Ma ka lā 29 o Mei, ua ʻāpono ka National Medical Products Administration (NMPA) i ke kūʻai aku ʻana o Zanidatamab, i waiho ʻia e BeiGene, no ka mālama ʻana i nā maʻi me ka maʻi ʻaʻai biliary tract (BTC) holomua kūloko a i ʻole metastatic i loaʻa mua i ka lāʻau lapaʻau systemic a hōʻike i ka hōʻike HER2 kiʻekiʻe (IHC 3+).
He antibody bispecific i hoʻopaʻa ʻia no ka HER2 ʻo Zanidatamab i hiki ke hoʻopaʻa i ʻelua epitopes non-overlapping o ka mea loaʻa HER2 i ka manawa like, i ʻike ʻia ʻo ka binding biparatopic. ʻO kēia hoʻolālā kū hoʻokahi a me ka hoʻonui ʻana i ka nakinaki ʻana e hopena i nā ʻano hana he nui, me ka pale ʻana i ka hōʻailona HER2 pālua, ka wehe ʻana i ka protein HER2 mai ka ʻili o ke kelepona, a me ka cytotoxicity i hoʻopili ʻia e ka pale ʻana i ka hoʻoikaika ʻana i ka hana antitumor i nā maʻi.
ʻO ka Receptor tyrosine-protein kinase, i ʻike nui ʻia ʻo Human Epidermal Growth Factor Receptor 2 (HER2) a i ʻole CD340, aia ma luna o nā ʻili o nā cell. He lālā kēia protein o ka ʻohana Epidermal Growth Factor Receptor (EGFR) a ua hoʻopili ʻia e ka gene Erythroblastic oncogene B (ERBB2). He mea nui ka gene ERBB2 no nā kaʻina hana maʻamau e like me ka mahele ʻana o ke cell, ka hoʻokaʻawale ʻana, a me ke ola. Ma o nā ala hōʻailona like ʻole, hoʻolaha nā receptors HER2 i ka hoʻonui ʻana o nā cell a kāohi i ka apoptosis (make cell i hoʻolālā ʻia). He mea nui e hoʻoponopono i kēia mau receptors e pale aku i ka ulu ʻana o nā cell i kāohi ʻole ʻia. ʻO nā maʻi kanesa e hoʻonui nui a hoʻonui paha i ka gene HER2 ua kapa ʻia ʻo nā malignancies HER2-positive. Hana kēia gene ma ke ʻano he biomarker koʻikoʻi a he pahuhopu koʻikoʻi no ka lāʻau lapaʻau.
Eia nō naʻe, i ka wā e hoʻonui ʻia ai a i ʻole e hoʻonui nui ʻia ai ka HER2, ʻo ka hoʻonui ʻole ʻia ʻana o nā cell a me ka mahele ʻana e hoʻolalelale i ka holomua o ka maʻi kanesa. ʻIke pinepine ʻia kēia hoʻonui a i ʻole ka hoʻonui nui ʻana ma nā ʻano puʻupuʻu like ʻole a he mea nui paha ka lāʻau lapaʻau no nā maʻi ʻino i manaʻo ʻole ʻia e pane maikaʻi i nā lāʻau anti-HER2.
Loaʻa ka HER2-positivity i nā ʻano maʻi ʻino like ʻole e like me ke kanesa gastric, biliary tract, umauma, esophageal, ovarian, a me ka uterine. Aia nā ʻano hanana, wehewehe, a me nā ʻano lapaʻau no nā puʻupuʻu HER2-positive pākahi ma ka Papa . I kēia manawa, ua ʻike ʻia kahi pilina me nā maʻi ʻaʻai pancreatic a me biliary tract (BTC). ʻOi aku ka maikaʻi ʻole o ka prognosis o nā maʻi me nā maʻi ʻaʻai HER2-positive i hoʻohālikelike ʻia me ka poʻe me nā maʻi ʻaʻai HER2-negative, ʻoiai ʻoi aku ka ikaika o kēia mau maʻi ʻino. Eia nō naʻe, ua hōʻike nā hoʻolālā lapaʻau hou i nā hopena hoʻohiki.
Hoʻokumu ʻia kēia ʻae ʻia ma nā hopena o ke aʻo ʻana lapaʻau koʻikoʻi ʻo HERIZON-BTC-01 (NCT04466891). He haʻawina honua kēia, multicenter, open-label, single-arm, Phase 2b i hoʻolālā ʻia e loiloi i ka pono a me ka palekana o zanidatamab i nā poʻe maʻi me ka BTC holomua a metastatic paha i mālama mua ʻia, hiki ʻole ke hoʻopau ʻia, HER2-amplified.
Ua hoʻopaʻa inoa ke aʻo ʻana i 87 mau maʻi BTC, me 62 me ka hōʻike kiʻekiʻe o HER2. Ua hōʻike nā hopena ua hōʻike ka monotherapy Zanidatamab i ka hopena koʻikoʻi ma ke ʻano lapaʻau i nā maʻi i mālama mua ʻia me ka BTC kiʻekiʻe HER2. ʻO ka helu pane pahuhopu i loiloi kūʻokoʻa ʻia (ORR) he 51.6%, me ka lōʻihi o ka pane (mDoR) o 14.9 mau mahina, kahi ola holomua ʻole (mPFS) o 7.2 mau mahina, a me ka ola holoʻokoʻa (mOS) o 18.1 mau mahina.
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: Iune-06-2025