Pa Disembala 31, bungwe la National Medical Products Administration (NMPA) la ku China lavomereza VYLOYTM (zolbetuximab), pamodzi ndi fluoropyrimidine ndi platinum-containing chemotherapy, kuti lipereke chithandizo choyamba kwa odwala omwe ali ndi adenocarcinoma ya gastric or gastroesophageal junction (GEJ) yomwe singathe kuchotsedwa kapena kufalikira kwa matendawa. HER2 (HER2)-negative gastric or gastroesophageal junction (GEJ) yomwe ili ndi zotupa zomwe zili ndi claudin (CLDN) 18.2 positive. Zolbetuximab ndiye antibody yoyamba ya monoclonal yovomerezedwa ndi NMPA yolimbana ndi maselo a chotupa cha m'mimba omwe akuwonetsa chizindikiro cha CLDN18.2, zomwe zimapereka njira yodziwika bwino yochizira khansa.
Kuvomerezedwa kwa NMPA kwa zolbetuximab kumathandizidwa ndi deta yochokera ku mayeso azachipatala apadziko lonse lapansi a Phase 3 GLOW ndi SPOTLIGHT omwe adaphatikizapo odwala 145 ndi 36 ochokera ku China, motsatana. Mayeso a GLOW adayesa zolbetuximab kuphatikiza ndi CAPOX (mankhwala ophatikizana a chemotherapy omwe amaphatikizapo capecitabine ndi oxaliplatin) poyerekeza ndi placebo kuphatikiza ndi CAPOX. Mayeso a SPOTLIGHT adayesa zolbetuximab kuphatikiza ndi mFOLFOX6 (mankhwala ophatikizana omwe amaphatikizapo oxaliplatin, leucovorin ndi fluorouracil) poyerekeza ndi placebo kuphatikiza ndi mFOLFOX6.
Kafukufuku wa SPOTLIGHT adayesa zolbetuximab kuphatikiza mFOLFOX6 (njira yophatikizana yomwe imaphatikizapo oxaliplatin, leucovorin ndi fluorouracil) poyerekeza ndi placebo kuphatikiza mFOLFOX6. Chithandizo cha zolbetuximab chidawonetsedwa kuti chimapereka kusintha kwakukulu pakupulumuka kosapitirira muyeso (PFS) ndi kupulumuka konse (OS) poyerekeza ndi mankhwala ena ochiritsira omwe ali ndi khansa ya m'mimba ndi GEJ. Mu kafukufuku wa GLOW, PFS yapakati ya miyezi 8.21 idakwaniritsidwa ndi zolbetuximab kuphatikiza CAPOX ngati chithandizo choyamba poyerekeza ndi miyezi 6.80 ndi placebo kuphatikiza CAPOX. Opaleshoni yapakati ya OS inali miyezi 14.39 poyerekeza ndi miyezi 12.16 m'magulu ochiritsira. Zotsatira zofanana za mphamvu zinawoneka mu kafukufuku wa SPOTLIGHT, pomwe PFS yapakati inali miyezi 10.61 poyerekeza ndi miyezi 8.67, ndipo OS yapakati inali miyezi 18.23 poyerekeza ndi miyezi 15.54, ndi zolbetuximab kuphatikiza mFOLFOX6, poyerekeza ndi placebo kuphatikiza mFOLFOX6. Mu mayeso onse a GLOW ndi SPOTLIGHT, kuchuluka kwa zochitika zoyipa zomwe zimachitika chifukwa cha chithandizo chachikulu (TEAEs) kunali kofanana m'magulu a chithandizo cha zolbetuximab poyerekeza ndi omwe amawongolera. Ma TEAE omwe amapezeka kwambiri m'magulu onse omwe adanenedwa m'magulu a chithandizo cha zolbetuximab anali nseru, kusanza komanso kuchepa kwa chilakolako.
Mu kusanthula konse, kupulumuka kwapakati popanda kupita patsogolo kunali miyezi 9.2 mu gulu la zolbetuximab ndi miyezi 8.2 mu gulu la placebo (chiŵerengero cha zoopsa pa kupita patsogolo kapena kufa, 0.71; 95% nthawi yodzidalira [CI], 0.61 mpaka 0.83). Odwala onse 377 mwa 537 (70.2%) mu gulu la zolbetuximab ndi 424 mwa odwala 535 (79.3%) mu gulu la placebo anamwalira. Kupulumuka kwapakati kunali miyezi 16.4 mu gulu la zolbetuximab ndi miyezi 13.7 mu gulu la placebo (chiŵerengero cha zoopsa pa imfa, 0.77; 95% CI, 0.67 mpaka 0.89). Mitundu ya mankhwala otsatira oletsa khansa inali yofanana pakati pa magulu ochizira.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Nthawi yotumizira: Januwale-09-2025