Thaum Lub Yim Hli 28, Lub Chaw Saib Xyuas Kev Tshuaj Xyuas Tshuaj (CDE) ntawm Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau tshaj tawm tias BL-B01D1 rau kev txhaj tshuaj raug pom zoo kom suav nrog hauv cov txheej txheem tshuaj xyuas tseem ceeb. Nws yog rau cov neeg mob uas muaj mob qog nqaij hlav nasopharyngeal rov tshwm sim lossis kis mus rau lwm qhov uas tau kho nrog PD-1/PD-L1 monoclonal antibodies thiab tau ua tsis tiav tsawg kawg yog ob kab ntawm chemotherapy (nrog tsawg kawg yog ib kab muaj platinum).
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
iza-bren yog thawj ADC hauv chav kawm uas muaj EGFR x HER3 bispecific antibody txuas nrog rau qhov tshiab topo-I inhibitor payload (Ed-04) ntawm qhov ruaj khov tetrapeptide-based cleavable linker. Iza-bren lub tshuab ua haujlwm ob npaug thaiv EGFR thiab HER3 cov cim rau cov hlwb qog noj ntshav, txo cov cim qhia kev loj hlob thiab kev ciaj sia. Tsis tas li ntawd, thaum antibody mediated internalization, iza-bren's therapeutic payload raug tso tawm ua rau muaj kev ntxhov siab genotoxic uas ua rau cov hlwb qog noj ntshav tuag.
Cov txiaj ntsig ntawm BL-B01D1 hauv cov neeg mob uas muaj mob qog nqaij hlav hauv lub ntsws uas tsis yog me me (NSCLC) uas muaj kev hloov pauv genomic (GA) sab nraud ntawm cov kev hloov pauv EGFR qub tau nthuav tawm ntawm 2025 American Society of Clinical Oncology (ASCO) Lub Rooj Sib Tham Txhua Xyoo.
Txoj Kev: Theem Ib ib feem ntawm txoj kev tshawb fawb no suav nrog cov pawg neeg nthuav dav, txhua tus txhais los ntawm GA uas tau teev tseg ua ntej, suav nrog EGFR exon 20 insertions, cov kev hloov pauv EGFR tsis yog classical, kev hloov pauv hauv HER2, ALK, ROS1, BRAF (V600E thiab lwm tus), KRAS (G12C thiab lwm tus), SMARCA4, MET (Exon 14), RET, thiab NTRK. Cov neeg koom nrog cov GA no uas tau nce qib ntawm cov kev kho mob tus qauv (yog tias muaj) thiab tsis pub ntau tshaj ib kab tshuaj chemotherapy ua ntej tau sau npe. iza-bren tau muab ntawm 2.5 mg / kg D1D8 Q3W.
Cov Txiaj Ntsig: Txij li thaum Lub Kaum Ob Hlis 5, 2024, tag nrho ntawm 73 NSCLC pts nrog teev GA tau sau npe. Tsib pts tseem nyob rau hauv kev kho mob, tab sis raug tshem tawm ntawm kev tshuaj xyuas vim tsis txaus kev saib xyuas rau thawj qhov kev tshuaj ntsuam tom qab-baseline (saib lub rooj hauv qab no). Ntawm 7 pts nrog EGFR exon 20 insertions, 85.7% (6 ntawm 7) tau ua tiav cPR. Ntawm 8 pts nrog KRAS G12C mutations, 3 cPR thiab 1 PR tos kev lees paub tau pom. Kev ua haujlwm zoo rau cov pab pawg me yuav raug nthuav tawm. Cov hematologic TRAEs feem ntau (txhua qib) yog anemia (87.7%), leukopenia (74.0%), thrombocytopenia (74.0%), thiab neutropenia (72.6%); Cov TRAEs uas tsis yog hematologic feem ntau yog asthenia (42.5%), xeev siab (41.1%), stomatitis (37.0%), raws plab (32.9%), thiab alopecia (31.5%). Qib 3 thiab siab dua TRAEs uas feem ntau yog hematologic hauv xwm, muaj peev xwm tswj tau zoo nrog kev ntsuas txhawb nqa tus qauv suav nrog kev txo cov koob tshuaj, raws li TRAE tau ua pov thawj ua rau tus nqi txiav ntawm 2.7%. Tsuas yog 1 rooj plaub ntawm G2 ILD tau pom. Qhov tseem ceeb, tsis muaj kev tuag ntsig txog iza-bren tau tshaj tawm. Tsis muaj cov cim qhia kev nyab xeeb tshiab tau pom.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
WeChat ID: 17801183037
Email：myimmnet@163.com
Lub sijhawm tshaj tawm: Cuaj hlis-05-2025