Musi wa19 Chikumi, Center for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) yakazivisa kuti jekiseni reLM-108 reLivzon Pharmaceutical rakurudzirwa kuti rivepo muchirongwa chekurapa kwekubudirira. Kusanganiswa kweKefeqibai monoclonal antibody injection (LM-108) netoripalimab kuri kutariswa kurapa varwere vane advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma vane CCR8-positive uye vakakundikana kurapwa kwekutanga.
LM-108 iantibody itsva yeFc-optimized, anti-CCR8 monoclonal antibody iyo inoderedza Tregs dzinopinda mugomarara.
NezveCCR8:
CCR8 (chemokine receptor 8) inhengo yemhuri yechemokine receptor iri pasi pemhuri yeG protein-coupled receptor (GPCR). Ongororo dzakapfuura dzakaratidza kuti kuratidzwa kweCCR8 kwakaderera mumasero eropa ekunze uye mumatishu akajairwa, asi zvakanyanya kuwedzera muTregs dzinopinda mugomarara mune akawanda magomarara anosanganisira kenza yemazamu, kenza yemudumbu, uye kenza yemapapu. Ma antibodies eAnit-CCR8 anogona kusarudza kubatsira kuderedza Tregs dzinopinda mugomarara, nokudaro zvichiwedzera simba rekudzivirira gomarara uye kudzivirira kukura kwegomarara.
PaMusangano weGore weAmerican Society of Clinical Oncology (ASCO) wa2024, ongororo yakabatanidzwa yezvidzidzo zvitatu zveChikamu 1/2 pamusoro pemusanganiswa weLM-108 nekurapa kwePD-1 muvarwere vegomarara remudumbu yakaitwa.
Nzira: Varwere vanokodzera vane kenza yemudumbu vakarapwa neLM-108 pamwe chete neanti-PD-1 antibody vakaverengerwa muongororo iyi. Varwere vakapihwa LM-108 neropa padanho re3 mg/kg Q2W, 6 mg/kg Q3W, kana 10 mg/kg Q3W pamwe chete neanti-PD-1 antibody (intravenous pembrolizumab 200 mg Q3W kana 400 mg Q6W kana toripalimab 240 mg Q3W). Mugumo wekutanga waive weORR yakaongororwa nevaongorori zvichienderana neRECIST v1.1. Mugumo wechipiri waisanganisira kuchengetedzeka, mimwe mhedzisiro yekushanda zvakanaka, uye ongororo yebiomarkers. Zuva rekupedzisira reongororo yakabatanidzwa raive Zvita 25, 2023.
Mhedzisiro: Varwere makumi mana nevasere vane kenza yemudumbu (zera repakati: makore 60.5; varume: 72.9%) vanobva kuChina, USA, neAustralia vakarapwa ≥ dose imwe yeLM-108 pamwe chete nepembrolizumab kana toripalimab. Vazhinji (n = 47, 97.9%) varwere vakamborapwa kanenge kamwe chete kare, uye 43 (89.6%) vakamborapwa anti-PD-1. Zviitiko zvisina kunaka zvine chekuita nekurapwa (TRAEs) zvakaitika muvarwere 39 (81.3%), umo zviitiko zvakajairika (≥15%) zvaive alanine transaminase yakawedzera (25.0%), aspartate transaminase yakawedzera (22.9%), masero machena eropa akaderera (22.9%), anemia (16.7%). Matambudziko eTraE eGiredhi ≥ 3 akaitika muvarwere gumi nevasere (37.5%), zviitiko zvakajairika (≥ 4%) zvaive anemia (8.3%), lipase yakawedzera (4.2%), mapundu (4.2%), uye huwandu hwelymphocyte hwakaderera (4.2%). Pakati pevarwere makumi matatu nevatanhatu vaiongororwa kushanda zvakanaka pamishonga yese, ORR yaive 36.1% uye DCR yaive 72.2%. PFS yepakati yaive mwedzi 6.53. Pakati pevarwere gumi nemumwe vane chirwere chakanga chafambira mberi pakurapwa kwekutanga, ORR yaive 63.6% uye DCR yaive 81.8%. Pavarwere gumi nemumwe vakafambira mberi pakurapwa kwekutanga, vasere vaive neCCR8 yakakwira. Pakati pevarwere vasere ava, ORR yaive 87.5% uye DCR yaive 100%, neCR imwe chete, 6 PR, uye SD imwe chete yakaonekwa.
Mhedziso: LM-108 pamwe chete neantibody inorwisa PD-1 yakaratidza kushanda kwakanaka kwekudzivirira bundu muvarwere vane kenza yemudumbu iyo yaisagona kurapwa nePD-1. Kurapa kwacho kwakabvumidzwa zvakanaka.
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.
Nhamba yefoni: 4008803716
Email：myimmnet@163.com
Nguva yekutumira: Chikumi-24-2025