Tsis ntev los no, GenFleet tshaj tawm cov ntaub ntawv theem II tshiab kawg ntawm kev tshawb fawb KROCUS, fulzerasib (GFH925, KRAS G12C inhibitor) ua ke nrog cetuximab rau kev kho mob qog nqaij hlav ntsws tsis yog me me (NSCLC) thawj kab, hauv kev sau luv luv ntawm kev nthuav qhia me me ntawm 2025 European Lung Cancer Conference (ELCC) lub rooj sib tham txhua xyoo.
Fulzerasib yog thawj tus tshuaj KRAS G12C inhibitor uas tau tsim los ntawm Tuam Tshoj uas tau txais thiab tso cai los ntawm NDA nrog Priority Review Designation los ntawm NMPA. Fulzerasib kuj tau txais Breakthrough Therapy Designations xyoo no rau kev kho cov neeg mob NSCLC KRAS G12C-mutant uas tau txais tsawg kawg ib qho kev kho mob systemic thiab cov neeg mob CRC uas tau txais tsawg kawg ob qho kev kho mob systemic. Tsev neeg protein RAS tuaj yeem faib ua pawg KRAS, HRAS thiab NRAS. KRAS mutations raug kuaj pom hauv yuav luag 90% ntawm cov mob qog noj ntshav pancreatic, 30-40% ntawm cov mob qog noj ntshav colon, thiab 15-20% cov neeg mob qog noj ntshav ntsws. Qhov tshwm sim ntawm KRAS G12C mutation subset feem ntau pom ntau dua li cov uas muaj ALK, ROS1, RET thiab TRK 1/2/3 mutations ua ke. GFH925 yog ib qho tshiab, ua haujlwm hauv qhov ncauj, muaj zog KRAS G12C inhibitor tsim los tsom mus rau GTP / GDP pauv, ib kauj ruam tseem ceeb hauv kev ua haujlwm ntawm txoj kev, los ntawm kev hloov kho cov cysteine ntawm KRAS G12C protein covalently thiab irreversibly. Cov kev tshawb fawb preclinical cysteine kev xaiv tau qhia txog kev xaiv siab ntawm fulzerasib rau G12C. Tom qab ntawd, fulzerasib zoo tiv thaiv txoj kev teeb liab downstream kom ua rau cov hlwb qog 'apoptosis thiab cell voj voog nres.
Tag nrho muaj 47 tus neeg mob KRAS G12C-mutant NSCLC uas tsis tau kho dua tshiab tau kho nrog fulzerasib ua ke nrog cetuximab (fulzerasib 600mg BID + cetuximab 500 mg/m2 Q2W) txij li Lub Ib Hlis 14, 2025.
Kev Ua Haujlwm Zoo: Txij li hnub txiav cov ntaub ntawv, ntawm 45 tus neeg mob uas tau txais tsawg kawg ib qho kev ntsuam xyuas qog tom qab kev kho mob, ORR yog 80% thiab DCR yog 100%; 57.8% muaj ≥ 50% qog ntsws. 16 tus neeg mob (34%) muaj kev kis mus rau lub hlwb; ntawm 14 tus neeg mob kis mus rau lub hlwb uas tau txais tsawg kawg ib qho kev ntsuam xyuas qog tom qab kev kho mob, ORR ib RECIST 1.1 yog 71.4%. Lub sijhawm nruab nrab ntawm kev teb (DoR) tseem tsis tau txog, thiab 24 tus neeg mob tseem tau kho nrog kev saib xyuas nruab nrab ntawm 10.1 lub hlis. mPFS yog 12.5 lub hlis thiab mOS tsis tau txog.
Kev Nyab Xeeb: Raws li hnub kawg ntawm cov ntaub ntawv, kev kho mob ua ke tau qhia txog qhov kev nyab xeeb / kev kam rau siab zoo. TRAEs tau tshwm sim hauv 87.2% ntawm cov neeg mob thiab feem ntau ntawm TRAEs tau qib 1-2; 14.9% ntawm cov neeg mob tau ntsib tsawg kawg ib qib 3 TRAEs; tsis muaj qib 4-5 TRAEs. 2 tus neeg mob muaj cov xwm txheej tsis zoo loj ntsig txog kev kho mob (TRSAE) thiab TRSAEs tau raug soj ntsuam tias tsuas yog cuam tshuam nrog cetuximab; 3 tus neeg mob tau ntsib TRAEs, tsis muaj feem cuam tshuam nrog fulzerasib, ua rau kev txiav tshuaj. KROCUS tau qhia txog qhov tshwm sim tsawg ntawm kev txiav tshuaj lossis txo qis ntawm cov kev tshawb fawb sib txawv ntawm kab G12C-mutant NSLCL combo. Tsis muaj cov cim qhia kev nyab xeeb tshiab tau txheeb xyuas piv rau fulzerasib lossis cetuximab ua ib tus neeg sawv cev.
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.
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Lub sijhawm tshaj tawm: Plaub Hlis-15-2025