Thaum Lub Peb Hlis 10, 2025, Sichuan Kelun-Biotech tshaj tawm tias Lub Tuam Txhab trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, yav tas los SKB264/MK-2870) tau txais kev pom zoo rau kev lag luam los ntawm National Medical Products Administration (NMPA) rau qhov cim thib ob uas yog rau kev kho mob rau cov neeg laus uas muaj epidermal growth factor receptor (EGFR) mutant-positive locally advanced lossis metastatic non-squamous non-small cell lung cancer (NSCLC) tom qab kev nce qib ntawm EGFR-tyrosine kinase inhibitor (TKI) kev kho mob thiab platinum-based chemotherapy. Qhov no yog thawj TROP2 ADC tshuaj tau pom zoo rau kev lag luam hauv mob qog noj ntshav thoob ntiaj teb. Piv nrog rau tus qauv kev kho mob tam sim no, sac-TMT ua rau cov neeg mob no muaj sia nyob ntau dua.
Kev pom zoo no yog raws li kev tshawb fawb ntau lub chaw, kev xaiv tsa, kev tswj hwm, thiab kev tshawb fawb tseem ceeb (OptiTROP-Lung03) uas ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm sac-TMT monotherapy 5mg/kg txhua ob lub lim tiam (Q2W) ua kev txhaj tshuaj rau hauv cov hlab ntsha piv rau docetaxel rau kev kho mob rau cov neeg mob uas muaj EGFR-mutant NSCLC uas tau kis mus rau lwm qhov chaw lossis kis mus rau lwm qhov chaw uas tau ua tsis tiav tom qab kev kho mob nrog EGFR-TKI thiab platinum-based chemotherapy (siv ua ntu zus lossis ua ke). Raws li tau pom hauv kev tshuaj xyuas ib ntus ua ntej, sac-TMT monotherapy tau qhia txog kev txhim kho tseem ceeb thiab muaj txiaj ntsig zoo hauv kev teb sai (ORR), kev ciaj sia tsis muaj kev nce qib (PFS) thiab kev ciaj sia tag nrho (OS) piv rau docetaxel.
Txog sac-TMT
Sac-TMT yog ib qho TROP2 ADC tshiab rau tib neeg uas Lub Tuam Txhab muaj cov cai lij choj txog kev txawj ntse, tsom mus rau cov qog nqaij hlav tawv xws li NSCLC, mob qog noj ntshav hauv lub mis (BC), mob qog noj ntshav hauv plab (GC), mob qog nqaij hlav poj niam, thiab lwm yam. Sac-TMT tau tsim los nrog ib qho txuas tshiab los txuas cov khoom thauj, ib qho belotecan-derivative topoisomerase I inhibitor nrog qhov sib piv ntawm tshuaj rau antibody (DAR) ntawm 7.4. Sac-TMT paub tshwj xeeb TROP2 ntawm qhov chaw ntawm cov hlwb qog noj ntshav los ntawm cov tshuaj recombinant anti-TROP2 humanized monoclonal antibodies, uas tom qab ntawd endocytosed los ntawm cov hlwb qog noj ntshav thiab tso tawm KL610023 intracellularly. KL610023, ua ib qho topoisomerase I inhibitor, ua rau DNA puas tsuaj rau cov hlwb qog noj ntshav, uas ua rau lub voj voog ntawm cov hlwb raug ntes thiab apoptosis. Tsis tas li ntawd, nws kuj tso tawm KL610023 hauv qhov chaw ib puag ncig ntawm cov hlwb qog noj ntshav. Vim tias KL610023 yog daim nyias nyias permeable, nws tuaj yeem ua rau muaj kev cuam tshuam bystander, lossis hais lwm yam tua cov hlwb qog nqaij hlav ze.
Yav dhau los, NMPA tau pom zoo rau kev lag luam ntawm sac-TMT hauv Suav teb rau cov neeg mob laus uas muaj mob qog noj ntshav triple negative mis (TNBC) uas tsis tuaj yeem phais tau uas tau txais tsawg kawg yog ob txoj kev kho mob thoob plaws lub cev (tsawg kawg yog ib qho ntawm lawv rau qhov chaw mob siab lossis kis mus rau lwm qhov) thiab tau txais daim ntawv thov tshuaj tshiab ntxiv (sNDA) thov kev pom zoo ntawm sac-TMT monotherapy rau cov neeg mob uas muaj EGFR-mutant NSCLC uas tau ua tsis tiav tom qab kev kho mob EGFR-TKI.
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
Email：myimmnet@163.com
Lub sijhawm tshaj tawm: Lub Peb Hlis-20-2025