17 Hōngongoi, 2025 – I panuitia e Innovent Biologics kua whakaputaina e Nature Medicine ngā hua o te rangahau haumanu Wāhanga 1 o IBI343, he anti-CLDN18.2 ADC auaha, mō te maimoatanga o te adenocarcinoma hononga puku/gastroesophageal (G/GEJ) matatau. Ko te whakaputanga i roto i tēnei hautaka mātauranga o te ao e tohu ana i te mōhiotanga kaha ki te pūmanawa haumanu o te rongoā, ā, he tohu anō tēnei i tētahi atu tohu nui i roto i te ahunga whakamua a Haina ki te whakawhanake i ngā rongoā anti-pukupuku hou. I runga i ngā kitenga o te rangahau, i whakarewahia he whakamātautau haumanu Wāhanga 3 maha-rohe (G-HOPE-001, NCT06238843) i te tau 2024 hei aromatawai anō i te IBI343 hei kōwhiringa maimoatanga haumaru me te whai hua mō ngā tūroro me te G/GEJ AC matatau.
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.
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Ko te mate pukupuku puku tetahi o ngā pukupuku kino tino noa o te ao. E ai ki ngā tatauranga a GLOBOCAN 2022, koia te tuarima o ngā pukupuku kino tino noa me te tuarima o ngā take matua o ngā mate e pā ana ki te mate pukupuku puta noa i te ao, me te whakatau tata ki te 970,000 ngā kēhi hou me te 660,000 ngā mate i ia tau. I ia tau, e ripoata ana a Haina i te 359,000 ngā kēhi hou me te 260,000 ngā mate mai i te mate pukupuku puku, e tohu ana i te 37.0% me te 39.4% o ngā tapeke o te ao, ia, e whakaatu ana i te hiahia hauora nui kāore anō kia tutuki.
Ko te CLDN 18.2 he pūmua hononga piripono e whakaatuhia ana i roto i ngā pūtau epithelial kua wehewehea i runga i te mucosa puku i raro i ngā āhuatanga ā-tinana noa. Kua whakaatuhia e ngā rangahau o mua he nui te whakaaturanga o Claudin18.2 i roto i ngā momo mate pukupuku maha, tae atu ki te mate pukupuku puku (60-80%), te mate pukupuku repeure (50%), te carcinoma esophageal (30-50%), me te mate pukupuku pūkahukahu (40-60%). Ko te arotahi ki te CLDN18.2 me ngā paturopi monoclonal (mAbs) me ngā ADC he huarahi hou e whai hua ana mō te rongoā i te mate pukupuku puku.
He whakamātautau haumanu ā-ao whānui tēnei rangahau kua whakaputaina, he maha ngā pokapū, Wāhanga 1 (ClinicalTrial.gov tohu: NCT05458219) i hangaia hei aromatawai i te haumaru, te manawanui me te whai huatanga tuatahi o te IBI343 i roto i ngā tūroro he pukupuku totoka kua whanake haere. I waenganui i te 26 o Oketopa, 2022, me te 30 o Hune, 2024, i whakaurua katoatia he 116 ngā tāngata he adenocarcinoma G/GEJ kua whanake haere ki te whiwhi i te IBI343 monotherapy (8 kei te piki haere, 108 kei te whānui haere).
Mō IBI343（Anti CLDN18.2 ADC）
Ko te IBI343 he hononga rongoā monoclonal anti-CLDN18.2 tangata (ADC) i hangaia e Innovent Biologics. Ka herea motuhake ki ngā pūtau pukupuku e whakaatu ana i te CLDN18.2, ka whakaoho i te whakaurunga o te ADC e whakawhirinaki ana ki te CLDN18.2. Kia uru ki roto i te pūtau, ka tukuna te kawenga cytotoxic, ka hua ake te kino o te DNA, ā, i te mutunga ka mate ngā pūtau pukupuku. Ka taea hoki e te rongoā i tukuna te horapa puta noa i te kiriuhi plasma kia tae atu ai, kia patu ai hoki i ngā pūtau tata, ka hua ake he "pānga patu tangata tū tata".
Hei TOPO1i ADC auaha, kua whakaatuhia e IBI343 te haumaru e taea ana te whakamanawanui me ngā tohu whai hua whakatenatena i roto i ēnei rangahau haumanu Wāhanga 1. Kei te tūhuratia te pūmanawa rongoā o IBI343 i roto i ngā momo pukupuku pēnei i te mate pukupuku puku me te mate pukupuku repeure.
