Ngomhla wama-28 ku-Agasti, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) libhengeze ukuba i-BL-B01D1 yokujova icetywayo ukuba ifakwe kwinkqubo yokuphononongwa okuphambili. Yenzelwe izigulana ezine-recurrent okanye i-metastatic nasopharyngeal carcinoma eziye zanyangwa ngaphambili nge-PD-1/PD-L1 monoclonal antibodies kwaye ziye zasilela ubuncinane kwimigca emibini ye-chemotherapy (enomgca omnye oqulethe i-platinum).
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
I-iza-bren yi-ADC yokuqala kwiklasi eyenziwe yi-EGFR x HER3 bispecific antibody edityaniswe ne-topo-I inhibitor payload entsha (Ed-04) nge-linker ecacileyo esekelwe kwi-tetrapeptide. Indlela yokusebenza ephindwe kabini ye-Iza-bren ithintela imiqondiso ye-EGFR kunye ne-HER3 kwiiseli zomhlaza, inciphisa ukwanda kunye nemiqondiso yokusinda. Ukongeza, xa i-antibody ilawulwa ngaphakathi, umthwalo we-patio we-iza-bren uyakhutshwa ubangela uxinzelelo lwe-genotoxic olukhokelela ekufeni kweeseli zomhlaza.
Iziphumo ze-BL-B01D1 kwizigulane ezine-local advanced okanye i-metastatic non-small cell lung cancer (NSCLC) ephethe utshintsho lwe-driver genomic (GA) ngaphandle kwe-classic EGFR mutations ziboniswe kwi-2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
Iindlela: Inxalenye yeSigaba se-Ib kolu phononongo yayiquka amaqela okwandisa, ngalinye lichazwe yi-GA echazwe kwangaphambili, kuquka ukufakwa kwe-EGFR exon 20, ukuguqulwa kwe-EGFR okungengokwakudala, ukuguqulwa kwe-HER2, ALK, ROS1, BRAF (V600E kunye nabanye), KRAS (G12C kunye nabanye), SMARCA4, MET (Exon 14), RET, kunye ne-NTRK. Amanqaku ane-GA aqhubele phambili kunyango oluqhelekileyo olujoliswe kuyo (ukuba lukhona) kwaye akukho ngaphezu komgca omnye we-chemotherapy obhalisiweyo. I-iza-bren yanikwa kwi-2.5 mg/kg D1D8 Q3W.
Iziphumo: Ukusukela nge-5 kaDisemba ngo-2024, kubhaliswe ii-pts ezingama-73 ze-NSCLC ezine-GA ezidwelisiweyo. Ii-pts ezintlanu zazisasetyenziswa kunyango, kodwa azizange zifakwe kuhlalutyo ngenxa yokungalandeli ngokwaneleyo uphononongo lokuqala emva kovavanyo lokuqala (jonga itheyibhile engezantsi). Phakathi kwee-pts ezi-7 ezine-EGFR exon 20 insertions, i-85.7% (6 kwi-7) ifumene i-cPR. Phakathi kwee-pts ezi-8 ezine-KRAS G12C mutations, i-cPR ezi-3 kunye ne-PR e-1 elinde ukuqinisekiswa. Ukusebenza kakuhle kwamaqela amancinci kuya kuboniswa. Ezona TRAEs ze-hematologic eziqhelekileyo (zonke iibakala) yayiyi-anemia (87.7%), i-leukopenia (74.0%), i-thrombocytopenia (74.0%), kunye ne-neutropenia (72.6%); Ii-TRAEs ezingezizo ezegazi ezixhaphakileyo yayiyi-asthenia (42.5%), isicaphucaphu (41.1%), i-stomatitis (37.0%), isifo sohudo (32.9%), kunye ne-alopecia (31.5%). Ii-TRAEs zebanga lesi-3 nangaphezulu ezazisetyenziswa kakhulu kwi-hematologic, zikwazile ukuphathwa ngempumelelo ngemilinganiselo eqhelekileyo yokuxhasa kuquka ukunciphisa idosi, njengoko kubonisiwe yi-TRAE ekhokelela kwizinga lokuyeka le-2.7%. Kuye kwabonwa ityala elinye kuphela le-G2 ILD. Okuphawulekayo kukuba, akukho kufa okunxulumene ne-iza-bren okubikiweyo. Akukho zimpawu zintsha zokhuseleko eziboniweyo.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Ixesha leposi: Septemba-05-2025