Ngomhlaka-11 Juni, iKelun-Biotech yamemezela ukuthi ithuthukise ngokuzimela umuthi wayo we-TROP2 ADC sac-TMT (佳泰莱), kanye ne-PD-L1 monoclonal antibody tagitanlimab (科泰莱), inikezwe i-Breakthrough Therapy Designation (BTD) yi-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yaseShayina ukuze kutholakale ukwelashwa kokuqala kweziguli ezinesifo somdlavuza wamaphaphu esingeyona i-squamous non-small cell (NSCLC) ezithuthukile noma ezisakazeke endaweni ngaphandle kokuguqulwa kwezakhi zofuzo zomshayeli.
I-Sac-TMT, umkhiqizo oyinhloko weNkampani, iyi-TROP2 ADC entsha yomuntu lapho iNkampani inamalungelo obunikazi obuyimfihlo, ihlose izimila eziqinile ezithuthukile njenge-NSCLC, umdlavuza webele (BC), umdlavuza wesisu (GC), izimila zezifo zabesifazane, phakathi kwezinye. I-Sac-TMT yakhiwe ngesixhumi esisha sokuxhumanisa umthwalo okhokhelwayo, i-belotecan-derivative topoisomerase I inhibitor ene-drug-to-antibody-ratio (DAR) engu-7.4. I-Sac-TMT iqaphela ngqo i-TROP2 ebusweni bamaseli ezimila ngama-antibodies e-recombinant anti-TROP2 humanized monoclonal, abese efakwa yi-endocytos ngamaseli ezimila bese ikhipha i-KL610023 ngaphakathi kweseli. I-KL610023, njenge-topoisomerase I inhibitor, ibangela ukulimala kwe-DNA kumaseli ezimila, okuholela ekumisweni kweseli kanye ne-apoptosis. Ngaphezu kwalokho, ikhipha ne-KL610023 endaweni encane yesimila. Njengoba i-KL610023 ingangena kalula esikhumbeni, ingenza kube nomphumela wokulinda, noma ngamanye amazwi ibulale amaseli esimila aseduze.
Lokhu Kuqanjwa Kwendlela Yokwelapha Ephumelelayo kusekelwe kudatha yokusebenza kahle kanye nokuphepha evela eqenjini elingelona i-squamous lesifundo se-Phase II OptiTROP-Lung01.
Imiphumela yocwaningo lwe-OptiTROP-Lung01 Phase II, oluhlola i-sac-TMT ngokuhlanganiswa ne-KL-A167 (i-antibody ye-monoclonal anti-PD-L1) njengokwelashwa kokuqala kweziguli ze-NSCLC ezithuthukile ezingenayo i-driver-gene, yethulwe eMhlanganweni Wonyaka Wezemfundo we-CSCO ka-2024.
Okutholakele kukhombisile: KwiQembu 1A, ukulandelwa okumaphakathi kwakuyizinyanga eziyi-14.0, kanye nesilinganiso sokuphendula esiqondile (ORR) esingu-48.6% (18/37, amacala ama-2 alinde ukuqinisekiswa), izinga lokulawula izifo (DCR) elingu-94.6%, ukusinda okumaphakathi okungenalo ukuqhubekela phambili (PFS) kwezinyanga eziyi-15.4 (95% CI: 6.7, NE), kanye nesilinganiso se-PFS sezinyanga eziyi-6 esingu-69.2%; kwiQembu 1B, ukulandelwa okumaphakathi kwakuyizinyanga eziyi-6.9, kanye ne-ORR engu-77.6% (45/58, amacala ama-5 alinde ukuqinisekiswa), i-DCR engu-100.0%, i-PFS emaphakathi engakafinyelelwa, kanye nesilinganiso se-PFS sezinyanga eziyi-6 esingu-84.6%.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Juni-12-2025