Ngomhla we-10 kweyeSilimela, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) libhengeze ukuba iTrastuzumab Deruxtecan (T-DXd, DS-8201a) icetywayo ukuba inikwe uphononongo oluphambili kunyango lwezigulane zabantu abadala abane-HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma ephucukileyo okanye esasazekileyo abafumene unyango olunye ngaphambili.
KwiSigaba sesiBini sovavanyo lwe-DESTINY-Gastric01, i-DS-8201 iphucule kakhulu amazinga okuphendula kunye nokusinda ngokubanzi kwizigulane ezine-HER2-positive gastric adenocarcinoma (GC) okanye i-gastroesophageal junction (GEJ) adenocarcinoma. Olu vavanyo lubhalise izigulane ezili-125 ezinyangwe nge-DS-8201, zibonisa izinga lokuphendula elichanekileyo (ORR) lama-51%, ixesha eliphakathi lokuphendula (DOR) leenyanga ezili-11.3, kunye nezinga lokulawula izifo (DCR) lama-86%.
Uphononongo lweSigaba sesiThathu se-DESTINY-Gastric04 luvavanye ukusebenza kakuhle kunye nokhuseleko lweTrastuzumab Deruxtecan (6.4 mg/kg) xa kuthelekiswa ne-ramucirumab kunye ne-paclitaxel njengonyango lwesibini kwizigulana ezine-HER2-positive engasuswayo kunye/okanye i-metastatic gastric okanye i-GEJ adenocarcinoma. Iziphumo zibonise ukuba, ukusukela nge-24 ka-Okthobha 2024, iqela le-trastuzumab deruxtecan libonise ukusinda okude kakhulu (OS) (iinyanga ezili-14.7 xa kuthelekiswa neenyanga ezili-11.4, i-HR=0.70, i-P=0.0044) kunye nokusinda okungenankqubela phambili (PFS) (iinyanga ezi-6.7 xa kuthelekiswa neenyanga ezi-5.6). I-ORR nayo yayiphezulu (44.3% xa kuthelekiswa ne-29.1%), njengoko kwakunjalo ne-DCR (91.9% xa kuthelekiswa ne-75.9%).
I-Trastuzumab deruxtecan (eyayisakuba yi-DS-8201), i-antibody-drug conjugate equlathe i-antibody ye-HER2 monoclonal eyenziwe ngumntu edibene ne-topoisomerase I inhibitor payload nge-tetrapeptide-based cleavable linker, ivunyiwe ukunyanga izigulana ezinomhlaza webele we-HER2-positive. Ngokungafaniyo nezinye iindlela zonyango ezivunyiweyo ze-HER2, i-trastuzumab deruxtecan inokuthi ijolise ngempumelelo kwiiseli ze-tumor eziveza amanqanaba aphantsi e-HER2 kwaye inokuhambisa umthwalo wayo onamandla we-cytotoxic (umlinganiselo we-drug-to-antibody, 8:1) ngokusebenzisa i-stander effect kwiiseli ze-tumor ezikufutshane eziveza i-HER2 ngokwahlukileyo.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Ixesha leposi: Juni-19-2025