Pa Ogasiti 28, Center for Drug Evaluation (CDE) ya National Medical Products Administration (NMPA) idalengeza kuti BL-B01D1 yoti ijayidwe ikuyembekezeka kuphatikizidwa mu ndondomeko yowunikiranso zinthu zofunika kwambiri. Idapangidwira odwala omwe ali ndi khansa ya m'mphuno yomwe imabwereranso kapena yofalikira kwambiri omwe adathandizidwapo kale ndi ma antibodies a PD-1/PD-L1 monoclonal ndipo adalephera kulandira mankhwala a chemotherapy osachepera mizere iwiri (ndi mzere umodzi wokhala ndi platinamu).
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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iza-bren ndi ADC yoyamba m'gulu lopangidwa ndi EGFR x HER3 bispecific antibody yolumikizidwa ku topo-I inhibitor payload yatsopano (Ed-04) kudzera mu cholumikizira chokhazikika cha tetrapeptide-based cleavable. Njira ziwiri za Iza-bren zogwirira ntchito zimaletsa zizindikiro za EGFR ndi HER3 ku maselo a khansa, kuchepetsa kuchulukana ndi zizindikiro zopulumuka. Kuphatikiza apo, pamene antibody ikugwiritsidwa ntchito mkati, katundu wochiritsira wa iza-bren umatulutsidwa zomwe zimapangitsa kuti maselo a khansa afe.
Zotsatira za BL-B01D1 mwa odwala omwe ali ndi khansa ya m'mapapo ya non-small cell (NSCLC) yomwe ili ndi kusintha kwa majini (GA) kunja kwa kusintha kwa EGFR kwachikhalidwe zinaperekedwa pa Msonkhano Wapachaka wa 2025 wa American Society of Clinical Oncology (ASCO).
Njira: Gawo la Gawo Ib la kafukufukuyu linaphatikizapo magulu owonjezera, lililonse lomwe limafotokozedwa ndi GA yodziwikiratu, kuphatikiza ma insertions a EGFR exon 20, ma mutations a EGFR omwe si achikhalidwe, ma mutations mu HER2, ALK, ROS1, BRAF (V600E ndi ena), KRAS (G12C ndi ena), SMARCA4, MET (Exon 14), RET, ndi NTRK. Ma Pts ndi GA awa omwe adapita patsogolo pa mankhwala ochizira omwe adayang'aniridwa (ngati alipo) ndipo palibe mzere umodzi wopitilira umodzi wa chemotherapy womwe udalembetsedwa. iza-bren idaperekedwa pa 2.5 mg/kg D1D8 Q3W.
Zotsatira: Pofika pa Disembala 5, 2024, ma pts 73 a NSCLC omwe ali ndi GA yolembedwa adalembedwa. Ma pts asanu anali akadali pa chithandizo, koma sanaphatikizidwe mu kusanthula chifukwa chosakwanira kutsatira kwa scan yoyamba pambuyo pa maziko (onani tebulo pansipa). Pakati pa ma pts 7 omwe ali ndi EGFR exon 20 insertions, 85.7% (6 mwa 7) adapeza cPR. Pakati pa ma pts 8 omwe ali ndi kusintha kwa KRAS G12C, 3 cPR ndi 1 PR yomwe ikudikira kutsimikizika idawonedwa. Kugwira ntchito bwino kwa magulu ang'onoang'ono kudzawonetsedwa. Ma TRAE omwe amapezeka kwambiri m'magazi (ma giredi onse) anali kuchepa kwa magazi (87.7%), leukopenia (74.0%), thrombocytopenia (74.0%), ndi neutropenia (72.6%); Matenda a TRAE omwe sali a magazi omwe amapezeka kwambiri anali asthenia (42.5%), nseru (41.1%), stomatitis (37.0%), kutsegula m'mimba (32.9%), ndi alopecia (31.5%). Matenda a TRAE a Giredi 3 ndi kupitirira apo omwe anali a magazi ambiri, adatha kuthandizidwa bwino ndi njira yothandiza yokhazikika kuphatikizapo kuchepetsa mlingo, monga momwe TRAE idawonetsera zomwe zidapangitsa kuti chiwerengero cha anthu asiye kumwa mankhwalawa ndi 2.7%. Munthu m'modzi yekha wa G2 ILD adapezeka. Chochititsa chidwi n'chakuti, palibe imfa yokhudzana ndi iza-bren yomwe idanenedwa. Palibe zizindikiro zatsopano zachitetezo zomwe zidawonedwa.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Chizindikiro cha WeChat: 17801183037
Email：myimmnet@163.com
Nthawi yotumizira: Sep-05-2025