Thaum Lub Kaum Ob Hlis 31st, Tuam Tshoj Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo VYLOYTM (zolbetuximab), ua ke nrog fluoropyrimidine- thiab platinum-muaj chemotherapy, rau thawj kab kev kho mob ntawm cov neeg mob uas muaj cov qog nqaij hlav hauv zos uas tsis tuaj yeem phais lossis metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric lossis gastroesophageal junction (GEJ) adenocarcinoma uas cov qog nqaij hlav yog claudin (CLDN) 18.2 zoo. Zolbetuximab yog thawj NMPA-pom zoo monoclonal antibody los tsom rau cov qog nqaij hlav hauv plab uas qhia txog biomarker CLDN18.2, muab txoj hauv kev kho mob qog nqaij hlav.
NMPA txoj kev pom zoo rau zolbetuximab yog txhawb nqa los ntawm cov ntaub ntawv los ntawm kev sim tshuaj thoob ntiaj teb Theem 3 GLOW thiab SPOTLIGHT uas suav nrog 145 thiab 36 tus neeg mob los ntawm thaj av Suav teb, raws li. Kev sim GLOW tau soj ntsuam zolbetuximab ntxiv rau CAPOX (kev kho mob chemotherapy ua ke uas suav nrog capecitabine thiab oxaliplatin) piv rau placebo ntxiv rau CAPOX. Kev sim SPOTLIGHT tau soj ntsuam zolbetuximab ntxiv rau mFOLFOX6 (kev kho mob ua ke uas suav nrog oxaliplatin, leucovorin thiab fluorouracil) piv rau placebo ntxiv rau mFOLFOX6.
Qhov kev sim SPOTLIGHT tau soj ntsuam zolbetuximab ntxiv rau mFOLFOX6 (kev sib xyaw ua ke uas muaj oxaliplatin, leucovorin thiab fluorouracil) piv rau placebo ntxiv rau mFOLFOX6. Kev kho mob nrog zolbetuximab tau pom tias muaj kev txhim kho tseem ceeb hauv kev ciaj sia tsis muaj kev nce qib (PFS) thiab kev ciaj sia tag nrho (OS) piv rau lwm cov tshuaj kho mob hauv cov neeg mob uas tsim nyog uas muaj mob qog noj ntshav hauv plab thiab GEJ. Hauv qhov kev sim GLOW, PFS nruab nrab ntawm 8.21 lub hlis tau ua tiav nrog zolbetuximab ntxiv rau CAPOX ua thawj kab kev kho mob piv rau 6.80 lub hlis nrog placebo ntxiv rau CAPOX. OS nruab nrab yog 14.39 lub hlis piv rau 12.16 lub hlis hauv cov pab pawg kho mob. Cov txiaj ntsig zoo sib xws tau pom hauv kev sim SPOTLIGHT, qhov twg PFS nruab nrab yog 10.61 lub hlis piv rau 8.67 lub hlis, thiab OS nruab nrab yog 18.23 lub hlis piv rau 15.54 lub hlis, nrog zolbetuximab ntxiv rau mFOLFOX6, piv rau placebo ntxiv rau mFOLFOX6. Hauv ob qho kev sim GLOW thiab SPOTLIGHT, qhov tshwm sim ntawm kev kho mob hnyav thaum muaj xwm txheej tsis zoo (TEAEs) zoo sib xws hauv cov pab pawg kho mob zolbetuximab piv rau cov pab pawg tswj. Cov TEAEs feem ntau uas tau tshaj tawm hauv cov pab pawg kho mob zolbetuximab yog xeev siab, ntuav thiab tsis xav noj mov.
Hauv kev tshuaj xyuas ua ke, qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib yog 9.2 lub hlis hauv pawg zolbetuximab thiab 8.2 lub hlis hauv pawg placebo (qhov piv txwv kev pheej hmoo rau kev nce qib lossis kev tuag, 0.71; 95% kev ntseeg siab [CI], 0.61 txog 0.83). Tag nrho ntawm 377 ntawm 537 tus neeg mob (70.2%) hauv pawg zolbetuximab thiab 424 ntawm 535 tus neeg mob (79.3%) hauv pawg placebo tuag. Qhov nruab nrab ntawm kev ciaj sia tag nrho yog 16.4 lub hlis hauv pawg zolbetuximab thiab 13.7 lub hlis hauv pawg placebo (qhov piv txwv kev pheej hmoo rau kev tuag, 0.77; 95% CI, 0.67 txog 0.89). Cov hom kev kho mob tiv thaiv kab mob qog noj ntshav tom qab ntawd tau sib npaug ntawm cov pab pawg kho mob.
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 Ib Hlis-09-2025