Ma ka lā 22 o Mei, 2025, ua hoʻolaha ʻo Kelun Bio ua ʻae ʻia ka noi no kahi hōʻailona hou o kāna trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, i ʻike ʻia hoʻi ʻo SKB264/MK – 2870) (®) e ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA) o Kina. ʻO kēia hōʻailona hou no ka mālama ʻana i nā maʻi makua me ka unresectable locally advanced a metastatic hormone receptor-positive (HR+) a me ka human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) i loaʻa i ka lāʻau lapaʻau endocrine mua a me nā lāʻau lapaʻau ʻōnaehana ʻē aʻe i ka hoʻonohonoho holomua a metastatic paha. Ua hoʻokumu ʻia kēia ʻae ʻana ma nā hopena maikaʻi o ke aʻo ʻana o ka Phase 3 OptiTROP – Breast02. ʻO kēia noi ka hā o ka noi hōʻailona no ka sac – TMT i ʻae ʻia e ka NMPA.
ʻO OptiTROP – ʻO Breast02 kahi haʻawina lapaʻau randomized, open-label, multicenter, Phase 3 i loiloi i ka pono a me ka palekana o ka sacituzumab tirumotecan monotherapy ma kahi mahele o 5 mg/kg i kēlā me kēia ʻelua pule (Q2W) i hoʻohālikelike ʻia me ke koho ʻana o ke kauka i ka chemotherapy i nā poʻe maʻi me ka maʻi ʻaʻai umauma HR+/HER2- (immunohistochemistry [IHC] 0, IHC 1+, a i ʻole IHC 2+/in situ hybridization [ISH]-) hiki ʻole ke hoʻopau ʻia. Ma muli o ka loiloi waena i kuhikuhi mua ʻia, ua hoʻokō ʻia ka hopena hopena mua o kēia haʻawina lapaʻau Phase 3. I hoʻohālikelike ʻia me ke koho ʻana o ke kauka i ka chemotherapy, ua hōʻike ka sac – TMT monotherapy i kahi hoʻomaikaʻi koʻikoʻi a me ke ʻano lapaʻau i ka hopena mua o ke ola ʻole holomua (PFS) e like me ka loiloi ʻana e ke komite loiloi kūʻokoʻa makapō (BIRC), me ka emi nui o ka pilikia o ka holomua o ka maʻi a i ʻole ka make. Ua hōʻike pū ʻo Sac – TMT i kahi ʻano maikaʻi i ke ola holoʻokoʻa (OS).
Ma ka lā 16 o Mei, 2024, ua hoʻolaha ka pūnaewele kūhelu o ka CDE e nānā ʻia ka Noi ma o ke kaʻina loiloi mua a me ka ʻāpono ʻana. ʻO kēia ka hōʻailona ʻehā o ka sac-TMT e hele ma o ke kaʻina loiloi mua a me ka ʻāpono ʻana o ka CDE, me ʻekolu mau hōʻailona sat-TMT ma mua i ʻāpono ʻia ma hope o ka loiloi mua.
E pili ana i ka sac-TMT (佳泰莱®)
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 ke kanesa māmā ʻaʻole liʻiliʻi (NSCLC), BC, kanesa ʻōpū (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 ka 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.
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.
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Email：myimmnet@163.com
Ka manawa hoʻouna: Mei-27-2025