Kwanan nan, GenFleet ta sanar da sabbin bayanai na mataki na biyu na binciken KROCUS, fulzerasib (GFH925, KRAS G12C inhibitor) tare da haɗin gwiwa da cetuximab don maganin cutar kansar huhu ta farko (NSCLC), a cikin wani taƙaitaccen bayani a lokacin gabatar da baki na taron shekara-shekara na Taron Ciwon Huhu na Turai (ELCC) na 2025.
Fulzerasib, maganin hana KRAS G12C na farko da aka samar a China wanda aka amince da shi kuma aka ba shi izinin amfani da shi tare da NMPA ta ba da takardar shaidar Bita ta Fifiko. Fulzerasib ta kuma sami takardar shaidar Breakthrough Therapy a wannan shekarar don kula da marasa lafiya masu fama da cutar KRAS G12C-mutant NSCLC waɗanda suka sami aƙalla maganin tsarin guda ɗaya da kuma marasa lafiya na CRC waɗanda suka sami aƙalla magungunan tsarin guda biyu. Ana iya raba dangin furotin na RAS zuwa nau'ikan KRAS, HRAS da NRAS. Ana gano maye gurbin KRAS a kusan kashi 90% na ciwon daji na pancreas, kashi 30-40% na ciwon daji na hanji, da kuma kashi 15-20% na marasa lafiya da ke fama da cutar kansa ta huhu. Ana yawan lura da faruwar maye gurbin KRAS G12C fiye da waɗanda ke da maye gurbin ALK, ROS1, RET da TRK 1/2/3 a hade. GFH925 wani sabon maganin hana KRAS G12C ne, mai aiki da baki, wanda aka tsara don ya kai ga musayar GTP/GDP yadda ya kamata, muhimmin mataki ne na kunna hanya, ta hanyar gyara ragowar cysteine na furotin KRAS G12C a hade kuma ba tare da juyawa ba. Nazarin cysteine na preclinical ya nuna babban zaɓi na fulzerasib zuwa G12C. Daga baya, fulzerasib yana hana hanyar siginar da ke ƙasa don haifar da apoptosis na ƙwayoyin ƙari da kamawar zagayowar ƙwayoyin halitta.
An yi wa jimillar marasa lafiya 47 da ba a yi musu magani ba a baya-bayan nan da aka yi wa KRAS G12C-mutant NSCLC magani da fulzerasib tare da cetuximab (fulzerasib 600mg BID + cetuximab 500 mg/m2 Q2W) har zuwa ranar 14 ga Janairu, 2025.
Inganci: Ya zuwa ranar da aka yanke bayanai, daga cikin marasa lafiya 45 da suka sami aƙalla kimantawar ƙari bayan magani, ORR ya kasance 80% kuma DCR ya kasance 100%; 57.8% sun sami raguwar ƙari ≥ 50%. Marasa lafiya 16 (34%) sun sami ci gaba a kwakwalwa; daga cikin marasa lafiya 14 da suka kamu da ciwon kwakwalwa waɗanda suka sami aƙalla kimantawar ƙari bayan magani, ORR ga kowane RECIST 1.1 ya kasance 71.4%. Ba a kai matsakaicin tsawon lokacin amsawa ba tukuna, kuma marasa lafiya 24 har yanzu suna kan magani tare da matsakaicin bin diddigin watanni 10.1. MPFS ya kasance watanni 12.5 kuma ba a kai ga mOS ba.
Tsaro: Ya zuwa ranar da aka yanke bayanai, maganin haɗin gwiwa ya gabatar da kyakkyawan bayanin aminci/jurewa. TRAEs sun faru a cikin 87.2% na marasa lafiya kuma yawancin TRAEs an sanya su a matsayi na 1-2; 14.9% na marasa lafiya sun sami aƙalla TRAEs guda ɗaya na aji na 3; babu TRAEs na aji na 4-5. Marasa lafiya 2 sun sami mummunan sakamako masu alaƙa da magani (TRSAE) kuma an kiyasta TRSAEs kawai suna da alaƙa da cetuximab; marasa lafiya 3 sun sami TRAEs, waɗanda ba su da alaƙa da fulzerasib, wanda ya haifar da dakatar da allurar. KROCUS ya nuna ƙarancin faruwar dakatarwa ko raguwar allurar a tsakanin nazarin haɗin gwiwa na G12C-mutant NSLCL na farko. Ba a gano sabbin siginar aminci ba idan aka kwatanta da fulzerasib ko cetuximab a matsayin wakili guda ɗaya.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Lokacin Saƙo: Afrilu-15-2025