Musi wa29 Chivabvu, National Medical Products Administration (NMPA) yakabvumidza kutengeswa kweZanidatamab, yakatumirwa neBeiGene, yekurapa varwere vane kenza yemudumbu isingarapike kana kuti ine metastatic biliary tract cancer (BTC) avo vakambogamuchira systemic therapy uye vanoratidza HER2 expression yakakwira (IHC 3+).
Zanidatamab iantibody inoongororwa yeHER2-targeted bispecific iyo inogona kusunga panguva imwe chete ma epitopes maviri asingapindirani eHER2 receptor, anozivikanwa se biparatopic binding. Dhizaini iyi yakasiyana uye kuwedzera kwekubatana kunoita kuti pave nenzira dzakawanda dzekushanda, kusanganisira dual HER2 signal blockade, kubviswa kweHER2 protein kubva pamusoro pesero, uye immune-mediated cytotoxicity inotungamira mukukurudzira anti-bumor activity muvarwere.
Receptor tyrosine-protein kinase, inozivikanwa seHuman Epidermal Growth Factor Receptor 2 (HER2) kana CD340, iri pamusoro pemasero. Puroteni iyi inhengo yemhuri yeEpidermal Growth Factor Receptor (EGFR) uye inonyorwa nejini reErythroblastic oncogene B (ERBB2). Jini reERBB2 rinokosha pakuita zvinhu zvakaita sekupatsanurwa kwemasero, kupatsanurwa, uye kurarama. Kuburikidza nenzira dzakasiyana-siyana dzekutumira mameseji, maHER2 receptors anokurudzira kuwanda kwemasero uye kudzivirira apoptosis (kufa kwemasero kwakarongwa). Zvakakosha kudzora mareceptor aya kudzivirira kukura kwemasero kusingadzoreki. Kenza dzinowedzera kana kuwedzera jini reHER2 dzinonzi HER2-positive malignancies. Jini iri rinoshanda sechiratidzo chakakosha uye chinangwa chikuru chekurapa nemishonga.
Zvisinei, kana HER2 yakawedzerwa kana kuti yakawandisa, kuwanda kwemasero nekupatsanurwa zvisina kutarisirwa kunokurumidza kufambira mberi kwekenza. Kukura uku kana kuwanda kunowanzo kuwanikwa mumhando dzakasiyana dzemamota uye kunogona kuva nehukuru hwakakosha pakurapa kwegomarara risingawanzo tarisirwa kuti ripindure zvakanaka pakurapwa kweHER2.
HER2-positivity inowanikwa mumhando dzakasiyana dzekenza dzemudumbu, dzemudumbu, dzepazamu, dzepahuro, dzeovarian, uye dzemudumbu. Kuwanda, tsananguro, uye mafambiro ekurapa kwekenza dzeHER2-positive yega yega zviri muTable . Munguva pfupi yapfuura, kwakawanikwa hukama nekenza dzepancreas nedzemudumbu (BTC). Varwere vane kenza dzeHER2-positive vanowanzova netariro yakaipa yechirwere ichi zvichienzaniswa nevaya vane kenza dzeHER2-negative, sezvo kenza idzi dzichiri dzakasimba. Zvisinei, nzira itsva dzekurapa dzakaratidza mhedzisiro yakanaka.
Kubvumidzwa uku kwakavakirwa pamhedzisiro yechidzidzo chakakosha chekiriniki cheHERIZIN-BTC-01 (NCT04466891). Ichi chaive chidzidzo chepasi rose, chenzvimbo dzakawanda, chakavhurika, chine ruoko rumwe chete, chePhase 2b chakagadzirirwa kuongorora kushanda uye kuchengetedzeka kwezanidatamab muvarwere vane BTC yakamborapwa, isingabvisike, HER2-amplified advanced kana metastatic.
Chidzidzo ichi chakanyoresa varwere 87 veBTC, kusanganisira 62 vane HER2 expression yakakwira. Zvakabuda zvakaratidza kuti Zanidatamab monotherapy yakaratidza kushanda zvakanaka mukurapa varwere vakamborapwa neHER2-high BTC. Chiyero chekupindura chakasimbiswa chakaongororwa chakazvimirira (ORR) chaive 51.6%, nepakati penguva yekupindura (mDoR) yemwedzi 14.9, pakati pemwedzi 7.2 yekurarama pasina progression (mPFS), uye pakati pemwedzi 18.1 yekurarama (mOS).
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.
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Nguva yekutumira: Chikumi-06-2025