Ma Malaki 18, 2025, ua hoʻolaha ʻo Alphamab Oncology ua hāʻawi ʻia ka anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 i ka Breakthrough Therapy Designation e ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA). ʻO ke koho ʻana no ka mālama ʻana i ka maʻi ʻaʻai ovarian epithelial recurrent platinum-resistant (PROC), ka maʻi ʻaʻai peritoneal mua, a i ʻole ka maʻi ʻaʻai tube fallopian, ʻaʻole i kaupalena ʻia i nā pae hōʻike HER2.
Hoʻokumu ʻia ka hāʻawi ʻana o ka Breakthrough Therapy Designation ma ka loiloi hui pū ʻia o ʻelua mau haʻawina lapaʻau, ʻo JSKN003-101 a me JSKN003-102. ʻO JSKN003-101 (NCT05494918) kahi haʻawina lapaʻau Phase I open-label, multicenter, dose-escalation i mālama ʻia ma Australia, e kākau inoa ana i nā maʻi me nā ʻōpū paʻa holomua e hōʻike ana i ka HER2 (IHC≥1+) a i ʻole me nā hoʻololi HER2. ʻO JSKN003-102 (NCT05744427) kahi haʻawina Phase I/II i mālama ʻia ma Kina. Ua kākau inoa ka ʻāpana Phase I i nā maʻi me ka hōʻike ʻana o HER2 (IHC≥1+) a i ʻole nā hoʻololi HER2 i nā ʻōpū paʻa holomua. Ua kākau inoa ka ʻāpana Phase II i nā maʻi me nā ʻōpū paʻa holomua me ka nānā ʻole i ka hōʻike ʻana o HER2 a i ʻole ke kūlana hoʻololi.
Ua hōʻike ʻia nā ʻikepili mua mai ka loiloi i hōʻuluʻulu ʻia o kēia mau haʻawina ʻelua i ka 2024 European Society for Medical Oncology (ESMO) Congress.
Ma Iulai 15, 2024, ua loaʻa i nā maʻi he 50 me PROC ka JSKN003 ma nā pae mahele ʻelima, ma waena o ia mau mea he 2 mau maʻi ma ka mahele o 4.2mg/kg, 2 mau maʻi ma ka mahele o 5.2mg/kg, 44 mau maʻi ma ka mahele o 6.3mg/kg, 1 maʻi ma ka mahele o 7.3mg/kg, a me 1 maʻi ma ka mahele o 8.4mg/kg. Ma waena o nā maʻi he 50 i kākau inoa ʻia ma muli o ka hoʻāʻo ʻana o ka hale hana kikowaena, aia he 17 mau maʻi me ka hōʻike ʻana o HER2 (IHC 1+, 2+ a me 3+) (2 mau maʻi wale nō me HER2 IHC 3+), 17 mau maʻi me IHC 0, a ʻaʻohe hopena HER2 o 16 mau maʻi no ka mea ʻaʻole i hoʻāʻo ʻia ma Iulai 15. He 28 mau maʻi (56.0%) i loaʻa ma ka liʻiliʻi he ʻekolu mau laina mua o ka lāʻau lapaʻau ʻōnaehana, 37 mau maʻi (74.0%) i loaʻa ka lāʻau bevacizumab, a he 28 mau maʻi (56.0%) i loaʻa ka lāʻau PARP inhibitor.
ʻO ka lōʻihi waena o ka lāʻau lapaʻau he 12.4 mau pule (pae: 0.7 - 51.0 mau pule), me 32 mau maʻi (64.0%) i noho ma ka lāʻau lapaʻau a hiki i ka lā ʻoki ʻikepili.
Palekana: Ma waena o nā maʻi he 50 i kākau inoa ʻia, ua loaʻa i 3 mau maʻi ka maʻi mama interstitial (ILD)/pneumonitis. Ua loaʻa i 5 mau maʻi (10.0%) nā hanana ʻino e pili ana i ka lāʻau lapaʻau (TRAEs) papa 3, me ka mea maʻamau ka maʻi diarrhea (2.0%) a me ka anemia (2.0%). ʻAʻohe TRAE i alakaʻi i ka make.
Pono: Ma waena o nā maʻi loiloi pono he 44 i loaʻa i ka liʻiliʻi o hoʻokahi loiloi tumo ma hope o ke kahua, ʻo ka helu pane pahuhopu (ORR) he 56.8%, me 39 mau maʻi (88.6%) e hōʻike ana i ka emi ʻana o ka tumo. ʻO ka ORR i nā maʻi me ka hōʻike ʻana o HER2 IHC 0 a me HER2 (IHC 1+, 2+ a me 3+) he 52.9% a me 68.8%, kēlā me kēia. No 33 mau maʻi i loaʻa i ka lāʻau bevacizumab ma mua, ʻo ka ORR he 54.5%, no 26 mau maʻi i loaʻa i ka lāʻau inhibitor PARP ma mua, ʻo ka ORR he 46.2%.
Ua hōʻike ʻia nā hopena i hui pū ʻia he ʻano hoʻomanawanui a palekana ko JSKN003 monotherapy, me nā hōʻailona pono e hoʻohiki ana i nā poʻe maʻi me PROC holomua, a ua ʻike ʻia ka pono ma waena o nā poʻe maʻi me (IHC 1+/2+3+) a i ʻole me ka ʻole o (IHC 0) hōʻike HER2, me a me ka ʻole o ka bevacizumab ma mua a me ka mea hoʻopaʻa PARP ma mua.
E pili ana iā JSKN003
ʻO JSKN003 kahi anti-HER2 bispecific antibody-drug conjugate (bis-ADC), i hoʻomohala ʻia i loko o ka hale me ka paepae conjugation Glycan-specific ponoʻī a Alphamab. Hiki iā JSKN003 ke hoʻopaʻa iā HER2 ma luna o ka ʻili o nā cell tumor a hoʻokuʻu i nā mea hoʻopaʻa topoisomerase I (TOPIi) ma o ka endocytosis cellular, a laila e hoʻopuka i nā hopena anti-tumor. Ke hoʻohālikelike ʻia me kona mau hoa ADC, ua hōʻike ʻo JSKN003 i ka paʻa serum maikaʻi aʻe a me ka hopena bystander ikaika, kahi e hoʻonui pono ai i ka puka makani therapeutic.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
Email：myimmnet@163.com
Nā Kuhikuhi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://www.alphamabonc.com/en/
Ka manawa hoʻouna: Malaki-18-2025