I-ADC Sac-TMT kaKelun-Biotech ifumene isikhundla sonyango oluphambili eTshayina

Ngomhla we-11 kuJuni, uKelun-Biotech ubhengeze ukuba i-TROP2 ADC drug sac-TMT (佳泰莱) eyilwe ngokuzimeleyo, kunye ne-PD-L1 monoclonal antibody tagitanlimab (科泰莱), inikwe iBreakthrough Therapy Designation (BTD) yiZiko loVavanyo lwaMayeza (CDE) le-National Medical Products Administration (NMPA) yaseTshayina kunyango lokuqala lwezigulane ezikwi-non-squamous non-small cell lung cancer (NSCLC) ezingenazo iinguqu zejini zomqhubi.

I-Sac-TMT, imveliso ephambili yeNkampani, 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 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.

Olu phawu lwe-Breakthrough Therapy lusekelwe kwidatha yokusebenza kakuhle kunye nokhuseleko oluvela kwi-non-squamous cohort yeSigaba sesiBini se-OptiTROP-Lung01.

Iziphumo zophando lwe-OptiTROP-Lung01 Phase II, oluvavanya i-sac-TMT kunye ne-KL-A167 (i-antibody ye-monoclonal anti-PD-L1) njengonyango lokuqala lwezigulane ze-NSCLC eziphucukileyo ezingenayo i-driver-gene, ziboniswe kwiNtlanganiso yoNyaka ye-CSCO Academic ka-2024.

Iziphumo zibonise: KwiQela 1A, ukulandelela okuphakathi bekuziinyanga ezili-14.0, kunye nezinga lokuphendula elichanekileyo (ORR) elingama-48.6% (18/37, amatyala ama-2 elinde ukuqinisekiswa), izinga lokulawula isifo (DCR) elingama-94.6%, ukusinda okuphakathi okungenankqubela phambili (PFS) kweenyanga ezili-15.4 (95% CI: 6.7, NE), kunye nezinga le-PFS leenyanga ezi-6 elingama-69.2%; kwiQela 1B, ukulandelela okuphakathi bekuziinyanga ezi-6.9, kunye ne-ORR engama-77.6% (45/58, amatyala ama-5 elinde ukuqinisekiswa), i-DCR engama-100.0%, i-PFS ephakathi ayikafikelelwa, kunye nezinga le-PFS leenyanga ezi-6 elingama-84.6%.

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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