Ngomhla wama-20 kweyeThupha ngo-2025, i-Abbisko Therapeutics ibhengeze ukuba iZiko loVavanyo lwaMayeza (i-CDE) le-China National Medical Products Administration (i-NlPA) livumile isicelo se-lND somthinteli wophando we-Abbisko we-PD-1, i-ABSK043, kunye nomthinteli we-Shanghai Alist Pharmaceuticals KRAS G12C, i-glecirasib, wokunyanga izigulane ze-NscLc ezine-KRAS G12C mutation.
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
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Malunga ne-ABSK043
I-ABSK043 yi-molecule entsha, efumaneka ngomlomo, ekhethiweyo kakhulu, i-PD-L1 inhibitor ephethwe ngokupheleleyo yi-Abbisko Therapeutics. Iiseli ze-tumor zinokusebenzisa iindawo zokujonga umzimba ezifana ne-PD-1 kunye ne-ligand yayo ye-PD-L1 ukuze ziphephe ukubonwa kunye nokususwa komzimba, ngaloo ndlela zicinezela okanye zithintele iimpendulo zeeseli ze-I, i-ABSK043 ibopha ngokukhethekileyo kwi-receptor ye-PD-L1 kwaye ibangele ukungena kwayo ngaphakathi kwi-surace yeseli, ithintela ngokufanelekileyo ukusebenzisana kwe-PD-1/PD-L1 kwaye inciphise ukucinezelwa kokusebenza kwe-T-cell okubangelwa yi-PD-L1. kwiimodeli zangaphambi kweklinikhi, i-ABSK043 ibonakalise ukusebenza kakuhle kwe-anti-tumor okufana nee-antibodies ze-PD-L1 ezivunyiweyo. Nangona ii-antibodies ezininzi ze-PD-1/PD-L1 monoconal zivunyiwe kulo lonke ihlabathi, okwangoku akukho PD-1/PD-L1 small molecule drys ezivunyiweyo ngomlomo, i-ABSK043 okwangoku ijongwa kuvavanyo lweklinikhi oluqhubekayo lweSigaba 1 see-tumor eziqinileyo eziphucukileyo e-Australia nase-China.
Kwisifundo sesigaba soku-1 (i-NCT04964375), i-ABSK043, i-PD-L1 inhibitor yomlomo, enamandla, ne-molecule encinci, ibonakalise ukusebenza kakuhle kwangaphambili.
Iindlela
Iingcali ezineethumba eziqinileyo eziphucukileyo zinikwe iikhaphu ze-ABSK043 eziqala kwi-200 mg kanye ngemini (QD) ukuya kwi-1000 mg kabini ngemini (BID), ukuvavanya iprofayili yokhuseleko kunye nokusebenza kwangaphambili. Ngaphezu koko kwavavanywa izalathisi ze-pharmacodynamic (PD), ezifana nomsebenzi we-T-cell kunye ne-PD-L1 yomphezulu.
Iziphumo
Ukususela ngomhla wokugqibela (nge-7 kaJuni 2024), abantu abangama-77 babhalisiwe baza banyangwa. Ama-87.0% abantu abafumana unyango olukhawulezileyo (ii-TEAE), kwaye ama-29.9% ayengama-≥ kwiBanga lesi-3. Ii-TEAE ≥15% zaziyi-anemia (22.1%). Akukho neuropathy echazwe. Kuzo zonke iziphumo ezivavanyiweyo zamaqela edosi esebenzayo ngokwezonyango (600 mg BID, 800 mg BID, kunye ne-1000 mg BID), i-ORR engama-24% (8/34) kwi-ICI-naïve pts yabonwa. Kwi-ICI-naïve pts ezili-10 ezinomhlaza wemiphunga (ezili-9 ezinyangiweyo kwangaphambili kunye ne-1-naïve yonyango), i-ORR yayiyi-40% (4/10). Okuphawulekayo kukuba, i-3 kwi-6 (50%) ye-EGFR eguquliweyo kunye ne-1 kwi-2 (50%) ye-KRAS-mutated pts ifumene impendulo engaphelelanga (PR). Bonke abaphenduli abathathu abane-EGFR mutations babene-PD-L1 TPS ≥ 50% kwaye baqhubela phambili emva komgca omnye ubuncinane we-EGFR TKI therapy, kuquka nesizukulwana sesi-3. Ezinye iimpendulo zenzeke kwiintlobo ezintlanu ze-tumor ezixutyiweyo: umhlaza wesisu we-MSI-H/dMMR, i-MSI-H/dMMR endometrial adenocarcinoma, i-vaginal squamous cell carcinoma, umhlaza webele (Lynch syndrome), kunye ne-melanoma. Ixesha elide lempendulo kolu phononongo yayiziinyanga ezili-17 (endometrial adenocarcinoma) kwaye i-pt isasetyenziswa. Ukusebenza kwe-T cell kunye nokwehla okuxhomekeke kwidosi ekubonakalisweni kwe-PD-L1 kumphezulu emva konyango lwe-ABSK043 kubonwe kuwo onke amaqela e-BID dose.
Malunga neGlecirasib
I-Glecirasib (AST-24081) sisithinteli se-KRAS G12C. Iimvavanyo ezininzi ze-cinical ziyaqhubeka okwangoku eTshayina, eMelika naseYurophu kwizigulane ezineethumba eziphucukileyo ezine-KRAS G12C mutation. Ezi ziquka iimvavanyo zonyango oludibeneyo kunye nesithinteli se-SHP2 i-AST-24082 kwi-NSCLC kunye nezilingo ze-monotherapy kumhlaza we-pancreatic. Ukongeza, isibonakaliso somhlaza we-pancreatic sifumene utyumbo lwamayeza oluyintandane eMelika kunye notyumbo lonyango oluphuhlileyo eTshayina. NgoMeyi 2025, iGlecirasib yavunywa ukuba iqaliswe kwimarike yi-NMPA yaseTshayina.
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
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Ixesha lokuthumela: Agasti-21-2025