Ma Iune 19, ua hoʻolaha ke Kikowaena no ka Loiloi Lāʻau Lapaʻau (CDE) o ka National Medical Products Administration (NMPA) ua hāpai ʻia ka inikini LM-108 a Livzon Pharmaceutical no ka hoʻokomo ʻia ʻana i loko o ka hoʻolālā lapaʻau holomua. Ke noʻonoʻo ʻia nei ka hui pū ʻana o ka inikini antibody monoclonal Kefeqibai (LM-108) me ka toripalimab no ka mālama ʻana i nā maʻi me ka adenocarcinoma gastric a i ʻole gastroesophageal junction (G/GEJ) holomua i loaʻa iā CCR8-positive a ua hāʻule i ka lāʻau lapaʻau maʻamau mua.
ʻO LM-108 kahi antibody monoclonal anti-CCR8 hou i hoʻomaikaʻi ʻia e Fc e hoʻopau koho ana i nā Tregs e komo ana i ka maʻi tumor.
E pili ana iā CCR8:
ʻO CCR8 (chemokine receptor 8) he lālā ia o ka ʻohana chemokine receptor ma lalo o ka ʻohana G protein-coupled receptor (GPCR). Ua hōʻike nā haʻawina mua he haʻahaʻa ka hōʻike ʻana o CCR8 i loko o nā hunaola koko peripheral a me nā ʻiʻo maʻamau, akā ua hoʻonui kūikawā ʻia i loko o nā Tregs tumor-infiltrating i nā maʻi kanesa he nui e like me ke kanesa umauma, ke kanesa colorectal, a me ke kanesa māmā. Hiki i nā antibodies Anit-CCR8 ke hoʻoponopono koho i ka hoʻopau ʻana o nā Tregs tumor-infiltrating, no laila e hoʻonui ai i ka pane pale anti-tumor a kāohi i ka ulu ʻana o ka tumor.
Ma ka Hālāwai Makahiki 2024 o ka American Society of Clinical Oncology (ASCO), ua hōʻike ʻia kahi loiloi i hui pū ʻia o ʻekolu mau haʻawina Phase 1/2 e pili ana i ka hui pū ʻana o ka LM-108 a me ka lāʻau anti-PD-1 i nā poʻe maʻi ʻaʻai ʻōpū.
Nā Hana: Ua hoʻokomo ʻia nā maʻi kūpono me ka maʻi ʻōpū i mālama ʻia me LM-108 i hui pū ʻia me kahi antibody anti-PD-1 i ka loiloi. Ua loaʻa i nā maʻi ka intravenous LM-108 ma nā pae mahele o 3 mg/kg Q2W, 6 mg/kg Q3W, a i ʻole 10 mg/kg Q3W me kahi antibody anti-PD-1 (intravenous pembrolizumab 200 mg Q3W a i ʻole 400 mg Q6W a i ʻole toripalimab 240 mg Q3W). ʻO ke kumu mua ʻo ORR i loiloi ʻia e ka mea noiʻi e like me RECIST v1.1. ʻO nā kumu lua i hoʻokomo i ka palekana, nā hopena pono ʻē aʻe, a me ka loiloi biomarkers. ʻO ka lā palena ʻikepili no ka loiloi i hui pū ʻia ʻo Dekemaba 25, 2023.
Nā Hualoaʻa: He kanahākūmāwalu mau maʻi me ke kanesa ʻōpū (makahiki waena: 60.5 mau makahiki; kāne: 72.9%) mai Kina, USA, a me Australia i mālama ʻia he ≥ 1 mahele o LM-108 i hui pū ʻia me ka pembrolizumab a i ʻole toripalimab. ʻO ka hapa nui (n = 47, 97.9%) nā maʻi i loaʻa ma ka liʻiliʻi he 1 lāʻau lapaʻau anticancer ma mua, a he 43 (89.6%) i loaʻa i ka lāʻau lapaʻau anti-PD-1 ma mua. Ua ʻike ʻia nā hanana ʻino e pili ana i ka lāʻau lapaʻau (TRAEs) i 39 (81.3%) mau maʻi, kahi i loaʻa ai nā hanana maʻamau (≥15%) ʻo ia ka hoʻonui ʻia ʻana o ka alanine transaminase (25.0%), ka hoʻonui ʻia ʻana o ka aspartate transaminase (22.9%), ka emi ʻana o ke koko keʻokeʻo (22.9%), ka anemia (16.7%). Ua ʻike ʻia nā TRAE papa ≥ 3 i loko o 18 (37.5%) mau maʻi, ʻo nā hanana maʻamau (≥ 4%) he anemia (8.3%), piʻi ka lipase (4.2%), ʻōhūhū (4.2%), a ua emi ka helu lymphocyte (4.2%). Ma waena o 36 mau maʻi hiki ke loiloi ʻia ka pono ma nā regimen āpau, ʻo ORR he 36.1% a ʻo DCR he 72.2%. ʻO ka PFS waena he 6.53 mau mahina. Ma waena o 11 mau maʻi i holomua ka maʻi ma ka lāʻau mua, ʻo ORR he 63.6% a ʻo DCR he 81.8%. No nā maʻi 11 i holomua ma ka lāʻau mua, he 8 ka nui o ka hōʻike ʻana o CCR8. Ma waena o kēia mau maʻi 8, ʻo ORR he 87.5% a ʻo DCR he 100%, me 1 CR, 6 PR, a me 1 SD i ʻike ʻia.
Nā hopena: Ua hōʻike ʻo LM-108 i hui pū ʻia me kahi antibody anti-PD-1 i ka hana antitumor hoʻohiki i nā poʻe maʻi me ka maʻi ʻōpū i kūʻē i ka lāʻau anti-PD-1. Ua ʻae maikaʻi ʻia ka lāʻau lapaʻau hui pū ʻia.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
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Ka manawa hoʻouna: Iune-24-2025