Musi wa4 Kurume, 2025, BeiGene yakazivisa kuti US Food and Drug Administration (FDA) yabvumidza TEVIMBRA(tislelizumab-jsgr), pamwe chete ne platinum-containing chemotherapy, yekurapa kwekutanga kwevanhu vakuru vane unrepactable kana metastatic esophageal squamous cell carcinoma (ESCC) vane mamota anoratidza PD-L1 (≥1).
Chiratidzo chekuwedzera chakavakirwa pamhedzisiro kubva kuRATIONALE-306 yaBeiGene (NCT03783442), chidzidzo chepasi rose chePhase 3 chakarongwa, chakadzorwa ne placebo, chisina kupofumadzwa kaviri, chekuongorora kushanda uye kuchengetedzeka kweTEVIMBRA pamwe chete ne platinum-containing chemotherapy senzira yekutanga yekurapa varwere vakuru (n=649) ne ESCC isingarapwe, inodzokororwa munharaunda kana metastatic. Chidzidzo ichi chakasvika pakuguma kwacho kukuru uye chakaratidza kuvandudzika kwakakosha mukurarama kwese (OS) kwevarwere vakuru vakangotorwa neTEVIMBRA pamwe chete ne chemotherapy zvichienzaniswa ne placebo pamwe chete ne chemotherapy. Ongororo dzekutsvaga dzakaratidza kuti kuvandudzika kwevanhu vanozvipira kurapwa (ITT) kwakakonzerwa zvakanyanya nemigumisiro yakaonekwa muboka diki revarwere vane PD-L1 ≥1. Kuongororwa kweOS muhuwandu hwevanhu vane PD-L1 positive (≥1) (n=481) kwakaratidza kuti OS yaive yemwedzi 16.8 kune varwere vakarapwa neTEVIMBRA pamwe nechemotherapy zvichienzaniswa nemwedzi 9.6 kune varwere vakarapwa neplacebo pamwe nechemotherapy (HR: 0.66, [95% CI: 0.53, 0.82]), zvichikonzera kudzikira kwe34% munjodzi yekufa. Mhedzisiro iyi inomiririra kuvandudzika kusati kwamboitika muOS muvarwere vekutanga veESCC.
Nezve TEVIMBRA (tislelizumab-jsgr)®
TEVIMBRA i immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody yakagadzirwa nevanhu ine hukama hwakakura uye hukama hwakanangana nePD-1. Yakagadzirirwa kuderedza kubatana kune Fc-gamma (Fcγ) receptors pama macrophages, zvichibatsira masero emuviri ekudzivirira chirwere kuona nekurwisa bundu.
Nezve Esophageal Squamous Cell Carcinoma (ESCC)
Pasi rose, kenza yemudumbu ndiyo inonyanya kukonzera rufu runokonzerwa nekenza, uye ESCC ndiyo inonyanya kukonzera histologic subtype, ichikonzera 90% yekenza yemudumbu. Vanhu vanosvika 957,000 vanonzi vane kenza yemudumbu vanorwara muna 2040, kuwedzera kweinenge 60% kubva muna 2020, zvichiratidza kudiwa kwemamwe marapirwo anoshanda.1 Kenza yemudumbu chirwere chinouraya nekukurumidza, uye vanopfuura zvikamu zviviri muzvitatu zvevarwere vane chirwere chakanyanya kana kuti chakapararira panguva yekuongororwa, uye huwandu hwekurarama hunotarisirwa huri pasi pe6% kune avo vane chirwere chiri kure.
TEVIMBRA inotenderwawo muUS senzira yekurapa varwere vakuru vane chirwere chegomarara remudumbu chisingabvisike kana kuti chinopararira mumuviri mushure mekurapwa kwechirwere chegomarara remudumbu chakanga chisina PD-(L)1 inhibitor uye pamwe chete nechemotherapy yekurapa vanhu vakuru vane gomarara remudumbu neremudumbu (G/GEJ).
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Email：myimmnet@163.com
Mareferensi
2.百济神州 |癌症沒有国界。我們也沒有。 (beigene.com)
Nguva yekutumira: Kurume-10-2025