Mushonga mutsva weNectin-4 ADC (9MW2821) wakagadzirirwa kurapwa nekukurumidza

Musi wa8 Ndira, 2025, 9MW2821 yakapihwa Breakthrough Therapy Designation (BTD) neCenter for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) muChina. 9MW2821 inopihwa pamwe chete ne toripalimab, antibody inorwisa PD-1 monoclonal, yekurapa carcinoma yemudumbu isina mushonga, isingabvisike, yakakwira munharaunda kana kuti yakapararira mumuviri (la/mUC).

Inenge 9MW2821

9MW2821 ndiyo yekutanga nzvimbo chaiyo yakagadzirwa neNectin-4-targeting ADC yakagadzirwa naMabwell ichishandisa ADC platform uye automated high-throughput hybridoma antibody molecular discovery platform, uye ndiyo yekutanga mushonga kupinda muchirongwa chekiriniki pakati peNectin-4-targeting ADCs yakagadzirwa nemakambani ekuChina, uye ndiyo yekutanga mushonga wekurapa unotarisa Nectin-4 pasi rose kuratidza ruzivo rwekiriniki rwekenza yemuromo wechibereko, kenza yemudumbu uye kenza yemazamu. 9MW2821 yakapihwa Fast Track Designation (FTD) yekurapa advanced, recurrent, kana metastatic esophageal squamous cell carcinoma muna Kukadzi 2024, uye yakapihwawo Orphan Drug Designation (ODD) neFTD yekurapa kenza yemudumbu uye recurrent kana metastatic cervical cancer yakaenderera mberi kana mushure mekurapwa kwakamboitwa ne platinum-based chemotherapy regimen muna Chivabvu 2024.

Zvakabuda muongororo yekiriniki yechikamu chekutanga/chipiri yakashandisa 9MW2821 yezvirwere zvakawanda zvakasimba zvakataurwa paMusangano weGore negore weAmerican Society of Clinical Oncology (ASCO) we2024.

Kubva musi wa1 Kubvumbi, 2024, pakati pevarwere mazana maviri nemakumi mana vari muboka re1.25 mg/kg dose muPhase II clinical trial:

Kansa yeUrothelial (UC)

Pavarwere makumi matatu nevanomwe vakaongororwa kuti vaone kushanda zvakanaka, chiyero chekupindura (ORR) uye chiyero chekudzora chirwere (DCR) zvaive 62.2% uye 91.9%, zvichiteerana, nepakati pehupenyu husina kufambira mberi (mPFS) yaive mwedzi 8.8 uye pakati pehupenyu hwese (mOS) yaive mwedzi 14.2.

Kenza yeMuromo (CC)

Pavarwere makumi mashanu nevatatu vakaongororwa kuti vaone kushanda zvakanaka, 51% vakamborapwa ne platinum-based doublet chemotherapy uye bevacizumab, uye 58% vakagamuchira platinum-based doublet chemotherapy uye immune checkpoint inhibitor, neORR neDCR vaive 35.8% uye 81.1%, zvichiteerana. MPFS yaive mwedzi 3.9, mOS isati yasvika. Pavarwere vaive neNectin-4 tumor cell staining intensity 3+, ORR yaive 43.6% pakati pevarwere makumi matatu nevapfumbamwe vakaongororwa.

Kenza yeMatumbu (EC)

Pavarwere makumi matatu nevapfumbamwe vakaongororwa kuti vaone kushanda zvakanaka kwemushonga, ORR neDCR zvaive 23.1% uye 69.2%, zvichiteerana, ne mPFS yemwedzi 3.9 uye mOS yemwedzi 8.2; makumi matatu nevanomwe vavo vakamborapwa ne platinum-based chemotherapy uye immunotherapy kare.

Kenza yeZamu ine Katatu Kasina Kubuda (TNBC)

Pavarwere makumi maviri vane kenza yemazamu yakakwira kana kuti yakapararira mumuviri uye yaitarisirwa kuongororwa kushanda kwayo, ORR neDCR zvaive 50.0% uye 80.0% zvichiteerana. MPFS yaive mwedzi 5.9, uye mOS yakanga isati yasvika, murwere mumwe chete akawana mhinduro yakakwana (CR) uye aive muCR kwemwedzi makumi maviri uye parizvino ari CR.

Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.

Nhamba yefoni: 4008803716

Email：myimmnet@163.com

Mareferensi

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

2.Mabwell - Ongorora Hupenyu, Batsirwa Hutano

3.9MW2821, mushonga unobatanidza nectin-4 antibody-drug (ADC), muvarwere vane bundu rakasimba rakakwira: Zvakabuda muongororo yechikamu 1/2a. | Journal of Clinical Oncology (ascopubs.org)