Ma ka lā 31 o Kēkēmapa, ua ʻāpono ka ʻAha Hoʻokele Huahana Lapaʻau Lahui o Kina (NMPA) iā VYLOYTM (zolbetuximab), i hui pū ʻia me ka chemotherapy fluoropyrimidine- a me platinum-containing, no ka mālama mua ʻana i nā maʻi me ka locally advanced unresectable a metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric a i ʻole gastroesophageal junction (GEJ) adenocarcinoma nona nā tumors he claudin (CLDN) 18.2 positive. ʻO Zolbetuximab ka antibody monoclonal mua i ʻāpono ʻia e NMPA e kuhikuhi i nā cell tumor gastric e hōʻike ana i ka biomarker CLDN18.2, e hāʻawi ana i kahi ala i kuhikuhi nui ʻia i ka mālama ʻana i ka maʻi kanesa.
Ua kākoʻo ʻia ka ʻae ʻana o ka NMPA i ka zolbetuximab e ka ʻikepili mai nā hoʻokolohua lapaʻau honua Phase 3 GLOW a me SPOTLIGHT i hoʻokomo pū ʻia me 145 a me 36 mau maʻi mai ka ʻāina nui o Kina. Ua loiloi ka hoʻokolohua GLOW i ka zolbetuximab me CAPOX (kahi hui chemotherapy e komo pū ana me ka capecitabine a me ka oxaliplatin) i hoʻohālikelike ʻia me ka placebo me CAPOX. Ua loiloi ka hoʻokolohua SPOTLIGHT i ka zolbetuximab me mFOLFOX6 (kahi hui pū ʻana e komo pū ana me ka oxaliplatin, leucovorin a me ka fluorouracil) i hoʻohālikelike ʻia me ka placebo me mFOLFOX6.
Ua loiloi ka hoʻokolohua SPOTLIGHT i ka zolbetuximab me mFOLFOX6 (kahi hui pū ʻana e komo pū ana me ka oxaliplatin, leucovorin a me ka fluorouracil) i hoʻohālikelike ʻia me ka placebo me mFOLFOX6. Ua hōʻike ʻia ka mālama ʻana me zolbetuximab e hāʻawi i nā hoʻomaikaʻi koʻikoʻi i ka hoʻomau ʻana o ke ola (PFS) a me ke ola holoʻokoʻa (OS) i hoʻohālikelike ʻia me nā chemotherapy mālama maʻamau ʻē aʻe i nā poʻe maʻi kūpono me nā maʻi ʻaʻai gastric a me GEJ. I ka hoʻokolohua GLOW, ua hoʻokō ʻia kahi PFS waena o 8.21 mau mahina me zolbetuximab me CAPOX ma ke ʻano he lāʻau lapaʻau mua e kūʻē i 6.80 mau mahina me ka placebo me CAPOX. ʻO ka OS waena he 14.39 mau mahina e kūʻē i 12.16 mau mahina i nā hui lapaʻau. Ua ʻike ʻia nā hopena like o ka hopena ma ka hoʻokolohua SPOTLIGHT, kahi o ka PFS waena he 10.61 mau mahina e kūʻē i 8.67 mau mahina, a ʻo ka OS waena he 18.23 mau mahina e kūʻē i 15.54 mau mahina, me zolbetuximab me mFOLFOX6, i hoʻohālikelike ʻia me ka placebo me mFOLFOX6. Ma nā hoʻokolohua GLOW a me SPOTLIGHT, ua like ka nui o nā hanana ʻino koʻikoʻi (TEAE) i nā hui lapaʻau zolbetuximab i hoʻohālikelike ʻia me nā kaohi. ʻO nā TEAE āpau maʻamau i hōʻike ʻia ma nā hui lapaʻau zolbetuximab he nausea, luaʻi a me ka emi ʻana o ka makemake.
Ma ka loiloi i hui pū ʻia, ʻo ka awelika o ke ola ʻana me ka ʻole o ka holomua he 9.2 mau mahina ma ka hui zolbetuximab a me 8.2 mau mahina ma ka hui placebo (lakio pilikia no ka holomua a i ʻole ka make, 0.71; 95% hilinaʻi waena [CI], 0.61 a 0.83). He 377 o 537 mau maʻi (70.2%) ma ka hui zolbetuximab a me 424 o 535 mau maʻi (79.3%) ma ka hui placebo i make. ʻO ka awelika o ke ola holoʻokoʻa he 16.4 mau mahina ma ka hui zolbetuximab a me 13.7 mau mahina ma ka hui placebo (lakio pilikia no ka make, 0.77; 95% CI, 0.67 a 0.89). Ua kaulike ʻia nā ʻano o nā lāʻau lapaʻau anticancer ma hope ma waena o nā hui lapaʻau.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
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Ka manawa hoʻouna: Ian-09-2025