Na June 19, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) kwupụtara na a tụrụ aro ka a tinye ọgwụ Livzon Pharmaceutical LM-108 n'ime aha ọgwụgwọ ọhụrụ. A na-atụle njikọta nke ọgwụ mgbochi monoclonal nke Kefeqibai (LM-108) na toripalimab maka ọgwụgwọ nke ndị ọrịa nwere adenocarcinoma afọ na-adịghị elu ma ọ bụ nke eriri afọ (G/GEJ) bụ ndị nwere CCR8-positive ma ghara inweta ọgwụgwọ mbụ.
LM-108 bụ ọgwụ mgbochi monoclonal nke Fc-emezigharịrị, nke na-egbochi CCR8 monoclonal nke na-ebelata Tregs nke na-abanye n'ime etuto ahụ nke ọma.
Banyere CCR8:
CCR8 (chemokine receptor 8) bụ otu n'ime ezinụlọ chemokine receptor n'okpuru ezinụlọ G protein-coupled receptor (GPCR). Ọmụmụ ihe ndị gara aga gosiri na ngosipụta nke CCR8 dị ala na mkpụrụ ndụ ọbara dị n'akụkụ na anụ ahụ nkịtị, mana a na-achịkwa ya nke ọma na Tregs ndị na-abanye n'ọrịa kansa dị iche iche gụnyere kansa ara, kansa eriri afọ, na kansa akpa ume. Mgbochi Anit-CCR8 nwere ike ime ka Tregs ndị na-abanye n'ọrịa dịkwuo mma, si otú a na-eme ka nzaghachi mgbochi ọrịa tumor dịkwuo mma ma na-egbochi uto tumor.
Na Nzukọ Kwa Afọ nke American Society of Clinical Oncology (ASCO) nke afọ 2024, e gosipụtara nyocha zuru oke nke ọmụmụ atọ nke Usoro 1/2 gbasara njikọta nke ọgwụgwọ LM-108 na ọgwụgwọ mgbochi PD-1 n'ahụ ndị ọrịa kansa afọ.
Usoro: Ndị ọrịa ruru eru nwere kansa afọ nke ejiri LM-108 gwọọ yana ọgwụ mgbochi PD-1 gụnyere na nyocha ahụ. Ndị ọrịa natara ọgwụ mgbochi LM-108 n'ime akwara na ọkwa dose nke 3 mg/kg Q2W, 6 mg/kg Q3W, ma ọ bụ 10 mg/kg Q3W tinyere ọgwụ mgbochi PD-1 (pembrolizumab 200 mg Q3W ma ọ bụ 400 mg Q6W ma ọ bụ toripalimab 240 mg Q3W). Isi ihe njedebe bụ ORR nke onye nyocha nyochachara kwa RECIST v1.1. Isi ihe njedebe nke abụọ gụnyere nchekwa, nsonaazụ arụmọrụ ndị ọzọ, na nyocha biomarkers. Ụbọchị njedebe data maka nyocha a chịkọtara bụ Disemba 25, 2023.
Nsonaazụ: Ndị ọrịa iri anọ na asatọ nwere kansa afọ (afọ etiti: afọ 60.5; nwoke: 72.9%) si China, USA, na Australia natara ọgwụgwọ ≥ otu dose nke LM-108 na njikọta ya na pembrolizumab ma ọ bụ toripalimab. Ọtụtụ (n = 47, 97.9%) ndị ọrịa natara ma ọ dịkarịa ala otu ọgwụgwọ mgbochi kansa tupu oge eruo, 43 (89.6%) enwetawokwa ọgwụgwọ mgbochi PD-1 tupu oge eruo. Ihe omume ọjọọ metụtara ọgwụgwọ (TRAEs) mere na ndị ọrịa 39 (81.3%), ebe ihe omume kachasị (≥15%) bụ mmụba nke alanine transaminase (25.0%), mmụba nke aspartate transaminase (22.9%), mbelata nke mkpụrụ ndụ ọbara ọcha (22.9%), ọbara ọbara (16.7%). Ọkwa ≥ 3 TRAE mere n'ime ndị ọrịa 18 (37.5%), ihe ndị a na-ahụkarị (≥ 4%) bụ anaemia (8.3%), mmụba lipase (4.2%), ihe ọkụ ọkụ (4.2%), na ọnụọgụ lymphocyte belatara (4.2%). N'ime ndị ọrịa 36 a na-enyocha arụmọrụ ha n'usoro ọgwụgwọ niile, ORR bụ 36.1% na DCR bụ 72.2% . PFS nke etiti bụ ọnwa 6.53. N'ime ndị ọrịa 11 ọrịa ha gara n'ihu na ọgwụgwọ mbụ, ORR bụ 63.6% na DCR bụ 81.8%. N'ime ndị ọrịa 11 gara n'ihu na ọgwụgwọ mbụ, mmadụ 8 nwere oke CCR8. N'ime ndị ọrịa 8 a, ORR bụ 87.5% na DCR bụ 100%, ebe a hụrụ 1 CR, 6 PR, na 1 SD.
Mmechi: LM-108 na ọgwụ mgbochi PD-1 gosiri na ọ na-arụ ọrụ dị mma maka igbochi etuto ahụ n'ime ndị ọrịa nwere kansa afọ nke na-eguzogide ọgwụgwọ mgbochi PD-1. A nabatara ọgwụgwọ njikọta ahụ nke ọma.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
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Oge ozi: Juun-24-2025