Ma ka lā 29 o Mei, ua ʻāpono ka National Medical Products Administration (NMPA) i ka HER2-targeted antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) no ke kūʻai aku ʻana. Ua hōʻike ʻia ia he monotherapy no ka mālama ʻana i nā poʻe maʻi makua me ka maʻi kanesa māmā non-small cell lung cancer (NSCLC) hiki ʻole ke hoʻopau ʻia ma kahi o ka poʻe i loaʻa nā mutations HER2 (ERBB2) a ua loaʻa iā lākou ma ka liʻiliʻi hoʻokahi ʻōnaehana lapaʻau mua. ʻO kēia ka ADC mua i hoʻomohala ʻia ma Kina i ʻāpono ʻia no nā poʻe maʻi me ka HER2-mutated NSCLC, e hāʻawi ana i kahi koho therapeutic hou no kēia heluna maʻi.
Ua hoʻokumu ʻia ka ʻāpono ʻia ma ke aʻo koʻikoʻi ʻo HORIZON-Lung, i alakaʻi ʻia e Polofesa Lu Shun mai ka Shanghai Chest Hospital.
ʻO ke aʻo ʻana ʻo HORIZON-Lung he hoʻokolohua lapaʻau multicenter, open-label, Phase I/II i alakaʻi ʻia e ka hui a Polofesa Lu Shun ma ka Halemai ʻo Shanghai Chest. ʻO ka manaʻo o ka ʻāpana Phase I e hoʻoholo i ka nui o ka lāʻau lapaʻau i ʻae ʻia (MTD) o trastuzumab rezetecan a loiloi i kona pono mua a me ka palekana i nā poʻe maʻi me ka HER2-mutated NSCLC. Ua komo pū ka hoʻolālā aʻo ʻana i nā pae dose-escalation a me ka dose-expansion. Ma ka ʻāpana Phase I, ua hōʻike ʻo trastuzumab rezetecan i ka hana anti-tumor mua a me kahi ʻano palekana maikaʻi. Ua hoʻolālā ʻia ke aʻo ʻana Phase II e loiloi hou aku i ka pono a me ka palekana o trastuzumab rezetecan i nā poʻe maʻi me ka HER2-mutated NSCLC.
Ua kākau inoa ʻia he 94 mau maʻi i loko o ke aʻo ʻana. Ua hōʻike nā hopena ʻo ka helu pane pahuhopu (ORR), e like me ka loiloi ʻana a ke Kōmike Loiloi Kūʻokoʻa (IRC), he 74.5%, me ka helu kaohi maʻi (DCR) o 98.9%. ʻO ka lōʻihi waena o ka pane (DoR) he 9.8 mau mahina. Ua hōʻike nā loiloi subgroup ua kūlike ka pono o ka trastuzumab rezetecan ma nā subgroups maʻi like ʻole, me ka nānā ʻole i ka mālama mua ʻana o ka anti-HER2 tyrosine kinase inhibitor (TKI) a i ʻole ke alo o nā metastases lolo baseline.
Ua hōʻike ka IRC-assessed progression-free survival (PFS) i kahi PFS waena o 11.5 mau mahina, me ka helu PFS 12 mahina o 48.6%. ʻO ka PFS i loiloi ʻia e ka mea noiʻi (INV) he 12.5 mau mahina, me ka helu PFS 12 mahina o 51.4%.
ʻAʻole i oʻo ka ʻikepili ola holoʻokoʻa (OS), ʻaʻole i hiki i ka OS waena a me ka helu OS 12 mahina o 88.2%.
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-04-2025