Ma Iune 10, ua hoʻolaha ke Kikowaena no ka Loiloi Lāʻau Lapaʻau (CDE) o ka National Medical Products Administration (NMPA) ua manaʻo ʻia e hāʻawi ʻia ʻo Trastuzumab Deruxtecan (T-DXd, DS-8201a) i ka loiloi koʻikoʻi no ka mālama ʻana i nā maʻi makua me ka HER2-positive gastric a i ʻole gastroesophageal junction (GEJ) adenocarcinoma kūloko holomua a metastatic paha i loaʻa i hoʻokahi papa hana lapaʻau ma mua.
Ma ka hoʻokolohua Phase II DESTINY-Gastric01, ua hoʻomaikaʻi nui ʻo DS-8201 i nā helu pane a me ke ola holoʻokoʻa i nā poʻe maʻi me HER2-positive gastric adenocarcinoma (GC) a i ʻole gastroesophageal junction (GEJ) adenocarcinoma. Ua hoʻopaʻa inoa ka hoʻokolohua i 125 mau maʻi i mālama ʻia me DS-8201, e hōʻike ana i kahi helu pane objective (ORR) o 51%, kahi lōʻihi waena o ka pane (DOR) o 11.3 mau mahina, a me kahi helu kaohi maʻi (DCR) o 86%.
Ua loiloi ka haʻawina Phase III DESTINY-Gastric04 i ka pono a me ka palekana o Trastuzumab Deruxtecan (6.4 mg/kg) e kū'ē i ka ramucirumab me ka paclitaxel ma ke ʻano he lāʻau lapaʻau laina lua no nā maʻi me ka HER2-positive unresectable a/a i ʻole metastatic gastric a i ʻole GEJ adenocarcinoma. Ua hōʻike nā hopena, e like me ʻOkakopa 24, 2024, ua hōʻike ka hui trastuzumab deruxtecan i kahi ola holoʻokoʻa i hoʻolōʻihi nui ʻia (OS) (14.7 mau mahina vs. 11.4 mau mahina, HR=0.70, P=0.0044) a me ke ola holomua ʻole (PFS) (6.7 mau mahina vs. 5.6 mau mahina). ʻOi aku ke kiʻekiʻe o ka ORR (44.3% vs. 29.1%), e like me ka DCR (91.9% vs. 75.9%).
ʻO Trastuzumab deruxtecan (ʻo DS-8201 ma mua), kahi hui antibody-drug i haku ʻia me kahi antibody monoclonal anti-HER2 humanized i hoʻopili ʻia i kahi ukana inhibitor topoisomerase I ma o kahi linker cleavable i hoʻokumu ʻia i ka tetrapeptide, ua ʻae ʻia no ka mālama ʻana i nā maʻi me ka maʻi ʻaʻai umauma metastatic HER2-positive. ʻAʻole like me nā ʻano lapaʻau HER2 ʻē aʻe i ʻae ʻia, hiki i ka trastuzumab deruxtecan ke kuhikuhi pono i nā cell tumor e hōʻike ana i nā pae haʻahaʻa o HER2 a hiki ke hāʻawi i kāna ukana cytotoxic ikaika (lākiō lāʻau-i-antibody, 8: 1) ma o ka hopena bystander i nā cell tumor kokoke e hōʻike like ʻole ana i ka HER2.
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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Email：myimmnet@163.com
Ka manawa hoʻouna: Iune-19-2025