Ma Malaki 10, 2025, ua hoʻolaha ʻo Sichuan Kelun-Biotech ua ʻae ʻia ka trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, ma mua ʻo SKB264/MK-2870) o ka Hui no ke kūʻai aku ʻana e ka National Medical Products Administration (NMPA) no ka lua o ka hōʻailona ʻo ia hoʻi no ka mālama ʻana i nā poʻe maʻi makua me ka epidermal growth factor receptor (EGFR) mutant-positive locally advanced a i ʻole metastatic non-squamous non-small cell lung cancer (NSCLC) ma hope o ka holomua ʻana o ka EGFR-tyrosine kinase inhibitor (TKI) therapy a me ka chemotherapy platinum-based. ʻO kēia ka lāʻau TROP2 ADC mua i ʻae ʻia no ke kūʻai aku ʻana i ka maʻi kanesa māmā ma ka honua holoʻokoʻa. Ke hoʻohālikelike ʻia me ke kūlana mālama o kēia manawa, hoʻonui nui ʻo sac-TMT i nā pono ola holoʻokoʻa o kēia mau maʻi.
Hoʻokumu ʻia ka ʻae ʻia ma kahi noiʻi multi-center, randomized, controlled, pivotal (OptiTROP-Lung03) e loiloi ana i ka pono a me ka palekana o ka sac-TMT monotherapy 5mg/kg i kēlā me kēia pule ʻē aʻe (Q2W) ma ke ʻano he injection intravenous versus docetaxel no ka mālama ʻana i nā maʻi me ka locally advanced a metastatic EGFR-mutant NSCLC i hāʻule ma hope o ka mālama ʻana me kahi EGFR-TKI a me ka chemotherapy platinum-based (hoʻohana ʻia ma ke ʻano he kaʻina a i ʻole ka hui pū ʻana). E like me ka mea i hōʻike ʻia ma kahi loiloi waena i kuhikuhi mua ʻia, ua hōʻike ka sac-TMT monotherapy i kahi hoʻomaikaʻi koʻikoʻi a me ka ʻike lapaʻau i ka objective response rate (ORR), progression-free survival (PFS) a me ke ola holoʻokoʻa (OS) i hoʻohālikelike ʻia me docetaxel.
E pili ana i ka sac-TMT
ʻO Sac-TMT kahi 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.
Ma mua, ua ʻāpono ka NMPA i ke kūʻai aku ʻana o sac-TMT ma Kina no nā poʻe maʻi makua me ka maʻi ʻaʻai umauma triple negative locally advanced a metastatic paha (TNBC) i loaʻa i ʻelua mau ʻano lapaʻau systemic ma mua (ma ka liʻiliʻi hoʻokahi o lākou no ka hoʻonohonoho holomua a metastatic paha) a ua ʻae i kahi noi lāʻau lapaʻau hou (sNDA) e ʻimi ana i ka ʻae ʻia o ka monotherapy sac-TMT no nā poʻe maʻi me ka EGFR-mutant NSCLC i hāʻule ma hope o ka lāʻau lapaʻau EGFR-TKI.
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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Ka manawa hoʻouna: Malaki-20-2025