I te 10 o Poutū-te-rangi, 2025, i panuitia e Sichuan Kelun-Biotech kua whakaaetia te trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, i mua ko SKB264/MK-2870) a te Kamupene kia hokohokohia e te National Medical Products Administration (NMPA) mō te tohu tuarua, arā, mō te maimoatanga o ngā tūroro pakeke me te mate pukupuku pūkahukahu epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous non-smamous cell (NSCLC) whai muri i te whanaketanga o te rongoā EGFR-tyrosine kinase inhibitor (TKI) me te chemotherapy platinum-based. Koinei te rongoā TROP2 ADC tuatahi kua whakaaetia kia hokohokohia i roto i te mate pukupuku pūkahukahu puta noa i te ao. Ki te whakatauritea ki te paerewa tiaki o nāianei, ka nui ake te painga o te sac-TMT ki te oranga whānui o ēnei tūroro.
Ko te whakaaetanga i ahu mai i tētahi rangahau maha-pokapū, matapōkeretia, whakahaeretia, matua (OptiTROP-Lung03) e aromatawai ana i te whai huatanga me te haumaru o te sac-TMT monotherapy 5mg/kg ia wiki tuarua (Q2W) hei werohanga uaua ki te docetaxel mō te maimoatanga o ngā tūroro he EGFR-mutant NSCLC kua horapa, kua horapa rānei, kua rahua i muri i te maimoatanga me te EGFR-TKI me te chemotherapy e hangai ana ki te platinum (e whakamahia ana i te raupapatanga, i te whakakotahitanga rānei). E ai ki te whakaaturanga i roto i tētahi tātaritanga wā poto kua tohua i mua, i whakaatu te sac-TMT monotherapy i tētahi whakapainga nui me te whai tikanga haumanu i roto i te reiti urupare whāinga (ORR), te oranga kore-haere (PFS) me te oranga whānui (OS) ki te whakataurite ki te docetaxel.
Mō sac-TMT
He TROP2 ADC tangata hou a Sac-TMT, kei a te Kamupene ngā mana pupuri ā-hinengaro, e aro ana ki ngā pukupuku totoka matatau pērā i te NSCLC, te mate pukupuku ū (BC), te mate pukupuku puku (GC), ngā pukupuku wahine, me ētahi atu. Kua whakawhanakehia a Sac-TMT me tētahi hononga hou hei hono i te kawenga, he aukati topoisomerase I belotecan-derivative me te ōwehenga rongoā-ki-te-antibody (DAR) o te 7.4. Ka mōhio motuhake a Sac-TMT ki a TROP2 i runga i te mata o ngā pūtau pukupuku mā roto i ngā paturopi monoclonal anti-TROP2 recombinant, ka whakapūmautia e ngā pūtau pukupuku ka tukuna a KL610023 ki roto i te pūtau. Ko KL610023, hei aukati topoisomerase I, ka puta te kino o te DNA ki ngā pūtau pukupuku, ka arahi ki te aukati huringa pūtau me te apoptosis. Hei tāpiri, ka tukuna hoki a KL610023 ki roto i te taiao moroiti pukupuku. I te mea he uruhanga ā-kiri te KL610023, ka taea e ia te whakahohe i tētahi pānga tūmatanui, arā, te patu i ngā pūtau pukupuku e tata ana.
I mua, kua whakaaetia e te NMPA te hokohoko o te sac-TMT i Haina mō ngā tūroro pakeke e pāngia ana e te mate pukupuku ū kua horapa ā-rohe, kua horapa rānei, ā, kua whiwhi i te iti rawa e rua ngā maimoatanga pūnaha o mua (kotahi mō te horopaki kua horapa, kua horapa rānei) ā, kua whakaae ki tētahi tono rongoā hou tāpiri (sNDA) e rapu ana i te whakaaetanga o te sac-TMT monotherapy mō ngā tūroro e pāngia ana e te NSCLC EGFR-mutant kua rahua i muri i te maimoatanga EGFR-TKI.
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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Wā tuku: Maehe-20-2025