I te 17 o Hūrae, i panuitia e te Center for Drug Assessment (CDE) o te National Medical Products Administration (NMPA) kua whakaaetia mana e te NMPA te tono hokohoko mō te Trastuzumab Deruxtecan (Enhertu®) mō te maimoatanga raina tuarua o te mate pukupuku puku. Ko te kaupapa o tēnei tono he maimoatanga mō ngā tūroro pakeke me te HER2-positive gastric, gastroesophageal junction adenocarcinoma rānei i te tautuhinga raina tuarua.
Ko te ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki i te US anake) he ADC e arohia ana e te HER2. I hangaia mā te whakamahi i te Hangarau DXd ADC motuhake a Daiichi Sankyo, ko te ENHERTU te ADC matua i roto i te putea oncology a Daiichi Sankyo me te kaupapa tino matatau i roto i te tūāpapa pūtaiao ADC a AstraZeneca. Kei roto i te ENHERTU he paturopi monoclonal HER2 e piri ana ki te maha o ngā kawenga aukati topoisomerase I (he exatecan derivative, DXd) mā roto i ngā hononga tapahi e hangai ana ki te tetrapeptide.
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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Ko te nuinga o tēnei tono rārangi e ahu mai ana i ngā hua whai hua ā-tatauranga me ngā hua whai hua haumanu o te rangahau DESTINY-Gstric04 (i whakaaturia ki te Huihuinga ASCO o te American Society of Clinical Oncology i te tau 2025).
DESTINY-Gastric04 (NCT04704934), he rangahau ā-ao, matapōkeretia, maha-pokapū, tuwhera-tapanga, wāhanga 3 e aromatawai ana i te whai huatanga me te haumaru o te T DXd vs RAM + PTX i roto i ngā tāngata me te HER2+ kāore e taea te tango/metastatic GC/GEJA i tēnei tautuhinga raina tuarua.
Ngā Tikanga:
I muri i te whakaūnga o te tūnga HER2+ i te koiora (IHC 3+, IHC 2+/ISH+ rānei), ka matapōkeretia ngā tohu 1:1 ki te T-DXd 6.4 mg/kg, RAM + PTX rānei. Ko te mutunga tuatahi ko te oranga whānui (OS). I whakaritea te OS i waenga i ngā ringa e rua mā te whakamātautau log-rank i whakarōpūtia mā te whakamahi i ngā āhuatanga matapōkeretia. Ko ngā mutunga tuarua mā te aromatawai a te kairangahau ko te oranga kore-haere whakamua (PFS), te reiti urupare whāinga kua whakaūtia (cORR), te reiti whakahaere mate (DCR), me te haumaru.
Ngā Hua:
I te wā i mutu ai ngā raraunga (Oketopa 24, 2024), i tohua he 494 ngā tohu (T-DXd, n = 246; RAM + PTX, n = 248). I runga i ngā takahanga OS 266 i kitea (wāhanga mōhiohio = 78.5%), i tutuki te hiranga whai huatanga (2-taha P < 0.0228). Ko te roanga waenga (m) (95% CI) o te aroturuki OS he 16.8 marama (14.0-20.0) mō T-DXd me te 14.4 marama (13.1-19.7) mō RAM + PTX. Ko te mOS (95% CI) he 14.7 marama (12.1-16.6) mō T-DXd vs 11.4 marama (9.9-15.5) mō RAM + PTX (ōwehenga mōrearea [HR], 0.70; P = 0.0044). Kei roto i te Ripanga ngā raraunga whai huatanga tāpiri. Ko te roanga o te maimoatanga waenga (awhe) he 5.4 marama (0.7-30.3) me te T-DXd me te 4.6 marama (0.9-34.9) me te RAM + PTX. I puta ngā pānga kino ohorere (TEAE) i roto i te 244/244 (100%) vs 228/233 ngā tohu (97.9%) me te T-DXd vs RAM + PTX, ia; 68.0% vs 73.8% he tohu (G) ≥3. I puta ngā TEAE kino me te T-DXd vs RAM + PTX i roto i te 41.0% vs 43.3% o ngā tohu; Ko ngā TEAE e pā ana ki te whakamutua o te rongoā i puta i roto i te 14.3% vs 17.2% o ngā tohu. I puta te mate pūkahukahu interstitial/pneumonitis e pā ana ki te rongoā i roto i te 34 ngā tohu (13.9%) me te T-DXd (1 G3, 0 G4/5) me te 3 ngā tohu (1.3%) me te RAM + PTX (2 G3, 1 G5).
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.
Tau Waea：4008803716
Email：myimmnet@163.com
Wā tuku: Hurae-22-2025