-agent okuvunyelwe ngqo iziguli ze-NSCLC ezi-MET amplified.
Ukuvunyelwa kwe-Vebreltinib eShayina kwalesi sibonakaliso esisha—ukwelapha iziguli ezinomdlavuza wamaphaphu ongewona amaseli amancane (i-NSCLC) othuthuke endaweni noma osakazeke kakhulu one-MET amplification—kwakusekelwe emiphumeleni emihle evela ku-Cohort 2 kanye ne-Cohort 3 yocwaningo lwe-KUNPENG (NCT04258033).
Iqembu lesi-2 labhalisa kakhulu iziguli ezelashwe ngaphambilini ezine-NSCLC ekhulisiwe yi-MET ezahluleka ukwelashwa okujwayelekile (kufaka phakathi i-chemotherapy esekelwe ku-platinum), kuyilapho iQembu lesi-3 lalihlanganisa kakhulu iziguli ezazingenalo ukwelashwa ezine-NSCLC ekhulisiwe yi-MET ezazenqaba i-chemotherapy.
Iziguli ezingu-86 ezine-NSCLC ethuthukisiwe noma esakazekile endaweni ethile zabhaliswa kuzo zombili izigaba (33 eQenjini 2 kanye no-53 eQenjini 3). Imiphumela yocwaningo ibonise izinga lokuphendula eliphelele (ORR) elingu-48.8%, izinga lokulawula izifo (DCR) elingu-77.9%, isikhathi esimaphakathi sempendulo (DoR) sezinyanga ezingu-12.1, ukusinda okumaphakathi okungenalo inqubekela phambili (PFS) kwezinyanga ezingu-7.4, kanye nokusinda okumaphakathi okuvamile (OS) kwezinyanga ezingu-13.9.
Ku-Cohort 2 (iziguli ezingu-33 ezelashwe ngaphambilini), i-ORR yayingu-48.5%, i-DCR yayingu-78.8%, i-DoR ephakathi yayizinyanga ezingu-11.0, i-PFS ephakathi yayizinyanga ezingu-6.2, kanti i-OS ephakathi yayizinyanga ezingu-11.7.
Ku-Cohort 3 (iziguli ezingama-53 ezingazi lutho ngokwelashwa), i-ORR yayingu-49.1%, i-DCR yayingu-77.4%, i-DoR ephakathi yayizinyanga eziyi-12.1, i-PFS ephakathi yayizinyanga eziyi-8.3, kanti i-OS ephakathi yayizinyanga eziyi-15.5.
Esifundweni se-KUNPENG, iziguli ezingu-21 ezine-baseline brain metastases zahlolwa yi-Independent Review Committee (IRC). Phakathi kwalezi, ezingu-10 zathola izimpendulo ezingaphelele eziqinisekisiwe (PR), okwaholela ku-ORR engu-47.6%, i-DCR engu-85.7%, kanye ne-DoR ephakathi yezinyanga ezingu-11.0. Ngaphezu kwalokho, i-PFS ephakathi kanye ne-OS zaziyizinyanga ezingu-8.3 kanye nezinyanga ezingu-14.7, ngokulandelana.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Julayi-08-2025