Thaum Lub Tsib Hlis 29, Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo rau kev lag luam ntawm Zanidatamab, uas BeiGene xa tuaj, rau kev kho mob rau cov neeg mob uas muaj mob qog nqaij hlav hauv zos lossis mob qog nqaij hlav metastatic (BTC) uas tsis tuaj yeem phais tau uas tau txais kev kho mob thoob plaws lub cev thiab muaj HER2 qhia siab (IHC 3+).
Zanidatamab yog ib qho tshuaj tiv thaiv kab mob HER2 uas tsom mus rau ob hom kab mob uas tuaj yeem khi ob lub epitopes ntawm HER2 receptor uas tsis sib tshooj, hu ua biparatopic binding. Qhov kev tsim tshwj xeeb no thiab kev khi ntxiv ua rau muaj ntau txoj hauv kev ua haujlwm, suav nrog kev thaiv ob lub teeb liab HER2, kev tshem tawm HER2 protein ntawm qhov chaw ntawm lub cell, thiab kev ua rau lub cev tiv thaiv kab mob ua rau muaj kev ua haujlwm tiv thaiv qog noj ntshav hauv cov neeg mob.
Receptor tyrosine-protein kinase, feem ntau hu ua Human Epidermal Growth Factor Receptor 2 (HER2) lossis CD340, nyob rau ntawm cov nplaim ntawm cov cell. Cov protein no yog ib tug tswv cuab ntawm Epidermal Growth Factor Receptor (EGFR) tsev neeg thiab yog encoded los ntawm Erythroblastic oncogene B (ERBB2) gene. Lub ERBB2 gene yog qhov tseem ceeb rau cov txheej txheem ib txwm xws li kev faib cell, kev sib txawv, thiab kev ciaj sia. Los ntawm ntau txoj kev signaling, HER2 receptors txhawb nqa cell proliferation thiab inhibit apoptosis (programmed cell death). Nws yog qhov tseem ceeb heev rau kev tswj hwm cov receptors no kom tiv thaiv kev loj hlob ntawm cell tsis tswj hwm. Cov qog nqaij hlav uas overexpress lossis amplify lub HER2 gene raug xa mus rau HER2-positive malignancies. Lub gene no ua haujlwm ua ib qho tseem ceeb biomarker thiab yog lub hom phiaj tseem ceeb rau kev kho mob tshuaj.
Txawm li cas los xij, thaum HER2 loj hlob lossis tshaj tawm ntau dhau, kev loj hlob ntawm cov cell thiab kev faib tsis raug tswj hwm ua rau mob qog noj ntshav nce siab sai dua. Qhov kev loj hlob lossis kev tshaj tawm ntau dhau no feem ntau pom muaj nyob rau ntau hom qog nqaij hlav thiab tuaj yeem muaj qhov tseem ceeb rau kev kho mob rau cov qog nqaij hlav uas feem ntau tsis xav tias yuav teb zoo rau kev kho mob tiv thaiv HER2.
HER2-positivity pom muaj nyob rau hauv ntau hom mob qog noj ntshav xws li mob qog noj ntshav hauv plab, mob qog noj ntshav hauv txoj hlab pas, mob qog noj ntshav hauv lub mis, mob qog noj ntshav hauv txoj hlab pas, mob qog noj ntshav hauv zes qe menyuam, thiab mob qog noj ntshav hauv tsev menyuam. Qhov tshwm sim, kev piav qhia, thiab kev kho mob rau cov qog HER2-positive ib tus zuj zus muaj nyob rau hauv Rooj. Tsis ntev los no, kev sib raug zoo tau pom nrog mob qog noj ntshav hauv txoj hlab pas thiab mob qog noj ntshav hauv txoj hlab pas (BTC). Cov neeg mob uas muaj mob qog noj ntshav HER2-positive feem ntau muaj kev kwv yees tsis zoo dua li cov neeg uas muaj mob qog noj ntshav HER2-negative, vim tias cov mob qog noj ntshav no hnyav dua. Txawm li cas los xij, cov tswv yim kho mob tshiab tau pom cov txiaj ntsig zoo.
Qhov kev pom zoo no yog raws li cov txiaj ntsig ntawm kev tshawb fawb tseem ceeb hauv kev kho mob HERIZON-BTC-01 (NCT04466891). Qhov no yog kev tshawb fawb thoob ntiaj teb, ntau lub chaw, qhib-daim ntawv lo, ib sab caj npab, Theem 2b uas tsim los ntsuam xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm zanidamab hauv cov neeg mob uas tau kho ua ntej, tsis tuaj yeem phais tau, HER2-amplified advanced lossis metastatic BTC.
Txoj kev tshawb fawb no tau sau npe rau 87 tus neeg mob BTC, suav nrog 62 tus uas muaj HER2 siab. Cov txiaj ntsig tau qhia tias Zanidatamab monotherapy tau ua pov thawj tias muaj txiaj ntsig zoo hauv kev kho mob hauv cov neeg mob uas tau kho nrog HER2-siab BTC. Tus nqi teb rov qab (ORR) uas tau tshuaj xyuas ywj pheej yog 51.6%, nrog rau lub sijhawm teb nruab nrab (mDoR) ntawm 14.9 lub hlis, qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib (mPFS) ntawm 7.2 lub hlis, thiab qhov nruab nrab ntawm kev ciaj sia tag nrho (mOS) ntawm 18.1 lub hlis.
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: Lub Rau Hli-06-2025