Musi wa10 Kurume, 2025, Sichuan Kelun-Biotech akazivisa kuti mushonga weKambani we trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, yaimbonzi SKB264/MK-2870) wakatenderwa kutengeswa neNational Medical Products Administration (NMPA) sechiratidzo chechipiri chiri chekurapa varwere vakuru vane epidermal growth factor receptor (EGFR) mutant-positive local advanced kana metastatic non-squamous non-small cell lung cancer (NSCLC) mushure mekufambira mberi kweEGFR-tyrosine kinase inhibitor (TKI) therapy uye platinum-based chemotherapy. Uyu ndiwo mushonga wekutanga weTROP2 ADC wakatenderwa kutengeswa mukenza yemapapu pasi rose. Kana tichienzanisa nemaitiro ekurapa aripo iye zvino, sac-TMT inowedzera zvakanyanya mabhenefiti ekurarama kwevarwere ava.
Kubvumidzwa kwacho kwakavakirwa pakudzidza kwakaitwa munzvimbo dzakawanda, kwakarongeka, kwakadzorwa, uye kwakakosha (OptiTROP-Lung03) kunoongorora kushanda uye kuchengetedzeka kwe sac-TMT monotherapy 5mg/kg vhiki imwe neimwe (Q2W) sejekiseni remutsinga richienzaniswa ne docetaxel yekurapa varwere vane EGFR-mutant NSCLC yakafambira mberi kana kuti yakapararira vakakundikana mushure mekurapwa neEGFR-TKI uye platinum-based chemotherapy (yakashandiswa zvakatevedzana kana pamwe chete). Sezvakaratidzwa muongororo yenguva yakatarwa, sac-TMT monotherapy yakaratidza kuvandudzika kwakakosha uye kune respiratory mu objective response rate (ORR), progression-free survival (PFS) uye overal survival (OS) zvichienzaniswa ne docetaxel.
Nezve sac-TMT
Sac-TMT ikambani itsva yeTROP2 ADC yevanhu umo Kambani ine kodzero dzepfuma yepfungwa, inotarisa bundu repamusoro-soro rakaita seNSCLC, kenza yemazamu (BC), kenza yemudumbu (GC), bundu remadzimai, nezvimwewo. Sac-TMT yakagadzirwa nechinhu chitsva chinosanganisa mutoro wemushonga, inhibitor ye topoisomerase I inobva ku belotecan ine mushonga we antibody-ratio (DAR) we7.4. Sac-TMT inonyatsoona TROP2 pamusoro pemasero ebundu ne recombinant anti-TROP2 humanized monoclonal antibodies, iyo inobva yaiswa mumasero ebundu uye yaburitsa KL610023 mukati memasero. KL610023, semushonga we topoisomerase I, inokonzera kukuvara kweDNA kumasero ebundu, izvo zvinozoita kuti cell-cycle imire uye apoptosis ibude. Pamusoro pezvo, inoburitsawo KL610023 munzvimbo yebundu. Zvichienderana nekuti KL610023 inopindirwa nemembrane, inogona kuita kuti pave nemhedzisiro yekutarisa, kana kuti nemamwe mazwi kuuraya masero egomarara ari pedyo.
Kare, NMPA yakabvumidza kutengeswa kwe sac-TMT muChina kune varwere vakuru vane kenza yemazamu isina kurapwa munharaunda kana metastatic triple negative cancer (TNBC) avo vakamborapwa kaviri kare (kamwe chete kekurapa kwe advanced kana metastatic setting) uye vakabvuma kuwedzerwa kwemushonga mutsva (sNDA) uchitsvaga mvumo ye sac-TMT monotherapy kune varwere vane EGFR-mutant NSCLC vakakundikana mushure mekurapwa neEGFR-TKI.
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: Kurume-20-2025