Kua whakaurua te rongoā auaha Nectin-4 ADC (9MW2821) ki te rongoā hou

I te 8 o Hānuere, 2025, i whakawhiwhia a 9MW2821 ki te Breakthrough Therapy Designation (BTD) e te Center for Drug Evaluation (CDE) o te National Medical Products Administration (NMPA) i Haina. Ka hoatu te 9MW2821 me te toripalimab, he paturopi monoclonal anti-PD-1, mō te mate pukupuku urothelial kāore anō kia rongoatia, kāore e taea te tango, kua ahu whakamua ā-rohe, kua horapa rānei (la/mUC).

Mō 9MW2821

Ko te 9MW2821 te ADC hou tuatahi e aro ana ki te Nectin-4 i whakawhanakehia e Mabwell mā te whakamahi i te tūāpapa ADC me te tūāpapa kitenga ngota ngota paturopi hybridoma tere-whakaputa aunoa, ā, koia te rongoā tuatahi ki te whakauru ki te rangahau haumanu i roto i ngā ADC e aro ana ki te Nectin-4 i whakawhanakehia e ngā kamupene Haina, me te rongoā tuatahi e aro ana ki te Nectin-4 i te ao ki te whakaatu i ngā raraunga whai huatanga haumanu o te mate pukupuku waha kōpū, te mate pukupuku korokoro me te mate pukupuku ū. Kua whakawhiwhia te 9MW2821 ki te Fast Track Designation (FTD) mō te maimoatanga o te mate pukupuku pūtau squamous esophageal kua matatau, kua hoki mai, kua horapa rānei i te Hui-tanguru 2024, ā, kua whakawhiwhia hoki ki te Orphan Drug Designation (ODD) me te FTD mō te maimoatanga o te mate pukupuku esophageal me te mate pukupuku waha kōpū kua hoki mai, kua horapa rānei i runga i te maimoatanga o mua, i muri rānei i te maimoatanga o mua me te tikanga chemotherapy e hangai ana ki te platinum i te marama o Mei 2024.

I te Hui-ā-Tau o te American Society of Clinical Oncology (ASCO) 2024, i puta ai ngā hua o tētahi rangahau haumanu wāhanga I/II e whakamahi ana i te 9MW2821 mō ngā pukupuku totoka maha kua whanake haere.

I te 1 o Paenga-whāwhā, 2024, i roto i ngā tūroro 240 i roto i te rōpū horopeta 1.25 mg/kg i te whakamātautau haumanu Wāhanga II:

Matepukupuku Urothelial (UC)

O ngā tūroro 37 i arotakengia mō te aromatawai whai huatanga, ko te auau urupare whāinga (ORR) me te auau whakahaere mate (DCR) he 62.2% me te 91.9%, ia, me te oranga kore-haere whakamua (mPFS) he 8.8 marama, ā, ko te oranga whānui toharite (mOS) he 14.2 marama.

Matepukupuku o te kōpū (CC)

O ngā tūroro 53 i arotakehia mō te aromatawai whai huatanga, 51% i rongoatia i mua ki te rongoā chemotherapy takirua-pūmua me te bevacizumab, ā, 58% i whiwhi i te rongoā chemotherapy takirua-pūmua me te aukati ārai mate, me te ORR me te DCR he 35.8% me te 81.1%, ia. Ko te mPFS he 3.9 marama, kāore anō kia eke ki te mOS. O ngā tūroro he kaha tae pūtau pukupuku Nectin-4 3+, ko te ORR he 43.6% i roto i ngā tūroro 39 i arotakehia.

Matepukupuku korokoro (EC)

O ngā tūroro 39 i arotakengia mō te aromatawai whai huatanga, ko te ORR me te DCR he 23.1% me te 69.2%, ia, me te mPFS o te 3.9 marama me te mOS o te 8.2 marama; 37 o rātou i rongoatia ki te chemotherapy me te immunotherapy e ahu mai ana i te platinum i mua.

Matepukupuku ū toru-kino (TNBC)

O ngā tūroro 20 e mate pukupuku ū kua horapa ki te rohe, kua horapa rānei, ā, ka taea te aromatawai i te whai huatanga, ko te ORR me te DCR he 50.0% me te 80.0% ia. Ko te mPFS he 5.9 marama, ā, kāore anō kia eke ki te mOS, kotahi te tūroro i eke ki te urupare katoa (CR) ā, kua 20 marama ia e noho ana i roto i te CR, ā, kei te mau tonu ia hei CR.

I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.

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Ngā Tohutoro

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

2.Mabwell – Tūhuratia te Oranga, Whai Hua te Hauora

3.9MW2821, he hononga paturopi-rongoā nectin-4 (ADC), i roto i ngā tūroro he pukupuku totoka kua whanake haere: Ngā hua mai i tētahi rangahau wāhanga 1/2a. | Journal of Clinical Oncology (ascopubs.org)