NgoMashi 18, 2025, i-Alphamab Oncology yamemezela ukuthi i-anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 inikezwe i-Breakthrough Therapy Designation yi-Center for Drug Evaluation (CDE) ye-National Medical Products Administration (NMPA). Lesi sikhundla singesokwelashwa komdlavuza we-ovarian ophindaphindayo we-epithelial ovarian (PROC) omelana ne-platinum (i-PROC), umdlavuza we-peritoneal oyinhloko, noma umdlavuza we-fallopian tube, ongagcini emazingeni okubonakaliswa kwe-HER2 kuphela.
Ukunikezwa kwe-Breakthrough Therapy Designation kusekelwe ekuhlaziyweni okuhlanganisiwe kwezifundo ezimbili zezokwelapha, i-JSKN003-101 kanye ne-JSKN003-102. I-JSKN003-101 (NCT05494918) iyisifundo sezokwelapha seSigaba I esivulekile, esiphakathi nendawo, esikhuphuka ngomthamo esenziwe e-Australia, sibhalisa iziguli ezinezimila eziqinile ezithuthukile eziveza i-HER2 (IHC≥1+) noma ezinezinguquko ze-HER2. I-JSKN003-102 (NCT05744427) iyisifundo seSigaba I/II esenziwa eShayina. Ingxenye yeSigaba I yabhalisa iziguli ezinezimpawu eziqinile eziqinisekisiwe ngokwesayensi ye-HER2 (IHC≥1+) noma izinguquko ze-HER2 ezithuthukile. Ingxenye yeSigaba II yabhalisa iziguli ezinezimila eziqinile ezithuthukile kungakhathaliseki ukubonakaliswa kwe-HER2 noma isimo sokuguquka.
Idatha yokuqala evela ekuhlaziyweni okuhlanganisiwe kwalezi zifundo ezimbili yethulwe kwi-2024 European Society for Medical Oncology (ESMO) Congress.
Kusukela ngoJulayi 15, 2024, iziguli ezingu-50 ezine-PROC zazithole i-JSKN003 emazingeni amahlanu omthamo, phakathi kwazo iziguli ezimbili ngesilinganiso esingu-4.2mg/kg, iziguli ezimbili ngesilinganiso esingu-5.2mg/kg, iziguli ezingu-44 ngesilinganiso esingu-6.3mg/kg, isiguli esisodwa ngesilinganiso esingu-7.3mg/kg, kanye nesiguli esisodwa ngesilinganiso esingu-8.4mg/kg. Phakathi kweziguli ezingu-50 ezibhalisiwe ngokusekelwe ekuhlolweni kwelabhorethri ephakathi, kwakukhona iziguli ezingu-17 ezine-HER2 expression (IHC 1+, 2+ kanye no-3+) (iziguli ezimbili kuphela ezine-HER2 IHC 3+), iziguli ezingu-17 ezine-IHC 0, kanye neziguli ezingu-16 ezazingenayo imiphumela ye-HER2 ngoba zazingakahlolwa ngoJulayi 15. Iziguli ezingu-28 (56.0%) zazine okungenani imigqa emithathu yokwelashwa okuhleliwe, iziguli ezingu-37 (74.0%) zazithole ukwelashwa kwe-bevacizumab, kanti iziguli ezingu-28 (56.0%) zazithole ukwelashwa kwe-PARP inhibitor.
Isikhathi esimaphakathi sokwelashwa sasingamaviki angu-12.4 (ububanzi: amasonto angu-0.7 - 51.0), kanti iziguli ezingu-32 (64.0%) zahlala ekwelashweni kuze kube usuku lokugcina lwedatha.
Ukuphepha: Phakathi kwazo zonke iziguli ezingu-50 ezibhalisiwe, iziguli ezingu-3 zabhekana nesifo samaphaphu esingaphakathi kwe-interstitial (ILD)/pneumonia. Iziguli ezingu-5 (10.0%) zabhekana nezenzakalo ezimbi ezihlobene nokwelashwa (TRAEs) zebanga lesi-3, ezivame kakhulu ukuba yisifo sohudo (2.0%) kanye ne-anemia (2.0%). Azikho i-TRAE ezaholela ekufeni.
Ukusebenza kahle: Phakathi kweziguli ezingu-44 ezihlolwe ukusebenza kahle ezazine okungenani ukuhlolwa okukodwa kwesimila ngemuva kokuqala, izinga lokuphendula eliqondile (ORR) lalingu-56.8%, kanti iziguli ezingu-39 (88.6%) zibonise ukuncipha kwesimila. I-ORR ezigulini ezine-HER2 IHC 0 kanye nokubonakaliswa kwe-HER2 okuqinisekisiwe okuphakathi (IHC 1+, 2+ kanye no-3+) yayingu-52.9% kanye no-68.8%, ngokulandelana. Ezigulini ezingu-33 ezathola ukwelashwa kwangaphambilini kwe-bevacizumab i-ORR yayingu-54.5%, ezigulini ezingu-26 ezathola ukwelashwa kwangaphambilini kwe-PARP inhibitor i-ORR yayingu-46.2%.
Imiphumela ehlanganisiwe ikhombisile ukuthi ukwelashwa okukodwa kwe-JSKN003 kunesimo esihle sokubekezeleleka kanye nephrofayili yokuphepha, kanye nezimpawu zokusebenza ezithembisayo ezigulini ezine-PROC ethuthukisiwe, futhi ukusebenza kahle kwabonwa kuzo zonke iziguli ezine-(IHC 1+/2+3+) noma ezingenayo (IHC 0) HER2 expression, ezine-bevacizumab yangaphambili kanye ne-PARP inhibitor yangaphambili noma ezingenayo.
Mayelana ne-JSKN003
I-JSKN003 iyi-anti-HER2 bispecific antibody-drug conjugate (bis-ADC), eyakhiwe ngaphakathi kweplatifomu yokuhlanganiswa kwe-Glycan-specific ye-Alphamab. I-JSKN003 ingabopha i-HER2 ebusweni bamaseli esimila futhi ikhulule ama-topoisomerase I inhibitors (TOPIi) nge-endocytosis yamaseli, ngaleyo ndlela ibe nemiphumela yokulwa nesimila. Uma iqhathaniswa ne-ADC, i-JSKN003 ibonise ukuzinza okungcono kwe-serum kanye nomphumela onamandla wokuma, okwandisa ngempumelelo ifasitela lokwelapha.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
Email：myimmnet@163.com
Izinkomba
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://www.alphamabonc.com/en/
Isikhathi sokuthunyelwe: Mashi-18-2025