Ngomhlaka-19 Juni, i-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) yamemezela ukuthi umjovo we-LM-108 we-Livzon Pharmaceutical uphakanyiswe ukuthi ufakwe ekwakhiweni kokwelashwa okuphumelelayo. Ukuhlanganiswa komjovo we-Kefeqibai monoclonal antibody (LM-108) ne-toripalimab kuyacatshangelwa ekwelapheni iziguli ezine-advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma ezine-CCR8-positive futhi ezihlulekile ukwelashwa okujwayelekile kwangaphambilini komugqa wokuqala.
I-LM-108 iyi-antibody entsha ye-Fc-optimized, anti-CCR8 monoclonal eqeda ngokukhetha ama-Tregs angena ngesimila.
Mayelana ne-CCR8:
I-CCR8 (i-chemokine receptor 8) iyilungu lomndeni ongaphansi kwe-chemokine receptor ngaphansi komndeni we-G protein-coupled receptor (GPCR). Izifundo zangaphambilini zembule ukuthi ukuvezwa kwe-CCR8 kuphansi kumaseli egazi angaphandle kanye nezicubu ezijwayelekile, kodwa kukhushulwa ikakhulukazi kuma-Tregs angena ngesimila emidlangeni eminingi yomdlavuza okuhlanganisa umdlavuza webele, umdlavuza we-colorectal, kanye nomdlavuza wamaphaphu. Ama-antibodies e-Anit-CCR8 angakhetha ukuqeda ukuncipha kwama-Tregs angena ngesimila, ngaleyo ndlela athuthukise impendulo yomzimba yokulwa nesimila futhi avimbele ukukhula kwesimila.
Emhlanganweni Waminyaka Yonke we-American Society of Clinical Oncology (ASCO) ka-2024, kwethulwe ukuhlaziywa okuhlanganisiwe kwezifundo ezintathu zeSigaba 1/2 ngokuhlanganiswa kwe-LM-108 kanye nokwelashwa okulwa ne-PD-1 ezigulini ezinomdlavuza wesisu.
Izindlela: Iziguli ezifanelekile ezinomdlavuza wesisu ezelashwe nge-LM-108 kanye ne-antibody ye-anti-PD-1 zifakiwe ekuhlaziyweni. Iziguli zathola i-LM-108 nge-intravenous emazingeni omthamo angu-3 mg/kg Q2W, 6 mg/kg Q3W, noma 10 mg/kg Q3W kanye ne-antibody ye-anti-PD-1 (i-intravenous pembrolizumab 200 mg Q3W noma 400 mg Q6W noma i-toripalimab 240 mg Q3W). I-endpoint eyinhloko kwakuyi-ORR ehlolwe ngumcwaningi ngokwe-RECIST v1.1. I-endpoint yesibili yayihlanganisa ukuphepha, eminye imiphumela yokusebenza kahle, kanye nokuhlaziywa kwama-biomarker. Usuku lokuphela kwedatha lokuhlaziywa okuhlanganisiwe kwakunguDisemba 25, 2023.
Imiphumela: Iziguli ezingamashumi amane nesishiyagalombili ezinomdlavuza wesisu (ubudala obuphakathi: iminyaka engama-60.5; abesilisa: 72.9%) abavela eShayina, e-USA, nase-Australia belashwe ngomthamo ongu-≥ owodwa we-LM-108 kuhlanganiswe ne-pembrolizumab noma i-toripalimab. Iningi leziguli (n = 47, 97.9%) lalithole okungenani ukwelashwa okukodwa kwangaphambilini kokulwa nomdlavuza, kanti ezingu-43 (89.6%) zazithole ukwelashwa kwangaphambilini kokulwa ne-PD-1. Izehlakalo ezimbi ezihlobene nokwelashwa (ama-TRAE) zenzeka ezigulini ezingu-39 (81.3%), lapho izehlakalo ezivame kakhulu (≥15%) kwakuyi-alanine transaminase ekhuphukile (25.0%), i-aspartate transaminase ekhuphukile (22.9%), amaseli amhlophe egazi ehlile (22.9%), i-anemia (16.7%). Ama-TRAE ebanga ≥ 3 enzeke ezigulini ezingu-18 (37.5%), izehlakalo ezivame kakhulu (≥ 4%) kwakuyi-anemia (8.3%), i-lipase yanda (4.2%), ukuqubuka (4.2%), kanye nenani lama-lymphocyte lehlile (4.2%). Phakathi kweziguli ezingu-36 ezihlolwa ngempumelelo kuzo zonke izinhlobo zemithi, i-ORR yayingu-36.1% kanti i-DCR yayingu-72.2%. I-PFS ephakathi yayizinyanga ezingu-6.53. Phakathi kweziguli ezingu-11 ezinesifo sazo saqhubeka nokwelashwa komugqa wokuqala, i-ORR yayingu-63.6% kanti i-DCR yayingu-81.8%. Ezigulini ezingu-11 ezaqhubeka nokwelashwa komugqa wokuqala, ezingu-8 zazinokubonakaliswa okuphezulu kwe-CCR8. Phakathi kwalezi ziguli ezingu-8, i-ORR yayingu-87.5% kanti i-DCR yayingu-100%, kwabonakala i-CR eyodwa, i-PR engu-6, kanye ne-SD eyodwa.
Iziphetho: I-LM-108 ehlanganiswe ne-antibody ye-anti-PD-1 ibonise umsebenzi othembisayo wokulwa nomdlavuza ezigulini ezinomdlavuza wesisu ophikisana nokwelashwa kwe-anti-PD-1. Ukwelashwa okuhlanganisiwe kwabekezelelwa kahle.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Juni-24-2025