Thaum Lub Yim Hli 20, 2025, Abbisko Therapeutics tshaj tawm tias Lub Chaw Saib Xyuas Tshuaj (CDE) ntawm Tuam Tshoj National Medical Products Administration (NlPA) tau pom zoo rau daim ntawv thov lND rau Abbisko's investigational oral PD-1 inhibitor, ABSK043, ua ke nrog Shanghai Alist Pharmaceuticals KRAS G12C inhibitor, glecirasib, rau kev kho mob ntawm cov neeg mob NscLc uas muaj KRAS G12C mutation.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Txog ABSK043
ABSK043 yog ib yam tshuaj tshiab, uas muaj nyob hauv qhov ncauj, thiab muaj cov tshuaj me me uas xaiv tau zoo heev uas Abbisko Therapeutics muaj. Cov qe ntshav dawb tuaj yeem siv cov chaw kuaj mob tiv thaiv kab mob xws li PD-1 thiab nws cov ligand PD-L1 kom zam kev kuaj pom thiab tshem tawm cov kab mob tiv thaiv kab mob, yog li ntawd nws thiaj li txwv lossis txwv cov lus teb ntawm I-cell, ABSK043 xaiv khi rau PD-L1 receptor thiab ua rau nws nkag mus rau hauv lub cell surace, tiv thaiv kev sib cuam tshuam ntawm PD-1/PD-L1 thiab txo qhov kev txwv ntawm T-cell activation los ntawm PD-L1. Hauv cov qauv preclinical, ABSK043 tau ua pov thawj tias muaj txiaj ntsig zoo rau kev tiv thaiv kab mob qog noj ntshav piv rau cov tshuaj tiv thaiv PD-L1 uas tau pom zoo. Txawm hais tias muaj ntau yam tshuaj PD-1/PD-L1 monoconal antibodies tau txais kev pom zoo thoob plaws ntiaj teb, tam sim no tsis muaj cov tshuaj me me PD-1/PD-L1 uas tau txais kev pom zoo los ntawm kev noj, ABSK043 tam sim no tab tom tshawb nrhiav hauv kev sim tshuaj theem 1 rau cov qog nqaij hlav khov kho hauv tebchaws Australia thiab Suav teb.
Hauv kev tshawb fawb theem I (NCT04964375), ABSK043, ib qho tshuaj inhibitor PD-L1 me me uas haus, muaj zog, tau pom tias muaj txiaj ntsig zoo thaum pib.
Cov txheej txheem
Cov neeg mob uas muaj cov qog nqaij hlav khov kho tau muab tshuaj ABSK043 capsules txij li 200 mg ib zaug ib hnub (QD) txog 1000 mg ob zaug ib hnub (BID), los ntsuam xyuas qhov kev nyab xeeb thiab kev ua haujlwm ua ntej. Tsis tas li ntawd, cov ntsuas pharmacodynamic (PD) tau soj ntsuam, xws li T-cell ua haujlwm thiab PD-L1 ntawm qhov chaw.
Cov txiaj ntsig
Txij li hnub kawg (Lub Rau Hli 7, 2024), muaj 77 pts tau sau npe thiab kho. 87.0% ntawm pts tau ntsib kev kho mob tsis zoo (TEAEs), thiab 29.9% yog ≥ Qib 3. Cov TEAEs ≥15% yog anemia (22.1%). Tsis muaj peripheral neuropathy tau tshaj tawm. Hauv txhua qhov kev ntsuas tau zoo ntawm cov pab pawg pharmacologically active dose (600 mg BID, 800 mg BID, thiab 1000 mg BID), ORR ntawm 24% (8/34) hauv ICI-naïve pts tau pom. Hauv 10 ICI-naïve pts nrog mob qog noj ntshav (9 pre-treatment thiab 1 treatment-naïve), ORR yog 40% (4/10). Qhov tseem ceeb, 3 ntawm 6 (50%) EGFR-mutated thiab 1 ntawm 2 (50%) KRAS-mutated pts tau ua tiav ib feem teb (PR). Tag nrho peb tus neeg teb nrog EGFR mutations muaj PD-L1 TPS ≥ 50% thiab nce qib tom qab tsawg kawg ib kab ntawm EGFR TKI kev kho mob, suav nrog tiam 3. Lwm cov lus teb tau tshwm sim hauv tsib hom qog sib xyaw: MSI-H/dMMR mob qog noj ntshav hauv plab, MSI-H/dMMR endometrial adenocarcinoma, vaginal squamous cell carcinoma, mob qog noj ntshav hauv lub mis (Lynch syndrome), thiab melanoma. Lub sijhawm ntev tshaj plaws ntawm kev teb hauv kev tshawb fawb yog 17 lub hlis (endometrial adenocarcinoma) thiab pt tseem nyob rau kev kho mob. T cell ua haujlwm thiab kev txo qis ntawm cov koob tshuaj hauv qhov chaw PD-L1 tom qab kev kho mob ABSK043 tau pom hauv txhua pawg BID koob tshuaj.
Txog Glecirasib
Glecirasib (AST-24081) yog ib qho tshuaj uas tiv thaiv KRAS G12C. Muaj ntau qhov kev sim tshuaj hauv Suav teb, Tebchaws Meskas thiab Tebchaws Europe rau cov neeg mob uas muaj cov qog nqaij hlav siab heev uas muaj KRAS G12C mutation. Cov no suav nrog kev sim tshuaj ua ke nrog SHP2 inhibitor AST-24082 hauv NSCLC thiab kev sim tshuaj monotherapy hauv mob qog nqaij hlav pancreatic. Ntxiv mus, cov cim qhia txog mob qog nqaij hlav pancreatic tau txais kev xaiv tshuaj tsis muaj txiaj ntsig hauv Tebchaws Meskas thiab kev xaiv tshuaj kho mob tshiab hauv Suav teb. Thaum Lub Tsib Hlis 2025, Glecirasib tau pom zoo rau kev tso tawm hauv kev lag luam los ntawm ChinaNMPA.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Lub sijhawm tshaj tawm: Lub Yim Hli-21-2025