Ku itariki ya 20 Kanama 2025, Abbisko Therapeutics yatangaje ko Ikigo cy’Isuzuma ry’Imiti (CDE) cy’Ikigo cy’Igihugu cy’Ubushinwa gishinzwe Ibikoresho by’Ubuvuzi (NlPA) cyemeye ubusabe bwa lND bwo gukoresha umuti wo mu kanwa wa Abbisko witwa ABSK043, hamwe n’umuti wo mu bwoko bwa Shanghai Alist Pharmaceuticals KRAS G12C, glecirasib, wo kuvura abarwayi ba NscLc bafite mutation ya KRAS G12C.
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
Nimero ya Terefone: 4008803716
Indangamuntu ya WeChat: 17801183037
Email：myimmnet@163.com
Ku bijyanye na ABSK043
ABSK043 ni ubwoko bushya, buboneka mu kanwa kandi butoranya cyane, butuma habaho inzitizi ya PD-L1, ikaba ari iya Abbisko Therapeutics. Uturemangingo tw’ibibyimba dushobora gukoresha uburyo bwo kugenzura ubudahangarwa bw’umubiri nka PD-1 na ligand yayo PD-L1 kugira ngo twirinde kugaragara no kuva mu mubiri, bityo tugahagarika cyangwa tugagabanya uburyo ubudahangarwa bw’uturemangingo tw’ingirabuzimafatizo, ABSK043 yihambira ku buryo bwihariye kuri receptor ya PD-L1 maze igatuma iva mu mubiri w’uturemangingo, ikabuza imikoranire ya PD-1/PD-L1 no kugabanya imikorere ya T-selile hifashishijwe PD-L1. Mu buryo bwa mbere y’ubuvuzi, ABSK043 yagaragaje ubushobozi bwo kurwanya ibibyimba nk’ubw’uturemangingo twemewe twa PD-L1. Nubwo antibodies nyinshi za PD-1/PD-L1 monoconal zemejwe n’inzoga hirya no hino ku isi, ubu nta molekile nto za PD-1/PD-L1 zemewe mu kanwa, ABSK043 irimo gusuzumwa mu igerageza rya Phase 1 ku ndwara zikomeye zo mu bwoko bwa kanseri muri Ositaraliya no mu Bushinwa.
Mu bushakashatsi bwakozwe mu cyiciro cya mbere (NCT04964375), ABSK043, umuti ugabanya ubukana bwa molekile ntoya, ukoreshwa mu kanwa, wagaragaje ubushobozi bwa mbere.
Uburyo
Indwara zifite ibibyimba bikomeye zahawe imiti ya ABSK043 capsules kuva kuri 200 mg rimwe ku munsi (QD) kugeza kuri 1000 mg kabiri ku munsi (BID), kugira ngo harebwe imiterere y’umutekano n’ubushobozi bw’ibanze. Ikindi kandi, hasuzumwe ibipimo bya pharmacodynamic (PD), nk’imikorere ya T-cell na PD-L1 yo hejuru.
Ibisubizo
Ku itariki ntarengwa (7 Kamena 2024), abantu 77 banditswe kandi baravurwa. 87.0% by'abantu bahuye n'ingaruka mbi zo kuvurwa (TEAEs), naho 29.9% bari ≥ Icyiciro cya 3. TEAEs ≥15% zari amaraso make (22.1%). Nta ndwara y'imitsi yo mu gice cy'imbere cy'umugongo yagaragaye. Mu mikorere yose y'amatsinda y'ibipimo byakoreshejwe mu buvuzi (600 mg BID, 800 mg BID, na 1000 mg BID), ORR ya 24% (8/34) mu bantu badafite ICI yagaragaye. Mu bantu 10 badafite ICI barwaye kanseri y'ibihaha (9 bavuwe mbere n'abandi badafite ICI yavuwe), ORR yari 40% (4/10). Ikigaragara ni uko 3 muri 6 (50%) byahinduwe na EGFR na 1 muri 2 (50%) byahinduwe na KRAS byagize igisubizo cy'igice (PR). Abantu batatu bose basubije bafite impinduka za EGFR bari bafite PD-L1 TPS ≥ 50% kandi bakomeza nyuma y'uburyo bumwe bwo kuvura EGFR TKI, harimo n'iy'igisekuru cya gatatu. Izindi ngaruka zabayeho mu bwoko butanu bw'ibibyimba: kanseri y'igifu ya MSI-H/dMMR, adenocarcinoma ya endometrial ya MSI-H/dMMR, kanseri y'ibere ya squamous cell carcinoma, kanseri y'ibere (Lynch syndrome), na melanoma. Igihe kirekire cyo gusubiza muri ubu bushakashatsi cyari amezi 17 (endometrial adenocarcinoma) kandi pt iracyari ku miti. Gukoresha uturemangingo twa T no kugabanuka kw'ishusho ya PD-L1 ku buso nyuma yo kuvurwa na ABSK043 byagaragaye mu matsinda yose ya BID dose.
Ku bijyanye na Glecirasib
Glecirasib (AST-24081) ni umuti ugabanya ubukana bwa KRAS G12C. Hari igeragezwa ry’imiti igabanya ubukana bw’indwara ya kanseri mu Bushinwa, muri Leta Zunze Ubumwe za Amerika no mu Burayi rikomeje ku barwayi bafite ibibyimba bikomeye bya KRAS G12C. Harimo igerageza ry’imiti ivanze hamwe n’umuti ugabanya ubukana bwa SHP2 AST-24082 muri NSCLC n’igerageza rya monotherapy muri kanseri ya kanseri ya kanseri ya kanseri. Byongeye kandi, ibimenyetso bya kanseri ya kanseri ya kanseri byahawe izina ry’umuti w’impfubyi muri Leta Zunze Ubumwe za Amerika n’iry’umuti uvura indwara mu Bushinwa. Muri Gicurasi 2025, Glecirasib yemejwe ko itangira ku isoko n’Ikigo cy’Ubushinwa NMPA.
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
Nimero ya Terefone: 4008803716
Indangamuntu ya WeChat: 17801183037
Email：myimmnet@163.com
Igihe cyo kohereza: Kanama-21-2025