Musi wa26 Ndira, 2025, Center for Drug Evaluation (CDE) yeChina National Medical Products Administration yakazivisa kuti jekiseni reLM-108 rakagadzirirwa kubatanidzwa mukurapa kwechirwere chegomarara rakasimba rine kusagadzikana kwe microsatellite (MSI-H) kana kusagadzirisa zvirwere (dMMR) zvakafambira mberi mushure mekurapwa ne immune checkpoint inhibitors (ICI).
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.
AMusangano weGore weASCO wa2024，Taura nezveongororo yakabatanidzwa yemigumisiro kubva muzvidzidzo zvechikamu chechitatu chechikamu (NCT05199753; NCT05255484; NCT05518045) kuti uongorore kushanda uye kuchengetedzeka kweLM-108 pamwe chete nekurapa kwekurwisa PD-1 muvarwere vane kenza yemudumbu.
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%). MaTRAE eGiredhi ≥ 3 akaitika muvarwere gumi nevasere (37.5%), zviitiko zvakajairika (≥ 4%) zvaive anemia (8.3%), lipase yakawedzera (4.2%), mapundu (4.2%), uye huwandu hwema lymphocyte hwakaderera (4.2%). Pakati pevarwere makumi matatu nevatanhatu vaiongororwa kushanda zvakanaka pamishonga yese, ORR yaive 36.1% (95% CI 20.8%–53.8%) uye DCR yaive 72.2% (95% CI 54.8%–85.8%). Avhareji yePFS yaive mwedzi 6.53 (95% CI 2.96–NA). Pakati pevarwere gumi nemumwe vane chirwere chakanga chafambira mberi pakurapwa kwekutanga, ORR yaive 63.6% (95% CI 30.8%–89.1%) uye DCR yaive 81.8% (95% CI 48.2%–97.7%). Pavarwere gumi nemumwe vakaenderera mberi nekurapwa kwekutanga, vasere vaiva neCCR8 yakanyanya kusimba. Pakati pevarwere vasere ava, ORR yaive 87.5% uye DCR yaive 100%, uye CR 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. Mhedzisiro iyi inotsigira kuongororwa kwakawedzerwa kweLM-108 mukenza yemudumbu ine CCR8.
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
Mareferensi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://www.lanovamedicines.com/en
3. https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2504
Nguva yekutumira: Kukadzi-06-2025