Pa 20 Ogasiti 2025, Abbisko Therapeutics idalengeza kuti Center forDrug Evaluation (CDE) ya China National Medical Products Administration (NlPA) yavomereza pempho la lND la Abbisko's investigative PD-1 inhibitor, ABSK043, pamodzi ndi Shanghai Alist Pharmaceuticals KRAS G12C inhibitor, glecirasib, pochiza odwala a NscLc omwe ali ndi kusintha kwa KRAS G12C.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Zokhudza ABSK043
ABSK043 ndi chinthu chatsopano, chopezeka pakamwa, chosankha kwambiri cha molekyulu yaying'ono ya PD-L1 choletsa chomwe chili ndi mwiniwake wa Abbisko Therapeutics. Maselo otupa amatha kugwiritsa ntchito malo owunikira chitetezo chamthupi monga PD-1 ndi ligand PD-L1 kuti apewe kupezeka ndi kutuluka kwa chitetezo chamthupi, motero kuletsa kapena kuchepetsa mayankho a maselo a I, ABSK043 imalumikizana ndi PD-L1 receptor ndikuyambitsa kufalikira kwake kuchokera ku selo, ndikuletsa kuyanjana kwa PD-1/PD-L1 ndikuchepetsa kuletsa kwa T-cell komwe kumachitika chifukwa cha PD-L1. M'machitidwe okonzekera, ABSK043 yawonetsa mphamvu yolimbana ndi chotupa yofanana ndi ma antibodies ovomerezeka a PD-L1. Ngakhale ma antibodies angapo a PD-1/PD-L1 monoconal avomerezedwa padziko lonse lapansi, pakadali pano palibe ma molecule ang'onoang'ono a PD-1/PD-L1 omwe amavomerezedwa pakamwa, ABSK043 ikufufuzidwa mu kafukufuku wachipatala wa Phase 1 wa zotupa zolimba zomwe zakula ku Australia ndi China.
Mu kafukufuku wa gawo loyamba (NCT04964375), ABSK043, mankhwala oletsa PD-L1 m'kamwa, amphamvu, komanso ang'onoang'ono, adawonetsa mphamvu yoyambirira.
Njira
Madokotala omwe ali ndi zotupa zolimba kwambiri adapatsidwa makapisozi a ABSK043 kuyambira 200 mg kamodzi patsiku (QD) mpaka 1000 mg kawiri patsiku (BID), kuti awone momwe chitetezo chilili komanso momwe zimagwirira ntchito poyamba. Komanso adafufuza zizindikiro za pharmacodynamic (PD), monga ntchito ya maselo a T ndi PD-L1 pamwamba.
Zotsatira
Pofika tsiku lomaliza (June 7, 2024), anthu 77 analembedwa ndi kuchiritsidwa. 87.0% ya anthu omwe adakumana ndi zovuta zomwe zidachitika mwadzidzidzi chifukwa cha chithandizo (TEAEs), ndipo 29.9% anali ≥ Giredi 3. Ma TEAE ≥15% anali kuchepa kwa magazi m'thupi (22.1%). Palibe vuto la mitsempha ya m'mitsempha lomwe linanenedwa. Pa ntchito zonse zomwe zidachitika bwino, magulu omwe adagwiritsa ntchito mankhwala (600 mg BID, 800 mg BID, ndi 1000 mg BID) adawona ORR ya 24% (8/34) mu ICI-naïve pts. Pa anthu 10 omwe adagwiritsa ntchito ICI-naïve ndi khansa ya m'mapapo (9 omwe adachiritsidwa kale ndi 1 omwe sanalandire chithandizo), ORR inali 40% (4/10). Chochititsa chidwi n'chakuti, 3 mwa 6 (50%) omwe adasinthidwa ndi EGFR ndi 1 mwa 2 (50%) omwe adasinthidwa ndi KRAS adapeza yankho laching'ono (PR). Onse atatu omwe adayankha ndi kusintha kwa EGFR anali ndi PD-L1 TPS ≥ 50% ndipo adapita patsogolo pambuyo pa mzere umodzi wa mankhwala a EGFR TKI, kuphatikiza m'badwo wachitatu. Mayankho ena adachitika m'mitundu isanu yosiyanasiyana ya chotupa: khansa ya m'mimba ya MSI-H/dMMR, adenocarcinoma ya endometrial ya MSI-H/dMMR, carcinoma ya vaginal squamous cell, khansa ya m'mawere (Lynch syndrome), ndi melanoma. Nthawi yayitali kwambiri yoyankhira mu kafukufukuyu inali miyezi 17 (endometrial adenocarcinoma) ndipo pt ikadali pa chithandizo. Kuyambitsa kwa maselo a T ndi kuchepa kwa PD-L1 pamwamba potengera mlingo pambuyo pa chithandizo cha ABSK043 zidawonedwa m'magulu onse a BID.
About Glecirasib
Glecirasib (AST-24081) ndi mankhwala oletsa khansa a KRAS G12C. Mayeso angapo a cinical akupitilira ku China, United States ndi Europe kwa odwala omwe ali ndi zotupa zapamwamba zomwe zili ndi kusintha kwa KRAS G12C. Izi zikuphatikizapo mayeso ophatikizana ndi mankhwala oletsa khansa a SHP2 AST-24082in NSCLC ndi mayeso a monotherapy mu khansa ya kapamba. Kuphatikiza apo, chizindikiro cha khansa ya kapamba chalandiridwa ngati mankhwala osachiritsika ku United States komanso chithandizo chotsogola ku China. Mu Meyi 2025, Glecirasib idavomerezedwa kuti iyambe kugwiritsidwa ntchito pamsika ndi ChinaNMPA.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Chizindikiro cha WeChat: 17801183037
Email：myimmnet@163.com
Nthawi yotumizira: Ogasiti-21-2025