Thaum Lub Ib Hlis 8, 2025, 9MW2821 tau txais Breakthrough Therapy Designation (BTD) los ntawm Lub Chaw Saib Xyuas Tshuaj (CDE) ntawm Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) hauv Suav teb. 9MW2821 tau muab ua ke nrog toripalimab, uas yog ib qho tshuaj anti-PD-1 monoclonal antibody, rau kev kho mob uas tsis tau kho, phais tsis tau, mob qog nqaij hlav hauv zos lossis mob qog nqaij hlav hauv lub cev (la/mUC).
Txog 9MW2821
9MW2821 yog thawj qhov chaw sib txuas tshiab Nectin-4-targeting ADC tsim los ntawm Mabwell siv ADC platform thiab automated high-throughput hybridoma antibody molecular discovery platform, thiab yog thawj tus neeg sib tw tshuaj uas nkag mus rau hauv kev tshawb fawb hauv kev kho mob ntawm Nectin-4-targeting ADCs tsim los ntawm cov tuam txhab Suav, thiab thawj tus neeg sib tw tshuaj kho mob uas tsom mus rau Nectin-4 hauv ntiaj teb los qhia cov ntaub ntawv kho mob ntawm mob qog noj ntshav hauv tsev menyuam, mob qog noj ntshav hauv txoj hlab pas thiab mob qog noj ntshav hauv lub mis. 9MW2821 tau txais Fast Track Designation (FTD) rau kev kho mob ntawm mob qog noj ntshav hauv esophageal squamous cell carcinoma uas mob heev, rov tshwm sim, lossis kis mus rau lwm qhov thaum Lub Ob Hlis 2024, thiab kuj tau txais Orphan Drug Designation (ODD) thiab FTD rau kev kho mob ntawm mob qog noj ntshav hauv txoj hlab pas thiab mob qog noj ntshav hauv tsev menyuam rov tshwm sim lossis kis mus rau lwm qhov uas tau nce qib ntawm lossis tom qab kev kho mob yav dhau los nrog platinum-based chemotherapy regimen thaum Lub Tsib Hlis 2024.
Cov txiaj ntsig ntawm kev tshawb fawb kho mob theem I/II siv 9MW2821 rau ntau yam qog nqaij hlav tau tshaj tawm ntawm 2024 American Society of Clinical Oncology Annual Meeting (ASCO).
Txij li thaum Lub Plaub Hlis 1, 2024, ntawm 240 tus neeg mob hauv pawg tshuaj 1.25 mg/kg hauv kev sim tshuaj theem II:
Mob qog nqaij hlav ntawm txoj hlab zis (UC)
Ntawm 37 tus neeg mob uas tuaj yeem soj ntsuam qhov ua tau zoo, qhov feem pua ntawm kev teb rov qab (ORR) thiab tus nqi tswj kab mob (DCR) yog 62.2% thiab 91.9%, raws li, nrog rau qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib (mPFS) yog 8.8 lub hlis thiab qhov nruab nrab ntawm kev ciaj sia tag nrho (mOS) yog 14.2 lub hlis.
Kab Mob Cancer ntawm Lub Ncauj Tsev Me Nyuam (CC)
Ntawm 53 tus neeg mob uas tau soj ntsuam rau kev ntsuam xyuas qhov ua tau zoo, 51% tau kho nrog platinum-based doublet chemotherapy thiab bevacizumab yav dhau los, thiab 58% tau txais platinum-based doublet chemotherapy thiab immune checkpoint inhibitor, nrog ORR thiab DCR yog 35.8% thiab 81.1%, raws li. mPFS yog 3.9 lub hlis, nrog mOS tsis tau mus txog. Ntawm cov neeg mob uas muaj Nectin-4 tumor cell staining intensity 3+, ORR yog 43.6% ntawm 39 tus neeg mob uas tau soj ntsuam.
Mob Cancer ntawm txoj hlab pas (EC)
Ntawm 39 tus neeg mob uas tau ntsuam xyuas rau kev ntsuam xyuas qhov ua tau zoo, ORR thiab DCR yog 23.1% thiab 69.2%, raws li, nrog mPFS ntawm 3.9 lub hlis thiab mOS ntawm 8.2 lub hlis; 37 ntawm lawv tau kho nrog platinum-based chemotherapy thiab immunotherapy ua ntej.
Mob Cancer Mis Peb Zaug Tsis Zoo (TNBC)
Ntawm 20 tus neeg mob uas muaj mob qog noj ntshav mis triple-negative hauv zos lossis metastatic thiab tuaj yeem ntsuas tau qhov ua tau zoo, ORR thiab DCR yog 50.0% thiab 80.0% feem. mPFS yog 5.9 lub hlis, thiab mOS tseem tsis tau mus txog, nrog rau ib tus neeg mob tau txais kev teb tiav (CR) thiab tau nyob hauv CR tau 20 lub hlis thiab tam sim no tau txhawb nqa kom yog CR.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Cov ntaub ntawv siv los ua piv txwv
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.Mabwell - Tshawb Nrhiav Lub Neej, Pab Tau Kev Noj Qab Haus Huv
Lub sijhawm tshaj tawm: Lub Ib Hlis-15-2025