Ngomhlaka-20 Agasti 2025, i-Abbisko Therapeutics yamemezela ukuthi i-Center forDrug Evaluation (CDE) ye-China National Medical Products Administration (NlPA) isivumile isicelo se-lND somuthi womlomo we-Abbisko ophenywayo we-PD-1, i-ABSK043, ohlanganiswe ne-Shanghai Alist Pharmaceuticals KRAS G12C inhibitor, i-glecirasib, yokwelapha iziguli ze-NscLc ezine-KRAS G12C mutation.
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.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Mayelana ne-ABSK043
I-ABSK043 iyi-molecule encane entsha, etholakalayo ngomlomo, ekhetha kakhulu i-PD-L1 inhibitor ephethwe ngokuphelele yi-Abbisko Therapeutics. Amaseli esimila angasebenzisa izindawo zokuhlola amasosha omzimba njenge-PD-1 kanye ne-ligand yayo ye-PD-L1 ukuze agweme ukutholakala nokususwa kwamasosha omzimba, ngaleyo ndlela acindezele noma anciphise izimpendulo zamaseli e-I, i-ABSK043 ibopha ngokuzikhethela kwi-receptor ye-PD-L1 futhi ibangele ukungena kwayo kusuka ku-surace yeseli, ivimbele ngempumelelo ukusebenzisana kwe-PD-1/PD-L1 futhi inciphise ukucindezelwa kokusebenza kwe-T-cell okwenziwa yi-PD-L1. kumamodeli angaphambi kokwelashwa, i-ABSK043 ibonise ukusebenza kahle kokulwa nesimila okufana nama-antibodies e-PD-L1 avunyiwe. Nakuba ama-antibodies amaningana e-PD-1/PD-L1 monoconal evunyelwe emhlabeni wonke, okwamanje azikho izinhlayiya ezincane ze-PD-1/PD-L1 ezivunyelwe ngomlomo, i-ABSK043 okwamanje iyahlolwa esivivinyweni somtholampilo seSigaba 1 esiqhubekayo sezimila eziqinile ezithuthukile e-Australia naseShayina.
Esifundweni sesigaba sokuqala (i-NCT04964375), i-ABSK043, i-PD-L1 inhibitor yomlomo enamandla, encane, esetshenziswa ngomlomo, ibonise ukusebenza kahle kokuqala.
Izindlela
Amacala anezimila eziqinile ezithuthukile anikezwa ama-capsule e-ABSK043 asukela ku-200 mg kanye ngosuku (QD) kuya ku-1000 mg kabili ngosuku (BID), ukuze kuhlolwe iphrofayili yokuphepha kanye nokusebenza kahle kokuqala. Ngaphezu kwalokho kwahlolwa izinkomba ze-pharmacodynamic (PD), njengomsebenzi we-T-cell kanye ne-PD-L1 engaphezulu.
Imiphumela
Kusukela ngosuku lokugcina (Juni 7, 2024), kwabhaliswa futhi kwelashwa abantu abangu-77. Ama-87.0% eziguli abhekane nemicimbi emibi yokwelashwa (ama-TEAE), kanti ama-29.9% ayengama-≥ Ibanga lesi-3. Ama-TEAE ≥15% ayeyi-anemia (22.1%). Akukho zinkinga ze-peripheral neuropathy ezibikiwe. Kuzo zonke iziguli ezihlolwe ukusebenza kahle kwamaqembu omthamo osebenzayo ngokwemithi (600 mg BID, 800 mg BID, kanye ne-1000 mg BID), kwabonwa i-ORR engu-24% (8/34) kuma-ICI-naïve pts. Kuma-ICI-naïve pts ayi-10 anomdlavuza wamaphaphu (ayi-9 ayelashwe kusengaphambili kanye ne-1 elashwe-naïve), i-ORR yayingu-40% (4/10). Okuphawulekayo ukuthi ama-pts amathathu kwangu-6 (50%) e-EGFR aguquliwe kanye ne-pts eyodwa kwangu-2 (50%) e-KRAS aguquliwe athole impendulo engaphelele (PR). Bonke abaphenduli abathathu abane-mutations ye-EGFR babene-PD-L1 TPS ≥ 50% futhi baqhubekela phambili ngemuva komugqa owodwa wokwelashwa kwe-EGFR TKI, okuhlanganisa nesizukulwane sesi-3. Ezinye izimpendulo zenzeke ezinhlotsheni ezinhlanu ezixubile zezimila: umdlavuza wesisu we-MSI-H/dMMR, i-MSI-H/dMMR endometrial adenocarcinoma, i-vaginal squamous cell carcinoma, umdlavuza webele (Lynch syndrome), kanye ne-melanoma. Isikhathi eside kakhulu sempendulo ocwaningweni kwakuyizinyanga ezingu-17 (i-endometrial adenocarcinoma) kanti i-pt isaphathwa. Ukusebenza kwe-T cell kanye nokwehla okuncike kumthamo ekubonakalisweni kwe-PD-L1 ebusweni ngemuva kokwelashwa kwe-ABSK043 kwabonwa kuwo wonke amaqembu e-BID dose.
Mayelana ne-Glecirasib
I-Glecirasib (AST-24081) iyi-KRAS G12C inhibitor. Izivivinyo eziningana ze-cinical ziyaqhubeka eShayina, e-United States naseYurophu zeziguli ezinezimila ze-soid ezithuthukile ezine-KRAS G12C mutation. Lokhu kufaka phakathi izivivinyo zokwelapha ezihlanganisiwe ezine-SHP2 inhibitor AST-24082in NSCLC kanye nezivivinyo ze-monotherapy kumdlavuza we-pancreatic. Ngaphezu kwalokho, isibonakaliso somdlavuza we-pancreatic sithole ukuqokwa kwemithi yezintandane e-United States kanye nokuqokwa kokwelashwa okuphumelelayo eShayina. NgoMeyi 2025, i-Glecirasib yavunyelwa ukwethulwa emakethe yi-China NMPA.
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.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Agasti-21-2025