Kei te kimihia ngā tūroro (G-HOPE-001, NCT06238843) i roto i te whakamātautau haumanu maha-rohe o te Wāhanga 3 o IBI343 mō te adenocarcinoma hononga puku/gastroesophageal matatau. Kua whakawhiwhia te tohu e tika ana ki te Breakthrough Therapy Designation (BTD) e te NMPA o Haina.
Kei te whakaurua hoki ngā tūroro (NCT05458219) ki te whakamātautau haumanu Wāhanga 1 maha-rohe o IBI343 mō te adenocarcinoma ductal pancreatic matatau. Kua whiwhi tēnei tohu i te Fast Track Designation (FTD) mai i te US FDA, ā, kua whakawhiwhia ki te BTD e te NMPA o Haina.
Kua whakaatuhia e IBI343 te urupare whakatenatena ki te pukupuku me te painga oranga
I tātarihia e te rangahau ngā raraunga whai huatanga o ngā tāngata i arotakehia me te nui o te whakaaturanga o te CLDN18.2 (≥75% ngā pūtau pukupuku me te kaha o te tae membranous ≥2+ e IHC), i roto i ngā rōpū horopeta e rua o te 6 mg/kg me te 8 mg/kg.
I te 6 mg/kg (N=31), 15 ngā tūroro i whai urupare hapa (PR) tae atu ki te 9 ngā tūroro me ngā PR kua whakaūtia me te 1 te tūroro e tatari ana kia whakaūtia. Ko te ORR kua whakaūtia he 29.0% (95% CI: 14.2-48.0) ā, ko te tere whakahaere mate (DCR) he 90.3% (95% CI: 74.2-98.0). I roto i te 9 ngā tūroro me te urupare kua whakaūtia, ko te roanga waenga o te urupare (DoR) he 5.6 marama (95% CI: 2.8-7.0). Ko te roanga waenga o te aroturukitanga he 10.6 marama (95% CI: 9.7-11.5) mō te PFS me te OS. Ko te PFS waenga he 5.5 marama (95% CI: 4.1-7.0). Kāore i pakari ngā raraunga OS me te OS waenga o nāianei o te 10.8 marama (95% CI: 6.8-NC). I muri i te tapahi raraunga, i whakaūtia te urupare a te tūroro kotahi i toe i te 26 o Hūrae, 2024, ā, i whakahōutia te ORR kua whakaūtia ki te 32.3% (95% CI: 16.7-51.4).
I te 8 mg/kg (N=17), 17 ngā tūroro he nui te whakaaturanga o te CLDN 18.2 i taea te aromatawai. I roto i a rātou, 9 ngā tūroro he PR tae atu ki te 8 ngā tūroro kua whakaūngia te PR. Ko te ORR kua whakaūngia ko te 47.1% (95% CI: 23.0-72.2), ā, ko te DCR ko te 88.2% (95% CI: 63.6-98.5). I roto i ngā tūroro e waru he urupare kua whakaūngia, ko te DoR toharite ko te 5.7 marama (95% CI: 2.7-NC). O ngā tūroro adenocarcinoma G/GEJ katoa he nui te whakaaturanga CLDN18.2 i rongoatia ki te 8 mg/kg (N=19, tae atu ki te 1 tūroro mai i te whakanui horopeta me te 18 tūroro mai i te whakawhānui horopeta), ko te aroturuki toharite ko te 8.1 marama (95% CI: 7.6-8.5) mō te PFS me te OS. Ko te PFS toharite he 6.8 marama (95% CI: 2.8-7.5), ā, kāore i eke ki te OS toharite me ngā huihuinga i puta i roto i te 36.8% o ngā tūroro.
I whakaatu hoki a IBI343 i te haumaru pai rawa atu
I roto i ngā tūroro katoa e pāngia ana e te adenocarcinoma G/GEJ (n=116, tae atu ki te 8 tūroro e pāngia ana e te matepukupuku puku mai i te wāhanga whakanui horopeta), 66.4% o ngā tūroro (77/116) he ≥3 ngā TEAE. Ko ngā TEAE ≥3 ngā TEAE tino kitea (≥35%) ko te hekenga o te maha o ngā neutrophil (28.4%), te hekenga o te maha o ngā pūtau toto mā (25.9%), me te anemia (16.4%). He iti noa iho ngā pānga kino o te puku ≥3, tae atu ki te 1.7% noa iho o te whakapairuaki ≥3. Kāore i pūrongohia he mate pūkahukahu interstitial o tētahi momo. I whakaitihia te paitini e pā ana ki te maimoatanga mā te maimoatanga tautoko e tika ana, ā, i taea te whakamanawanui i te haumaru whānui.
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
Īmēra：myimmnet@163.com
Wā tuku: Hurae-22-2025