Kua whakaaetia a HERNEXEOS® i Haina hei rongoā ā-waha tuatahi mō ngā tūroro kua rongoatia i mua me te NSCLC matatau HER2-mutant

29 o Ākuhata, Kua whakaaetia te HERNEXEOS® (papa zongertinib) a Boehringer Ingelheim hei rongoā kotahi e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) mō te maimoatanga o ngā tūroro pakeke he mate pukupuku pūkahukahu kore-pūtau iti kāore e taea te tango, kua whanake ā-rohe, kua horapa rānei (NSCLC) kei roto i ō rātou pukupuku he whakarerekētanga HER2 whakahohe (ERBB2) ā, kua whiwhi i te iti rawa i te kotahi raina o te rongoā pūnaha o mua.

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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

WeChat ID: 17801183037

Email:myimmnet@163.com

Kua whakaaetia te whakaaetanga ā-ture i runga i ngā raraunga mai i te whakamātautau Phase Ib Beamion-LUNG 1 (NCT04886804): He whakamātautau whakanui horopeta Wāhanga I tuwhera-tohu, me te whakaū me te whakawhānui i te horopeta, o te zongertinib hei rongoā kotahi i roto i te hunga he pukupuku totoka kāore e taea te tango, he pukupuku totoka kua horapa rānei me ngā whakarerekētanga HER2. E rua ngā wāhanga o te rangahau. Ko te wāhanga tuatahi e tuwhera ana ki ngā pakeke he momo mate pukupuku matatau rerekē me ngā whakarerekētanga HER2 tae atu ki ngā whakarerekētanga, ngā whakanui, te whakanui rawa me ngā whakakotahitanga kāore i angitu te maimoatanga o mua. Ko te wāhanga tuarua e tuwhera ana ki te hunga he mate pukupuku pūkahukahu kore-pūtau iti HER2-mutant.

I roto i te rōpū 1, e 75 ngā tūroro katoa i whiwhi i te zongertinib i te horopeta o te 120 mg. I te wā mutunga raraunga (29 o Noema, 2024), 71% o ēnei tūroro (95% te wā whakawhirinaki [CI], 60 ki te 80; P<0.001 ki te paearu ≤30%) i whai urupare whai take kua whakaūtia; ko te roanga waenga o te urupare he 14.1 marama (95% CI, 6.9 ki te kore e taea te aromatawai), ā, ko te oranga kore-haere whakamua toharite he 12.4 marama (95% CI, 8.2 ki te kore e taea te aromatawai). I puta ngā pānga kino e pā ana ki te rongoā taumata 3, teitei ake rānei i roto i te 13 tūroro (17%). I roto i te rōpū 5 (31 tūroro), 48% o ngā tūroro (95% CI, 32 ki te 65) i whai urupare whai take kua whakaūtia. I puta ngā pānga kino e pā ana ki te rongoā taumata 3, teitei ake rānei i roto i te 1 tūroro (3%). I roto i te rōpū 3 (20 tūroro), 30% o ngā tūroro (95% CI, 15 ki te 52) i whakamanahia he urupare ā-taurangi. I puta ngā pānga kino e pā ana ki te rongoā taumata 3, teitei ake rānei, i roto i te 5 tūroro (25%). I roto i ngā rōpū e toru, kāore he mate pūkahukahu interstitial e pā ana ki te rongoā i puta.

"He mea whakatenatena te kite i te mōhio tonu a te NMPA ki te pūmanawa o te zongertinib. Ko te Tohu Whakaora Hou mō te whakamahinga tuatahi o te zongertinib i Haina e whakaatu ana i te hiahia nui o tēnei taupori tūroro. He taahiraa nui tēnei hei whai ake kia wātea ai tēnei rongoā ki ētahi atu tūroro e hiahia ana," te kī a Shashank Deshpande, Tiamana o te Poari Kaiwhakahaere Matua i Boehringer Ingelheim.

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

WeChat ID: 17801183037

Email:myimmnet@163.com

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Wā tuku: Hepetema-02-2025