Ma Iune 11, ua hoʻolaha ʻo Kelun-Biotech ua hāʻawi ʻia kāna TROP2 ADC drug sac-TMT (佳泰莱) i hoʻomohala kūʻokoʻa ʻia, i hui pū ʻia me ka PD-L1 monoclonal antibody tagitanlimab (科泰莱"), i ka Breakthrough Therapy Designation (BTD) e ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA) o Kina no ka mālama mua ʻana i nā maʻi maʻi ʻaʻai māmā non-squamous non-small cell lung cancer (NSCLC) holomua kūloko a metastatic paha me ka ʻole o nā mutations gene driver.
ʻO Sac-TMT, kahi huahana koʻikoʻi o ka Hui, he TROP2 ADC kanaka hou kahi i loaʻa ai i ka Hui nā kuleana waiwai noʻeau ponoʻī, e kuhikuhi ana i nā puʻupuʻu paʻa holomua e like me NSCLC, ka maʻi ʻaʻai umauma (BC), ka maʻi ʻaʻai gastric (GC), nā puʻupuʻu gynecological, a me nā mea ʻē aʻe. Ua hoʻomohala ʻia ʻo Sac-TMT me kahi mea hoʻopili hou e hoʻohui i ka payload, kahi mea hoʻopaʻa topoisomerase I belotecan-derivative me kahi lāʻau-i-antibody-ratio (DAR) o 7.4. Hoʻomaopopo kūikawā ʻo Sac-TMT iā TROP2 ma luna o ka ʻili o nā cell tumor e nā antibodies monoclonal humanized anti-TROP2 recombinant, a laila endocytosed e nā cell tumor a hoʻokuʻu iā KL610023 intracellularly. ʻO KL610023, ma ke ʻano he mea hoʻopaʻa topoisomerase I, hoʻoulu i ka hōʻino DNA i nā cell tumor, kahi e alakaʻi ai i ka hopu ʻana o ke kaʻina hana cell a me ka apoptosis. Eia kekahi, hoʻokuʻu pū ia iā KL610023 i loko o ka microenvironment tumor. No ka mea he membrane permeable ʻo KL610023, hiki iā ia ke hoʻāla i kahi hopena bystand, a i ʻole ma nā huaʻōlelo ʻē aʻe e pepehi i nā cell tumor e pili ana.
Ua hoʻokumu ʻia kēia Breakthrough Therapy Designation ma ka ʻikepili pono a me ka palekana mai ka hui non-squamous o ke aʻo ʻana o Phase II OptiTROP-Lung01.
Ua hōʻike ʻia nā hopena o ke aʻo ʻana ʻo OptiTROP-Lung01 Phase II, e loiloi ana i ka sac-TMT i ka hui pū ʻana me KL-A167 (he antibody monoclonal anti-PD-L1) ma ke ʻano he lāʻau lapaʻau mua no nā maʻi NSCLC holomua driver-gene-negative, ma ka 2024 CSCO Academic Annual Meeting.
Ua hōʻike ʻia nā ʻike: No Cohort 1A, ʻo ka awelika o ka hahai ʻana he 14.0 mau mahina, me ka helu pane pahuhopu (ORR) o 48.6% (18/37, 2 mau hihia e kali ana i ka hōʻoia), kahi helu kaohi maʻi (DCR) o 94.6%, kahi awelika o ka holomua ʻole (PFS) o 15.4 mau mahina (95% CI: 6.7, NE), a me ka helu PFS 6 mahina o 69.2%; no Cohort 1B, ʻo ka awelika o ka hahai ʻana he 6.9 mau mahina, me ka ORR o 77.6% (45/58, 5 mau hihia e kali ana i ka hōʻoia), kahi DCR o 100.0%, kahi awelika o ka PFS i hiki ʻole, a me ka helu PFS 6 mahina o 84.6%.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
Email：myimmnet@163.com
Ka manawa hoʻouna: Iune-12-2025