A ranar 19 ga Yuni, Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Kasa (NMPA) ta sanar da cewa an gabatar da allurar LM-108 ta Livzon Pharmaceutical don haɗawa a cikin tsarin maganin gaggawa. Ana la'akari da haɗa allurar rigakafin Kefeqibai monoclonal antibody (LM-108) tare da toripalimab don maganin marasa lafiya da ke da ciwon daji na ciki ko na gastroesophageal junction (G/GEJ) waɗanda ke da CCR8-positive kuma sun gaza a farkon maganin.
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.
A taron shekara-shekara na Ƙungiyar Kula da Cututtukan Cututtuka ta Amurka (ASCO) na shekarar 2024, an gabatar da wani bincike mai zurfi kan nazarin matakai uku na 1/2 kan haɗin LM-108 da maganin hana PD-1 ga masu fama da cutar kansar 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 ya kasance 36.1% kuma DCR ya kasance 72.2%. Matsakaicin PFS shine watanni 6.53. Daga cikin marasa lafiya 11 waɗanda cutar ta ci gaba a kan maganin farko, ORR ya kasance 63.6% kuma DCR ya kasance 81.8%. Daga cikin marasa lafiya 11 da suka ci gaba a kan maganin farko, 8 suna da babban bayyanar 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 hana PD-1 antibody ya nuna kyakkyawan aikin hana ƙarko ga marasa lafiya da ke fama da ciwon daji na ciki wanda ke da juriya ga maganin hana PD-1. An yi haƙuri da maganin haɗin gwiwa sosai.
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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Lokacin Saƙo: Yuni-24-2025