Pa 18 Marichi, 2025, Alphamab Oncology idalengeza kuti anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 yapatsidwa Breakthrough Therapy Designation ndi Center for Drug Evaluation (CDE) ya National Medical Products Administration (NMPA). Udindowu ndi wochizira khansa ya ovarian yobwerezabwereza ya epithelial yosagonjetsedwa ndi platinum (PROC), khansa ya peritoneal yoyamba, kapena khansa ya fallopian tube, osati pamlingo wokha wa HER2.
Kupatsidwa kwa Breakthrough Therapy Designation kumachokera pa kusanthula komwe kwachitika m'maphunziro awiri azachipatala, JSKN003-101 ndi JSKN003-102. JSKN003-101 (NCT05494918) ndi kafukufuku wachipatala wa Phase I wotseguka, wopangidwa m'malo osiyanasiyana, wokhudza kuchuluka kwa mlingo womwe unachitika ku Australia, womwe umalembetsa odwala omwe ali ndi zotupa zolimba zomwe zikuwonetsa HER2 (IHC≥1+) kapena omwe ali ndi HER2 mutations. JSKN003-102 (NCT05744427) ndi kafukufuku wa Phase I/II womwe unachitika ku China. Gawo loyamba linalembetsa odwala omwe ali ndi HER2 expression (IHC≥1+) kapena HER2 mutations zomwe zili ndi zotupa zolimba zomwe zimadziwika bwino. Gawo lachiwiri linalembetsa odwala omwe ali ndi zotupa zolimba zomwe zimadziwika bwino mosasamala kanthu za HER2 expression kapena kusintha kwa thupi.
Deta yoyamba kuchokera ku kusanthula komwe kwaphatikizidwa kwa maphunziro awiriwa idaperekedwa ku 2024 European Society for Medical Oncology (ESMO) Congress.
Pofika pa Julayi 15, 2024, odwala 50 omwe ali ndi PROC adalandira JSKN003 pamlingo wa mlingo wa milingo isanu, pakati pawo odwala awiri omwe anali ndi mlingo wa 4.2mg/kg, odwala awiri omwe anali ndi mlingo wa 5.2mg/kg, odwala 44 omwe anali ndi mlingo wa 6.3mg/kg, wodwala m'modzi pa mlingo wa 7.3mg/kg, ndi wodwala m'modzi pa mlingo wa 8.4mg/kg. Pakati pa odwala 50 omwe adalembetsa kutengera mayeso apakati a labotale, panali odwala 17 omwe anali ndi HER2 expression (IHC 1+, 2+ ndi 3+) (odwala awiri okha omwe anali ndi HER2 IHC 3+), odwala 17 omwe anali ndi IHC 0, ndi odwala 16 sanapeze zotsatira za HER2 chifukwa anali asanayesedwe pofika pa Julayi 15. Odwala 28 (56.0%) anali ndi njira zitatu zochiritsira m'thupi, odwala 37 (74.0%) adalandira chithandizo cha bevacizumab, ndipo odwala 28 (56.0%) adalandira chithandizo cha PARP inhibitor.
Nthawi yapakati ya chithandizo inali masabata 12.4 (kuyambira: masabata 0.7 mpaka 51.0), ndipo odwala 32 (64.0%) anakhalabe ndi chithandizo mpaka tsiku lomaliza la deta.
Chitetezo: Pakati pa odwala onse 50 omwe adalembetsa, odwala atatu adakumana ndi matenda a m'mapapo (ILD)/chibayo. Odwala asanu (10.0%) adakumana ndi zovuta zokhudzana ndi chithandizo (TRAEs) cha giredi 3, zomwe zofala kwambiri ndi kutsegula m'mimba (2.0%) ndi kuchepa kwa magazi m'thupi (2.0%). Palibe TRAEs yomwe idapangitsa kuti munthu afe.
Kugwira Ntchito: Pakati pa odwala 44 omwe adayesedwa kuti ali ndi mphamvu yogwira ntchito omwe adayesedwa kamodzi pambuyo pa kafukufuku woyamba wa chotupa, chiŵerengero cha yankho lolunjika (ORR) chinali 56.8%, ndipo odwala 39 (88.6%) adawonetsa kuchepa kwa chotupa. ORR mwa odwala omwe ali ndi HER2 IHC 0 ndi HER2 expression (IHC 1+, 2+ ndi 3+) inali 52.9% ndi 68.8%, motsatana. Kwa odwala 33 omwe adalandira chithandizo cha bevacizumab kale, ORR inali 54.5%, kwa odwala 26 omwe adalandira chithandizo cha PARP choletsa ORR inali 46.2%.
Zotsatira zomwe zapezeka zasonyeza kuti JSKN003 monotherapy ili ndi kulekerera bwino komanso chitetezo chabwino, yokhala ndi zizindikiro zabwino zogwira ntchito mwa odwala omwe ali ndi PROC yapamwamba, ndipo kugwira ntchito bwino kunawonedwa kwa odwala omwe ali ndi (IHC 1+/2+3+) kapena opanda (IHC 0) HER2 expression, omwe ali ndi kapena opanda bevacizumab komanso PARP inhibitor yomwe idagwiritsidwa ntchito kale.
Zokhudza JSKN003
JSKN003 ndi mankhwala oletsa ma antibodies a HER2 bispecific antibody-drug conjugate (bis-ADC), omwe amapangidwa mkati mwa Alphamab's proprietary Glycan-specific conjugation platform. JSKN003 imatha kumangirira HER2 pamwamba pa maselo a chotupa ndikutulutsa topoisomerase I inhibitors (TOPIi) kudzera mu cell endocytosis, motero imakhala ndi zotsatira zotsutsana ndi chotupa. Poyerekeza ndi ADC, JSKN003 inawonetsa kukhazikika kwabwino kwa serum komanso mphamvu yolimba yoyang'anira, zomwe zimakulitsa bwino njira yochiritsira.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Email：myimmnet@163.com
Zolemba
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://www.alphamabonc.com/en/
Nthawi yotumizira: Marichi-18-2025