Ngomhla we-19 kuJuni, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration (i-NMPA) libhengeze ukuba inaliti ye-LM-108 yeLivzon Pharmaceutical icetyisiwe ukuba ifakwe kunyango oluphambili. Ukudibanisa inaliti ye-Kefeqibai monoclonal antibody (LM-108) kunye ne-toripalimab kuyacingelwa ukunyanga izigulana ezine-advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma ezine-CCR8-positive kwaye ezingaphumelelanga kunyango oluqhelekileyo lwangaphambili.
I-LM-108 yi-antibody entsha ye-Fc-optimized, i-anti-CCR8 monoclonal antibody ekhethayo ukunciphisa ii-Tregs ezifaka iithumba.
Malunga neCCR8:
I-CCR8 (i-chemokine receptor 8) lilungu le-subfamily ye-chemokine receptor phantsi kosapho lwe-G protein-coupled receptor (GPCR). Izifundo zangaphambili zityhile ukuba ukubonakaliswa kwe-CCR8 kuphantsi kwiiseli zegazi ezingaphandle kunye nezicubu eziqhelekileyo, kodwa kunyuswa ngokukodwa kwi-Tregs ezifaka i-tumor kwimihlaza emininzi kubandakanya umhlaza webele, umhlaza we-colorectal, kunye nomhlaza wemiphunga. Ii-antibodies ze-Anit-CCR8 zinokukhetha ukuphelisa i-Tregs ezifaka i-tumor, ngaloo ndlela ziphucula impendulo yomzimba yokulwa ne-tumor kwaye zithintele ukukhula kwe-tumor.
KwiNtlanganiso yoNyaka ye-American Society of Clinical Oncology (ASCO) ka-2024, uhlalutyo oludibeneyo lwezifundo ezintathu zeSigaba 1/2 malunga nokudityaniswa kwe-LM-108 kunye nonyango lwe-anti-PD-1 kwizigulana ezinomhlaza wesisu luye lwaboniswa.
Iindlela: Izigulana ezifanelekileyo ezinomhlaza wesisu ezinyangwe nge-LM-108 kunye ne-anti-PD-1 antibody zibandakanyiwe kuhlalutyo. Izigulana zifumene i-LM-108 ngemithambo kumanqanaba edosi ye-3 mg/kg Q2W, 6 mg/kg Q3W, okanye 10 mg/kg Q3W kunye ne-anti-PD-1 antibody (i-intravenous pembrolizumab 200 mg Q3W okanye 400 mg Q6W okanye i-toripalimab 240 mg Q3W). Isiphelo esiphambili yayiyi-ORR evavanyiweyo ngumphandi ngokwe-RECIST v1.1. Isiphelo sesibini siquka ukhuseleko, ezinye iziphumo zokusebenza kakuhle, kunye nohlalutyo lwee-biomarkers. Umhla wokugqibela wedatha yohlalutyo oludibeneyo yayinguDisemba 25, 2023.
Iziphumo: Izigulane ezingamashumi amane anesibhozo ezinomhlaza wesisu (ubudala obuphakathi: iminyaka engama-60.5; amadoda: 72.9%) ezivela eTshayina, eMelika, nase-Australia zinyangwe nge-≥ idosi enye ye-LM-108 kunye ne-pembrolizumab okanye i-toripalimab. Uninzi lwezigulane (n = 47, 97.9%) zazifumene ubuncinane unyango olunye lwangaphambili lokulwa nomhlaza, kwaye ezingama-43 (89.6%) zazifumene unyango lwangaphambili lwe-anti-PD-1. Iziganeko ezimbi ezinxulumene nonyango (ii-TRAE) zenzeka kwizigulane ezingama-39 (81.3%), apho iziganeko eziqhelekileyo (≥15%) yayikukwanda kwe-alanine transaminase (25.0%), ukwanda kwe-aspartate transaminase (22.9%), ukuncipha kweeseli ezimhlophe zegazi (22.9%), i-anemia (16.7%). Ii-TRAE zeBanga ≥ 3 zenzeke kwizigulane ezili-18 (37.5%), ezona ziganeko zixhaphakileyo (≥ 4%) yayiyi-anemia (8.3%), i-lipase yanda (4.2%), irhashalala (4.2%), kunye nenani le-lymphocyte lehlile (4.2%). Phakathi kwezigulane ezingama-36 ezivavanywayo ngempumelelo kuzo zonke iirejimeni, i-ORR yayiyi-36.1% kwaye i-DCR yayiyi-72.2%. I-PFS ephakathi yayiyiinyanga eziyi-6.53. Phakathi kwezigulane ezili-11 ezinesifo sazo saqhubeka kunyango lokuqala, i-ORR yayiyi-63.6% kwaye i-DCR yayiyi-81.8%. Kwizigulane ezili-11 ezaqhubeka kunyango lokuqala, ezi-8 zazine-CCR8 ephezulu. Phakathi kwezi zigulane zi-8, i-ORR yayiyi-87.5% kwaye i-DCR yayiyi-100%, kwaye kwabonwa i-CR e-1, i-PR e-6, kunye ne-SD e-1.
Izigqibo: I-LM-108 xa idibene ne-antibody ye-anti-PD-1 ibonise umsebenzi othembisayo wokulwa nomhlaza kwizigulana ezinomhlaza wesisu ochasene nonyango lwe-anti-PD-1. Unyango oludibeneyo lwanyanyezelwa kakuhle.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Ixesha leposi: Juni-24-2025