Ua ʻae ʻia ʻo Finotonlimab no ka hoʻohana ʻana i ka carcinoma cell squamous poʻo a me ka ʻāʻī

Ma Pepeluali 8, 2025, ua ʻāpono ka National Medical Products Administration (NMPA) o Kina i ka finotonlimab a Sinocelltech Group Ltd, he programmed-death 1 (PD-1) monoclonal antibody (mAb), no ka hoʻohana ʻana me ka chemotherapy platinum-based ma ke ʻano he lāʻau lapaʻau mua no ka recurrent a/a i ʻole metastatic squamous cell carcinoma o ke poʻo a me ka ʻāʻī.

ʻO Finotonlimab kahi antibody monoclonal IgG4 subtype anti-PD-1 recombinant humanized me nā kuleana waiwai noʻonoʻo piha. Ma ke ʻano he lāʻau lapaʻau hou i hoʻopaʻa ʻia, he kū hoʻokahi kona ʻano molekala a he mau pono hana. Hoʻopaʻa ʻo Finotonlimab iā PD-1 me ka pilina kiʻekiʻe, e pale pono ana i ke ala PD-1/PD-L1, e hoʻihoʻi a hoʻoikaika i ka hana pepehi ʻana o nā pūnaewele T, a no laila e pale ana i ka ulu ʻana o ka puʻupuʻu.

AUa loiloi ka hoʻokolohua randomized, double-blind phase 3 i ka pono a me ka palekana o ka finotonlimab (SCT-I10A), kahi antibody monoclonal make cell 1 (PD-1) i hoʻonohonoho ʻia, i hui pū ʻia me cisplatin me 5-fluorouracil (C5F) no ka mālama mua ʻana o R/M HNSCC. Ua hāʻawi ʻia nā mea maʻi kūpono (n = 370) ma ke ʻano random 2:1 e loaʻa iā finotonlimab me C5F (n = 247) a i ʻole placebo me C5F (n = 123). ʻO ke kumu mua ka ola holoʻokoʻa (OS). I ka hui finotonlimab me C5F, ʻo OS he 14.1 mau mahina (95% confidence interval (CI) 11.1–16.4), i hoʻohālikelike ʻia me 10.5 mau mahina (95% CI 8.1–11.8) i ka hui placebo me C5F. ʻO ka lakio pōpilikia he 0.73 (95% CI 0.57–0.95, P = 0.0165), e hoʻokō ana i nā pae hoʻohālikelike i hoʻākāka mua ʻia no ka hopena mua. Ua hōʻike ʻo Finotonlimab me C5F i ka ʻoi aku ka maikaʻi o OS i hoʻohālikelike ʻia me C5F wale nō a me ka ʻaoʻao palekana i ʻae ʻia me R/M HNSCC, e kākoʻo ana i kona hoʻohana ʻana ma ke ʻano he koho lapaʻau laina mua no R/M HNSCC. Hōʻoia kēia mau hopena i ka pono a me ka palekana o ka hui pū ʻana o finotonlimab a me C5F i nā poʻe maʻi ʻAsia me R/M HNSCC.

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

Email：myimmnet@163.com

Nā Kuhikuhi

1.国家药品监督管理局 (nmpa.gov.cn)

2.ʻO Finotonlimab me ka chemotherapy i ka maʻi poʻo a me ka ʻāʻī e hoʻomau hou ʻia a metastatic paha: kahi hoʻokolohua pae 3 randomized | Lapaʻau kūlohelohe