Thaum Lub Rau Hli 11, Kelun-Biotech tshaj tawm tias nws tus kheej tsim TROP2 ADC tshuaj sac-TMT (佳泰莱), ua ke nrog PD-L1 monoclonal antibody tagitanlimab (科泰莱) tau txais Breakthrough Therapy Designation (BTD) los ntawm Center for Drug Evaluation (CDE) ntawm National Medical Products Administration (NMPA) ntawm Tuam Tshoj rau kev kho mob thawj kab ntawm cov neeg mob hauv zos lossis metastatic non-squamous non-small cell lung cancer (NSCLC) uas tsis muaj kev hloov pauv gene.
Sac-TMT, yog ib yam khoom tseem ceeb ntawm Lub Tuam Txhab, 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 nqaij xws li NSCLC, mob qog nqaij hlav mis (BC), mob qog nqaij hlav 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 tshuaj belotecan-derivative topoisomerase I inhibitor nrog rau qhov sib piv ntawm tshuaj rau antibody (DAR) ntawm 7.4. Sac-TMT paub tshwj xeeb txog TROP2 ntawm qhov chaw ntawm cov qog nqaij hlav los ntawm cov tshuaj recombinant anti-TROP2 humanized monoclonal antibodies, uas tom qab ntawd endocytosed los ntawm cov qog nqaij hlav thiab tso tawm KL610023 hauv cov hlwb. KL610023, ua ib qho tshuaj topoisomerase I inhibitor, ua rau DNA puas tsuaj rau cov qog nqaij hlav, uas ua rau lub voj voog ntawm cov qog nqaij hlav nres thiab apoptosis. Tsis tas li ntawd, nws kuj tso tawm KL610023 hauv qhov chaw ib puag ncig ntawm cov qog nqaij hlav. 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.
Qhov Kev Kho Mob Tshiab no yog raws li cov ntaub ntawv ua tau zoo thiab kev nyab xeeb los ntawm pawg neeg tsis yog squamous ntawm txoj kev tshawb fawb Theem II OptiTROP-Lung01.
Cov txiaj ntsig ntawm kev tshawb fawb OptiTROP-Lung01 Theem II, kev soj ntsuam sac-TMT ua ke nrog KL-A167 (ib qho anti-PD-L1 monoclonal antibody) ua thawj txoj kev kho mob rau cov neeg mob NSCLC uas tsis muaj noob caj ces, tau nthuav tawm ntawm Lub Rooj Sib Tham Txhua Xyoo 2024 CSCO Academic.
Cov kev tshawb pom qhia tau tias: Rau Cohort 1A, qhov nruab nrab ntawm kev saib xyuas yog 14.0 lub hlis, nrog rau tus nqi teb (ORR) ntawm 48.6% (18/37, 2 rooj plaub tos kev lees paub), tus nqi tswj kab mob (DCR) ntawm 94.6%, qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib (PFS) ntawm 15.4 lub hlis (95% CI: 6.7, NE), thiab tus nqi 6-hli PFS ntawm 69.2%; rau Cohort 1B, qhov nruab nrab ntawm kev saib xyuas yog 6.9 lub hlis, nrog rau ORR ntawm 77.6% (45/58, 5 rooj plaub tos kev lees paub), DCR ntawm 100.0%, PFS nruab nrab tseem tsis tau txog, thiab tus nqi 6-hli PFS ntawm 84.6%.
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.
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Lub sijhawm tshaj tawm: Lub Rau Hli-12-2025