TROP2 ADC sac-TMT y'udushya igaragaza imikorere myiza yo kurwanya kanseri mu tumori tw’inyongera

Ku ya 6 Kamena, ikinyamakuru mpuzamahanga cy’ubuvuzi cyitwa Journal of Hematology & Oncology cyasohoye ibyavuye mu bushakashatsi bw’icyiciro cya mbere n’icya kabiri (KL264-01/MK-2870-001) by’umuti mushya wa TROP2 ADC sacituzumab tirumotecan (sac-TMT) nk’umuti umwe ku tumori tw’indwara tudakira cyangwa tudafite uburyo bwo kuvura indwara zisanzwe.

Sacituzumab tirumotecan (sac-TMT) ni antibody-drug conjugate igizwe na antibody ya monoclonal anti-TROP2 ihujwe na cytotoxic belotecan-derived topoisomerase I inhibitor (KL610023) binyuze ku rubuga rushya rwo guhuza.

Uburyo

Abarwayi bari bafite ibibyimba bikomeye bitaravurwa mu gace runaka/bitaravurwa mu buryo busanzwe, bidashobora kuvurwa mu buryo busanzwe. Mu cyiciro cya mbere cy’izamuka ry’umuti, abarwayi bari bafite ibibyimba bikomeye bitaravurwa mu buryo busanzwe, bidashobora kuvurwa mu buryo busanzwe. Sac-TMT yatangwaga mu mitsi buri byumweru 2 kuri 2 kugeza kuri 12 mg/kg. Mu cyiciro cya 2, abarwayi ba kanseri y’ibere ya TNBC na HR+/HER2− bahawe sac-TMT kuri dose yagenwe yo kwagura (RDEs) yabonetse mu cyiciro cya 1. Intego z’ibanze zari ukugena dose ntarengwa yihanganirwa (MTD) ya sac-TMT no gushyiraho RDEs (icyiciro cya 1) no kugena ORR kuri RECIST v1.1 hakoreshejwe isuzuma ry’ubushakashatsi (icyiciro cya 2). Ingaruka mbi zasuzumwe hakurikijwe NCI-CTCAE verisiyo ya 5.0.

Ibisubizo

Abarwayi mirongo itatu biyandikishije mu cyiciro cya 1 kandi bahawe sac-TMT 2 mg/kg (n = 4), 4 mg/kg (n = 7), 5 mg/kg (n = 7), 5.5 mg/kg (n = 5), na 6 mg/kg (n = 7). Abarwayi batanu bari bafite uburozi bugabanya urugero rw'umuti: stomatitis yo mu cyiciro cya 3 kuri 4, 5.5, na 6 mg/kg; ibisebe byo mu cyiciro cya 3 kuri 5 mg/kg; na urticaria yo mu cyiciro cya 3 kuri 6 mg/kg. MTD yari 5.5 mg/kg naho RDEs zari 4 na 5 mg/kg. Mu kongera urugero rw'umuti mu cyiciro cya 2, ORR (95% CI) yari 34.8% (16.4%, 57.3%) mu itsinda rya 4-mg/kg (n = 23) na 38.9% (23.1%, 56.5%) mu itsinda rya 5-mg/kg (n = 36) kuri TNBC. ORR (95% CI) yari 31.7% (18.1%, 48.1%) kuri kanseri y'ibere ya HR+/HER2− (n = 41).

Umwanzuro

Sac-TMT yagaragaje umutekano muke ku barwayi bafite ibibyimba bikomeye bitavurwa mu gace runaka kandi bitanga icyizere cyo kurwanya ibibyimba muri kanseri y'ibere ya TNBC na HR+/HER2. Sac-TMT irimo gukorwaho ubushakashatsi mu cyiciro cya 3.

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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