Musi wa11 Chikumi, Kelun-Biotech yakazivisa kuti yakagadzira yega mushonga weTROP2 ADC sac-TMT (佳泰莱), pamwe chete nePD-L1 monoclonal antibody tagitanlimab (科泰莱), yakapihwa Breakthrough Therapy Designation (BTD) neCenter for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) yeChina yekurapa varwere vekenza yemapapu isina squamous non-small cell cancer (NSCLC) vasina driver gene mutations.
Sac-TMT, chigadzirwa chikuru cheKambani, iTROP2 ADC itsva yevanhu umo Kambani ine kodzero dzepfuma yepfungwa, inotarisa bundu rakasimba repamusoro senge NSCLC, kenza yemazamu (BC), kenza yemudumbu (GC), bundu revakadzi, nezvimwewo. Sac-TMT yakagadzirwa nechinhu chitsva chinosanganisa mutoro wepayload, inhibitor ye belotecan-derivative topoisomerase I ine mushonga we antibody-ratio (DAR) we7.4. Sac-TMT inonyatsoona TROP2 pamusoro pemasero ebundu ne recombinant anti-TROP2 humanized monoclonal antibodies, iyo inobva yaiswa mu endocytos nemasero ebundu uye yoburitsa KL610023 mukati memasero. KL610023, se inhibitor ye topoisomerase I, inokonzera kukuvara kweDNA kumasero ebundu, izvo zvinozokonzera kumisa kwemasero uye apoptosis. Pamusoro pezvo, inoburitsawo KL610023 munzvimbo yebundu. Zvichienderana nekuti KL610023 inopindirwa nemembrane, inogona kuita kuti pave nemhedzisiro yekutarisa, kana kuti nemamwe mazwi kuuraya masero egomarara ari pedyo.
Kusarudzwa kweBreakthrough Therapy uku kwakavakirwa padata rekushanda uye kuchengetedzeka kubva kuboka risiri rema squamous rechidzidzo chePhase II OptiTROP-Lung01.
Zvakabuda muongororo yeOptiTROP-Lung01 Phase II, iyo yakaongorora sac-TMT pamwe chete neKL-A167 (anti-PD-L1 monoclonal antibody) senzira yekutanga yekurapa varwere veNSCLC vasina magene ekutyaira, zvakapihwa paMusangano weGore Negore weCSCO we2024.
Zvakawanikwa zvakaratidza kuti: Kuboka 1A, kuteverwa kwepakati kwaive kwemwedzi 14.0, nechiyero chekupindura chakanangana (ORR) che48.6% (18/37, nyaya mbiri dzichiri kumirira kusimbiswa), chiyero chekudzora chirwere (DCR) che94.6%, avhareji yekurarama pasina progression-free survival (PFS) yemwedzi 15.4 (95% CI: 6.7, NE), uye avhareji yePFS yemwedzi 6 ye69.2%; kuboka 1B, avhareji yekutevera yaive mwedzi 6.9, neORR ye77.6% (45/58, nyaya 5 dzichiri kumirira kusimbiswa), DCR ye100.0%, avhareji yePFS haisati yasvika, uye avhareji yePFS yemwedzi 6 ye84.6%.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
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Nguva yekutumira: Chikumi-12-2025