I kēia mau lā iho nei, ua hoʻolaha ʻo GenFleet i ka ʻikepili pae II hou loa o ke aʻo ʻana ʻo KROCUS, fulzerasib (GFH925, KRAS G12C inhibitor) i hui pū ʻia me cetuximab no ka lāʻau lapaʻau mua ʻole o ka maʻi kanesa māmā (NSCLC), i loko o kahi hōʻuluʻulu manaʻo lohi ma ka hōʻike waha liʻiliʻi o ka hālāwai makahiki 2025 European Lung Cancer Conference (ELCC).
ʻO Fulzerasib ka mea hoʻopaʻa KRAS G12C mua i hoʻomohala ʻia e Kina i ʻae ʻia kāna waiho ʻana NDA a hāʻawi ʻia me ka Priority Review Designation e NMPA. Ua loaʻa pū iā Fulzerasib nā Breakthrough Therapy Designations i kēia makahiki no ka mālama ʻana i nā maʻi KRAS G12C-mutant NSCLC holomua i loaʻa i hoʻokahi lāʻau lapaʻau systemic a me nā maʻi CRC i loaʻa i ʻelua mau lāʻau lapaʻau systemic. Hiki ke hoʻokaʻawale ʻia ka ʻohana protein RAS i nā ʻano KRAS, HRAS a me NRAS. ʻIke ʻia nā mutations KRAS ma kahi o 90% o ka maʻi kanesa pancreatic, 30-40% o ka maʻi kanesa colon, a me 15-20% o nā maʻi kanesa māmā. ʻIke pinepine ʻia ka hanana ʻana o ka subset mutation KRAS G12C ma mua o nā mea me ALK, ROS1, RET a me TRK 1/2/3 i hui pū ʻia. ʻO GFH925 kahi mea hoʻopaʻa KRAS G12C ikaika, hana waha, i hoʻolālā ʻia e kuhikuhi pono i ka hoʻololi GTP/GDP, kahi ʻanuʻu koʻikoʻi i ka hoʻāla ʻana i ke ala, ma ka hoʻololi ʻana i ke koena cysteine o ka protein KRAS G12C covalently a me ka irreversibly. Ua hōʻike nā haʻawina koho cysteine preclinical i ke koho kiʻekiʻe o fulzerasib i ka G12C. Ma hope mai, kāohi pono ka fulzerasib i ke ala hōʻailona ma lalo e hoʻoulu i ka apoptosis o nā cell tumor a me ka hoʻopau ʻana o ke kaʻina hana cell.
Ua mālama ʻia he 47 mau maʻi KRAS G12C-mutant NSCLC holomua i mālama ʻole ʻia ma mua me ka fulzerasib i hui pū ʻia me cetuximab (fulzerasib 600mg BID + cetuximab 500 mg/m2 Q2W) e like me Ianuali 14, 2025.
Pono: E like me ka lā palena ʻikepili, ma waena o nā maʻi 45 i loaʻa i hoʻokahi loiloi puʻupuʻu ma hope o ka mālama ʻana, ʻo 80% ka ORR a ʻo 100% ka DCR; 57.8% he ≥ 50% ka emi ʻana o ka puʻupuʻu. 16 mau maʻi (34%) i loaʻa ka metastasis lolo; ma waena o nā maʻi 14 i metastatic i ka lolo i loaʻa i hoʻokahi loiloi puʻupuʻu ma hope o ka mālama ʻana, ʻo 71.4% ka ORR no RECIST 1.1%. ʻAʻole i hiki i ka wā waena o ka pane (DoR), a he 24 mau maʻi e mālama ʻia ana me ka nānā ʻana o 10.1 mau mahina. ʻO 12.5 mau mahina ka mPFS a ʻaʻole i hiki i ka mOS.
Palekana: E like me ka lā palena ʻikepili, ua hōʻike ka hui pū ʻana i kahi ʻano palekana/hoʻomanawanui maikaʻi. Ua loaʻa nā TRAE i 87.2% o nā maʻi a ʻo ka hapa nui o nā TRAE i helu ʻia he 1-2; 14.9% o nā maʻi i loaʻa i ka liʻiliʻi he hoʻokahi TRAE papa 3; ʻaʻohe TRAE papa 4-5. 2 mau maʻi i loaʻa nā hanana koʻikoʻi e pili ana i ka lāʻau lapaʻau (TRSAE) a ua loiloi ʻia nā TRSAE e pili wale ana me cetuximab; 3 mau maʻi i loaʻa nā TRAE, ʻaʻole pili i ka fulzerasib, e alakaʻi ana i ka hoʻopau ʻana i ka lāʻau. Ua hōʻike ʻo KROCUS i kahi hanana haʻahaʻa o ka hoʻopau ʻana i ka lāʻau a i ʻole ka hōʻemi ʻana i waena o nā haʻawina hui mua G12C-mutant NSLCL. ʻAʻohe hōʻailona palekana hou i ʻike ʻia i hoʻohālikelike ʻia me fulzerasib a i ʻole cetuximab ma ke ʻano he mea hoʻokahi.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
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Ka manawa hoʻouna: ʻApelila-15-2025