Umuthi omusha we-Nectin-4 ADC oqondiwe (9MW2821) ufakiwe ekwelashweni okuphumelelayo

Ngomhlaka-8 Januwari 2025, i-9MW2821 yanikezwa i-Breakthrough Therapy Designation (BTD) yi-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA) eShayina. I-9MW2821 inikezwa ngokuhlanganiswa ne-toripalimab, i-antibody ye-monoclonal anti-PD-1, yokwelapha i-carcinoma ye-urothelial engalapheki, ethuthukisiwe endaweni noma esakazeka kalula (la/mUC).

Cishe i-9MW2821

I-9MW2821 iyi-ADC yokuqala entsha eqondiswe endaweni ethile ehlanganiswe yi-Nectin-4 eqondiswe endaweni ethile eyenziwe nguMabwell esebenzisa ipulatifomu ye-ADC kanye nepulatifomu yokutholakala kwama-antibody e-hybridoma asezingeni eliphezulu ezenzakalelayo, futhi iyisidakamizwa sokuqala esizongena ocwaningweni lwezokwelapha phakathi kwama-ADC aqondiswe yi-Nectin-4 athuthukiswe yizinkampani zaseShayina, kanye nesidakamizwa sokuqala esiqondiswe ku-Nectin-4 emhlabeni ukuze sembule idatha yokusebenza kahle kwezokwelapha komdlavuza wesibeletho, umdlavuza womphimbo kanye nomdlavuza webele. I-9MW2821 inikezwe i-Fast Track Designation (FTD) yokwelapha i-carcinoma ye-squamous cell ethuthukisiwe, ephindaphindayo, noma ephindaphindayo ngoFebhuwari 2024, futhi yanikezwa i-Orphan Drug Designation (ODD) kanye ne-FTD yokwelapha umdlavuza womphimbo kanye nomdlavuza womphimbo ophindaphindayo noma ophindaphindayo oqhubekele phambili noma ngemuva kokwelashwa kwangaphambilini nge-chemotherapy esekelwe eplatinum ngoMeyi 2024.

Imiphumela yocwaningo lwezokwelapha lwesigaba sokuqala/sesibili olusebenzisa i-9MW2821 yezimila eziningi eziqinile ezithuthukile yabikwa eMhlanganweni Waminyaka Yonke we-American Society of Clinical Oncology (ASCO) ka-2024.

Kusukela ngomhlaka-1 kuMbasa 2024, phakathi kweziguli ezingu-240 eqenjini lomthamo ongu-1.25 mg/kg esivivinyweni somtholampilo seSigaba II:

I-Urothelial Carcinoma (UC)

Ezigulini ezingu-37 ezihlolwe ukuhlolwa kokusebenza kahle, izinga lokuphendula eliqondile (ORR) kanye nezinga lokulawula izifo (DCR) kwakungu-62.2% kanye no-91.9%, ngokulandelana, kanti ukusinda okuphakathi kokungenazo inqubekela phambili (mPFS) kwakungu-8.8 izinyanga kanti ukusinda okuphakathi kokuphila (mOS) kwakungu-14.2 izinyanga.

Umdlavuza Wesibeletho (CC)

Kulezi ziguli ezingu-53 ezihlolwe ukuhlolwa kokusebenza kahle, u-51% ngaphambilini welashwe nge-platinum-based doublet chemotherapy kanye ne-bevacizumab, kanti u-58% wathola i-platinum-based doublet chemotherapy kanye ne-immune checkpoint inhibitor, kanti i-ORR kanye ne-DCR kwakungu-35.8% kanye no-81.1%, ngokulandelana. I-mPFS yayinezinyanga ezingu-3.9, kanti i-mOS ayifinyelelwanga. Kulezi ziguli ezine-Nectin-4 tumor cell staining intensity 3+, i-ORR yayingu-43.6% phakathi kweziguli ezingu-39 ezihlolwe.

Umdlavuza Wesisu (EC)

Kulezi ziguli ezingu-39 ezihlolwe ukuhlolwa kokusebenza kahle, i-ORR kanye ne-DCR kwakungu-23.1% kanye no-69.2%, ngokulandelana, nge-mPFS yezinyanga ezingu-3.9 kanye ne-mOS yezinyanga ezingu-8.2; ezingu-37 zazo zelashwe nge-chemotherapy esekelwe eplatinum kanye ne-immunotherapy ngaphambilini.

Umdlavuza Webele Ongenazo Izinhlobo Ezintathu (TNBC)

Ezigulini ezingu-20 ezinomdlavuza webele othuthuke kakhulu noma osakazeke kathathu futhi ohlolwayo ukuze kuhlolwe ukusebenza kahle, i-ORR kanye ne-DCR kwakungu-50.0% kanye no-80.0% ngokulandelana. I-mPFS yayinezinyanga ezingu-5.9, kanti i-mOS yayingakafinyelelwa, kanti isiguli esisodwa sithole impendulo ephelele (CR) futhi besise-CR izinyanga ezingu-20 futhi okwamanje siqinisekisiwe ukuthi siyi-CR.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

Inombolo yocingo: 4008803716

Email：myimmnet@163.com

Izinkomba

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

2.Mabwell - Hlola Impilo, Zuza Impilo

3.I-9MW2821, i-nectin-4 antibody-drug conjugate (ADC), ezigulini ezine-tumor eqinile ethuthukile: Imiphumela evela ocwaningweni lwesigaba 1/2a. | Ijenali ye-Clinical Oncology (ascopubs.org)