ʻAukake 29, Ua ʻāpono ʻia ʻo Boehringer Ingelheim's HERNEXEOS® (nā papa zongertinib) ma ke ʻano he monotherapy e ka National Medical Products Administration (NMPA) o Kina no ka mālama ʻana i nā poʻe maʻi makua me ka maʻi kanesa māmā non-small cell lung (NSCLC) hiki ʻole ke hoʻopau ʻia, holomua kūloko a i ʻole metastatic nona nā puʻupuʻu i loaʻa nā mutations HER2 (ERBB2) a ua loaʻa iā lākou ma ka liʻiliʻi hoʻokahi laina o ka lāʻau lapaʻau systemic mua.
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.
Helu Kelepona：4008803716
ʻIkepili WeChat: 17801183037
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Ua hāʻawi ʻia ka ʻae ʻia ʻana ma muli o ka ʻikepili mai ka hoʻokolohua Phase Ib Beamion-LUNG 1 (NCT04886804): He hoʻokolohua hoʻonui dosis Phase I hāmama, me ka hōʻoia ʻana i ka dosis a me ka hoʻonui ʻana, o zongertinib ma ke ʻano he monotherapy i nā poʻe me nā ʻōpū paʻa hiki ʻole ke hoʻopau ʻia a i ʻole metastatic me nā hoʻololi HER2. Loaʻa i ke aʻo ʻana he 2 mau ʻāpana. Ua wehe ʻia ka ʻāpana mua i nā pākeke me nā ʻano maʻi kanesa holomua like ʻole me nā hoʻololi HER2 e komo pū ana me nā mutations, amplifications, over-expression a me nā fusions no ka mea ʻaʻole i holomua ka lāʻau ma mua. Ua wehe ʻia ka ʻāpana ʻelua i nā poʻe me ka maʻi kanesa māmā HER2-mutant non-small cell.
Ma ka hui 1, ua loaʻa i ka huina o 75 mau maʻi ka zongertinib ma kahi mahele o 120 mg. Ma ka ʻoki ʻikepili (Nowemapa 29, 2024), 71% o kēia mau maʻi (95% hilinaʻi waena [CI], 60 a 80; P<0.001 e kūʻē i kahi benchmark ≤30%) i loaʻa kahi pane pahuhopu i hōʻoia ʻia; ʻo ka lōʻihi waena o ka pane he 14.1 mau mahina (95% CI, 6.9 a hiki ʻole ke loiloi ʻia), a ʻo ke ola waena me ka ʻole o ka holomua he 12.4 mau mahina (95% CI, 8.2 a hiki ʻole ke loiloi ʻia). Ua loaʻa nā hanana ʻino e pili ana i ka lāʻau lapaʻau papa 3 a ʻoi aku paha i 13 mau maʻi (17%). Ma ka hui 5 (31 mau maʻi), ua loaʻa i ka 48% o nā maʻi (95% CI, 32 a 65) kahi pane pahuhopu i hōʻoia ʻia. Ua loaʻa nā hanana ʻino e pili ana i ka lāʻau lapaʻau papa 3 a ʻoi aku paha i 1 mau maʻi (3%). Ma ka hui 3 (20 mau maʻi), ua loaʻa i ka 30% o nā maʻi (95% CI, 15 a 52) kahi pane i hōʻoia ʻia. Ua loaʻa nā hanana ʻino e pili ana i ka lāʻau lapaʻau papa 3 a ʻoi aku paha i 5 mau maʻi (25%). Ma nā hui ʻekolu a pau, ʻaʻohe hihia o ka maʻi māmā interstitial e pili ana i ka lāʻau lapaʻau.
"He mea hoʻoikaika ka ʻike ʻana i ka hoʻomau ʻana o ka NMPA i ka ʻike ʻana i ka hiki o ka zongertinib. ʻO ka Breakthrough Therapy Designation no ka hoʻohana mua ʻana o ka zongertinib ma Kina e hōʻike ana i ka pono wikiwiki i kēia heluna maʻi. He hana koʻikoʻi ia e hiki mai ana i ka hoʻolako ʻana i kēia lāʻau lapaʻau i nā poʻe maʻi hou aku e pono ai," wahi a Shashank Deshpande, Luna Hoʻomalu o ka Papa Hoʻokele Hoʻokele ma Boehringer Ingelheim.
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.
Helu Kelepona：4008803716
ʻIkepili WeChat: 17801183037
Email：myimmnet@163.com
Ka manawa hoʻouna: Sep-02-2025