Nō nā tata nei, GenFleet Therapeuticsi panuitia kua whakaaetia e te Tari Whakahaere Rongoā (ISAF) o te Rohe Whakahaere Motuhake o Macau o Haina a Dupert®（fulzerasib, GFH925/IBI351）hei rongoā mō ngā tūroro he mate pukupuku pūkahukahu kore-pūtau iti (NSCLC) kei roto ko te whakarerekētanga KRAS G12C kua whiwhi i te iti rawa i te kotahi rongoā pūnaha.
Ko Fulzerasib te aukati KRAS G12C tuatahi i whakawhanakehia i Haina, ā, i whakaaetia tōna NDA me te Priority Review Designation i te marama o Ākuhata 2024 e te NMPA.
Mō Dupert® (fulzerasib, KRAS G12C Inhibitor)
I kitea e GenFleet Therapeutics, ko te fulzerasib (GFH925/IBI351) he aukati KRAS G12C hou, kaha ki te waha, i hangaia hei aro tika ki te whakawhiti GTP/GDP, he taahiraa nui i roto i te whakahohenga ara, mā te whakarerekē i te toenga cysteine o te pūmua KRAS G12C kia taurite me te kore e taea te whakahoki. I whakaatuhia e ngā rangahau whiriwhiringa cysteine mua-haumanu te whiriwhiringa teitei o GFH925 ki te G12C. I muri mai, ka aukati pai a GFH925 i te ara tohu o raro ki te whakaoho i te apoptosis o ngā pūtau pukupuku me te aukati huringa pūtau.
Kua whiwhi hoki a Fulzerasib i te taunakitanga Akomanga 1 mō te maimoatanga mō te KRAS G12C-mutant NSCLC i roto i ngā aratohu CSCO 2025, e tuku ana i tētahi kōwhiringa hou mō te rongoā arotahi me te whai huatanga roa me te manawanui pai.
E ai ki ngā raraunga wāhanga II o te rangahau rēhita i waenga i ngā tūroro me te KRAS G12C mutant NSCLC, i eke te fulzerasib monotherapy ki te ORR o te 49.1% me te PFS toharite o te 9.7 marama; ko te reiti OS 12-marama he 54.4%, ā, ko te reiti DoR 12-marama he 53.7%. I whakawhiwhia hoki te monotherapy ki ngā Tohu Whakaora Pakari e rua mō te rongoā i ngā tūroro KRAS G12C-mutant NSCLC matatau me te mate pukupuku colorectal.
I raro i te arataki a GenFleet me ngā tohunga mate pukupuku pūkahukahu o Ūropi, i puta te whai huatanga whakamiharo o te rangahau KROCUS mō te fulzerasib me te cetuximab puta noa i ngā tūroro NSCLC raina tuatahi katoa, ā, he tino pai te urupare a te pukupuku ki ngā tūroro kua horapa te roro. I tua atu, i whakaatuhia e te tikanga he pai ake te haumaru/te manawanui i te fulzerasib monotherapy i roto i te maimoatanga raina tuarua me runga ake i te NSCLC. Hei huinga pai o te aukati KRAS G12C (fulzerasib) me te paturopi anti-EGFR (cetuximab) i roto i te maimoatanga mate pukupuku pūkahukahu raina tuatahi, kei roto i tēnei huarahi auaha te kaha ki te whakatū i te SOC whakatupuranga hou mō te maimoatanga NSCLC raina tuatahi.
E ai ki ngā raraunga i roto i tētahi whakarāpopototanga poto i te whakaaturanga ā-waha poto o te hui ā-tau o te Huihuinga Mate Pukupuku Pūkahukahu o Ūropi (ELCC) 2025, 45 o ngā kaiuru i te whakamātautau i whiwhi i te iti rawa i te kotahi aromatawai pukupuku i muri i te maimoatanga i te Hanuere 14 o te tau 2025: i eke te ORR ki te 80%; i eke te DCR ki te 100%; ko te mPFS he 12.5 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: Hurae-15-2025