Noofambar 17, 2025, Abbisko wuxuu ku dhawaaqay soo bandhigidda saameynta muddada dheer, badbaadada iyo natiijooyinka bukaanka laga soo sheegay daraasadda caalamiga ah ee MENUVER ee wejiga saddexaad ee pimicotinib (ABSK021) ee bukaanada qaba burooyinka unugyada waaweyn ee tenosynovial (TGCT) ee Shirka Sannadlaha ah ee Bulshada Oncology ee Connective Tissue (CTOS) 2025.
Pimicotinib waa daawo cusub oo afka laga qaato, aad loo soo xulay, oo awood badan leh oo ka hortagta unugyada yaryar ee CSF-1R oo si madax-bannaan loo sameeyay oo ay samaysay Abbisko Therapeutics. Daraasadda MANEUVER waa tijaabo caafimaad oo heer caalami ah, oo xarun badan leh, aan kala sooc lahayn, indho-la'aan ah, oo placebo-lagu xakameeyay oo ka kooban saddex qaybood, oo loogu talagalay in lagu qiimeeyo waxtarka iyo badbaadada pimicotinib ee bukaanada qaba TGCT. Dhibcaha ugu horreeya iyo dhammaan dhibcaha ugu dambeeya ee labaad ee muhiimka ah ayaa lagu soo bandhigay Qaybta 1 toddobaadka 25, natiijooyinka u dhigmana waxaa lagu soo bandhigay Shirka Sannadlaha ah ee Bulshada Mareykanka ee Kansarka Kiliinikada (ASCO) ee 2025. Dhibcaha ugu horreeya waa heerka jawaabta ujeeddada leh (ORR) dhammaadka Qaybta 1, sida ay qiimeeyeen guddiga dib u eegista madax-bannaan ee indho-la'aanta ah (BIRC) halkii RECIST v1.1. Toddobaadka 25, pimicotinib wuxuu muujiyay horumar tirakoob ahaan muhiim ah oo ku yimid ORR marka la barbar dhigo placebo toddobaadka 25 (54.0% vs 3.2%, P＜0.0001).
Natiijooyinka lagu soo bandhigay Shir-sannadeedka CTOS 2025 waxay ahaayeen xog waxtar leh iyo badbaado muddo dheer ah laga soo bilaabo dhammaystirka Qaybta 2aad ee daraasadda MANEUVER. Iyada oo la raacayo celcelis ahaan 14.3 bilood, bukaannada qaatay pimicotinib bilowgii daraasadda waxay muujiyeen jawaab celin buro oo adag oo waara. ORR-ka ay sameeyeen guddiga dib-u-eegista madaxa-bannaan ee indhoolayaasha ah (BIRC) halkii RECIST v1.1 ayaa ka kordhay 54% usbuucii 25 ilaa 76.2% (95% CI: 63.8, 86.0), iyadoo afar bukaan ay gaareen jawaab dhammaystiran.
Dhanka kale, daraasaddu waxay sidoo kale muujisay horumarro joogto ah oo macno leh oo ku yimid qiimaynta natiijooyinka kiliinikada (COAs) ee la xiriira tayada nolosha bukaanada TGCT, oo ay ku jiraan kala duwanaanshaha dhaqdhaqaaqa, adkaanta, xanuunka, iyo shaqada jirka. Boodhadhku wuxuu sidoo kale soo bandhigay faa'iidooyinka tayada nolosha (QoL) oo lagu qiimeeyay miisaanka analoogga muuqaalka EQ-5D-5L (VAS). Bukaannada qaata daaweynta pimicotinib waxay muujiyeen horumar celcelis ahaan QoL ah oo ah 7.4% laga bilaabo bilowga Toddobaadka 25, kaas oo sii kordhay ilaa 13.1% Toddobaadka 73.
Intaa waxaa dheer, bukaanada markii hore lagu kala soocay gacanta placebo ee Qaybta 1aad ka dibna loo beddelay pimicotinib Qaybta 2aad ayaa sidoo kale helay faa'iido caafimaad, iyagoo gaaray ORR ah 64.5% dabagal dhexdhexaad ah oo ah 8.5 bilood, oo ay weheliso horumar la taaban karo oo ku yimid COA-yada.
Marka laga hadlayo badbaadada, qiyaasta dhexdhexaadka ah ee qiyaasta ayaa weli sarreysa 88.2% inta lagu jiro daaweynta. Inta badan dhacdooyinka xun ee daaweynta-soo-baxa (TEAEs) waxay ahaayeen Fasalka 1-2. Lama arag calaamado badbaado oo cusub, mana jirin wax caddayn ah oo muujinaya sunta beerka ee kolestaroolka, dhaawaca beerka ee daroogada, ama midabka timaha/maqaarka oo yaraada.
Waxaa xusid mudan in shirkii Ururka Yurub ee Caafimaadka Kansarka (ESMO) ee 2025 ee la qabtay bishii Oktoobar ee sanadkan, Professor Xiaohui Niu oo ka socda Isbitaalka Beijing Jishuitan, oo ah baaraha ugu sareeya (PI) ee daraasadda MENUEVER, uu ku soo bandhigay natiijooyinkan cilmi-baarista ee muhiimka ah bandhig afka ah.
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
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Waqtiga boostada: Noofambar-18-2025