Ua ʻāpono ʻia ka KRAS G12C Inhibitor Fulzerasib (Dupert®) a GenFleet ma Macau no ka NSCLC Kiʻekiʻe

I kēia mau lā, ʻo GenFleet Therapeuticsua hoʻolaha ʻo Pharmaceutical Administration Bureau (ISAF) o ka Macau Special Administrative Region ma Kina ua ʻāpono ʻo Dupert®（fulzerasib, GFH925/IBI351）no ka mālama ʻana i nā poʻe maʻi me ka maʻi ʻaʻai māmā ʻaʻole liʻiliʻi (NSCLC) me ka mutation KRAS G12C i loaʻa i ka liʻiliʻi o hoʻokahi lāʻau lapaʻau systemic.

ʻO Fulzerasib ka mea hoʻopaʻa KRAS G12C mua i hoʻokumu ʻia ma Kina i ʻāpono ʻia kona NDA me ka Priority Review Designation i ʻAukake 2024 e NMPA.

E pili ana iā Dupert® (fulzerasib, KRAS G12C Inhibitor)

Ua ʻike ʻia e GenFleet Therapeutics, ʻo fulzerasib (GFH925/IBI351) he mea hoʻopaʻa KRAS G12C ikaika, hana waha, i hoʻolālā ʻia e kuhikuhi pono i ka hoʻololi GTP/GDP, kahi hana 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 hiki ʻole ke hoʻihoʻi ʻia. Ua hōʻike nā haʻawina koho cysteine ​​​​preclinical i ke koho kiʻekiʻe o GFH925 i G12C. Ma hope mai, ua kāohi pono ʻo GFH925 i ke ala hōʻailona ma hope e hoʻoulu i ka apoptosis o nā cell tumor a me ka hopu ʻana o ke kaʻina hana cell.

Ua loaʻa iā Fulzerasib ka ʻōlelo aʻoaʻo Class 1 no ka mālama ʻana no KRAS G12C-mutant NSCLC ma nā alakaʻi 2025 CSCO, e hāʻawi ana i nā mea maʻi i kahi koho hou o ka lāʻau lapaʻau i hoʻopaʻa ʻia me ka hopena mau loa a me ka hoʻomanawanui maikaʻi.

Wahi a ka ʻikepili pae II o ke aʻo hoʻopaʻa inoa ma waena o nā poʻe maʻi me KRAS G12C mutant NSCLC, ua loaʻa i ka monotherapy fulzerasib kahi ORR o 49.1% a me ka PFS waena o 9.7 mau mahina; ʻo ka helu OS 12 mahina he 54.4%, a ʻo ka helu DoR 12 mahina he 53.7%. Ua hāʻawi pū ʻia ka monotherapy i ʻelua Breakthrough Therapy Designations no ka mālama ʻana i nā poʻe maʻi KRAS G12C-mutant NSCLC holomua a me nā maʻi kanesa colorectal.

I alakaʻi ʻia e GenFleet me ka laulima ʻana me nā loea maʻi kanesa māmā kiʻekiʻe o ʻEulopa, ua hāʻawi pū ka haʻawina KROCUS o fulzerasib i hui pū ʻia me cetuximab i ka hopena kupaianaha ma waena o nā poʻe maʻi NSCLC laina mua a me ka pane ʻokoʻa loa i waena o nā poʻe maʻi metastatic lolo. Eia kekahi, ua hōʻike ka regimen i ka palekana/ka hiki ke hoʻomanawanui maikaʻi ma mua o ka monotherapy fulzerasib ma ka lāʻau NSCLC laina lua a ma luna. Ma ke ʻano he hui paionia o kahi mea hoʻopaʻa KRAS G12C (fulzerasib) a me kahi antibody anti-EGFR (cetuximab) i ka lāʻau maʻi kanesa māmā laina mua, loaʻa i kēia ala hana hou ka hiki ke hoʻokumu i ka SOC hanauna hou no ka lāʻau NSCLC laina mua.

Wahi a ka ʻikepili i loko o kahi hōʻuluʻulu manaʻo lohi ma ka hōʻike waha liʻiliʻi o ka hālāwai makahiki 2025 European Lung Cancer Conference (ELCC), ua loaʻa i ka 45 o nā mea komo i ka hoʻokolohua ma ka liʻiliʻi he hoʻokahi loiloi tumor ma hope o ka mālama ʻana e like me Ianuali 14 i ka makahiki 2025: ua hōʻea ka ORR i 80%; ua hōʻea ka DCR i 100%; he 12.5 mahina ka mPFS.

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.

Helu Kelepona：4008803716

Email：myimmnet@163.com