Thaum Lub Rau Hli 04, 2025, Akeso tshaj tawm tias Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo rau lub tuam txhab thawj zaug hauv chav kawm PD-1 / CTLA-4 bispecific antibody, cadonilimab, rau kev kho mob thawj kab ntawm mob qog nqaij hlav caj dab, rov tshwm sim, lossis metastatic, ua ke nrog platinum-based chemotherapy, nrog lossis tsis muaj bevacizumab. Kev pom zoo NMPA yog qhov cim qhia thib peb pom zoo rau cadonilimab.
Kev pom zoo rau kev siv cadonilimab ua ke nrog kev kho mob chemotherapy (nrog lossis tsis muaj bevacizumab) hauv kab mob qog nqaij hlav thawj zaug yog raws li cov ntaub ntawv kho mob los ntawm kev tshawb fawb theem III COMPASSION-16 (AK104-303).
Hauv qhov kev sim theem 3 uas tau xaiv los ntawm cov kws kho mob, ob leeg dig muag, ntau lub chaw, thiab tswj los ntawm cov tshuaj placebo no, cov poj niam hnub nyoog 18-75 xyoo thoob plaws 59 qhov chaw kho mob hauv Suav teb uas tau kho mob qog nqaij hlav uas tsis tau kho dua, rov tshwm sim dua, lossis kis mus rau lwm qhov tau raug xaiv los ntawm cov kws kho mob (1:1) kom tau txais cadonilimab (10 mg/kg) lossis placebo ntxiv rau platinum-based chemotherapy nrog lossis tsis muaj bevacizumab txhua 3 lub lis piam rau rau lub voj voog, ua raws li kev kho mob txhua 3 lub lis piam rau txog 2 xyoos. Kev xaiv los ntawm cov kws kho mob tau ua tiav hauv nruab nrab los ntawm kev sib tham hauv web-response system. Cov yam ntxwv ntawm kev faib tawm yog kev siv bevacizumab (yog lossis tsis yog) thiab kev kho mob chemoradiotherapy ua ke yav dhau los (yog lossis tsis yog). Cov txiaj ntsig ob qho tib si yog kev ciaj sia tsis muaj kev nce qib raws li kev ntsuas los ntawm kev tshuaj xyuas hauv nruab nrab tsis pom kev thiab kev ciaj sia tag nrho hauv cov txheej txheem tshuaj xyuas tag nrho.
Hauv COMPASSION-16, kev kho mob cadonilimab ua ke tau qhia txog qhov txiaj ntsig zoo rau cov neeg mob uas muaj qog nqaij hlav uas muaj qhov tsis zoo ntawm PD-L1 (CPS <1), suav nrog 27.9% ntawm cov pej xeem hauv pawg kho mob, piv rau 24.2% hauv pawg tswj. Kev tshawb fawb tau ntsib ob qho tib si kev ciaj sia tsis muaj kev nce qib (PFS) thiab kev ciaj sia tag nrho (OS), qhia txog kev txhim kho tseem ceeb hauv ob qho tib si rau cov neeg mob uas tau kho nrog kev kho mob cadonilimab piv rau cov kev kho mob txheem hauv kab thawj zaug rau mob qog nqaij hlav hauv tsev menyuam.
Cov kev tshuaj xyuas pawg me los ntawm kev tshawb fawb COMPASSION-16 qhia tau hais tias ob qho tib si PD-L1-positive thiab PD-L1-negative cov pej xeem, tsis hais txog bevacizumab suav nrog, tau txais txiaj ntsig los ntawm kev kho mob. Cov txiaj ntsig ntawm kev sim COMPASSION-16 tau nthuav tawm ua Late-Breaking Abstract (LBA) ntawm 2024 International Gynecologic Cancer Society (IGCS) Global Meeting, thiab tom qab ntawd tau luam tawm hauv The Lancet thiab tom qab ntawd tau tshaj tawm dua hauv Nature Reviews Clinical Oncology.
Kev txhais lus
Qhov ntxiv ntawm cadonilimab rau hauv thawj kab kev kho mob chemotherapy tau txhim kho qhov muaj sia nyob tsis muaj kev nce qib thiab kev muaj sia nyob tag nrho nrog rau qhov kev nyab xeeb uas tswj tau hauv cov neeg koom nrog uas muaj mob qog nqaij hlav caj dab uas pheej rov qab los, rov tshwm sim, lossis kis mus rau lwm qhov. Cov ntaub ntawv txhawb nqa kev siv cadonilimab ntxiv rau chemotherapy ua ib txoj kev kho mob thawj kab zoo hauv kev mob qog nqaij hlav caj dab uas pheej rov tshwm sim, rov tshwm sim, lossis kis mus rau lwm qhov.
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