I-Finotonlimab ivunyelwe ukusetshenziswa ekwelapheni i-squamous cell carcinoma yekhanda nentamo

Ngomhlaka-8 kuNhlolanja 2025, i-National Medical Products Administration (NMPA) yaseShayina ivumile i-finotonlimab ye-Sinocelltech Group Ltd, i-programmed-death 1 (PD-1) monoclonal antibody (mAb), ukuze isetshenziswe kanye ne-chemotherapy esekelwe eplatinum njengokwelashwa kokuqala kwe-recurrent kanye/noma i-metastatic squamous cell carcinoma yekhanda nentamo.

I-Finotonlimab iyi-antibody ye-monoclonal ye-IgG4 ephinde yahlanganiswa futhi enamalungelo aphelele empahla yobuhlakani. Njengomuthi omusha onelungelo lobunikazi, isakhiwo sayo sama-molecule sihlukile futhi sinezinzuzo zendlela yokusebenza. I-Finotonlimab ibopha i-PD-1 ngokuqina okuphezulu, ivimba ngempumelelo indlela ye-PD-1/PD-L1, ibuyisele futhi ithuthukise umsebenzi wokubulala amasosha omzimba wamaseli e-T, ngaleyo ndlela ivimbele ukukhula kwesimila.

AIsivivinyo sesigaba sesi-3 esingahleliwe, esingaboni kabili sihlole ukusebenza kahle kanye nokuphepha kwe-finotonlimab (SCT-I10A), i-antibody ye-monoclonal yokufa kweseli 1 (PD-1) ehleliwe, ehlanganiswe ne-cisplatin kanye ne-5-fluorouracil (C5F) yokwelashwa kokuqala kwe-R/M HNSCC. Iziguli ezifanelekile (n = 370) zabelwa ngokungahleliwe i-2:1 ukuthola i-finotonlimab kanye ne-C5F (n = 247) noma i-placebo kanye ne-C5F (n = 123). Isiphetho esiyinhloko kwakuwukusinda okuphelele (OS). Eqenjini le-finotonlimab kanye ne-C5F, i-OS yayiyizinyanga ezingu-14.1 (95% isikhathi sokuqiniseka (CI) 11.1–16.4), uma kuqhathaniswa nezinyanga ezingu-10.5 (95% CI 8.1–11.8) eqenjini le-placebo kanye ne-C5F. Isilinganiso sengozi sasingu-0.73 (95% CI 0.57–0.95, P = 0.0165), sihlangabezana nezindinganiso zokuphakama ezichazwe ngaphambilini ze-endpoint eyinhloko. I-Finotonlimab kanye ne-C5F ibonise ukuphakama okukhulu kwe-OS uma kuqhathaniswa ne-C5F yodwa kanye nephrofayili yokuphepha eyamukelekayo ne-R/M HNSCC, isekela ukusetshenziswa kwayo njengenketho yokwelapha yokuqala ye-R/M HNSCC. Le miphumela iqinisekisa ukusebenza kahle nokuphepha kokuhlanganiswa kwe-finotonlimab kanye ne-C5F ezigulini zase-Asia ezine-R/M HNSCC.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

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Izinkomba

1.国家药品监督管理局 (nmpa.gov.cn)

2.I-Finotonlimab ene-chemotherapy kumdlavuza wekhanda nentamo ophindaphindayo noma osakazekile: isivivinyo sesigaba sesi-3 esingahleliwe | Imithi Yemvelo