Ma Nowemapa 17, 2025, ua hoʻolaha ʻo Abbisko i ka hōʻike ʻana o ka hopena lōʻihi, ka palekana a me nā hopena i hōʻike ʻia e ka mea maʻi mai ka noiʻi honua Phase III MANEUVER o pimicotinib (ABSK021) i nā poʻe maʻi me ka tenosynovial giant cell tumor (TGCT) ma ka Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting.
He mea hoʻopaʻa waha, koho nui, a ikaika hoʻi ʻo Pimicotinib i hoʻomohala kūʻokoʻa ʻia e Abbisko Therapeutics. ʻO ke aʻo ʻana ʻo MANEUVER he hoʻokolohua lapaʻau Phase III honua, multicenter, randomized, double-blind, placebo-controlled Phase III i hoʻokumu ʻia i ʻekolu ʻāpana, i hoʻolālā ʻia e loiloi i ka pono a me ka palekana o ka pimicotinib i nā poʻe maʻi me TGCT. Ua hālāwai ʻia ke kiko hope mua a me nā kiko hope lua koʻikoʻi āpau ma ka Māhele 1 ma ka pule 25, a ua hōʻike ʻia nā hopena pili i ka 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. ʻO ke kiko hope mua ka helu pane pahuhopu (ORR) ma ka hopena o ka Māhele 1, e like me ka loiloi ʻana e ke kōmike loiloi kūʻokoʻa makapō (BIRC) e like me RECIST v1.1. Ma ka Pule 25, ua hōʻike ʻo pimicotinib i kahi hoʻomaikaʻi koʻikoʻi ma ka ORR i hoʻohālikelike ʻia me ka placebo ma ka Pule 25 (54.0% vs 3.2%, P <0.0001).
ʻO nā hopena i hōʻike ʻia ma ka Hālāwai Makahiki CTOS 2025 ʻo ia ka ʻikepili pono a me ka palekana lōʻihi mai ka hoʻopau ʻana o ka Māhele 2 o ke aʻo ʻana MANEUVER. Me ka nānā ʻana ma waena o 14.3 mau mahina, ua hōʻike nā maʻi i loaʻa ka pimicotinib mai ka hoʻomaka ʻana o ke aʻo ʻana i nā pane puʻupuʻu ikaika a paʻa. Ua piʻi ka ORR e ke kōmike loiloi kūʻokoʻa makapō (BIRC) no RECIST v1.1 mai 54% ma ka pule 25 a i 76.2% (95% CI: 63.8, 86.0), me ʻehā mau maʻi i loaʻa ka pane piha.
I kēia manawa, ua hōʻike pū ka haʻawina i ka hoʻomau ʻana o nā hoʻomaikaʻi koʻikoʻi i nā loiloi hopena lapaʻau (COAs) e pili ana i ke ʻano o ke ola o nā maʻi TGCT, me ka laulā o ka neʻe ʻana, ka ʻoʻoleʻa, ka ʻeha, a me ka hana kino. Ua hōʻike pū ka mea hoʻolaha i nā pono o ke ola (QoL) i loiloi ʻia e ka EQ-5D-5L visual analog scale (VAS). Ua hōʻike nā maʻi e loaʻa ana i ka lāʻau pimicotinib i ka awelika o ka hoʻomaikaʻi ʻana o QoL o 7.4% mai ka baseline ma ka Pule 25, kahi i hoʻonui hou ʻia i 13.1% ma ka Pule 73.
Eia kekahi, ʻo nā maʻi i hoʻokaʻawale mua ʻia i ka lima placebo ma ka Māhele 1 a ma hope ua hoʻololi i ka pimicotinib ma ka Māhele 2 ua loaʻa pū kekahi pono lapaʻau, e hoʻokō ana i kahi ORR o 64.5% ma kahi hahai waena o 8.5 mau mahina, me nā hoʻomaikaʻi koʻikoʻi i nā COA.
Ma ke ʻano o ka palekana, ua mau ke kiʻekiʻe o ka nui o ka lāʻau lapaʻau ma 88.2% i ka wā o ka mālama ʻana. ʻO ka hapa nui o nā hanana ʻino e kū mai ana i ka mālama ʻana (TEAEs) he Papa 1-2. ʻAʻohe hōʻailona palekana hou i ʻike ʻia, a ʻaʻohe hōʻike o ka cholestatic hepatotoxicity, ka hōʻeha ʻana o ke akepaʻa i hoʻokomo ʻia e ka lāʻau lapaʻau, a i ʻole ka hypopigmentation o ka lauoho/ʻili.
He mea kūpono ia e hoʻomaopopo ʻia ma ka ʻAhaʻōlelo ʻEulopa no ka ʻOihana Lapaʻau Oncology (ESMO) 2025 i mālama ʻia i ʻOkakopa o kēia makahiki, ua hōʻike ʻo Polofesa Xiaohui Niu mai ka Halemai ʻo Beijing Jishuitan, ke alakaʻi nui o ka noiʻi MANEUVER, i kēia mau ʻike noiʻi koʻikoʻi ma kahi hōʻike waha.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
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Ka manawa hoʻouna: Nov-18-2025