Umuti ugezweho wa Nectin-4 ADC (9MW2821) uri mu buvuzi bugezweho

Ku ya 8 Mutarama 2025, 9MW2821 yahawe inyito yo kuvura indwara ya Breakthrough Therapy (BTD) n'Ikigo gishinzwe gusuzuma imiti (CDE) cy'Ikigo cy'Igihugu gishinzwe Ibikoresho by'Ubuvuzi (NMPA) mu Bushinwa. 9MW2821 itangwa hamwe na toripalimab, antibody ya monoclonal anti-PD-1, kugira ngo ivurwe kanseri y'umura idakira, iteye imbere cyangwa yanduye (la/mUC).

Hafi 9MW2821

9MW2821 ni yo miti mishya ya mbere ya Nectin-4-targeting ADC yakozwe na Mabwell ikoresheje urubuga rwa ADC n'urubuga rwo kuvumbura antibody hybridoma antibody rwikora, kandi ni wo muti wa mbere winjijwe mu bushakashatsi mu miti ya Nectin-4-targeting ADCs yakozwe n'ibigo by'Abashinwa, ikaba n'umuti wa mbere uvura wibanda kuri Nectin-4 ku isi mu kugaragaza amakuru y'imikorere y'indwara za kanseri y'inkondo y'umura, kanseri y'umuhogo na kanseri y'ibere. 9MW2821 yahawe Fast Track Designation (FTD) mu kuvura kanseri y'inkondo y'umura iteye imbere, isubira inyuma, cyangwa isubira inyuma muri Gashyantare 2024, ndetse inahabwa Orphan Drug Designation (ODD) na FTD mu kuvura kanseri y'umuhogo na kanseri y'inkondo y'umura isubira inyuma cyangwa isubira inyuma yatewe mbere cyangwa nyuma yo kuvurwa hakoreshejwe uburyo bwa platine-based chemotherapy regimen muri Gicurasi 2024.

Ibisubizo by’ubushakashatsi bwakorewe mu cyiciro cya mbere n’icya kabiri hakoreshejwe 9MW2821 ku ndwara nyinshi zikomeye zagaragaye mu nama ngarukamwaka y’Umuryango w’Abanyamerika wita ku ndwara za kanseri (ASCO) yo mu 2024.

Ku itariki ya 1 Mata 2024, mu barwayi 240 bari mu itsinda rya dose ya 1.25 mg/kg mu igerageza rya kabiri ry’ikizamini:

Kansinoma y'umura (UC)

Mu barwayi 37 bapimwe kugira ngo hakorwe isuzuma ry’imikorere, igipimo cy’ubwitabire bw’ibanze (ORR) n’igipimo cyo kurwanya indwara (DCR) byari 62.2% na 91.9%, uko bikurikirana, naho ikigereranyo cy’ubuzima budafite iterambere (mPFS) cyari amezi 8.8 naho ikigereranyo cy’ubuzima rusange (mOS) cyari amezi 14.2.

Kanseri y'inkondo y'umura (CC)

Mu barwayi 53 bapimwe kugira ngo bakore isuzuma ry’imikorere yabo, 51% bavuwe mbere hakoreshejwe imiti ya platinum-based doublet chemotherapy na bevacizumab, naho 58% bahabwa imiti ya platinum-based doublet chemotherapy na immunocheckpoint inhibitor, ORR na DCR bari 35.8% na 81.1%, uko bikurikirana. MPFS yamaze amezi 3.9, mOS itaragerwaho. Mu barwayi bafite Nectin-4 tumor cell staining intensity 3+, ORR yari 43.6% mu barwayi 39 bapimwe.

Kanseri yo mu ruhu (EC)

Mu barwayi 39 bapimwe kugira ngo bapime neza, ORR na DCR bari 23.1% na 69.2%, uko bikurikirana, hamwe na mPFS y'amezi 3.9 na mOS y'amezi 8.2; 37 muri bo bavuwe na platine-based chimiotherapie na immunotherapy mbere.

Kanseri y'ibere ifite ingaruka eshatu (TNBC)

Mu barwayi 20 barwaye kanseri y'ibere yateye imbere cyangwa yanduye kanseri y'ibere ya triple-negative mu gace runaka, kandi hakenewe gupimwa uburyo bwo kuyipima, ORR na DCR bari 50.0% na 80.0% uko bikurikirana. MPFS yari imaze amezi 5.9, kandi mOS yari itaragerwaho, umurwayi umwe yabashije gusubiza neza (CR) kandi yari amaze amezi 20 muri CR, ubu akaba akomeje kuba CR.

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.

Nimero ya Terefone: 4008803716

Email：myimmnet@163.com

Amareferensi

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.Mabwell - Suzuma Ubuzima, Ugire Akamaro ku Buzima

3.9MW2821, umuti uhuza antibody-drug wa nectin-4 (ADC), ku barwayi bafite ikibyimba gikomeye: Ibisubizo bivuye mu bushakashatsi bwakozwe mu cyiciro cya 1/2a. | Ikinyamakuru cya Clinical Oncology (ascopubs.org)