TEVIMBRA Yavomerezedwa ku US kuti Igwiritsidwe Ntchito Pochiza Khansa Yaikulu ya Esophageal Squamous Cell Carcinoma Pophatikizana ndi Chemotherapy

Pa Marichi 4, 2025, BeiGene idalengeza kuti US Food and Drug Administration (FDA) yavomereza TEVIMBRA(tislelizumab-jsgr), pamodzi ndi chemotherapy yokhala ndi platinum, kuti igwiritsidwe ntchito pochiza akuluakulu omwe ali ndi khansa ya squamous cell carcinoma (ESCC) yosachiritsika kapena yofalikira m'thupi yomwe imatulutsa PD-L1 (≥1).

Chizindikiro chowonjezerachi chikuchokera pa zotsatira za RATIONALE-306 ya BeiGene (NCT03783442), kafukufuku wapadziko lonse wa Gawo 3 wosankhidwa mwachisawawa, wolamulidwa ndi placebo, wosawona mbali ziwiri, kuti awone momwe TEVIMBRA imagwirira ntchito komanso chitetezo chake pamodzi ndi chemotherapy yokhala ndi platinum ngati chithandizo choyamba mwa odwala akuluakulu (n=649) ndi ESCC yosachira, yopitira patsogolo kapena yofalikira. Kafukufukuyu adakwaniritsa cholinga chake chachikulu ndipo adawonetsa kusintha kwakukulu pakupulumuka konse (OS) kwa odwala akuluakulu omwe adasankhidwa mwachisawawa ku TEVIMBRA pamodzi ndi chemotherapy poyerekeza ndi placebo pamodzi ndi chemotherapy. Kusanthula kofufuza kunawonetsa kuti kusintha kwa anthu omwe akufuna kuchiza (ITT) kudachitika makamaka chifukwa cha zotsatira zomwe zidawonedwa m'gulu laling'ono la odwala omwe ali ndi PD-L1 ≥1. Kusanthula kwa OS mwa anthu omwe ali ndi PD-L1 positive (≥1) (n=481) kunawonetsa OS yapakati ya miyezi 16.8 kwa odwala omwe adalandira chithandizo cha TEVIMBRA kuphatikiza chemotherapy poyerekeza ndi miyezi 9.6 kwa odwala omwe adalandira chithandizo cha placebo kuphatikiza chemotherapy (HR: 0.66, [95% CI: 0.53, 0.82]), zomwe zinapangitsa kuti chiopsezo cha imfa chichepe ndi 34%. Zotsatirazi zikuyimira kusintha kwakukulu kwa OS mwa odwala oyamba a ESCC.

Zokhudza TEVIMBRA (tislelizumab-jsgr)®

TEVIMBRA ndi antibody ya immunoglobulin G4 (IgG4) yopangidwa mwapadera yokhala ndi puloteni ya imfa ya maselo 1 (PD-1) yokhala ndi mphamvu yolimba komanso yolumikizana ndi PD-1. Yapangidwa kuti ichepetse kulumikizana ndi ma receptors a Fc-gamma (Fcγ) pa macrophages, kuthandiza maselo a chitetezo cha mthupi kuzindikira ndikulimbana ndi zotupa.

Zokhudza Esophageal Squamous Cell Carcinoma (ESCC)

Padziko lonse lapansi, khansa ya m'mero ​​ndi chifukwa chachisanu ndi chimodzi chomwe chimayambitsa imfa zokhudzana ndi khansa, ndipo ESCC ndiye mtundu wofala kwambiri wa histologic, womwe umawerengera pafupifupi 90% ya khansa ya m'mero. Milandu yatsopano ya khansa ya m'mero ​​yokwana 957,000 ikuyembekezeredwa mu 2040, kuwonjezeka kwa pafupifupi 60% kuchokera mu 2020, zomwe zikugogomezera kufunika kwa chithandizo chowonjezera chogwira mtima.1 Khansa ya m'mero ​​ndi matenda omwe amapha mwachangu, ndipo odwala oposa awiri mwa atatu ali ndi matenda opitirira muyeso kapena ofalikira panthawi yodziwira matendawa, ndipo chiŵerengero cha moyo wa zaka zisanu chikuyembekezeka kukhala chochepera 6% kwa iwo omwe ali ndi matenda akutali.

TEVIMBRA imavomerezedwanso ku US ngati chithandizo cha monotherapy kwa odwala akuluakulu omwe ali ndi khansa ya squamous cell carcinoma yosachira kapena yofalikira pambuyo pa chithandizo cha chemotherapy chomwe sichinaphatikizepo PD-(L)1 inhibitor komanso kuphatikiza ndi chemotherapy pochiza odwala akuluakulu omwe ali ndi khansa ya m'mimba ndi gastroesophageal junction (G/GEJ).

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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Zolemba

1.国家药品监督管理局 (nmpa.gov.cn)

2.百济神州 | 癌症沒有国界。我們也沒有。 (beigene.com)