Ngomhla we-17 kweyeNkanga, ngo-2025, u-Abbisko ubhengeze umboniso wepowusta wokusebenza kakuhle kwexesha elide, ukhuseleko kunye neziphumo ezixeliweyo zezigulana ezivela kwiSigaba sesiThathu se-MANEUVER sehlabathi jikelele se-pimicotinib (ABSK021) kwizigulane ezine-tenosynovial giant cell tumor (TGCT) kwiNtlanganiso yoNyaka ye-Connective Tissue Oncology Society (CTOS) ka-2025.
I-Pimicotinib yi-inhibitor entsha, yomlomo, ekhetha kakhulu, nenamandla ye-CSF-1R ye-molecule encinci eyenziwe ngokuzimeleyo yi-Abbisko Therapeutics. Uphononongo lwe-MANEUVER luvavanyo lweklinikhi lweSigaba III sehlabathi, oluneziko ezininzi, olucwangcisiweyo, olungaboni kabini, olulawulwa yi-placebo oluqulathe amacandelo amathathu, oluyilelwe ukuvavanya ukusebenza kakuhle kunye nokhuseleko lwe-pimicotinib kwizigulane ezine-TGCT. Isiphelo sokuqala kunye nazo zonke iisiphelo eziphambili zesibini zahlangatyezwa kwiCandelo loku-1 kwiveki yama-25, kwaye iziphumo ezihambelanayo zavezwa kwiNtlanganiso yoNyaka ye-American Society of Clinical Oncology (ASCO) ka-2025. Isiphelo sokuqala yi-objective response rate (ORR) ekupheleni kweCandelo loku-1, njengoko kuhlolwe yi-blind independent review committe (BIRC) ngokwe-RECIST v1.1. Kwiveki yama-25, i-pimicotinib ibonise ukuphucuka okubalulekileyo kwi-ORR xa kuthelekiswa ne-placebo kwiVeki yama-25 (54.0% vs 3.2%, P<0.0001).
Iziphumo ezivezwe kwiNtlanganiso yoNyaka ye-CTOS ka-2025 yayiziidatha zokusebenza kakuhle kunye nokhuseleko lwexesha elide ukususela ekugqityweni kweCandelo lesi-2 lophando lwe-MANEUVER. Ngokulandelela okuphakathi kweenyanga ezili-14.3, izigulane ezazifumene i-pimicotinib ukususela ekuqaleni kophando zibonise iimpendulo eziqinileyo nezihlala ixesha elide zesifo se-tumor. I-ORR yi-blind independent review committe (BIRC) ngokwe-RECIST v1.1 inyuke ukusuka kwi-54% kwiveki yama-25 ukuya kwi-76.2% (95% CI: 63.8, 86.0), kunye nezigulane ezine ezifumene impendulo epheleleyo.
Okwangoku, olu phononongo lukwabonise uphuculo oluqhubekayo olubalulekileyo lwezonyango kuvavanyo lweziphumo zeklinikhi (ii-COA) ezinxulumene nomgangatho wobomi bezigulane ze-TGCT, kubandakanya uluhlu lokuhamba, ukuqina, iintlungu, kunye nokusebenza komzimba. Ipowusta ikwabonise iingenelo zomgangatho wobomi (ii-QoL) ezivavanywe yi-EQ-5D-5L visual analog scale (i-VAS). Izigulana ezifumana unyango lwe-pimicotinib zibonise uphuculo oluphakathi lwe-QoL lwe-7.4% ukusuka ekuqaleni kwiVeki yama-25, oluye lwanda ngakumbi ukuya kwi-13.1% kwiVeki yama-73.
Ukongeza, izigulane ezaqala zanikwa i-placebo engalweni kwiCandelo loku-1 zaza emva koko zatshintshela kwi-pimicotinib kwiCandelo lesi-2 nazo zafumana inzuzo yeklinikhi, zafumana i-ORR engama-64.5% kulandelelwano oluphakathi lweenyanga ezi-8.5, kunye nophuculo olubonakalayo kwi-COAs.
Ngokuphathelele ukhuseleko, umlinganiselo wedosi ephakathi wahlala uphezulu kwi-88.2% ngexesha lonyango. Uninzi lweziganeko ezingalunganga ezivele emva konyango (ii-TEAE) zazikwiBanga loku-1 ukuya kwelesi-2. Akukho zimpawu zintsha zokhuseleko eziboniweyo, kwaye akukho bungqina bokuba i-cholestatic hepatotoxicity, ukwenzakala kwesibindi okubangelwa ngamayeza, okanye i-hypopigmentation yeenwele/ulusu.
Kuyaphawuleka ukuba kwiNgqungquthela ye-European Society for Medical Oncology (ESMO) ka-2025 ebibanjwe ngo-Okthobha kulo nyaka, uNjingalwazi uXiaohui Niu waseBeijing Jishuitan Hospital, umphandi oyintloko ophambili (PI) wophando lwe-MANEUVER, uveze ezi ziphumo zibalulekileyo zophando kwintetho yomlomo.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Ixesha leposi: Novemba-18-2025