Ma Malaki 16, 2025, ua hoʻolaha ʻo Akeso ua ʻāpono ʻia kāna antibody monoclonal anti-PD-1 i hoʻomohala ponoʻī ʻia, ʻo penpulimab, e ka National Medical Products Administration (NMPA) no ka mālama mua ʻana i ka maʻi ʻaʻai nasopharyngeal recurrent a metastatic paha (NPC) i hui pū ʻia me ka chemotherapy.
ʻO Penpulimab (PD-1 Monoclonal Antibody) i kēia manawa wale nō ka antibody PD-1 monoclonal i hoʻokaʻawale ʻia e hoʻopili ana i ka subtype IgG1 me ka Fc-nulldomain i hoʻololi ʻia, hiki ke hoʻonui maikaʻi i ka pono immunotherapeutic a hōʻemi i nā hopena ʻino e pili ana i ka pale ʻana. Hoʻohana ʻia ia i ka mālama ʻana i nā maʻi nui e like me ke kanesa māmā, lymphoma, kanesa nasopharyngeal, kanesa ate, a me ke kanesa ʻōpū, me ka palekana a me ka pono i hoʻomaikaʻi ʻia e like me ka mea i hōʻike ʻia ma nā haʻawina lapaʻau.
ʻO kēia ka hōʻailona ʻehā i ʻae ʻia no ka penpulimab. Ma waho aʻe o nā hōʻailona ʻelua o ka NPC, ua ʻae ʻia hoʻi ka penpulimab no ka mālama mua ʻana i ka maʻi kanesa māmā squamous non-small cell (NSCLC) i hoʻomohala ʻia ma kahi kūloko a i ʻole metastatic i ka wā e hui pū ʻia me ka chemotherapy, a no ka monotherapy i nā maʻi me ka relapsed a i ʻole refractory classical Hodgkin lymphoma (cHL) i loaʻa mua ma ka liʻiliʻi he ʻelua laina o ka chemotherapy systemic. Eia kekahi, ke nānā ʻia nei kahi noi lāʻau lapaʻau hou (sNDA) no ka penpulimab i hui pū ʻia me ka anlotinib no ka mālama mua ʻana i ka carcinoma hepatocellular holomua (HCC).
Ma mua, ua ʻae ʻia ka penpulimab no ka hoʻohana ʻana ma ke ʻano he lāʻau lapaʻau laina ʻekolu no ka NPC holomua. Me kēia ʻae hou, hāʻawi ʻo penpulimab i kēia manawa i ka uhi lapaʻau piha ma nā pae āpau o NPC, e hāʻawi ana i nā mea maʻi i kahi koho immunotherapy hoʻomau mai ka laina mua a i ka lāʻau lapaʻau laina ʻekolu.
Ma Iune 19, 2024, ua paʻi ka "Signal Transduction and Targeted Therapy" i nā hopena o kahi noiʻi pae II e pili ana i ka mālama ʻana i ka metastatic nasopharyngeal carcinoma i mālama mua ʻia me ka pembrolizumab.
ʻO kēia hoʻokolohua hoʻokahi lima, pae II i mālama ʻia ma waena o 20 mau kikowaena mālama kula kiʻekiʻe ma Kina i hoʻopaʻa inoa i nā maʻi makua me ka metastatic nasopharyngeal carcinoma (NPC) i hāʻule i ʻelua a ʻoi aku paha mau laina o ka chemotherapy systemic ma mua. Ua loaʻa i nā maʻi ka 200-mg penpulimab intravenously i kēlā me kēia 2 pule (4 pule no kēlā me kēia pōʻaiapuni) a hiki i ka holomua ʻana o ka maʻi a i ʻole nā mea ʻawaʻawa hiki ʻole ke hoʻomanawanui. ʻO ka hopena mua ʻo ka objective response rate (ORR) no RECIST (mana 1.1), e like me ka loiloi ʻana e kahi kōmike loiloi radiological kūʻokoʻa. ʻO nā hopena lua i hoʻokomo i ka holomua ʻole o ke ola (PFS) a me ke ola holoʻokoʻa (OS). Hoʻokahi haneli kanakolu mau maʻi i kākau inoa ʻia a he 125 i hiki ke loiloi ʻia ka pono. I ka lā palena ʻikepili (Kepakemapa 28, 2022), ua loaʻa i ka maʻi 1 ka pane piha a ua loaʻa i ka 34 mau maʻi ka pane hapa. ʻO ka ORR he 28.0% (95% CI 20.3–36.7%). Ua paʻa ka pane, me 66.8% i pane mau i 9 mau mahina. He kanakolukumamākolu mau maʻi (26.4%) e mālama ʻia ana. ʻO ka PFS waena a me OS he 3.6 mau mahina (95% CI = 1.9–7.3 mau mahina) a me 22.8 mau mahina (95% CI = 17.1 mau mahina i hiki ʻole ai), kēlā me kēia. He ʻumi (7.6%) mau maʻi i loaʻa i ka papa 3 a ʻoi aku paha nā irAE. Loaʻa iā Penpulimab nā hana anti-tumor hoʻohiki a me nā mea ʻawaʻawa i ʻae ʻia i nā maʻi NPC metastatic i mālama mua ʻia, e kākoʻo ana i ka hoʻomohala lapaʻau hou aʻe ma ke ʻano he lāʻau lapaʻau laina ʻekolu o ka metastatic NPC.
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: ʻApelila-25-2025