Mankhwala atsopano a Nectin-4 ADC (9MW2821) omwe akuphatikizidwa mu chithandizo chamakono

Pa Januwale 8, 2025, 9MW2821 idapatsidwa Breakthrough Therapy Designation (BTD) ndi Center for Drug Evaluation (CDE) ya National Medical Products Administration (NMPA) ku China. 9MW2821 imaperekedwa pamodzi ndi toripalimab, antibody yotsutsana ndi PD-1 monoclonal, kuti igwiritsidwe ntchito pochiza khansa ya urothelial carcinoma yosachiritsika, yodziwika bwino m'deralo kapena yofalikira m'thupi (la/mUC).

Pafupifupi 9MW2821

9MW2821 ndi kampani yoyamba ya Nectin-4-targeting ADC yomwe idapangidwa ndi Mabwell pogwiritsa ntchito nsanja ya ADC ndi njira yodziwira yokha ya hybridoma antibody molecular discovery platform, ndipo ndi kampani yoyamba ya mankhwala yomwe yalowa mu kafukufuku wa zachipatala pakati pa Nectin-4-targeting ADCs yomwe idapangidwa ndi makampani aku China, komanso kampani yoyamba ya mankhwala yochizira yomwe ikuyang'ana Nectin-4 padziko lonse lapansi kuti iwulule zambiri zokhudzana ndi khansa ya pachibelekero, khansa ya pachibelekero ndi khansa ya m'mawere. 9MW2821 yapatsidwa Fast Track Designation (FTD) yochizira khansa ya pachibelekero, yobwerezabwereza, kapena yofalikira mu February 2024, komanso inapatsidwa Orphan Drug Designation (ODD) ndi FTD yochizira khansa ya pachibelekero ndi khansa ya pachibelekero yobwerezabwereza kapena yofalikira yomwe idapititsidwa patsogolo kapena pambuyo pa chithandizo cham'mbuyomu ndi mankhwala a chemotherapy ochokera ku platinum mu Meyi 2024.

Zotsatira za kafukufuku wachipatala wa gawo loyamba/lachiwiri pogwiritsa ntchito 9MW2821 pa matenda ambiri olimba zidanenedwa pa Msonkhano Wapachaka wa 2024 wa American Society of Clinical Oncology (ASCO).

Pofika pa Epulo 1, 2024, pakati pa odwala 240 omwe anali mgulu la 1.25 mg/kg mu kafukufuku wachipatala wa Gawo Lachiwiri:

Khansa ya m'mimba (UC)

Mwa odwala 37 omwe adayesedwa kuti ayese bwino, chiŵerengero cha mayankho olondola (ORR) ndi chiŵerengero chowongolera matenda (DCR) chinali 62.2% ndi 91.9%, motsatana, ndipo kupulumuka kwapakati popanda kupita patsogolo (mPFS) kunali miyezi 8.8 ndipo kupulumuka kwapakati konse (mOS) kunali miyezi 14.2.

Khansa ya pachibelekero (CC)

Mwa odwala 53 omwe adayesedwa kuti aone ngati ali ndi mphamvu, 51% adathandizidwa kale ndi platinum-based doublet chemotherapy ndi bevacizumab, ndipo 58% adalandira platinum-based doublet chemotherapy ndi immune checkpoint inhibitor, ndipo ORR ndi DCR anali 35.8% ndi 81.1%, motsatana. MPFS inali miyezi 3.9, ndipo mOS sinafike. Mwa odwala omwe anali ndi Nectin-4 tumor cell staining intensity 3+, ORR inali 43.6% mwa odwala 39 omwe adayesedwa.

Khansa ya M'mero ​​(EC)

Mwa odwala 39 omwe adayesedwa kuti ayese bwino, ORR ndi DCR anali 23.1% ndi 69.2%, motsatana, ndi mPFS ya miyezi 3.9 ndi mOS ya miyezi 8.2; 37 mwa iwo adathandizidwa kale ndi platinum-based chemotherapy ndi immunotherapy.

Khansa ya m'mawere yoipa katatu (TNBC)

Mwa odwala 20 omwe ali ndi khansa ya m'mawere yodziwika bwino kapena yofalikira m'derali ndipo omwe akuyenera kuyesedwa kuti agwire bwino ntchito, ORR ndi DCR anali 50.0% ndi 80.0% motsatana. MPFS inali miyezi 5.9, ndipo mOS sinafikebe, ndipo wodwala m'modzi adapeza yankho lathunthu (CR) ndipo adakhala mu CR kwa miyezi 20 ndipo pakadali pano akutsimikiziridwa kuti ndi CR.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

Nambala ya Foni: 4008803716

Email：myimmnet@163.com

Zolemba

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

2.Mabwell - Fufuzani Moyo, Pindulani ndi Thanzi

3.9MW2821, mankhwala opangidwa ndi nectin-4 antibody-drug conjugate (ADC), mwa odwala omwe ali ndi chotupa cholimba: Zotsatira kuchokera ku kafukufuku wa gawo 1/2a. | Journal of Clinical Oncology (ascopubs.org)