I-Finotonlimab ivunyiwe ukuba isetyenziswe kwi-squamous cell carcinoma yentloko nentamo

Ngomhla wesi-8 kuFebruwari 2025, i-National Medical Products Administration (NMPA) yaseTshayina ivumile i-finotonlimab yeSinocelltech Group Ltd, i-programmed-death 1 (PD-1) monoclonal antibody (mAb), ukuba isetyenziswe kunye ne-chemotherapy esekelwe kwi-platinum njengonyango lokuqala lwe-recurrent kunye/okanye i-metastatic squamous cell carcinoma yentloko nentamo.

I-Finotonlimab yi-antibody ye-monoclonal ye-IgG4 ephinda-phindwe ibe ngumntu ene-anti-PD-1 monoclonal enelungelo elipheleleyo lepropathi yobuchopho. Njengeyeza elitsha elinelungelo lobunikazi, ulwakhiwo lwayo lweemolekyuli luhlukile kwaye luneengenelo zendlela yokusebenza. I-Finotonlimab ibopha kwi-PD-1 nge-affinity ephezulu, ivala ngempumelelo indlela ye-PD-1/PD-L1, ibuyisela kwaye iphucula umsebenzi wokubulala amajoni omzimba weeseli ze-T, kwaye ngaloo ndlela ithintela ukukhula kwethumba.

AUvavanyo lwesigaba sesi-3 olucwangcisiweyo, olungaboni kabini luvavanye ukusebenza kakuhle kunye nokhuseleko lwe-finotonlimab (SCT-I10A), i-antibody ye-monoclonal yokufa kweseli 1 (PD-1) ecwangcisiweyo, edityaniswe ne-cisplatin kunye ne-5-fluorouracil (C5F) kunyango lokuqala lwe-R/M HNSCC. Izigulane ezifanelekileyo (n = 370) zabelwa ngokungacwangciswanga i-2:1 ukufumana i-finotonlimab kunye ne-C5F (n = 247) okanye i-placebo kunye ne-C5F (n = 123). Isiphelo esiphambili yayikukusinda ngokupheleleyo (OS). Kwiqela le-finotonlimab kunye ne-C5F, i-OS yayiziinyanga ezili-14.1 (95% isithuba sokuzithemba (CI) 11.1–16.4), xa kuthelekiswa neenyanga ezili-10.5 (95% CI 8.1–11.8) kwiqela le-placebo kunye ne-C5F. Umlinganiselo wengozi yayiyi-0.73 (95% CI 0.57–0.95, P = 0.0165), ihlangabezana neemfuno zokuphakama ezichazwe kwangaphambili zesiphelo sokuqala. I-Finotonlimab kunye ne-C5F ibonise ukuphakama okukhulu kwe-OS xa kuthelekiswa ne-C5F yodwa kwaye iprofayili yokhuseleko eyamkelekileyo ne-R/M HNSCC, ixhasa ukusetyenziswa kwayo njengokhetho lonyango lokuqala lwe-R/M HNSCC. Ezi ziphumo ziqinisekisa ukusebenza kakuhle kunye nokhuseleko lokudibanisa i-finotonlimab kunye ne-C5F kwizigulane zaseAsia ezine-R/M HNSCC.

Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

Inombolo yefowuni: 4008803716

Email：myimmnet@163.com

Iireferensi

1.国家药品监督管理局 (nmpa.gov.cn)

2.I-Finotonlimab ene-chemotherapy kumhlaza wentloko nentamo ophindaphindayo okanye osasazekayo: uvavanyo lwesigaba sesi-3 olucwangcisiweyo | Unyango lweNdalo