Ka Whakaatuhia e Abbisko Therapeutics ngā Hua Whai Hua me te Haumaru mō te Wā Roa mai i te Rangahau MANEUVER Wāhanga III o Pimicotinib i te Hui-ā-Tau a CTOS 2025

I te 17 o Noema, 2025, i pānuitia e Abbisko te whakaaturanga o te whai huatanga mō te wā roa, te haumaru me ngā putanga i pūrongohia e te tūroro mai i te rangahau MANEUVER Wāhanga III o te ao mō te pimicotinib (ABSK021) i roto i ngā tūroro he pukupuku pūtau nui tenosynovial (TGCT) i te Hui-ā-Tau a te Connective Tissue Oncology Society (CTOS) 2025.

He rongoā hou, ā-waha, he tino whiriwhiri, he kaha hoki te Pimicotinib, he aukati CSF-1R ngota iti, i whakawhanakehia motuhaketia e Abbisko Therapeutics. Ko te rangahau MANEUVER he whakamātautau haumanu Wāhanga III ā-ao, maha-pokapū, matapōkeretia, matapo-rua, e whakahaerehia ana e te placebo, e toru ngā wāhanga, i hangaia hei aromatawai i te whai huatanga me te haumaru o te pimicotinib i roto i ngā tūroro me te TGCT. I tutuki te pito tuatahi me ngā pito tuarua matua katoa i te Wāhanga 1 i te wiki 25, ā, i whakaaturia ngā hua e rite ana i te Hui-ā-Tau a te American Society of Clinical Oncology (ASCO) 2025. Ko te pito tuatahi ko te reiti urupare whāinga (ORR) i te mutunga o te Wāhanga 1, e ai ki te aromatawai a te komiti arotake matapo motuhake (BIRC) ia RECIST v1.1. I te Wiki 25, i whakaatu te pimicotinib i te whakapainga nui o te ORR ki te placebo i te Wiki 25 (54.0% vs 3.2%, P <0.0001).

Ko ngā putanga i whakaaturia i te Hui-ā-Tau a te CTOS 2025 ko ngā raraunga whai huatanga me te haumaru mō te wā roa mai i te otinga o te Wāhanga 2 o te rangahau MANEUVER. Me te roanga o te aroturukitanga toharite o te 14.3 marama, i whakaatuhia e ngā tūroro i whiwhi pimicotinib mai i te tīmatanga o te rangahau he urupare pukupuku pakari me te roa. I piki ake te ORR e te komiti arotake motuhake matapo (BIRC) mō ia RECIST v1.1 mai i te 54% i te wiki 25 ki te 76.2% (95% CI: 63.8, 86.0), me te whā o ngā tūroro i tutuki te urupare katoa.

I taua wā anō, i whakaatuhia hoki e te rangahau he whakapainga haumanu tonu i roto i ngā aromatawai putanga haumanu (COA) e pā ana ki te kounga o te oranga o ngā tūroro TGCT, tae atu ki te whānuitanga o te nekehanga, te pakari, te mamae, me te mahi tinana. I whakaatuhia hoki e te pānui ngā painga kounga o te oranga (QoL) i aromatawaitia e te tauine tirohanga EQ-5D-5L (VAS). Ko ngā tūroro e whiwhi ana i te maimoatanga pimicotinib i whakaatu i te whakapainga QoL toharite o te 7.4% mai i te turanga i te Wiki 25, i piki ake ki te 13.1% i te Wiki 73.

Hei tāpiritanga, ko ngā tūroro i tuatahitia ki te rōpū placebo i te Wāhanga 1, ā, i muri mai ka huri ki te pimicotinib i te Wāhanga 2, i whiwhi i ngā painga haumanu, i te whakatutuki i te ORR o te 64.5% i te wā aroturuki toharite o te 8.5 marama, me ngā whakapainga nui i roto i ngā COA.

Mō te haumaru, i noho teitei tonu te kaha o te horopeta toharite ki te 88.2% i te wā o te maimoatanga. Ko te nuinga o ngā pānga kino i puta mai i te maimoatanga (TEAE) he Tau 1–2. Kāore i kitea he tohu haumaru hou, ā, kāore he taunakitanga o te paitini ki te ate, te whara o te ate i puta mai i te rongoā, te ngoikore rānei o te huruhuru/kiri.

He mea nui kia mōhiotia i te Huihuinga a te Rōpū Pākehā mō te Matepukupuku Hauora (ESMO) 2025 i tū i te marama o Oketopa o tēnei tau, i whakaatuhia e Ahorangi Xiaohui Niu o te Hōhipera Jishuitan o Beijing, te kairangahau matua (PI) o te rangahau MANEUVER, ēnei kitenga rangahau nui i roto i tētahi whakaaturanga ā-waha.

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: Whiringa-ā-rangi 18-2025