I te 29 o Mei, i whakaaetia e te National Medical Products Administration (NMPA) te hokohoko o Zanidatamab, i tukuna mai e BeiGene, hei rongoā i ngā tūroro he mate pukupuku ā-rohe kua horapa, kāore e taea te tango, he mate pukupuku ara biliary tract kua horapa rānei (BTC) kua whiwhi i te rongoā pūnaha i mua, ā, he nui te whakaaturanga HER2 (IHC 3+).
Ko te Zanidatamab he paturopi takirua e arohia ana ki te HER2 e taea ai te here i ngā epitope e rua o te kaiwhakawhiwhi HER2, e mōhiotia ana ko te here biparatopic. Nā tēnei hoahoa ahurei me te pikinga o te here ka hua ake he maha ngā tikanga mahi, tae atu ki te aukati tohu HER2 takirua, te tango i te pūmua HER2 mai i te mata o te pūtau, me te cytotoxicity e whakahaerehia ana e te ārai mate e ārahi ana ki te whakatenatena i te mahi ārai pukupuku i roto i ngā tūroro.
Kei runga i ngā mata o ngā pūtau te receptor tyrosine-protein kinase, e mōhiotia whānuitia ana ko te Human Epidermal Growth Factor Receptor 2 (HER2) CD340 rānei, kei roto. He mema tēnei pūmua nō te whānau Epidermal Growth Factor Receptor (EGFR) ā, e whakakōwaea ana e te ira Erythroblastic oncogene B (ERBB2). He mea nui te ira ERBB2 mō ngā tukanga noa pēnei i te wehenga pūtau, te rerekētanga, me te oranga. Mā roto i ngā ara tohu maha, ka whakatairangahia e ngā receptor HER2 te tipu o ngā pūtau me te aukati i te apoptosis (te mate pūtau kua whakaritea). He mea nui kia whakahaeretia ēnei receptor hei ārai i te tipu pūtau kāore i te whakahaeretia. Ko ngā mate pukupuku e nui rawa ana te whakaputa, e whakanui ana rānei i te ira HER2 ka kiia ko ngā mate pukupuku HER2-positive. He tohu koiora nui tēnei ira, ā, he whāinga matua mō te rongoā.
Heoi, ina whakanuia, ina nui rawa rānei te HER2, ka tere ake te whanaketanga me te wehenga o ngā pūtau kāore e āraihia te haere whakamua o te mate pukupuku. Ko tēnei whakanuia, tēnei whakanuinga rānei, ka kitea i roto i ngā momo pukupuku rerekē, ā, tera pea he tikanga nui hei rongoā mō ngā mate pukupuku kāore e tika ana kia pai te urupare ki ngā maimoatanga anti-HER2.
Ka kitea te HER2-positive i roto i ngā momo mate pukupuku pēnei i te mate pukupuku puku, te mate pukupuku ara biliary, te mate pukupuku ū, te mate pukupuku esophageal, te mate pukupuku ovarian, me te mate pukupuku uterine. Kei roto i te Ripanga te auau, te whakaahuatanga, me ngā au o te maimoatanga mō ngā pukupuku HER2-positive takitahi. Nō nā tata nei, kua kitea he hononga ki ngā mate pukupuku pancreatic me te mate pukupuku ara biliary (BTC). Ko ngā tūroro he mate pukupuku HER2-positive he kino ake te matapae ki te hunga he mate pukupuku HER2-negative, nā te mea he kaha ake te kaha o ēnei mate pukupuku. Heoi, kua whakaatuhia e ngā rautaki maimoatanga hou he hua pai.
I ahu mai tēnei whakaaetanga i ngā hua o te rangahau haumanu matua HERIZON-BTC-01 (NCT04466891). He rangahau ā-ao tēnei, maha-pokapū, tuwhera-tapanga, kotahi-ringa, Wāhanga 2b i hangaia hei aromatawai i te whai huatanga me te haumaru o te zanidatamab i roto i ngā tūroro kua rongoatia i mua, kāore i taea te tango, kua whakanuia te HER2-whakanuia, kua horapa rānei.
I whakaurua te rangahau ki te 87 ngā tūroro BTC, tae atu ki te 62 he nui te whakaaturanga HER2. I whakaatuhia e ngā hua ko te Zanidatamab monotherapy i whakaatu i te whai huatanga haumanu nui i roto i ngā tūroro i rongoatia i mua he nui te BTC HER2. Ko te reiti urupare whāinga (ORR) kua arotakehia motuhake he 51.6%, me te roanga urupare toharite (mDoR) o te 14.9 marama, ko te oranga kore-haere whakamua toharite (mPFS) o te 7.2 marama, me te oranga whānui toharite (mOS) o te 18.1 marama.
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-06-2025