Na Nọvemba 17, 2025, Abbisko kwupụtara ngosipụta nke arụmọrụ ogologo oge, nchekwa na nsonaazụ ndị ọrịa kọrọ site na ọmụmụ zuru ụwa ọnụ nke Phase III MENUEVER nke pimicotinib (ABSK021) na ndị ọrịa nwere tenosynovial giant cell tumor (TGCT) na Nzukọ Kwa Afọ nke Connective Tissue Oncology Society (CTOS) 2025.
Pimicotinib bụ ọgwụ mgbochi CSF-1R ọhụrụ, nke a na-anụ n'ọnụ, nke a na-ahọrọ nke ọma, ma dịkwa ike nke Abbisko Therapeutics mepụtara n'onwe ya. Ọmụmụ ihe MANEUVER bụ nnwale ahụike zuru ụwa ọnụ, nke nwere ọtụtụ etiti, nke a na-agbanweghị agbanwe, nke a na-achịkwa nke ọma, nke nwere akụkụ atọ, nke e mere iji nyochaa irè na nchekwa nke pimicotinib na ndị ọrịa nwere TGCT. E mezuru isi njedebe mbụ na isi njedebe nke abụọ niile na Nkebi nke 1 na izu 25, e gosipụtakwara nsonaazụ ndị kwekọrọ na ya na Nzukọ Kwa Afọ nke American Society of Clinical Oncology (ASCO) nke 2025. Isi njedebe bụ ọnụego nzaghachi ebumnuche (ORR) na njedebe nke Nkebi nke 1, dịka kọmitii nyocha onwe onye kpuru ìsì (BIRC) nyochachara site na RECIST v1.1 kwa. Na Izu 25, pimicotinib gosipụtara mmụba dị ukwuu na ORR ma e jiri ya tụnyere placebo na Izu 25 (54.0% vs 3.2%, P＜0.0001).
Nsonaazụ e gosipụtara na Nzukọ Kwa Afọ nke CTOS 2025 bụ data arụmọrụ ogologo oge na nchekwa site na mmecha nke Akụkụ nke 2 nke ọmụmụ MANEUVER. Site na nleba anya etiti nke ọnwa 14.3, ndị ọrịa natara pimicotinib site na mmalite ọmụmụ ihe ahụ gosipụtara mmeghachi omume etuto siri ike ma sie ike. ORR site na kọmitii nyocha onwe onye kpuru ìsì (BIRC) kwa RECIST v1.1 mụbara site na 54% na izu 25 ruo 76.2% (95% CI: 63.8, 86.0), ebe ndị ọrịa anọ nwetara nzaghachi zuru oke.
Ka ọ dịgodị, ọmụmụ ihe ahụ gosikwara mmụba dị mkpa n'ihe gbasara ahụike na nyocha nsonaazụ ahụike (COAs) metụtara ụdị ndụ ndị ọrịa TGCT, gụnyere oke mmegharị ahụ, isi ike, ihe mgbu, na ọrụ anụ ahụ. Akwụkwọ ozi ahụ gosikwara uru dị mma nke ndụ (QoL) nke a tụlere site na nha anya EQ-5D-5L (VAS). Ndị ọrịa natara ọgwụgwọ pimicotinib gosipụtara mmụba nke QoL nkezi nke 7.4% site na mmalite na Izu 25, nke mụbara ruo 13.1% na Izu 73.
Tinyere nke ahụ, ndị ọrịa e bu ụzọ tinye aka na placebo na Nkebi nke 1 wee gbanwee gaa na pimicotinib na Nkebi nke 2 nwetakwara uru ahụike, na-enweta ORR nke 64.5% na nyocha nke ọkara nke ọnwa 8.5, yana mmụba pụtara ìhè na COAs.
Maka nchekwa, oke ọgwụ ahụ nọgidere na-adị elu na 88.2% n'oge ọgwụgwọ ahụ. Ọtụtụ ihe omume ọjọọ ndị na-apụta n'ọgwụgwọ (TEAEs) bụ ọkwa nke 1–2. Ahụbeghị ihe mgbaàmà nchekwa ọhụrụ, enweghịkwa ihe akaebe nke cholestatic hepatotoxicity, mmerụ ahụ imeju nke ọgwụ kpatara, ma ọ bụ hypopigmentation ntutu/akpụkpọ ahụ.
Ọ dị mkpa ịmara na na European Society for Medical Oncology (ESMO) Congress nke afọ 2025 nke emere na Ọktoba afọ a, Prọfesọ Xiaohui Niu si na Beijing Jishuitan Hospital, onye bụ isi nyocha (PI) nke ọmụmụ MANEUVER, gosipụtara nchọpụta nchọpụta ndị a dị mkpa n'okwu ọnụ.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
Nọmba ekwentị: 4008803716
WeChat ID: 17801183037
Email ①：myimmnet@163.com
Email ②：100085_010@163.com
Oge ozi: Nọvemba-18-2025