Finotonlimab tau pom zoo rau kev siv rau hauv lub taub hau thiab caj dab squamous cell carcinoma

Thaum Lub Ob Hlis 8, 2025, Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) ntawm Tuam Tshoj tau pom zoo rau Sinocelltech Group Ltd's finotonlimab, uas yog ib qho tshuaj monoclonal antibody (mAb) uas tau tsim los siv ua ke nrog platinum-based chemotherapy ua thawj txoj kev kho mob rau cov mob qog nqaij hlav squamous cell carcinoma uas rov tshwm sim thiab/lossis metastatic ntawm lub taub hau thiab caj dab.

Finotonlimab yog ib qho tshuaj tiv thaiv kab mob IgG4 subtype anti-PD-1 monoclonal antibody uas muaj cov cai lij choj txog kev txawj ntse tag nrho. Ua ib qho tshuaj tshiab uas tau txais patent, nws cov qauv molecular yog qhov tshwj xeeb thiab muaj cov txiaj ntsig zoo ntawm cov txheej txheem. Finotonlimab khi rau PD-1 nrog kev sib raug zoo siab, thaiv txoj kev PD-1/PD-L1, kho thiab txhim kho kev ua haujlwm tua kab mob ntawm T cell, thiab yog li ntawd tiv thaiv kev loj hlob ntawm qog.

IbKev sim theem 3 uas tau muab faib ua ob pawg, uas yog kev sim tshuaj uas tsis tau muab cais ua pawg, tau soj ntsuam qhov ua tau zoo thiab kev nyab xeeb ntawm finotonlimab (SCT-I10A), uas yog ib qho tshuaj monoclonal antibody uas tau muab tso rau hauv kev kho mob rau cov neeg mob uas muaj mob R/M HNSCC, ua ke nrog cisplatin thiab 5-fluorouracil (C5F) rau kev kho mob thawj kab ntawm R/M HNSCC. Cov neeg mob uas tsim nyog (n = 370) tau raug xaiv los ntawm kev faib ua pawg 2:1 kom tau txais finotonlimab thiab C5F (n = 247) lossis placebo thiab C5F (n = 123). Qhov kawg tseem ceeb yog kev ciaj sia tag nrho (OS). Hauv pawg finotonlimab thiab C5F, OS yog 14.1 lub hlis (95% kev ntseeg siab (CI) 11.1–16.4), piv rau 10.5 lub hlis (95% CI 8.1–11.8) hauv pawg placebo thiab C5F. Tus piv ntawm kev phom sij yog 0.73 (95% CI 0.57–0.95, P = 0.0165), ua tau raws li cov qauv kev ua tau zoo ua ntej rau qhov kawg tseem ceeb. Finotonlimab ntxiv rau C5F tau qhia txog qhov zoo dua ntawm OS piv rau C5F ib leeg thiab cov qauv kev nyab xeeb uas txais tau nrog R/M HNSCC, txhawb nqa nws siv ua thawj kab kev kho mob rau R/M HNSCC. Cov txiaj ntsig no lees paub qhov ua tau zoo thiab kev nyab xeeb ntawm kev sib xyaw ua ke ntawm finotonlimab thiab C5F hauv cov neeg mob Es Xias uas muaj R/M HNSCC.

Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.

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Cov ntaub ntawv siv los ua piv txwv

1.国家药品监督管理局 (nmpa.gov.cn)

2.Finotonlimab nrog kev kho mob qog noj ntshav hauv kev rov tshwm sim lossis metastatic mob qog noj ntshav taub hau thiab caj dab: kev sim theem 3 randomized | Tshuaj Xwm