E hoʻokomo ʻia ʻo PLB1004 i loko o ka breakthrough therapy

ʻO PLB1004, i hoʻomohala ʻia e Beijing Avistone Biotechnology Co., Ltd., he mea palekana, koho kiʻekiʻe, a me ka pono ʻole o ka irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) i hoʻohana ʻia no ka mālama ʻana i ka maʻi kanesa non-small-cell-lung (NSCLC).

Ma ʻApelila 9, 2025, ua hōʻike ka National Medical Products Administration Drug Evaluation Center (CDE) ua manaʻo ʻia ʻo PLB1004 o Beijing Avistone Biotechnology e hoʻokomo ʻia i loko o ka lāʻau lapaʻau holomua no nā poʻe maʻi me ka maʻi kanesa māmā non-small cell locally advanced a i ʻole METastatic (NSCLC) nona ka mutation EGFR, met amplification a/a i ʻole overexpression ma hope o ka hāʻule ʻana o ka lāʻau EGFR-TKI.

Ua hoʻolaha ʻia nā hopena lapaʻau mua o PLB1004 i hui pū ʻia me Vebreltinib i ka mālama ʻana i nā poʻe maʻi maʻi kanesa māmā ʻaʻole liʻiliʻi me nā hoʻololi EGFR, MET amplification a i ʻole MET overexpression ma hope o EGFR-TKI ma ka 2024 World Conference on Lung Cancer.

Ua loaʻa i nā maʻi he kanahākūmāhā ʻo Vebreltinib 100mg me PLB1004 160mg (n=15), Vebreltinib 150mg me PLB1004 160mg (n=13), Vebreltinib 200mg me PLB1004 80mg (n=3), a i ʻole Vebreltinib 150mg me PLB1004 80mg (n=13) a ua hoʻokomo ʻia i loko o ka loiloi palekana holoʻokoʻa. Ma waena o nā maʻi he 44 i loiloi ʻia, 36.4% o nā maʻi i loaʻa nā metastases o ka lolo a 86.4% o nā maʻi i loaʻa mua i ka hanauna ʻekolu o EGFR-TKI, kēlā me kēia. Ua loaʻa nā pane kūʻokoʻa ma nā pae dose āpau o Vebreltinib a me PLB1004 i hoʻāʻo ʻia, me nā pane hapa (PRs) i ʻike ʻia ma 19/32 (59.4%) mau maʻi i hiki ke loiloi ʻia e ka pane. Ma waena o nā maʻi me nā metastases o ka lolo, ʻo ka ORR he 75.0% (9/12). ʻO ka ORR he 58.6% (17/29) i nā poʻe maʻi i loaʻa i ka hanauna ʻekolu o EGFR-TKI. ʻO nā TRAE maʻamau ka ʻulaʻula a me ka paronychia. ʻAʻohe poʻe maʻi i hoʻōki i ka mālama ʻana ma muli o nā TRAE.

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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