Kev Txais Daim Ntawv Thov Daim Ntawv Tso Cai Biologics rau TIVDAK rau Kev Kho Mob Cov Neeg Mob uas Muaj Mob Cancer Cervical Cancer Rov Qab Los Los Yog Metastatic

Thaum Lub Peb Hlis 12, 2025, Zai Lab Limited tshaj tawm tias Tuam Tshoj Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau lees txais Daim Ntawv Thov Daim Ntawv Tso Cai Biologics (BLA) rau TIVDAK (tisotumab vedotin-tftv) rau kev kho mob rau cov neeg mob uas muaj mob qog nqaij hlav rov tshwm sim lossis kis mus rau lwm qhov nrog kev nce qib ntawm tus kab mob rau lossis tom qab kev kho mob thoob plaws.

Cov ntaub ntawv xa mus rau BLA tau txais kev txhawb nqa los ntawm cov txiaj ntsig los ntawm kev sim tshuaj thoob ntiaj teb, randomized, Theem 3 innovaTV 301 (NCT04697628) thiab cov txiaj ntsig los ntawm Suav teb cov pej xeem ntawm txoj kev tshawb fawb no.

Tag nrho muaj 502 tus neeg mob tau raug xaiv los ntawm kev xaiv (253 tus tau raug xaiv rau pawg tisotumab vedotin thiab 249 tus rau pawg chemotherapy); cov pawg zoo sib xws hais txog cov yam ntxwv ntawm cov neeg mob thiab tus kab mob. Qhov nruab nrab ntawm kev ciaj sia ntev dua hauv pawg tisotumab vedotin dua li hauv pawg chemotherapy (11.5 lub hlis [95% kev ntseeg siab {CI}, 9.8 txog 14.9] vs. 9.5 lub hlis [95% CI, 7.9 txog 10.7]), cov txiaj ntsig uas sawv cev rau 30% qis dua kev pheej hmoo ntawm kev tuag nrog tisotumab vedotin dua li nrog chemotherapy (qhov piv txwv txaus ntshai, 0.70; 95% CI, 0.54 txog 0.89; ob sab P = 0.004). Qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib yog 4.2 lub hlis (95% CI, 4.0 txog 4.4) nrog tisotumab vedotin thiab 2.9 lub hlis (95% CI, 2.6 txog 3.1) nrog chemotherapy (qhov piv txwv txaus ntshai, 0.67; 95% CI, 0.54 txog 0.82; ob sab P<0.001). Qhov feem pua ​​​​​​ntawm kev teb tau lees paub yog 17.8% hauv pawg tisotumab vedotin thiab 5.2% hauv pawg chemotherapy (qhov sib piv, 4.0; 95% CI, 2.1 txog 7.6; ob sab P<0.001). Tag nrho ntawm 98.4% ntawm cov neeg mob hauv pawg tisotumab vedotin thiab 99.2% hauv pawg chemotherapy muaj tsawg kawg ib qho xwm txheej tsis zoo uas tshwm sim thaum lub sijhawm kho mob (txhais tau tias yog lub sijhawm txij li hnub 1 ntawm koob tshuaj 1 txog 30 hnub tom qab koob tshuaj kawg); qib 3 lossis cov xwm txheej loj dua tau tshwm sim hauv 52.0% thiab 62.3%, raws li. Tag nrho ntawm 14.8% ntawm cov neeg mob tau tso tseg kev kho mob tisotumab vedotin vim muaj cov teebmeem lom.

Txog TIVDAK (tisotumab vedotin-tftv)

TIVDAK (tisotumab vedotin) yog ib qho tshuaj antibody-drug conjugate (ADC) uas muaj Genmab's human monoclonal antibody uas taw qhia rau cov ntaub so ntswg (TF) thiab Pfizer's ADC technology uas siv protease-cleavable linker uas txuas cov microtubule-disrupting agent monomethyl auristatin E (MMAE) rau cov antibody. Cov ntaub ntawv tsis yog clinical qhia tias cov tshuaj anticancer activity ntawm tisotumab vedotin yog vim muaj kev sib txuas ntawm ADC rau TF-expressing cells, ua raws li kev sib xyaw ntawm ADC-TF complex, thiab tso tawm ntawm MMAE ntawm proteolytic cleavage. MMAE cuam tshuam rau microtubule network ntawm cov cell faib ua haujlwm, ua rau lub voj voog cell nres thiab apoptotic cell tuag. Hauv vitro, tisotumab vedotin kuj tseem cuam tshuam cov antibody-dependent cellular phagocytosis thiab antibody-dependent cellular cytotoxicity.

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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Cov ntaub ntawv siv los ua piv txwv

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.https://cn.zailaboratory.com/

3.Tisotumab Vedotin ua Kev Kho Mob Kab Mob Qog Ncauj Tsev Me Nyuam Rov Qab Los | New England Journal of Medicine (nejm.org)