Thaum Lub Peb Hlis 18, 2025, Alphamab Oncology tshaj tawm tias anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 tau txais Breakthrough Therapy Designation los ntawm Center for Drug Evaluation (CDE) ntawm National Medical Products Administration (NMPA). Lub npe no yog rau kev kho mob qog nqaij hlav epithelial ovarian (PROC), qog nqaij hlav peritoneal thawj zaug, lossis qog nqaij hlav fallopian tube, tsis txwv rau HER2 qib kev qhia tawm.
Qhov kev tso cai ntawm Breakthrough Therapy Designation yog raws li kev tshuaj xyuas ua ke ntawm ob txoj kev tshawb fawb hauv tsev kho mob, JSKN003-101 thiab JSKN003-102. JSKN003-101 (NCT05494918) yog ib txoj kev tshawb fawb qhib-npe, ntau lub chaw, thiab nce koob tshuaj theem I uas tau ua nyob rau hauv tebchaws Australia, sau npe cov neeg mob uas muaj cov qog nqaij hlav tawv nqaij uas qhia txog HER2 (IHC≥1+) lossis nrog HER2 mutations. JSKN003-102 (NCT05744427) yog ib txoj kev tshawb fawb theem I/II uas tau ua nyob rau hauv Suav teb. Theem I ib feem tau sau npe cov neeg mob uas muaj HER2 expression (IHC≥1+) lossis HER2 mutations uas tau lees paub cov qog nqaij hlav tawv nqaij uas tau hloov pauv. Theem II ib feem tau sau npe cov neeg mob uas muaj cov qog nqaij hlav tawv nqaij uas tau hloov pauv tsis hais txog HER2 expression lossis mutation status.
Cov ntaub ntawv pib los ntawm kev tshuaj xyuas ua ke ntawm ob txoj kev tshawb fawb no tau nthuav tawm ntawm 2024 European Society for Medical Oncology (ESMO) Congress.
Txij li thaum Lub Xya Hli 15, 2024, 50 tus neeg mob uas muaj PROC tau txais JSKN003 thoob plaws tsib qib koob tshuaj, ntawm cov neeg mob uas muaj 2 tus neeg mob ntawm qhov koob tshuaj 4.2mg/kg, 2 tus neeg mob ntawm qhov koob tshuaj 5.2mg/kg, 44 tus neeg mob ntawm qhov koob tshuaj 6.3mg/kg, 1 tus neeg mob ntawm qhov koob tshuaj 7.3mg/kg, thiab 1 tus neeg mob ntawm qhov koob tshuaj 8.4mg/kg. Ntawm 50 tus neeg mob uas tau sau npe raws li kev kuaj hauv chaw kuaj mob hauv nruab nrab, muaj 17 tus neeg mob uas muaj HER2 qhia tawm (IHC 1+, 2+ thiab 3+) (tsuas yog 2 tus neeg mob uas muaj HER2 IHC 3+), 17 tus neeg mob uas muaj IHC 0, thiab 16 tus neeg mob tsis muaj cov txiaj ntsig HER2 vim lawv tsis tau kuaj thaum Lub Xya Hli 15. 28 tus neeg mob (56.0%) muaj tsawg kawg yog peb kab kev kho mob ua ntej, 37 tus neeg mob (74.0%) tau txais kev kho mob bevacizumab, thiab 28 tus neeg mob (56.0%) tau txais kev kho mob PARP inhibitor.
Lub sijhawm kho mob nruab nrab yog 12.4 lub lis piam (ntau yam: 0.7 - 51.0 lub lis piam), nrog rau 32 tus neeg mob (64.0%) tseem kho mob txog hnub kawg ntawm cov ntaub ntawv.
Kev Nyab Xeeb: Ntawm tag nrho 50 tus neeg mob uas tau sau npe, 3 tus neeg mob tau muaj tus kab mob ntsws interstitial (ILD)/pneumonitis. 5 tus neeg mob (10.0%) tau muaj cov teeb meem tsis zoo ntawm kev kho mob theem 3 (TRAEs), feem ntau yog raws plab (2.0%) thiab ntshav tsis txaus (2.0%). Tsis muaj TRAEs ua rau tuag.
Kev Ua Haujlwm Zoo: Ntawm 44 tus neeg mob uas tau ntsuam xyuas qhov ua tau zoo uas muaj tsawg kawg ib qho kev ntsuam xyuas qog tom qab pib, qhov feem pua ntawm kev teb (ORR) yog 56.8%, nrog rau 39 tus neeg mob (88.6%) qhia tias qog nqaij hlav me me. ORR hauv cov neeg mob uas tau lees paub HER2 IHC 0 thiab HER2 kev qhia tawm (IHC 1+, 2+ thiab 3+) yog 52.9% thiab 68.8%, raws li. Rau 33 tus neeg mob uas tau txais kev kho mob bevacizumab ua ntej ORR yog 54.5%, rau 26 tus neeg mob uas tau txais kev kho mob PARP inhibitor ua ntej ORR yog 46.2%.
Cov txiaj ntsig sib sau ua ke tau qhia tias JSKN003 monotherapy muaj kev kam rau siab thiab kev nyab xeeb, nrog rau cov cim qhia txog kev ua tau zoo hauv cov neeg mob uas muaj PROC siab heev, thiab qhov ua tau zoo tau pom thoob plaws cov neeg mob uas muaj (IHC 1+/2+3+) lossis tsis muaj (IHC 0) HER2 kev qhia tawm, nrog lossis tsis muaj bevacizumab ua ntej thiab PARP inhibitor ua ntej.
Txog JSKN003
JSKN003 yog ib qho tshuaj antibody-drug conjugate (bis-ADC) uas yog tsim los ntawm Alphamab lub platform Glycan tshwj xeeb. JSKN003 tuaj yeem khi HER2 rau ntawm qhov chaw ntawm cov hlwb qog thiab tso tawm cov tshuaj topoisomerase I inhibitors (TOPIi) los ntawm kev ua haujlwm ntawm cov hlwb endocytosis, yog li ua rau muaj cov teebmeem tiv thaiv kab mob qog. Piv nrog nws cov ADC counterparts, JSKN003 tau ua pov thawj tias cov tshuaj serum ruaj khov dua thiab muaj zog dua, uas ua rau lub sijhawm kho mob dav dua.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
Email：myimmnet@163.com
Cov ntaub ntawv siv los ua piv txwv
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://www.alphamabonc.com/en/
Lub sijhawm tshaj tawm: Lub Peb Hlis-18-2025