An haɗa maganin Nectin-4 ADC mai inganci (9MW2821) a cikin maganin nasara

A ranar 8 ga Janairu, 2025, Cibiyar Nazarin Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Ƙasa (NMPA) a China ta ba da 9MW2821 a matsayin Naɗin Maganin Farko (BTD). An ba da 9MW2821 tare da toripalimab, wani maganin rigakafi na monoclonal anti-PD-1, don maganin cutar kansa ta urothelial (la/mUC) wanda ba shi da magani, wanda ba za a iya cire shi ba, wanda ya ci gaba a gida ko kuma wanda ya kamu da cutar kansa ta urothelial (la/mUC).

Game da 9MW2821

9MW2821 ita ce sabuwar ADC mai hadewa ta Nectin-4 da Mabwell ya kirkira ta amfani da dandamalin ADC da kuma dandamalin gano kwayoyin halitta masu amfani da hybridoma mai sarrafa kansa, kuma ita ce ta farko da ta shiga binciken asibiti tsakanin ADCs masu niyya na Nectin-4 da kamfanonin kasar Sin suka kirkira, kuma ita ce ta farko da ta shiga gwajin maganin Nectin-4 a duniya don bayyana bayanai kan tasirin cutar kansar mahaifa, cutar kansar makogwaro da kuma cutar kansar nono. An ba da 9MW2821 a matsayin Fast Track Nametation (FTD) don maganin cutar kansar squamous cell mai ci gaba, maimaituwa, ko kuma mai yaduwa a watan Fabrairun 2024, kuma an ba da ita a jere a matsayin Orphane Drug Nameation (ODD) da FTD don maganin cutar kansar makogwaro da kuma cutar kansar mahaifa maimaituwa ko mai yaduwa da ta ci gaba a kan ko bayan magani na baya tare da tsarin maganin chemotherapy na tushen platinum a watan Mayun 2024.

An bayar da rahoton sakamakon wani bincike na asibiti na mataki na I/II ta amfani da 9MW2821 don ciwon daji masu tasowa da yawa a taron shekara-shekara na American Society of Clinical Oncology (ASCO) na 2024.

Ya zuwa ranar 1 ga Afrilu, 2024, daga cikin marasa lafiya 240 a cikin rukunin allurai na 1.25 mg/kg a cikin gwajin asibiti na Mataki na II:

Ciwon daji na Urothelial (UC)

Daga cikin marasa lafiya 37 da aka kimanta don kimanta inganci, ƙimar amsawar da aka yi niyya (ORR) da ƙimar kula da cututtuka (DCR) sun kasance 62.2% da 91.9%, bi da bi, tare da matsakaicin rayuwa ba tare da ci gaba ba (mPFS) shine watanni 8.8 kuma matsakaicin rayuwa gabaɗaya (mOS) shine watanni 14.2.

Ciwon Daji na Mahaifa (CC)

Daga cikin marasa lafiya 53 da aka kimanta don kimanta inganci, kashi 51% an yi musu magani da maganin doublet na tushen platinum da bevacizumab, kuma kashi 58% sun sami maganin doublet na tushen platinum da kuma maganin hana garkuwar jiki, tare da ORR da DCR sun kasance 35.8% da 81.1%, bi da bi. MPFS ya kasance watanni 3.9, tare da ba a kai ga mOS ba. Daga cikin marasa lafiya da ke da ƙarfin tabon ƙwayoyin cutar Nectin-4 3+, ORR ya kasance 43.6% daga cikin marasa lafiya 39 da ake kimantawa.

Ciwon Sanyi na Esophageal (EC)

Daga cikin marasa lafiya 39 da aka kimanta don kimanta inganci, ORR da DCR sun kasance 23.1% da 69.2%, bi da bi, tare da mPFS na watanni 3.9 da mOS na watanni 8.2; 37 daga cikinsu an yi musu magani da maganin chemotherapy na tushen platinum da immunotherapy a baya.

Ciwon Nono Mai Rauni Uku (TNBC)

Daga cikin marasa lafiya 20 da suka kamu da cutar kansar nono mai saurin yaduwa ko kuma wacce ba ta da alamun cutar, kuma ana iya kimanta ta don kimanta inganci, ORR da DCR sun kasance kashi 50.0% da 80.0% bi da bi. MPFS ya kasance watanni 5.9, kuma ba a kai ga mOS ba tukuna, inda wani majiyyaci ya sami cikakken amsawa (CR) kuma ya kasance a cikin CR na tsawon watanni 20 kuma a halin yanzu ana ci gaba da kasancewa CR.

A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.

Lambar Waya: 4008803716

Email：myimmnet@163.com

Nassoshi

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

2.Mabwell - Bincika Rayuwa, Amfanin Lafiya

3.9MW2821, wani maganin rigakafi na nectin-4 (ADC), a cikin marasa lafiya da ciwon daji mai tsanani: Sakamako daga wani bincike na mataki na 1/2a. | Mujallar Oncology ta Asibiti (ascopubs.org)