I te 31 o Poutū-te-rangi, 2025, i panuitia e Innovent Biologics kua whakawhiwhia e te Center for Drug Assessment (CDE) o te National Medical Products Administration (NMPA) te Breakthrough Therapy Designation (BTD) mō IBI363, he pūmua whakakotahitanga paturopi PD-1/IL-2α-bias bispecific tuatahi o te karaehe, hei monotherapy mō te maimoatanga o te melanoma mucosal, acral rānei kua horapa ā-rohe, kāore anō kia whiwhi i te rongoā pūnaha i mua.
Mō IBI363 (Te pūmua whakakotahitanga paturopi 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 i 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 o IBI363 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 kua piki haere te mate. Kua tīmatahia te rangahau matua tuatahi o IBI363, mō te maimoatanga o te melanoma mucosal, acral rānei kāore anō kia puta i te IO.
Hei tāpiritanga, kua whiwhi a IBI363 i ngā tohu ara tere e rua (FTD) mai i te US FDA, mō te maimoatanga o te melanoma me te squamous NSCLC. Kua whiwhi hoki a IBI363 i te tohu whakaora hou mai i te NMPA o Haina mō te maimoatanga o te melanoma.
I te Hui-ā-Tau ASCO 2024, ka whakaatuhia e Innovent ngā Raraunga Hauora Wāhanga 1 o te Pūmua Whakakotahitanga Antibody Bispecific PD-1/IL-2α Tuatahi o te Karaehe (IBI363) i roto i te Melanoma.
E 67 ngā tāngata whai mate pukupuku melanoma kua horapa ki te rohe, kāore i eke ki te taumata teitei, kāore rānei i aro ki te maimoatanga paerewa, i whakaurua, ā, i whiwhi i te IBI363 mā te uaua i ngā taumata horopeta i waenga i te 100 μg/kg QW me te 2 mg/kg Q3W. 89.6% o ngā tāngata whai mate ārai mate kua whiwhi i mua i te rongoā ārai mate, ā, 61.2% o ngā tāngata whai ≥ 2 rārangi rongoā pūnaha o mua. 25.4% o ngā tāngata whai mate pukupuku ate taketake, ā, 70.1% o ngā tāngata whai mate kiri-waewae, kiri-waha rānei.
I te 11 o Hānuere, 2024, e 57 ngā tāngata i arotakengia te iti rawa i te 1 te pukupuku i muri i te tīmatanga. Ko te urupare whānui pai rawa atu ko te urupare katoa (CR) i roto i te 1 tāngata, te urupare wāhanga (PR) i roto i te 15 tāngata. Ko te reiti urupare whānui (ORR) he 28.1% (95%CI: 17.0-41.5) ā, ko te DCR he 71.9% (95%CI: 58.5-83.0). I roto i te 25 ngā tāngata i rongoatia ki te immunotherapy (IO) i roto i te rōpū horopeta 1mg/kg Q2W (n=25), ko te ORR he 32.0% (95%CI: 14.9-53.5), ko te DCR he 80.0% (95%CI: 59.3-93.2).
Mō te haumaru, 16 (23.9%) ngā tāngata i pāngia e ngā pānga kino ohorere o te maimoatanga (TEAE) taumata ≥3. Ko ngā TEAE tino kitea ko te mamae o te hononga (34.3%), te hyperthyroidism (29.9%), me te anemia (25.4%). Ko ngā pānga kino e pā ana ki te ārai mate (irAE) taumata ≥3 i puta i roto i te 8 (11.9%) tāngata. Kāore he TRAE i mate ai.
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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Wā tuku: Paenga-whāwhā-01-2025