I te 29 o Mei, i whakaaetia e te National Medical Products Administration (NMPA) te HER2-targeted antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) hei hokohoko. E tohuhia ana hei rongoā kotahi mō ngā tūroro pakeke e pangia ana e te mate pukupuku pūkahukahu kore-pūtau iti (NSCLC) kāore e taea te tango, e mau ana hoki ngā whakarerekētanga HER2 (ERBB2) whakahohe, ā, kua whiwhi i te iti rawa i te kotahi rongoā pūnaha o mua. Koinei te ADC tuatahi i whakawhanakehia e Haina kua whakaaetia mō ngā tūroro e pangia ana e te NSCLC kua whakarerekētia e te HER2, e tuku ana i tētahi kōwhiringa rongoā hou mō tēnei taupori tūroro.
Ko te whakaaetanga i ahu mai i te rangahau matua a HORIZON-Lung, i arahina e Ahorangi Lu Shun o te Hōhipera Uma o Shanghai.
He whakamātautau haumanu maha-pokapū, tuwhera-tapanga, Wāhanga I/II te rangahau HORIZON-Lung i arahina e te tīma a Ahorangi Lu Shun i te Hōhipera o te Uma o Shanghai. Ko te whāinga o te wāhanga Wāhanga I he whakatau i te horopeta manawanui nui (MTD) o te trastuzumab rezetecan me te aromatawai i tōna whai huatanga me te haumaru tuatahi i roto i ngā tūroro he NSCLC kua whakarerekētia ki te HER2. I whakaurua e te hoahoa rangahau ngā wāhanga whakanui horopeta me te whakawhānui horopeta. I te wāhanga Wāhanga I, i whakaatu te trastuzumab rezetecan i te mahi ārai-pukupuku tuatahi me te kōtaha haumaru pai. I hangaia te rangahau Wāhanga II hei aromatawai anō i te whai huatanga me te haumaru o te trastuzumab rezetecan i roto i ngā tūroro he NSCLC kua whakarerekētia ki te HER2.
I te mutunga, e 94 ngā tūroro i whakaurua ki te rangahau. I whakaatuhia e ngā hua ko te reiti urupare whāinga (ORR), i aromatawaitia e te Komiti Arotake Motuhake (IRC), he 74.5%, me te reiti whakahaere mate (DCR) o te 98.9%. Ko te roanga urupare toharite (DoR) he 9.8 marama. I whakaatuhia e ngā tātaritanga rōpū iti he rite tonu te whai huatanga o te trastuzumab rezetecan puta noa i ngā rōpū iti tūroro rerekē, ahakoa te maimoatanga anti-HER2 tyrosine kinase inhibitor (TKI) o mua, te aroaro rānei o ngā metastases roro taketake.
Ko te roanga ora kore-haere (PFS) i aromatawaitia e te IRC i whakaatu i te PFS toharite o te 11.5 marama, me te reiti PFS 12-marama o te 48.6%. Ko te PFS i aromatawaitia e te kairangahau (INV) he 12.5 marama, me te reiti PFS 12-marama o te 51.4%.
Kāore anō kia pakari ngā raraunga oranga katoa (OS), kāore anō kia eke ki te OS toharite, ā, ko te reiti OS 12-marama he 88.2%.
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: Pipiri-04-2025