I te 20 o Ākuhata 2025, i panuitia e Abbisko Therapeutics kua whakaaetia e te Center for Drug Assessment (CDE) o te China National Medical Products Administration (NlPA) te tono lND mō te aukati PD-1 ā-waha rangahau a Abbisko, ABSK043, i honoa ki te aukati KRAS G12C a Shanghai Alist Pharmaceuticals, glecirasib, hei rongoā i ngā tūroro NscLc me te whakarerekētanga KRAS G12C.
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
WeChat ID: 17801183037
Email：myimmnet@163.com
Mō ABSK043
He aukati PD-L1 ngota iti hou, e wātea ana ki te waha, he tino whiriwhiri te ABSK043, nō Abbisko Therapeutics katoa. Ka taea e ngā pūtau puku te whakamahi i ngā arai ārai mate pēnei i te PD-1 me tana ligand PD-L1 hei karo i te kitenga me te whakakorenga o te ārai mate, ā, mā reira ka pehi, ka whakawhāiti rānei i ngā urupare pūtau-I. Ka herea te ABSK043 ki te kaiwhiwhi PD-L1 ka whakaoho i tōna whakaurunga mai i te mata pūtau, ka whakaoho i te taunekeneke PD-1/PD-L1 me te whakaiti i te pehitanga o te whakahohenga pūtau-T e te PD-L1. I roto i ngā tauira haumanu-mua, kua whakaatuhia e te ABSK043 te whai huatanga anti-pukupuku e rite ana ki ngā paturopi PD-L1 kua whakaaetia. Ahakoa kua whakaaetia ētahi paturopi monoconal PD-1/PD-L1 puta noa i te ao, kāore he maroke ngota iti PD-1/PD-L1 kua whakaaetia ki te waha, kei te tirotirohia te ABSK043 i roto i tētahi whakamātautau haumanu Wāhanga 1 e haere tonu ana mō ngā pukupuku totoka matatau i Ahitereiria me Haina.
I roto i tētahi rangahau wāhanga tuatahi (NCT04964375), i whakaatuhia e te ABSK043, he aukati PD-L1 iti-ngota, kaha, ā-waha, te whai huatanga tuatahi.
Ngā Tikanga
I hoatu he horopeta ki ngā tāngata whai pukupuku totoka kua whanake haere ki ngā kāpū ABSK043 mai i te 200 mg kotahi i te rā (QD) ki te 1000 mg e rua i te rā (BID), hei aromatawai i te āhua haumaru me te whai huatanga tuatahi. I arotakehia anō hoki ngā tohu pharmacodynamic (PD), pērā i te mahi pūtau-T me te PD-L1 mata.
Ngā Hua
I te rā kati (7 o Hune, 2024), e 77 ngā tohu i whakaurua, ā, i rongoatia. 87.0% o ngā tohu i pāngia e ngā pānga kino ohorere o te maimoatanga (TEAE), ā, 29.9% i ≥ Tau 3. Ko ngā TEAE ≥15% he anemia (22.1%). Kāore i puta he pūrongo mō te neuropathy peripheral. I roto i ngā tohu aromatawai whai huatanga katoa o ngā rōpū horopeta hohenga rongoā (600 mg BID, 800 mg BID, me te 1000 mg BID), i kitea he ORR o te 24% (8/34) i roto i ngā tohu ICI-kāore anō kia whiwhi. I roto i ngā tohu 10 ICI-kāore anō kia whiwhi me te mate pukupuku pūkahukahu (9 i mua i te maimoatanga me te 1 i mua i te maimoatanga), ko te ORR he 40% (4/10). He mea nui, e 3 o te 6 (50%) ngā tohu i whakarerekētia te EGFR me te 1 o te 2 (50%) ngā tohu i whakarerekētia te KRAS i eke ki te urupare ā-wāhanga (PR). Ko ngā kaiwhakautu e toru me ngā whakarerekētanga EGFR he PD-L1 TPS ≥ 50% ā, i ahu whakamua i muri i te iti rawa i te kotahi raina o ngā maimoatanga EGFR TKI, tae atu ki te whakatupuranga tuatoru. I puta ētahi atu urupare i roto i ngā momo pukupuku whakauru e rima: te mate pukupuku puku MSI-H/dMMR, te adenocarcinoma endometrial MSI-H/dMMR, te carcinoma pūtau squamous tara, te mate pukupuku ū (Lynch syndrome), me te melanoma. Ko te roanga roa o te urupare i roto i te rangahau he 17 marama (adenocarcinoma endometrial) ā, kei te rongoatia tonu te tohu. I kitea te whakahohenga pūtau-T me te hekenga i runga i te horopeta o te whakaaturanga PD-L1 mata i muri i te maimoatanga ABSK043 i roto i ngā rōpū horopeta BID katoa.
Mō Glecirasib
Ko te Glecirasib (AST-24081) he aukati KRAS G12C. He maha ngā whakamātautau haumanu kei te haere tonu i Haina, i te Hononga o Amerika me Ūropi mō ngā tūroro he pukupuku matū kua whanake haere kei roto ko te whakarerekētanga KRAS G12C. Kei roto i ēnei ko ngā whakamātautau whakaora whakakotahi me te aukati SHP2 AST-24082 i roto i te NSCLC me ngā whakamātautau whakaora kotahi i roto i te mate pukupuku repeure. Hei tāpiri, kua tohua te tohu mate pukupuku repeure hei rongoā kore i te Hononga o Amerika me te tohu whakaora hou i Haina. I te marama o Mei 2025, i whakaaetia a Glecirasib mō te whakarewatanga mākete e te ChinaNMPA.
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
WeChat ID: 17801183037
Email：myimmnet@163.com
Wā tuku: 21 o Ākuhata-2025