Vuba aha, GenFleet yatangaje amakuru aheruka y’icyiciro cya kabiri cy’ubushakashatsi bwa KROCUS, fulzerasib (GFH925, KRAS G12C inhibitor) hamwe na cetuximab mu kuvura kanseri y’ibihaha itari iy’uturemangingo duto (NSCLC), mu ncamake y’incamake mu nama ngarukamwaka y’Inama ngarukamwaka y’Umuryango w’Ubumwe bw’u Burayi ya 2025 (ELCC).
Fulzerasib ni yo miti ya mbere ya KRAS G12C yakozwe mu Bushinwa, kandi inyandiko yayo ya NDA yemejwe kandi yemejwe na NMPA. Fulzerasib yanahawe iyi miti ya Breakthrough Therapy Designations muri uyu mwaka kubera kuvura abarwayi ba NSCLC ba KRAS G12C bateye imbere, bahawe nibura umuti umwe wa 'systemic therapy' n'abarwayi ba CRC bahawe nibura imiti ibiri ya 'systemic therapy'. Umuryango wa poroteyine wa RAS ushobora kugabanywamo ibice bibiri bya KRAS, HRAS na NRAS. Impinduka za KRAS zigaragara hafi 90% bya kanseri ya pancreas, 30-40% bya kanseri y'amara, na 15-20% by'abarwayi ba kanseri y'ibihaha. Impinduka za KRAS G12C zigaragara cyane kurusha abafite ALK, ROS1, RET na TRK 1/2/3 hamwe. GFH925 ni umuti mushya, ukora mu kanwa kandi ukomeye wa KRAS G12C inhibitor wagenewe kwibasira neza ihererekanya rya GTP/GDP, intambwe y'ingenzi mu gukora inzira, binyuze mu guhindura ibisigazwa bya cysteine bya poroteyine ya KRAS G12C mu buryo buhuriweho kandi butavaho. Inyigo zakozwe mbere yo gusuzuma cysteine zagaragaje ko fulzerasib ihitamo cyane kuri G12C. Nyuma yaho, fulzerasib ibuza neza inzira y'ikimenyetso yo hasi kugira ngo itere apoptosis y'uturemangingo tw'ikibyimba no guhagarika uruhererekane rw'uturemangingo.
Abarwayi 47 ba KRAS G12C-mutant NSCLC batari baravuwe mbere bavuwe na fulzerasib hamwe na cetuximab (fulzerasib 600mg BID + cetuximab 500 mg/m2 Q2W) kugeza ku ya 14 Mutarama 2025.
Ingufu: Ku itariki ntarengwa yo gutanga amakuru, mu barwayi 45 bakorewe isuzuma rya nyuma yo kuvurwa, ORR yari 80% naho DCR yari 100%; 57.8% bagabanutseho ikibyimba ≥ 50%. Abarwayi 16 (34%) banduye ubwonko; mu barwayi 14 banduye ubwonko bakorewe isuzuma rya nyuma yo kuvurwa, ORR kuri buri RECIST 1.1 yari 71.4%. Igihe cyo hagati cyo gusubiza (DoR) nticyagerwaho, kandi abarwayi 24 bari bakiri ku miti, hakurikiranwa hagati y'amezi 10.1. MPFS yari amezi 12.5 kandi mOS ntiyari yagerwaho.
Umutekano: Ku itariki yo gusoza amakuru, uburyo bwo kuvura buvanze bwagaragaje umutekano/uburyo bwo kwihanganira. TRAEs zabaye ku barwayi 87.2% kandi abenshi muri TRAEs bari bafite amanota ya 1-2; 14.9% by'abarwayi bahuye n'ingaruka mbi zikomeye za TRAEs zo mu cyiciro cya 3; nta TRAEs zo mu cyiciro cya 4-5. Abarwayi 2 bagize ingaruka mbi zikomeye zijyanye n'ubuvuzi (TRSAE) kandi TRSAEs zasuzumwe ko zifitanye isano na cetuximab gusa; abarwayi 3 bahuye n'ingaruka za TRAEs, zidafite aho zihuriye na fulzerasib, bituma bahagarika dose. KROCUS yagaragaje ko habayeho kugabanuka guke cyangwa kugabanuka k'umuti mu bushakashatsi butandukanye bwa mbere bwa G12C-mutant NSLCL. Nta bimenyetso bishya by'umutekano byagaragaye ugereranije na fulzerasib cyangwa cetuximab nk'ikintu kimwe.
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
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Igihe cyo kohereza: 15 Mata 2025