I te 18 o Poutū-te-rangi, 2025, i panuitia e Alphamab Oncology kua whakawhiwhia te tohu Breakthrough Therapy ki te anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 e te Center for Drug Evaluation (CDE) o te National Medical Products Administration (NMPA). Ko te tohu nei mō te maimoatanga o te mate pukupuku ovarian epithelial recurrent resistant platinum (PROC), te mate pukupuku peritoneal tuatahi, te mate pukupuku ngongo fallopian rānei, kāore i te herea ki ngā taumata whakaaturanga HER2 anake.
Ko te whakawhiwhinga o te Tohunga Whakaora Pakari i ahu mai i te tātaritanga whakakotahi o ngā rangahau haumanu e rua, arā, ko JSKN003-101 me JSKN003-102. Ko te JSKN003-101 (NCT05494918) he rangahau haumanu Wāhanga I tuwhera-tohu, maha-pokapū, whakanui horopeta i whakahaerehia i Ahitereiria, e whakauru ana i ngā tūroro he pukupuku totoka matatau e whakaatu ana i te HER2 (IHC≥1+) me ngā whakarerekētanga HER2 rānei. Ko te JSKN003-102 (NCT05744427) he rangahau Wāhanga I/II i whakahaerehia i Haina. I whakaurua e te wāhanga Wāhanga I ngā tūroro he whakaaturanga HER2 kua whakaūtia e te histology (IHC≥1+) he whakarerekētanga HER2 rānei he pukupuku totoka matatau. I whakaurua e te wāhanga Wāhanga II ngā tūroro he pukupuku totoka matatau ahakoa te āhua whakaaturanga HER2, te whakarerekētanga rānei.
I whakaaturia ngā raraunga tuatahi mai i te tātaritanga whakakotahi o ēnei rangahau e rua i te Huihuinga o te Rōpū Pākehā mō te Matepukupuku Hauora (ESMO) i te tau 2024.
I te 15 o Hūrae, 2024, e 50 ngā tūroro PROC kua whiwhi i te JSKN003 i roto i ngā taumata horopeta e rima, arā, e 2 ngā tūroro i te horopeta o te 4.2mg/kg, e 2 ngā tūroro i te horopeta o te 5.2mg/kg, e 44 ngā tūroro i te horopeta o te 6.3mg/kg, kotahi te tūroro i te horopeta o te 7.3mg/kg, me te kotahi te tūroro i te horopeta o te 8.4mg/kg. I roto i ngā tūroro 50 kua rēhitatia i runga i ngā whakamātautau taiwhanga matua, 17 ngā tūroro he whakaaturanga HER2 (IHC 1+, 2+ me te 3+) (2 anake ngā tūroro he HER2 IHC 3+), 17 ngā tūroro he IHC 0, ā, 16 ngā tūroro kāore i whiwhi hua HER2 nā te mea kāore anō kia whakamatautauria i mua i te 15 o Hūrae. 28 ngā tūroro (56.0%) i whiwhi i te iti rawa i te toru ngā raina maimoatanga pūnaha o mua, 37 ngā tūroro (74.0%) i whiwhi i te maimoatanga bevacizumab, ā, 28 ngā tūroro (56.0%) i whiwhi i te maimoatanga aukati PARP.
Ko te roanga toharite o te maimoatanga he 12.4 wiki (awhe: 0.7 – 51.0 wiki), me te 32 ngā tūroro (64.0%) i noho tonu ki te maimoatanga tae noa ki te rā kati raraunga.
Haumaru: I roto i ngā tūroro 50 katoa i rēhitatia, e 3 ngā tūroro i pāngia e te mate pūkahukahu interstitial (ILD)/pneumonitis. E 5 ngā tūroro (10.0%) i pāngia e ngā pānga kino e pā ana ki te maimoatanga taumata 3 (TRAE), ko te mea tino noa ko te mate korere (2.0%) me te anemia (2.0%). Kāore he TRAE i mate ai.
Whai Huatanga: I roto i ngā tūroro 44 i arotakehia te whai huatanga, ā, kotahi te iti rawa o te aromatawai pukupuku i muri i te tīmatanga, ko te reiti urupare whāinga (ORR) he 56.8%, me te 39 tūroro (88.6%) e whakaatu ana i te whakahekenga o te pukupuku. Ko te ORR i roto i ngā tūroro me te HER2 IHC 0 kua whakapumautia i waenganui me te whakaaturanga HER2 (IHC 1+, 2+ me te 3+) he 52.9% me te 68.8%, ia. Mō ngā tūroro 33 i whiwhi i te maimoatanga bevacizumab i mua, ko te ORR he 54.5%, mō ngā tūroro 26 i whiwhi i te maimoatanga aukati PARP i mua, ko te ORR he 46.2%.
Kua whakaatuhia e ngā hua whakakotahi he pai te manawanui me te haumaru o te rongoā JSKN003, me ngā tohu whai huatanga pai i roto i ngā tūroro he PROC matatau, ā, i kitea te whai huatanga puta noa i ngā tūroro he (IHC 1+/2+3+) he kore rānei (IHC 0) te whakaaturanga HER2, me te kore rānei he bevacizumab o mua me te aukati PARP o mua.
Mō JSKN003
Ko te JSKN003 he hononga paturopi-rongoā anti-HER2 bispecific (bis-ADC), i whakawhanakehia i roto i te whare me te tūāpapa hononga Glycan-specific motuhake a Alphamab. Ka taea e te JSKN003 te here i te HER2 ki te mata o ngā pūtau pukupuku me te tuku i ngā aukati topoisomerase I (TOPIi) mā te endocytosis pūtau, ā, ka puta he pānga anti-pukupuku. Ki te whakatauritea ki ōna hoa ADC, i whakaatu a JSKN003 i te pumau toto pai ake me te pānga tūmatanui kaha ake, e whakawhānui ana i te matapihi rongoā.
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
Tau Waea：4008803716
Email：myimmnet@163.com
Ngā Tohutoro
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://www.alphamabonc.com/en/
Wā tuku: Maehe-18-2025