Kua whakaaetia a Limertinib i Haina mō te EGFR T790M+ NSCLC

I te 16 o Hānuere, 2025, i whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te Tono Rongoā Hou (NDA) o te limertinib mō te rongoā i ngā tūroro pakeke e pangia ana e te mate pukupuku pūkahukahu kore-pūtau iti (NSCLC) kua whanake haere i te rohe, kua horapa rānei ki te EGFR T790M.

Mō Limertinib

Ko Limertinib he rongoā EGFR TKI tuatoru-whakatipuranga e tukuna ana ki te waha, he mana pupuri, kua whakaaetia e te NMPA o Haina mō te maimoatanga o ngā tūroro pakeke e pangia ana e te mate pukupuku pūkahukahu kore-pūtau iti (NSCLC) kua whanake haere, kua horapa rānei ki te EGFR T790M. Kei raro i te arotake a te NMPA tētahi atu NDA mō te maimoatanga raina-tuatahi o ngā tūroro pakeke e pangia ana e te NSCLC kua whanake haere, kua horapa rānei ki te rohe, e mau ana i ngā mukunga EGFR exon 19, i ngā whakarerekētanga exon 21 L858R rānei.

I whakaatuhia te angitu o te rongoā i roto i tētahi whakamātautau haumanu Wāhanga 3 maha-pokapū, matapōkeretia, matapo-rua, whakahaeretia, e whakataurite ana i tōna whai huatanga me te haumaru o te gefitinib i roto i te maimoatanga raina tuatahi o ngā tūroro he NSCLC kua horapa ā-rohe, kua horapa rānei, e mau ana i ngā whakarerekētanga EGFR. Ina tutuki te pito whakamutunga tuatahi, ka whakaatuhia ngā hua ki ngā huihuinga mātauranga e haere ake nei, ka whakaputaina rānei ki roto i ngā puka mātauranga.

I tautokona te whakataunga ture e ngā raraunga mai i tētahi whakamātautau wāhanga 2b matua (NCT03502850). He rangahau wāhanga 2b kotahi-ringa tēnei, he tuwhera-tapahanga, i whakahaerehia i ngā hōhipera 62 puta noa i te Repupiripia o te Iwi o Haina. I whakaurua ngā tūroro he NSCLC kua horapa ki te rohe, kua horapa rānei, me ngā whakarerekētanga EGFR T790M kua whakapumautia ki te pokapū i roto i te kiko pukupuku, i te toto toto rānei, i ahu whakamua i muri i ngā aukati EGFR tyrosine kinase whakatupuranga tuatahi, tuarua rānei, me ngā whakarerekētanga EGFR T790M tuatahi rānei.

Mai i te 16 o Hūrae, 2019, ki te 10 o Poutū-te-rangi, 2021, e 301 ngā tūroro katoa i whakaurua, ā, i tīmata te maimoatanga ki te limertinib. I uru katoa ngā tūroro ki te huinga tātaritanga katoa me te huinga haumaru. I te rā kati raraunga i te 9 o Hepetema, 2021, e 76 (25.2%) i noho tonu ki te maimoatanga. Ko te wā aroturuki toharite he 10.4 marama. I runga i te huinga tātaritanga katoa, ko te ORR i aromatawaihia e te komiti arotake motuhake he 68.8%, ā, ko te reiti whakahaere mate he 92.4%. Ko te PFS toharite he 11.0 marama, ko te DoR toharite he 11.1 marama, ā, kāore i tutuki te OS toharite. I tutuki ngā urupare whāinga puta noa i ngā rōpū iti kua tohua. Mō ngā tūroro 99 (32.9%) kua horapa ki te pūnaha io matua (CNS), ko te ORR he 64.6%, ko te PFS toharite he 9.7 marama (95% CI: 5.9–11.6), ā, ko te DoR toharite he 9.6 marama. Mō ngā tūroro 41 i whara te CNS ka taea te aromatawai, ko te CNS-ORR kua whakapumautia he 56.1%, ā, ko te CNS-PFS toharite he 10.6 marama.

I roto i te huinga haumaru, 289 ngā tūroro (96.0%) i pāngia e te iti rawa kotahi te pānga kino e pā ana ki te maimoatanga (TRAE), ko te mea tino noa ko te mate korere (81.7%), te anemia (32.6%), te ponana (29.9%), me te kore kai (28.2%). I puta ngā TRAE taumata ≥3 i roto i te 104 ngā tūroro (34.6%), ko te mea tino noa ko te mate korere (13.0%), te hypokalemia (4.3%), te anemia (4.0%), me te ponana (3.3%). I puta ngā TRAE i arahi ai ki te whakamutu i te horopeta me te whakamutu i te horopeta i roto i te 24.6% me te 2% o ngā tūroro. Kāore he TRAE i arahi ai ki te mate.

Ngā Whakatau

I kitea he whai huatanga pai tō Limertinib (ASK120067) me te haumaru e whakaaetia ana mō te maimoatanga o ngā tūroro he NSCLC kua whanake haere ā-rohe, kua horapa rānei ki te EGFR T790M.

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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Ngā Tohutoro

1.国家药品监督管理局 (nmpa.gov.cn)

2.Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) (ask-pharm.com)

3.I Pānui Ngātahi a Innovent me ASK Pharm i te Whakaaetanga NMPA mō Limertinib, he EGFR TKI o te whakatupuranga tuatoru mō te Maimoatanga o te Mate Pukupuku Pūkahukahu (prnewswire.com)

4.https://www.jto.org/article/S1556-0864(22)00267-2/fulltext