LM-108 yahawe uburenganzira bwo kuvura indwara zidasanzwe

Ku ya 19 Kamena, Ikigo gishinzwe Isuzuma ry'Imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi (NMPA) cyatangaje ko inshinge za LM-108 za Livzon Pharmaceutical zatanzwe kugira ngo zishyirwe mu cyiciro cy'ubuvuzi bugezweho. Guhuza inshinge za Kefeqibai monoclonal antibody (LM-108) na toripalimab biri kwitabwaho mu kuvura abarwayi bafite ikibazo cyo mu nda cyangwa mu gastroesophageal junction (G/GEJ) adenocarcinoma bafite CCR8-positive kandi bakaba barananiwe ubuvuzi bwa mbere.

LM-108 ni antibody nshya ya Fc-optimized, anti-CCR8 monoclonal antibody igabanya mu buryo bwihariye Tregs zinjira mu tumori.

Ku bijyanye na CCR8:

CCR8 (receptor ya chemokine 8) ni imwe mu zigize umuryango wa chemokine receptor ugizwe na receptor ya G protein-coupled (GPCR). Ubushakashatsi bwakozwe mbere bwagaragaje ko CCR8 igaragara hasi mu tunyangingo tw’amaraso two mu mpande no mu tunyangingo dusanzwe, ariko cyane cyane yiyongera mu tunyangingo twinjira mu tunyangingo muri kanseri nyinshi zirimo kanseri y’ibere, kanseri y’inkondo y’umura, na kanseri y’ibihaha. Utunyangingo twa Anit-CCR8 dushobora gufasha mu buryo bwihariye kugabanuka kwa Tregs zinjira mu tunyangingo, bityo bikongera ubushobozi bwo kurwanya kanseri kandi bikabuza gukura kwa kanseri.

Mu nama ngarukamwaka y’Umuryango w’Abanyamerika wita ku ndwara za kanseri (ASCO) yo mu 2024, hatanzwe isesengura ry’ubushakashatsi butatu bwakozwe mu cyiciro cya 1/2 ku bijyanye no guhuza imiti ya LM-108 n’imiti irwanya PD-1 ku barwayi ba kanseri y’igifu.

Uburyo: Abarwayi bemewe barwaye kanseri y'igifu bavuwe na LM-108 hamwe na antibody ya anti-PD-1 bashyizwe mu isesengura. Abarwayi bahawe LM-108 mu mitsi ku gipimo cya 3 mg/kg Q2W, 6 mg/kg Q3W, cyangwa 10 mg/kg Q3W hamwe na antibody ya anti-PD-1 (impyiko ya pembrolizumab 200 mg Q3W cyangwa 400 mg Q6W cyangwa toripalimab 240 mg Q3W). Incamake y'ibanze yari ORR yasuzumwe n'umushakashatsi kuri RECIST v1.1. Incamake y'inyongera yarimo umutekano, ibindi bisubizo by'ingirakamaro, n'isesengura ry'ibipimo. Itariki ntarengwa yo gusesengura hamwe yari ku ya 25 Ukuboza 2023.

Ibisubizo: Abarwayi 48 barwaye kanseri y'igifu (imyaka iri hagati: imyaka 60.5; abagabo: 72.9%) bakomoka mu Bushinwa, muri Amerika na Ositaraliya bavuwe ≥ dose 1 ya LM-108 hamwe na pembrolizumab cyangwa toripalimab. Abenshi mu barwayi (n = 47, 97.9%) bari barahawe nibura ubuvuzi bumwe mbere bwo kurwanya kanseri, naho 43 (89.6%) bari barahawe ubuvuzi bwa anti-PD-1 mbere. Ingaruka mbi zijyanye n'ubuvuzi (TRAEs) zabaye ku barwayi 39 (81.3%), aho ingaruka zikunze kugaragara cyane (≥15%) zari iziyongereyeho alanine transaminase (25.0%), aspartate transaminase yiyongeraho (22.9%), uturemangingo tw'amaraso twagabanutseho (22.9%), amaraso make (16.7%). Impamyabumenyi y’indwara ya TRAE ya ≥ 3 yagaragaye ku barwayi 18 (37.5%), indwara zikunze kugaragara cyane (≥ 4%) zari amaraso make (8.3%), lipase yiyongera (4.2%), ibisebe (4.2%), n’umubare wa limfositi waragabanutse (4.2%). Mu barwayi 36 bapimwe ubushobozi bwabo mu mikorere yose, ORR yari 36.1% naho DCR yari 72.2%. Igipimo cya PFS cyari amezi 6.53. Mu barwayi 11 barwaye indwara bari bamaze kuvura ku murongo wa mbere, ORR yari 63.6% naho DCR yari 81.8%. Mu barwayi 11 bavuwe ku murongo wa mbere, 8 bari bafite CCR8 nyinshi. Muri abo barwayi 8, ORR yari 87.5% naho DCR yari 100%, hagaragaye CR 1, PR 6, na SD 1.

Umwanzuro: LM-108 hamwe n'umuti urwanya kanseri ya PD-1 byagaragaje ko birwanya kanseri ku barwayi ba kanseri y'igifu, ariko bikaba byarananiye imiti irwanya kanseri ya PD-1. Uburyo bwo kuvura buvanze bwari bwihanganiwe neza.

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

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