Musi wa29 Chivabvu, National Medical Products Administration (NMPA) yakabvumidza mushonga weHER2-targeted antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) wekutengesa. Unoratidzwa semushonga mumwe chete wekurapa varwere vakuru vane kenza yemapapu isingabvisike kana kuti metastatic non-small cell lung cancer (NSCLC) ine shanduko dzinoita kuti HER2 (ERBB2) ishande uye vakamborapwa kamwe chete kare. Uyu ndiwo mushonga wekutanga weADC wakagadzirwa neChina wakatenderwa kuvarwere vane HER2-mutated NSCLC, uchipa nzira itsva yekurapa varwere ava.
Kubvumidzwa uku kwakavakirwa pakudzidza kwakakosha kweHORIZON-Lung, kwakatungamirirwa naProfessor Lu Shun vekuShanghai Chest Hospital.
Chidzidzo cheHORIZON-Lung iongororo yekiriniki yePhase I/II yakavhurika, yakavhurika, inotungamirwa nechikwata chaProfessor Lu Shun kuShanghai Chest Hospital. Chikamu chePhase I chaive nechinangwa chekuona kuti mushonga wetrastuzumab rezetecan unobvumirwa sei (MTD) uye kuongorora kushanda kwawo kwekutanga uye kuchengetedzeka kwawo muvarwere vane HER2-mutated NSCLC. Dhizaini yechidzidzo ichi yaisanganisira kuwedzera kwemushonga uye kuwedzera kwemushonga. Muchikamu chePhase I, trastuzumab rezetecan yakaratidza kushanda kwekutanga kwekurwisa bundu uye kuchengetedza kwakanaka. Chidzidzo chePhase II chakagadzirwa kuti chiongorore kushanda uye kuchengetedzeka kwemushonga wetrastuzumab rezetecan muvarwere vane HER2-mutated NSCLC.
Varwere vanosvika makumi mapfumbamwe nevana vakazopedzisira vanyoreswa muchidzidzo ichi. Zvakabuda zvakaratidza kuti chiyero chekupindura chakanangana (ORR), sezvakaongororwa neIndependent Review Committee (IRC), chaive 74.5%, nechiyero chekudzora chirwere (DCR) che98.9%. Nguva yepakati yekupindura (DoR) yaive mwedzi 9.8. Ongororo dzeboka diki dzakaratidza kuti kushanda kwetrastuzumab rezetecan kwaienderana mumapoka akasiyana evarwere, zvisinei nekurapwa kwekare kweanti-HER2 tyrosine kinase inhibitor (TKI) kana kuvapo kwehutachiona hwekutanga hweuropi.
Kurarama kweIRC-assessed progression-free survival (PFS) kwakaratidza avhareji yePFS yemwedzi 11.5, ine mwero wePFS wemwedzi 12 we48.6%. PFS yemuongorori-assessed (INV) yaive mwedzi 12.5, ine mwero wePFS wemwedzi 12 we51.4%.
Ruzivo rwese rwehupenyu (OS) harusati rwakura, neavhareji yeOS isati yasvika uye chiyero cheOS chemwedzi gumi nemiviri che88.2%.
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-04-2025