I te 25 o Pēpuere, 2025, kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te finotonlimab me te SCT510 mōte rongoā i te mate pukupuku hepatocellular kāore e taea te tango, te mate pukupuku rānei kua horapa ki roto i te tinana, kāore nei i whiwhi i te rongoā pūnaha o mua.
Ko te Finotonlimab he paturopi monoclonal momo IgG4 kua whakahōuhia ki te tangata, he mana pupuri hinengaro katoa tōna. Hei rongoā hou kua patenttia, he ahurei tōna hanganga ngota, ā, he painga tikanga hoki. Ka herea e Finotonlimab ki te PD-1 me te kaha nui, ka ārai i te ara PD-1/PD-L1, ka whakaora me te whakarei ake i te mahi patu ārai mate o ngā pūtau-T, ā, nā reira ka ārai i te tipu o te pukupuku.
I te Hui-ā-Tau a te ASCO 2024, i kōrerotia hewhakamātautau wāhanga 3 matapōkere of I honoa te SCT-I10A me te bevacizumab biosimilar (SCT510) ki te whakarite ki te sorafenib i te maimoatanga tuatahi o te mate pukupuku hepatocellular matatau.
I roto i tēnei whakamātautau tuwhera-tapanga, maha-pokapū, wāhanga 3 (NCT04560894) i whakahaerehia i Haina, i whakaurua ngā tūroro he HCC matatau kāore anō kia whiwhi i te rongoā pūnaha o mua, ā, i tohaina matapōkeretia (2:1) ki te whiwhi SCT-I10A (200 mg ia toru wiki [Q3W]) me te SCT510 (he bevacizumab biosimilar, 15 mg/kg Q3W) me te sorafenib rānei (400 mg ā-waha e rua i te rā) tae noa ki te korenga o te painga haumanu, te paitini kāore e whakaaetia. I wehewehea te matapōkeretia e te mana mahi ECOG (0 vs. 1), te taumata alpha-fetoprotein taketake (<400ng/ml vs. ≥400ng/ml), te whakaekenga macrovascular, te metastasis waho-hepatic rānei (āe vs. kāo). Ko ngā pito mutunga tuatahi ko te oranga whānui (OS) me te oranga kore-haere whakamua (PFS) i aromatawaitia e te arotake pokapū motuhake matapo (BICR) e ai ki ngā Paearu Aromatawai Urupare i roto i ngā Tumors Totoka (RECIST) putanga 1.1 i roto i te huinga tātaritanga katoa.
I te wā kati raraunga mō te tātaritanga wā poto (2 o Noema, 2023), e 346 ngā tūroro katoa i whakaurua, ā, i whiwhi i te iti rawa kotahi te horopeta (rōpū SCT-I10A me SCT510, n=230; rōpū sorafenib, n=116), ā, ko te roanga o te aroturukitanga toharite he 19.7 marama. Ko te rōpū SCT-I10A me SCT510 i whakaatu i te roanga o te OS toharite he roa ake i tērā i roto i te rōpū sorafenib (22.1 vs. 14.2 marama, ōwehenga mōrearea [HR] 0.60; 95% wā whakawhirinaki [CI]: 0.44, 0.81; p=0.0008). I roa ake te PFS waenga i roto i te rōpū SCT-I10A me te SCT510 ki te rōpū sorafenib (7.1 vs. 2.9 marama; HR 0.50; 95%CI: 0.38, 0.65; p<0.0001). He teitei ake te reiti urupare whāinga (ORR) i roto i te rōpū SCT-I10A me te SCT510 (32.8% [75/229]) i te rōpū sorafenib (4.3% [5/116]). I kitea ngā pānga kino e pā ana ki te maimoatanga (TRAE) taumata ≥3 i roto i te 42.6% (98/230) o ngā tūroro i roto i te rōpū SCT-I10A me te SCT510 me te 33.6% (39/116) o ngā tūroro i roto i te rōpū sorafenib. Ko te taumata ≥3 TRAE tino kitea ko te toto toto tiketike (SCT-I10A me te rōpū SCT510 vs. rōpū sorafenib: 7.8% [18/230] vs. 4.3% [5/116]). E toru ngā mate e pā ana ki te rongoā (kāore i te mōhiotia te take, te toto i roto i te angaanga, te toto rānei i te puku o runga i te tūroro kotahi) i puta, ā, e pā ana ki te SCT510.
Ngā Whakatau: I whakaatuhia e te huinga o SCT-I10A me SCT510 he painga haumanu nui me te kōtaha haumaru e whakaaetia ana i roto i ngā tūroro me te HCC matatau, nā reira i tautoko i tōna pai hei kōwhiringa maimoatanga raina tuatahi mō te HCC.
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
Wā tuku: Maehe-10-2025