Ngomhlaka-28 Agasti, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yamemezela ukuthi i-BL-B01D1 yokujova ihlongozwa ukuthi ifakwe enkambisweni yokubuyekezwa okubalulekile. Ihloselwe iziguli ezine-carcinoma ye-nasopharyngeal ephindaphindayo noma esakazeke kakhulu ezike zelashwa ngama-antibodies e-PD-1/PD-L1 monoclonal futhi zehlulekile okungenani imigqa emibili ye-chemotherapy (okungenani umugqa owodwa oqukethe i-platinum).
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
I-iza-bren iyi-ADC yokuqala ekilasini eyakhiwe yi-EGFR x HER3 bispecific antibody ehlanganiswe ne-topo-I inhibitor payload entsha (Ed-04) nge-linker ehlanganisiwe esekelwe ku-tetrapeptide eqinile. Indlela yokusebenza ekabili ye-Iza-bren ivimba izimpawu ze-EGFR kanye ne-HER3 kumaseli omdlavuza, inciphisa ukwanda kanye nezimpawu zokusinda. Ngaphezu kwalokho, lapho i-antibody isetshenziswa ngaphakathi, umthwalo wokwelapha we-iza-bren uyakhishwa obangela ukucindezeleka kwe-genotoxic okuholela ekufeni kwamaseli omdlavuza.
Imiphumela ye-BL-B01D1 ezigulini ezinomdlavuza wamaphaphu ongewona omncane (i-NSCLC) othuthuke endaweni noma osakazeke kakhulu onezinguquko ze-genomic (GA) ngaphandle kwezinguquko ze-EGFR zakudala yethulwe eMhlanganweni Waminyaka Yonke we-American Society of Clinical Oncology (ASCO) ka-2025.
Izindlela: Ingxenye yesigaba se-Ib yalolu cwaningo yayihlanganisa amaqembu okwandisa, ngalinye lichazwa yi-GA echazwe kusengaphambili, kufaka phakathi ukufakwa kwe-EGFR exon 20, ukuguqulwa kwe-EGFR okungeyona eyakudala, ukuguqulwa kwe-HER2, ALK, ROS1, BRAF (V600E nabanye), KRAS (G12C nabanye), SMARCA4, MET (Exon 14), RET, kanye ne-NTRK. Amaphuzu anala ma-GA aqhubekele phambili ekwelashweni okuqondiswe okujwayelekile (uma kutholakala) futhi akukho ngaphezu komugqa owodwa wangaphambilini we-chemotherapy obhalisiwe. I-iza-bren yanikezwa ku-2.5 mg/kg D1D8 Q3W.
Imiphumela: Kusukela ngoDisemba 5, 2024, kwabhaliswa ama-pts angu-73 e-NSCLC ane-GA ebhalwe ohlwini. Ama-pts amahlanu ayesaphathwa, kodwa akhishwa ekuhlaziyweni ngenxa yokungalandeli kahle kokuskena kokuqala ngemuva kwesisekelo (bheka ithebula elingezansi). Phakathi kwama-pts angu-7 ane-EGFR exon 20 efakiwe, ama-85.7% (ayisithupha kwangu-7) athole i-cPR. Phakathi kwama-pts angu-8 ane-KRAS G12C mutations, ama-cPR angu-3 kanye ne-PR eyodwa elinde ukuqinisekiswa. Ukusebenza kahle kwamaqembu amancane kuzovezwa. Ama-TRAE avame kakhulu e-hematologic (wonke amamaki) kwakuyi-anemia (87.7%), i-leukopenia (74.0%), i-thrombocytopenia (74.0%), kanye ne-neutropenia (72.6%); I-TRAE ezivame kakhulu ezingezona ezegazi kwakuyi-asthenia (42.5%), isicanucanu (41.1%), i-stomatitis (37.0%), isifo sohudo (32.9%), kanye ne-alopecia (31.5%). I-TRAE zebanga lesi-3 nangaphezulu ezazivame kakhulu njenge-hematologic, zakwazi ukuphathwa ngempumelelo ngesilinganiso esijwayelekile sokusekela okuhlanganisa nokunciphisa umthamo, njengoba kuboniswe yi-TRAE okwaholela ekumisweni kwesilinganiso esingu-2.7%. Kubonwe icala elilodwa kuphela le-G2 ILD. Okuphawulekayo ukuthi akukho ukufa okuhlobene ne-iza-bren okubikiwe. Azikho izimpawu ezintsha zokuphepha ezibonwe.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-ID ye-WeChat: 17801183037
Email：myimmnet@163.com
Isikhathi sokuthunyelwe: Septhemba-05-2025