Ngomhla wama-22 kuCanzibe, ngo-2025, uKelun Bio wabhengeza ukuba isicelo sesalathiso esitsha se-trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, ekwaziwa ngokuba yi-SKB264/MK – 2870) (®) samkelwa yiZiko loVavanyo lwaMayeza (CDE) le-National Medical Products Administration (NMPA) yaseTshayina. Esi salathiso sitsha sesonyango lwezigulane zabantu abadala ezine-nonresectable local advanced okanye metastatic hormone receptor-positive (HR+) kunye ne-human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) ezifumene unyango lwe-endocrine ngaphambili kunye nezinye iindlela zonyango kwinkqubo ephucukileyo okanye eguqukileyo. Olu kwamkelwa lusekelwe kwiziphumo ezilungileyo zophononongo lweSigaba sesi-3 lwe-OptiTROP – Breast02. Esi sicelo sesalathiso sesine sesalathiso se-sac – TMT esamkelwe yi-NMPA.
I-OptiTROP – I-Breast02 luphononongo lweklinikhi lweSigaba sesi-3 olucwangcisiweyo, oluvulelekileyo, oluneziko ezininzi, oluvavanye ukusebenza kakuhle kunye nokhuseleko lwe-sacituzumab tirumotecan monotherapy kwidosi ye-5 mg/kg rhoqo kwiiveki ezimbini (Q2W) xa kuthelekiswa nokukhetha kukagqirha i-chemotherapy kwizigulana ezine-HR+/HER2- (immunohistochemistry [IHC] 0, IHC 1+, okanye i-IHC 2+/in situ hybridization [ISH]-) umhlaza webele. Ngokusekelwe kuhlalutyo lwexeshana oluchazwe kwangaphambili, isiphelo sokuqala sokusebenza kakuhle kwesi sifundo seklinikhi seSigaba sesi-3 sahlangatyezwa. Xa kuthelekiswa nokukhetha kukagqirha i-chemotherapy, i-sac – TMT monotherapy ibonise ukuphucuka okubalulekileyo nokubalulekileyo ngokwezibalo kwisiphelo sokuqala sokusinda okungenankqubela phambili (PFS) njengoko kuhlolwe yikomiti yophononongo ezimeleyo eyi-blindless (BIRC), enomngcipheko oncitshisiweyo kakhulu wokuqhubela phambili kwesifo okanye ukufa. I-Sac – TMT ikwabonise umkhwa olungileyo wokusinda ngokubanzi (OS).
Ngomhla we-16 kuCanzibe, ngo-2024, iwebhusayithi esemthethweni ye-CDE yabhengeza ukuba isicelo siza kuhlolwa ngenkqubo yokuphononongwa nokuvunywa kwezinto eziphambili. Oku kubonisa uphawu lwesine lwe-sac-TMT lokudlula kwinkqubo yokuphononongwa nokuvunywa kwezinto eziphambili ze-CDE, kunye neempawu ezintathu zangaphambili ze-sat-TMT ezamkelweyo emva kokuphononongwa kwezinto eziphambili.
Malunga nesac-TMT (佳泰莱®)
I-Sac-TMT, imveliso ephambili yeNkampani, yi-TROP2 ADC entsha yomntu apho iNkampani inamalungelo obunini obungobungcali, ijolise kwiithumba eziqinileyo eziphambili ezifana nomhlaza wamaphaphu ongengoweseli encinci (NSCLC), BC, umhlaza wesisu (GC), iithumba zesini, 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 ngee-antibodies ze-anti-TROP2 eziguqulweyo, ezithi emva koko zifakwe i-endocytosed ziiseli zethumba kwaye zikhuphe i-KL610023 ngaphakathi kweseli. I-KL610023, njenge-topoisomerase I inhibitor, ibangela umonakalo kwi-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.
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 leposi: Meyi-27-2025