A ranar 18 ga Maris, 2025, Alphamab Oncology ta sanar da cewa Cibiyar Nazarin Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Kasa (NMPA) ta ba da izinin yin gwajin maganin cutar anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003. An yi wannan gwajin ne don maganin cutar kansar ovarian mai sake jurewa platinum (PROC), cutar kansar peritoneal ta farko, ko cutar kansar bututun fallopian, ba a iyakance ga matakan bayyanar HER2 ba.
An bayar da kyautar Breakthrough Therapy An yi shi ne bisa ga binciken da aka tattara na nazarin asibiti guda biyu, JSKN003-101 da JSKN003-102. JSKN003-101 (NCT05494918) wani bincike ne na asibiti na Phase I wanda aka gudanar a Ostiraliya, wanda aka yi wa rijistar marasa lafiya da ciwon daji mai tsanani wanda ke bayyana HER2 (IHC≥1+) ko kuma tare da maye gurbin HER2. JSKN003-102 (NCT05744427) wani bincike ne na Phase I/II da aka gudanar a China. Sashen Phase I ya yi rajistar marasa lafiya da suka sami bayyanar HER2 (IHC≥1+) ko maye gurbin HER2 wanda aka tabbatar da shi ta hanyar histological histologically. Sashen Phase II ya yi rajistar marasa lafiya da ciwon daji mai tsanani ba tare da la'akari da bayyanar HER2 ko matsayin maye gurbin ba.
An gabatar da bayanai na farko daga binciken da aka tattara na waɗannan binciken guda biyu a taron ƙungiyar kula da cututtukan daji ta Turai (ESMO) na 2024.
Ya zuwa ranar 15 ga Yuli, 2024, marasa lafiya 50 da ke dauke da PROC sun karɓi JSKN003 a cikin matakan allurai guda biyar, daga cikinsu akwai marasa lafiya 2 a cikin allurai na 4.2mg/kg, marasa lafiya 2 a cikin allurai na 5.2mg/kg, marasa lafiya 44 a cikin allurai na 6.3mg/kg, mara lafiya 1 a cikin allurai na 7.3mg/kg, da kuma mara lafiya 1 a cikin allurai na 8.4mg/kg. Daga cikin marasa lafiya 50 da aka yi wa rajista bisa ga gwajin dakin gwaje-gwaje na tsakiya, akwai marasa lafiya 17 da ke da HER2 expression (IHC 1+, 2+ da 3+) (marasa lafiya 2 kawai da ke da HER2 IHC 3+), marasa lafiya 17 da ke da IHC 0, da kuma marasa lafiya 16 ba su sami sakamakon HER2 ba saboda ba a yi musu gwajin ba kafin ranar 15 ga Yuli. Marasa lafiya 28 (56.0%) sun sami akalla layuka uku na magani na yau da kullun, marasa lafiya 37 (74.0%) sun sami maganin bevacizumab, kuma marasa lafiya 28 (56.0%) sun sami maganin hana PARP.
Matsakaicin tsawon lokacin maganin shine makonni 12.4 (tsakanin: makonni 0.7 - 51.0), tare da marasa lafiya 32 (64.0%) sun ci gaba da jinya har zuwa ranar da aka yanke bayanan.
Tsaro: Daga cikin dukkan marasa lafiya 50 da aka yi wa rajista, marasa lafiya 3 sun fuskanci cutar huhu ta interstitial (ILD)/pneumonia. Marasa lafiya 5 (10.0%) sun fuskanci mummunan sakamako na magani na aji 3 (TRAEs), wanda ya fi yawa shine gudawa (2.0%) da rashin jini (2.0%). Babu TRAEs da ya kai ga mutuwa.
Inganci: Daga cikin marasa lafiya 44 da aka kimanta ingancinsu waɗanda aka kimanta aƙalla ɗaya daga cikin gwaje-gwajen ciwon daji bayan tushe, ƙimar amsawar da aka yi da gangan (ORR) shine 56.8%, tare da marasa lafiya 39 (88.6%) sun nuna raguwar ciwon daji. ORR a cikin marasa lafiya da aka tabbatar da HER2 IHC 0 da HER2 (IHC 1+, 2+ da 3+) ya kasance 52.9% da 68.8%, bi da bi. Ga marasa lafiya 33 da suka sami maganin bevacizumab a baya ORR shine 54.5%, ga marasa lafiya 26 da suka sami maganin hana PARP a baya ORR shine 46.2%.
Sakamakon da aka tattara ya nuna cewa JSKN003 monotherapy yana da kyakkyawan juriya da aminci, tare da alamun inganci masu kyau ga marasa lafiya da ke da ci gaba da PROC, kuma an lura da ingancinsa a cikin marasa lafiya da ke da (IHC 1+/2+3+) ko ba tare da (IHC 0) HER2 ba, tare da ko ba tare da bevacizumab na baya ba da kuma wanda ke hana PARP na baya.
Game da JSKN003
JSKN003 wani maganin hana ƙwayoyin cuta ne mai hana ƙwayoyin cuta na HER2 (bis-ADC), wanda aka haɓaka shi a cikin tsarin haɗin Glycan na musamman na Alphamab. JSKN003 na iya ɗaure HER2 a saman ƙwayoyin ciwon daji kuma ya saki masu hana topoisomerase I (TOPIi) ta hanyar endocytosis na ƙwayoyin halitta, don haka yana haifar da tasirin hana ƙari. Idan aka kwatanta da takwarorinsa na ADC, JSKN003 ya nuna ingantaccen kwanciyar hankali a cikin jini da kuma ƙarfin tasirin gani, wanda ke faɗaɗa taga ta hanyar magani yadda ya kamata.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
Lambar Waya: 4008803716
Email：myimmnet@163.com
Nassoshi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://www.alphamabonc.com/en/
Lokacin Saƙo: Maris-18-2025