Nō nā tata nei, i pānuitia e GenFleet ngā raraunga wāhanga II hou o te rangahau KROCUS, arā, ko te fulzerasib (GFH925, te aukati KRAS G12C) me te cetuximab mō te maimoatanga tuatahi o te mate pukupuku pūkahukahu kore-pūtau iti (NSCLC), i roto i tētahi whakarāpopototanga poto i te whakaaturanga ā-waha poto o te hui ā-tau o te Huihuinga Mate Pukupuku Pūkahukahu Pākehā (ELCC) 2025.
Ko Fulzerasib te aukati KRAS G12C tuatahi i whakawhanakehia i Haina, ā, kua whakaaetia tana tuku NDA me te Whakamana Arotake Matua e te NMPA. I whiwhi hoki a Fulzerasib i ngā Whakamana Whakaora Pakari i tēnei tau mō te rongoā i ngā tūroro NSCLC KRAS G12C-mutant matatau kua whiwhi i te iti rawa i te kotahi te rongoā pūnaha me ngā tūroro CRC kua whiwhi i te iti rawa i te rua ngā rongoā pūnaha. Ka taea te wehewehe i te whānau pūmua RAS ki ngā kāwai KRAS, HRAS me NRAS. Ka kitea ngā whakarerekētanga KRAS i roto i te tata ki te 90% o ngā mate pukupuku repeure, 30-40% o ngā mate pukupuku koroni, me te 15-20% o ngā tūroro mate pukupuku pūkahukahu. Ko te putanga mai o te rōpū whakarerekētanga KRAS G12C he mea kitea ake i ērā me ngā whakarerekētanga ALK, ROS1, RET me TRK 1/2/3 kua whakakotahihia. Ko te GFH925 he aukati KRAS G12C hou, kaha ki te waha, i hangaia hei arotahi pai 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 i mua i te haumanu te whiriwhiringa teitei o te fulzerasib ki a G12C. Nō muri mai, ka ārai pai te fulzerasib i te ara tohu o raro hei whakaoho i te apoptosis o ngā pūtau pukupuku me te aukati i te huringa pūtau.
I te 14 o Hānuere, 2025, e 47 ngā tūroro KRAS G12C-mutant NSCLC kua pāngia e te mate pukupuku kāore anō kia rongoatia i mua, i rongoatia ki te fulzerasib me te cetuximab (fulzerasib 600mg BID + cetuximab 500 mg/m2 ia marama).
Whai Huatanga: I te rā kati raraunga, i roto i ngā tūroro 45 i whiwhi i te iti rawa i te kotahi aromatawai pukupuku i muri i te maimoatanga, ko te ORR he 80% me te DCR he 100%; 57.8% he ≥ 50% te whakahekenga o te pukupuku. 16 ngā tūroro (34%) i horapa ki te roro; i roto i ngā tūroro 14 i horapa ki te roro i whiwhi i te iti rawa i te kotahi aromatawai pukupuku i muri i te maimoatanga, ko te ORR mō ia RECIST 1.1 he 71.4%. Kāore anō kia tae ki te roanga waenga o te urupare (DoR), ā, 24 ngā tūroro kei te rongoatia tonutia me te roanga waenga o te aroturukitanga he 10.1 marama. Ko te mPFS he 12.5 marama, ā, kāore anō kia tae ki te mOS.
Haumaru: I te rā kati raraunga, he pai te āhua o te haumaru/manawanui o te rongoā whakakotahi. I puta ngā TRAE i roto i te 87.2% o ngā tūroro, ā, ko te nuinga o ngā TRAE i whakatauria ki te 1-2; 14.9% o ngā tūroro i pāngia e te iti rawa kotahi te TRAE taumata 3; kāore he TRAE taumata 4-5. Tokorua ngā tūroro i pāngia e ngā pānga kino kino e pā ana ki te maimoatanga (TRSAE) ā, i aromatawaitia ngā TRSAE he hononga noa iho ki te cetuximab; Tokotoru ngā tūroro i pāngia e ngā TRAE, kāore i te pā ki te fulzerasib, ā, i mutu ai te horopeta. I whakaatu a KROCUS i te iti o te mutunga o te horopeta, te whakaiti rānei i waenga i ngā rangahau whakakotahitanga NSLCL G12C-mutant raina tuatahi. Kāore i kitea he tohu haumaru hou i whakaritea ki te fulzerasib, ki te cetuximab rānei hei kaihoko kotahi.
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: 15 Paenga-whāwhā 2025