Ngomhla we-10 kweyoKwindla, ngo-2025, uSichuan Kelun-Biotech wabhengeza ukuba i-trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, eyayisakuba yi-SKB264/MK-2870) yeNkampani ivunyiwe ukuba ithengiswe yiNational Medical Products Administration (NMPA) njengophawu lwesibini olulonyango lwezigulane zabantu abadala abane-epidermal growth factor receptor (EGFR) mutant-positive local advanced okanye metastatic non-squamous non-small cell lung cancer (NSCLC) emva kokuqhubela phambili kunyango lwe-EGFR-tyrosine kinase inhibitor (TKI) kunye ne-platinum-based chemotherapy. Eli liyeza lokuqala le-TROP2 ADC elivunyiweyo ukuba lithengiswe kumhlaza wemiphunga kwihlabathi liphela. Xa kuthelekiswa nomgangatho wonyango wangoku, i-sac-TMT inika kakhulu izibonelelo zokusinda kwezi zigulane.
Olu vunyiweyo lusekelwe kuphando oluneziko ezininzi, olucwangcisiweyo, olulawulwayo, nolubalulekileyo (i-OptiTROP-Lung03) oluvavanya ukusebenza kakuhle kunye neprofayili yokhuseleko lwe-sac-TMT monotherapy ye-5mg/kg rhoqo emva kweveki (Q2W) njengenaliti ye-intravenous ngokuchasene ne-docetaxel yokunyanga izigulane ezine-NSCLC ye-EGFR-mutant ephucukileyo okanye eguqukileyo eziye zasilela emva konyango nge-EGFR-TKI kunye ne-chemotherapy esekelwe kwi-platinum (esetyenziswa ngokulandelelana okanye ngokudibeneyo). Njengoko kubonisiwe kuhlalutyo lwexeshana oluchazwe kwangaphambili, i-sac-TMT monotherapy ibonise ukuphucuka okubalulekileyo kunye nokubalulekileyo ngokwezonyango kwizinga lokuphendula okujolisekileyo (ORR), ukusinda okungenankqubela phambili (PFS) kunye nokusinda ngokubanzi (OS) xa kuthelekiswa ne-docetaxel.
Malunga ne-sac-TMT
I-Sac-TMT yi-TROP2 ADC entsha yomntu apho iNkampani inamalungelo obunini obungobungcali, ijolise kwiithumba eziqinileyo eziphambili ezifana ne-NSCLC, umhlaza webele (BC), umhlaza wesisu (GC), iithumba zezifo zabasetyhini, phakathi kwezinye. I-Sac-TMT yenziwe nge-linker entsha yokudibanisa umthwalo ohlawulelwayo, i-belotecan-derivative topoisomerase I inhibitor ene-drug-to-antibody-ratio (DAR) ye-7.4. I-Sac-TMT iqaphela ngokukodwa i-TROP2 kumphezulu weeseli zethumba ngama-antibodies e-anti-TROP2 humanized monoclonal, emva koko i-endocytosed ziiseli zethumba kwaye ikhuphe i-KL610023 ngaphakathi kweseli. I-KL610023, njenge-topoisomerase I inhibitor, ibangela umonakalo we-DNA kwiiseli zethumba, nto leyo ekhokelela ekumisweni kweseli kunye ne-apoptosis. Ukongeza, ikwakhupha i-KL610023 kwindawo encinci yethumba. Ngenxa yokuba i-KL610023 iyakwazi ukungena kwi-membrane, inokwenza ukuba i-stander effect ibonakale, okanye ngamanye amazwi ibulale iiseli ze-tumor ezikufutshane.
Ngaphambili, i-NMPA ivumile ukuthengiswa kwe-sac-TMT eTshayina kwizigulane zabantu abadala abanomhlaza webele ophucukileyo okanye onesifo se-metastatic triple negative (TNBC) ongenakunyangwa abafumene ubuncinane unyango lwenkqubo oluphindwe kabini ngaphambili (ubuncinane olunye lwazo lonyango oluphucukileyo okanye olusasazekayo) kwaye yamkela isicelo esitsha esongezelelweyo samayeza (sNDA) esifuna imvume ye-sac-TMT monotherapy kwizigulane ezine-EGFR-mutant NSCLC eziye zasilela emva konyango lwe-EGFR-TKI.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Ixesha lokuthumela: Matshi-20-2025