I te 17 o Pēpuere, 2025, i panuitia e Innovent Biologics kua whiwhi tana pūmua whakakotahitanga paturopi bispecific PD-1/IL-2α-bias tuatahi o te karaehe, IBI363, i tana Tohu Ara Tere tuarua (FTD) mai i te US Food and Drug Administration (FDA). E pā ana tēnei tohu ki te maimoatanga o te mate pukupuku pūkahukahu kore-pūtau iti kāore e taea te tango, kua whanake ā-rohe, kua horapa rānei (sqNSCLC) kua whanake haere i muri i te rongoā aukati ārai mate anti-PD-(L)1 me te chemotherapy e hangai ana ki te platinum. Kua whakaatuhia e IBI363 te whai huatanga me te haumaru whakatenatena puta noa i ngā momo pukupuku totoka maha. I tēnei wā, kei te whakahaerehia e Innovent ngā whakamātautau haumanu Wāhanga 1/2 o IBI363 i Haina me te US, ko te nuinga i Haina me te US.
Ko te Whakatūnga Ara Tere (FTD) he tukanga whakahaere i hangaia hei whakateretere i te whanaketanga haumanu me te arotake i ngā rongoā hei rongoā i ngā āhuatanga kino me te aro atu ki ngā hiahia hauora kāore anō kia tutuki. Ko ngā rongoā kua whakawhiwhia ki te FTD ka whai hua mai i te whakapiki ake i te whakawhitiwhiti kōrero ki te FDA puta noa i te whanaketanga rongoā i muri mai, ka tere ake pea te whanaketanga haumanu me te tukanga whakaae.
Mō IBI363 (Te pūmua whakakotahitanga paturopi bispecific PD-1/IL-2α-bias tuatahi o te akomanga))
Ko te IBI363 te rongoā tuatahi o te akomanga i whakawhanakehia motuhaketia e Innovent Biologics. He pūmua whakakotahi paturopi takirua PD-1/IL-2 i hangaia hei whakarei ake i te whai huatanga me te whakaiti i te paitini. Kua hangaia te ringa IL-2 o IBI363 hei arotau i ngā pānga rongoā me te whakaiti i ngā pānga taha, ko te ringa here PD-1 ka taea te aukati i te PD-1 me te tuku IL-2 whiriwhiri. Mā te aukati i te ara PD-1/PD-L1 me te whakahohe i te ara IL-2 i te wā kotahi, ka āwhina a IBI363 i te arotahi me te whakahohe tika ake me te whai hua o ngā pūtau-T motuhake ki te pukupuku. Kua whakaatuhia e ngā rangahau haumanu-mua he kaha te mahi ārai-pukupuku a IBI363 puta noa i ngā tauira rongoā maha e mau ana i te pukupuku, tae atu ki ngā mea e ātete ana ki ngā aukati PD-1 me ngā tauira metastatic. Hei tāpiri, kua whakaatuhia he kōtaha haumaru pai i roto i ngā tauira haumanu-mua. Kei te haere tonu ngā whakamātautau haumanu i Haina, i te Hononga o Amerika, me Ahitereiria hei aromatawai i tōna haumaru, tōna manawanui me tōna whai huatanga tuatahi i roto i ngā tāngata he mate pukupuku matatau.
I te Huihuinga o te Ao mō te Mate Pukupuku Pūkahukahu (WCLC) i te marama o Hepetema 2024, i whakaatu a IBI363 i ngā tohu whai huatanga whakapūmau i roto i ngā tūroro sqNSCLC kua whiwhi i te rongoā ārai mate i mua:
I roto i te rōpū horopeta 3 mg/kg, i roto i ngā tūroro kua 12 wiki te roa o te aroturukitanga, kua oti rānei te rangahau (n=18), ko te reiti urupare whāinga (ORR) he 50.0%, ā, ko te reiti whakahaere mate (DCR) he 88.9%. Kāore anō kia tutuki te oranga kore-haere-ake toharite (PFS) ā, kei te aroturukitia tonutia.
I roto i te rōpū horopeta 1/1.5 mg/kg, ko te PFS toharite he 5.5 marama (95% CI: 1.5, 8.3), me te reiti PFS 12-marama o te 30.7%, e whakaatu ana i ngā painga roa pea o te immunotherapy.
I roto i ngā rōpū horopeta 1/1.5/3 mg/kg, i tutuki i ngā tūroro he PD-L1 TPS<1% (n=22) me te hunga he PD-L1 TPS≥1% (n=22) ngā ORR whakatenatena o te 36.4% me te 31.8%, ia, e whakaatu ana i te painga pea o IBI363 i roto i ngā taupori iti-whakapuakitanga PD-L1.
Mō te Matepukupuku Pūkahukahu Kore-Pūtau Iti (sqNSCLC)
Ko te mate pukupuku pūkahukahu te mate pukupuku tino noa me te tino whakamate o te ao, tae atu ki Haina[1], he wero nui ki te hauora tūmatanui. Neke atu i te 80% o ngā mate pukupuku pūkahukahu katoa te mate pukupuku pūkahukahu kore-pūtau iti (NSCLC)[2], ko te mate pukupuku pūtau squamous tētahi o ōna momo matua e rua[2]. I ngā tau tata nei, kua hurihia e ngā aukati ārai mate te whenua maimoatanga mō te NSCLC. Heoi, mō ngā tūroro he NSCLC kua rahua te rongoā ārai mate, ā, kāore he whakarerekētanga ira taraiwa, kei te noho tonu he hiahia nui me te tere mō ngā kōwhiringa maimoatanga whai hua. Ko te maimoatanga raina tuarua, tuatoru rānei paerewa, ko te docetaxel, he iti noa te whai huatanga, me te oranga kore-haere whakamua (PFS) toharite iti iho i te whā marama[3],[4]. Ahakoa kua whakaatu ngā hononga rongoā-antibody (ADC) i te tumanako, e rua ngā rangahau Wāhanga 3 nui i roto i te NSCLC squamous kāore anō kia whakaatu i te whai huatanga pai.
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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Te wā tuku: 20-Pepuere-2025