Maarso 18, 2025, Alphamab Oncology waxay ku dhawaaqday in isku-darka daawada antibody-ga ee laba-paratopic-ka ah (ADC) JSKN003 la siiyay Magacaabista Daaweynta Degdegga ah ee Xarunta Qiimaynta Daawada (CDE) ee Maamulka Badeecadaha Caafimaadka Qaranka (NMPA). Magacaabista waxaa loogu talagalay daaweynta kansarka ugxan-sidaha ee soo noqnoqda ee ugxan-sidaha ee platinum-ka u adkaysta (PROC), kansarka peritoneal-ka aasaasiga ah, ama kansarka tuubada fallopian, oo aan ku koobnayn heerarka muujinta HER2.
Deeqda Magacaabista Daaweynta Breakthrough waxay ku salaysan tahay falanqaynta la isku daray ee laba daraasadood oo caafimaad, JSKN003-101 iyo JSKN003-102. JSKN003-101 (NCT05494918) waa daraasad caafimaad oo heer sare ah oo lagu sameeyay Australia, iyadoo la diiwaangelinayo bukaanada qaba burooyinka adag ee horumarsan ee muujinaya HER2 (IHC≥1+) ama isbeddellada HER2. JSKN003-102 (NCT05744427) waa daraasad Marxaladda I/II ah oo laga sameeyay Shiinaha. Qaybta Marxaladda I waxay diiwaangelisay bukaanada qaba muujinta HER2 ee la xaqiijiyay ee histologically (IHC≥1+) ama isbeddellada HER2 waxay horumariyeen burooyinka adag. Qaybta Marxaladda II waxay diiwaangelisay bukaanada qaba burooyinka adag ee horumarsan iyadoon loo eegin muujinta HER2 ama xaaladda isbeddelka.
Xog hordhac ah oo laga helay falanqaynta la isku daray ee labadan daraasadood ayaa lagu soo bandhigay Shirweynihii Ururka Yurub ee Cudurrada Caafimaadka (ESMO) ee 2024.
Laga bilaabo Luulyo 15, 2024, 50 bukaan oo qaba PROC ayaa qaatay JSKN003 shan heer oo qiyaas ah, kuwaas oo ay ka mid yihiin 2 bukaan oo qiyaasta 4.2mg/kg ah, 2 bukaan oo qiyaasta 5.2mg/kg ah, 44 bukaan oo qiyaasta 6.3mg/kg ah, 1 bukaan oo qiyaasta 7.3mg/kg ah, iyo 1 bukaan oo qiyaasta 8.4mg/kg ah. 50-ka bukaan ee isdiiwaangeliyey iyadoo lagu saleynayo baaritaanka shaybaarka dhexe, waxaa jiray 17 bukaan oo qaba muujinta HER2 (IHC 1+, 2+ iyo 3+) (kaliya 2 bukaan oo qaba HER2 IHC 3+), 17 bukaan oo qaba IHC 0, iyo 16 bukaan oo aan helin natiijooyin HER2 ah sababtoo ah lama baarin ilaa Luulyo 15. 28 bukaan (56.0%) ayaa lahaa ugu yaraan saddex saf oo hore oo daaweyn nidaamsan ah, 37 bukaan (74.0%) ayaa helay daaweynta bevacizumab, iyo 28 bukaan (56.0%) ayaa helay daaweynta ka hortagga PARP.
Muddada dhexdhexaadka ah ee daaweyntu waxay ahayd 12.4 toddobaad (inta u dhaxaysa: 0.7 - 51.0 toddobaad), iyadoo 32 bukaan (64.0%) ay ku sii jireen daaweynta ilaa taariikhda la jarayo xogta.
Badbaadada: Dhammaan 50-ka bukaan ee isdiiwaangeliyey, 3 bukaan ayaa la kulmay cudurka sambabada ee interstitial (ILD)/pneumonia. 5 bukaan (10.0%) ayaa la kulmay dhacdooyin xun oo la xiriira daaweynta heerka 3aad (TRAEs), kuwaas oo ugu badan ay yihiin shuban (2.0%) iyo dhiig-yaraan (2.0%). Ma jiraan wax TRAE ah oo horseeday dhimasho.
Waxtarka: 44-ka bukaan ee la qiimeyn karo waxtarka ee ugu yaraan hal qiimeyn burooyinka ka dib saldhigga, heerka jawaab celinta ujeeddada (ORR) wuxuu ahaa 56.8%, iyadoo 39 bukaan (88.6%) ay muujiyeen yaraanta burooyinka. ORR-ka bukaanada qaba muujinta HER2 IHC 0 iyo HER2 ee bartamaha la xaqiijiyay (IHC 1+, 2+ iyo 3+) wuxuu ahaa 52.9% iyo 68.8%, siday u kala horreeyaan. 33 bukaan oo helay daaweynta bevacizumab ee hore ORR wuxuu ahaa 54.5%, 26 bukaan oo helay daaweynta ka hortagga PARP ee hore ORR wuxuu ahaa 46.2%.
Natiijooyinka la soo ururiyay waxay muujiyeen in daaweynta JSKN003 ee isku-darka ah ay leedahay dulqaad wanaagsan iyo astaan badbaado, oo leh calaamado wax-ku-ool ah oo rajo leh bukaanada qaba PROC-ga horumarsan, waxtarkana waxaa lagu arkay bukaanada qaba (IHC 1+/2+3+) ama aan lahayn muujinta HER2 (IHC 0), iyadoo leh ama aan lahayn bevacizumab hore iyo ka-hortagga PARP ee hore.
Ku saabsan JSKN003
JSKN003 waa isku-xidhka antibody-drog-ka laba-geesoodka ah ee ka hortagga HER2 (bis-ADC), kaas oo lagu sameeyay gudaha madal isku-xidhka gaarka ah ee Alphamab ee Glycan. JSKN003 wuxuu ku xidhi karaa HER2 dusha sare ee unugyada burooyinka wuxuuna sii deyn karaa inhibitors-ka topoisomerase I (TOPIi) iyada oo loo marayo endocytosis-ka unugyada, sidaas darteedna wuxuu ku yeelan karaa saameyn ka-hortagga burooyinka. Marka la barbardhigo dhiggiisa ADC, JSKN003 wuxuu muujiyay xasillooni ka wanaagsan seeramka iyo saameyn xoog leh oo dhinaca daawada ah, taas oo si wax ku ool ah u ballaarinaysa daaqadda daaweynta.
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
Lambarka Taleefanka: 4008803716
Email：myimmnet@163.com
Tixraacyada
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://www.alphamabonc.com/en/
Waqtiga boostada: Maarso-18-2025