A ranar 26 ga Janairu, 2025, Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Ƙasa ta China ta sanar da cewa allurar LM-108 an yi ta ne don a haɗa ta a cikin maganin ciwace-ciwacen da suka yi tsanani waɗanda ke da rashin kwanciyar hankali na microsatellite (MSI-H) ko lahani na gyara mara daidai (dMMR) waɗanda suka ci gaba bayan an yi musu magani da masu hana binciken garkuwar jiki (ICI).
LM-108 wani sabon maganin rigakafi ne na Fc wanda aka inganta, wanda ke hana CCR8 monoclonal antibody wanda ke rage yawan ƙwayoyin cuta da ke shiga cikin Tregs.
Game da CCR8:
CCR8 (mai karɓar chemokine 8) memba ne na dangin mai karɓar chemokine a ƙarƙashin dangin mai karɓar furotin na G (GPCR). Nazarin da aka yi a baya ya nuna cewa bayyanar CCR8 ba ta da yawa a cikin ƙwayoyin jini na gefe da kyallen takarda na yau da kullun, amma an inganta ta musamman a cikin Tregs masu shigar ƙari a cikin ciwon daji da yawa ciki har da ciwon nono, ciwon hanji, da ciwon huhu. Kwayoyin rigakafi na Anit-CCR8 na iya yin sulhu da rage yawan ƙwayoyin cuta da ke shiga cikin Tregs, ta haka suna haɓaka amsawar garkuwar jiki ta hana ci gaban ƙari.
ATaron Shekara-shekara na ASCO na 2024，bayar da rahoton cikakken bincike na sakamako daga nazarin matakai 3 na 1/2 (NCT05199753; NCT05255484; NCT05518045) don tantance inganci da amincin LM-108 tare da maganin hana PD-1 ga marasa lafiya da ke fama da ciwon daji na ciki.
Hanyoyi: An haɗa marasa lafiya da suka cancanta da ciwon daji na ciki da aka yi wa magani da LM-108 tare da haɗin gwiwar anti-PD-1 antibody a cikin binciken. An karɓi marasa lafiya ta hanyar jijiya LM-108 a matakan allurai na 3 mg/kg Q2W, 6 mg/kg Q3W, ko 10 mg/kg Q3W tare da antibody na anti-PD-1 (pembrolizumab 200 mg Q3W ko 400 mg Q6W ko toripalimab 240 mg Q3W). Babban ƙarshen binciken shine ORR da mai bincike ya tantance ga kowane RECIST v1.1. Ƙarshen binciken na biyu ya haɗa da aminci, sauran sakamakon inganci, da nazarin alamun halitta. Ranar yanke bayanai don binciken da aka tattara ita ce Disamba 25, 2023.
Sakamako: An yi wa marasa lafiya arba'in da takwas da ke fama da ciwon daji na ciki (matsakaicin shekaru: shekaru 60.5; maza: 72.9%) daga China, Amurka, da Ostiraliya magani ≥ 1 na LM-108 tare da pembrolizumab ko toripalimab. Yawancin marasa lafiya (n = 47, 97.9%) sun sami aƙalla maganin cutar kansa 1 a baya, kuma 43 (89.6%) sun sami maganin cutar PD-1 a baya. Abubuwan da suka shafi rashin lafiya (TRAEs) sun faru a cikin marasa lafiya 39 (81.3%), inda abubuwan da suka fi faruwa (≥15%) sune alanine transaminase ya karu (25.0%), aspartate transaminase ya karu (22.9%), farin ƙwayoyin jini ya ragu (22.9%), anemia (16.7%). Aji ≥ 3 TRAEs sun faru a cikin marasa lafiya 18 (37.5%), abubuwan da suka fi faruwa (≥ 4%) sune rashin jini (8.3%), ƙaruwar lipase (4.2%), kuraje (4.2%), da raguwar adadin lymphocytes (4.2%). Daga cikin marasa lafiya 36 da za a iya kimantawa da inganci a duk tsarin, ORR shine 36.1% (95% CI 20.8%–53.8%) kuma DCR shine 72.2% (95% CI 54.8%–85.8%). Matsakaicin PFS shine watanni 6.53 (95% CI 2.96–NA). Daga cikin marasa lafiya 11 waɗanda cutar ta ci gaba a kan magani na farko, ORR shine 63.6% (95% CI 30.8%–89.1%) kuma DCR shine 81.8% (95% CI 48.2%–97.7%). Daga cikin marasa lafiya 11 da suka ci gaba da samun ci gaba a kan magani a layin farko, 8 sun sami babban ƙarfin CCR8. Daga cikin waɗannan marasa lafiya 8, ORR ya kasance 87.5% kuma DCR ya kasance 100%, tare da lura da CR 1, PR 6, da SD 1.
Kammalawa: LM-108 tare da maganin rigakafi na PD-1 ya nuna kyakkyawan aikin maganin ƙari ga marasa lafiya da ke fama da ciwon daji na ciki wanda ke da juriya ga maganin rigakafi na PD-1. An jure wa maganin haɗin gwiwa sosai. Waɗannan sakamakon suna tallafawa ƙarin kimantawa na LM-108 a cikin ciwon daji na ciki mai kyau na CCR8.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Nassoshi
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
Lokacin Saƙo: Fabrairu-06-2025