Kua Whakaaetia te Arotake Matua mō te Trastuzumab Deruxtecan i Haina mō te Mate Pukupuku Kōpū Matatau HER2-Pai

I te 10 o Hune, i panuitia e te Center for Drug Assessment (CDE) o te National Medical Products Administration (NMPA) kua whakaarohia kia arotakehia te Trastuzumab Deruxtecan (T-DXd, DS-8201a) mō te maimoatanga o ngā tūroro pakeke e pangia ana e te adenocarcinoma gastric, gastroesophageal junction (GEJ) kua horapa ā-rohe, kua horapa rānei, kua whiwhi i tētahi maimoatanga o mua.

I roto i te whakamātautau Wāhanga II o DESTINY-Gastric01, i tino whakapai ake a DS-8201 i ngā reiti urupare me te oranga whānui i roto i ngā tūroro he HER2-positive gastric adenocarcinoma (GC) he gastroesophageal junction (GEJ) adenocarcinoma rānei. I whakaurua te whakamātautau ki te 125 ngā tūroro i rongoatia ki te DS-8201, e whakaatu ana i te reiti urupare whāinga (ORR) o te 51%, te roanga urupare toharite (DOR) o te 11.3 marama, me te reiti whakahaere mate (DCR) o te 86%.

I arotakehia e te rangahau Wāhanga III DESTINY-Gastric04 te whai huatanga me te haumaru o Trastuzumab Deruxtecan (6.4 mg/kg) me te ramucirumab me te paclitaxel hei maimoatanga tuarua mō ngā tūroro he HER2-pai kāore e taea te tango me/ranei he metastatic gastric adenocarcinoma, he GEJ adenocarcinoma rānei. I whakaatuhia e ngā hua, i te 24 o Oketopa, 2024, i whakaatu te rōpū trastuzumab deruxtecan i te roa o te oranga whānui (OS) (14.7 marama vs. 11.4 marama, HR=0.70, P=0.0044) me te oranga kore-haere (PFS) (6.7 marama vs. 5.6 marama). He teitei ake hoki te ORR (44.3% vs. 29.1%), me te DCR (91.9% vs. 75.9%).

Kua whakaaetia te Trastuzumab deruxtecan (i mua ko te DS-8201), he hononga paturopi-rongoā kei roto he paturopi monoclonal anti-HER2 kua whakawhaiarotia e hono ana ki te kawenga aukati topoisomerase I mā roto i te hononga wehewehe e hangai ana ki te tetrapeptide, mō te maimoatanga o ngā tūroro he mate pukupuku ū metastatic HER2-pai. Kāore i rite ki te maha atu o ngā maimoatanga HER2 kua whakaaetia, ka taea hoki e te trastuzumab deruxtecan te arotahi ki ngā pūtau pukupuku e whakaatu ana i ngā taumata iti o te HER2, ā, ka taea te tuku i tana kawenga cytotoxic kaha (ōwehenga rongoā-ki-paturopi, 8:1) mā roto i te pānga tūmatanui ki ngā pūtau pukupuku tata e whakaatu ana i te HER2.

I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.

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