Ngomhlaka-17 Novemba 2025, u-Abbisko wamemezela isethulo sephosta sokusebenza kahle kwesikhathi eside, ukuphepha kanye nemiphumela ebikwe yiziguli evela ocwaningweni lomhlaba wonke lweSigaba III se-MANEUVER se-pimicotinib (ABSK021) ezigulini ezine-tenosynovial giant cell tumor (TGCT) eMhlanganweni Waminyaka Yonke we-Connective Tissue Oncology Society (CTOS) ka-2025.
I-Pimicotinib iyi-inhibitor entsha, yomlomo, ekhetha kakhulu, futhi enamandla ye-CSF-1R yama-molecule amancane ethuthukiswe ngokuzimela yi-Abbisko Therapeutics. Ucwaningo lwe-MANEUVER luyisilingo somtholampilo seSigaba III somhlaba wonke, esinama-multicenter, esingahleliwe, esingaboni kabili, esilawulwa yi-placebo esiqukethe izingxenye ezintathu, ezenzelwe ukuhlola ukusebenza kahle nokuphepha kwe-pimicotinib ezigulini ezine-TGCT. I-endpoint eyinhloko kanye nazo zonke i-endpoints zesibili ezibalulekile zahlangatshezwa eNgxenyeni 1 ngesonto lama-25, futhi imiphumela ehambisanayo yethulwe eMhlanganweni Waminyaka Yonke we-American Society of Clinical Oncology (ASCO) ka-2025. I-endpoint eyinhloko yi-objective response rate (ORR) ekupheleni kweNgxenye 1, njengoba kuhlolwe yikomidi lokubuyekeza elizimele eliyi-blind (BIRC) ngokwe-RECIST v1.1. Ngeviki lama-25, i-pimicotinib ibonise ukuthuthuka okuphawulekayo kwezibalo ku-ORR uma kuqhathaniswa ne-placebo ngeviki lama-25 (54.0% vs 3.2%, P<0.0001).
Imiphumela eyethulwe eMhlanganweni Waminyaka Yonke we-CTOS ka-2025 kwakuyidatha yokusebenza kahle nokuphepha kwesikhathi eside kusukela ekuqedweni kweNgxenye 2 yocwaningo lwe-MANEUVER. Ngokulandela okuphakathi kwezinyanga ezingu-14.3, iziguli ezazithole i-pimicotinib kusukela ekuqaleni kocwaningo zibonise izimpendulo eziqinile nezihlala isikhathi eside zomdlavuza. I-ORR yikomidi lokubuyekeza elizimele eliyimpumputhe (BIRC) nge-RECIST v1.1 ikhuphuke isuka ku-54% ngesonto lama-25 yaya ku-76.2% (95% CI: 63.8, 86.0), lapho iziguli ezine zithola impendulo ephelele.
Okwamanje, ucwaningo luphinde lwabonisa ukuthuthuka okuqhubekayo okubalulekile emtholampilo ekuhlolweni kwemiphumela yezokwelapha (ii-COA) okuhlobene nekhwalithi yokuphila kweziguli ze-TGCT, okuhlanganisa ububanzi bokunyakaza, ukuqina, ubuhlungu, kanye nokusebenza ngokomzimba. Iphosta iphinde yaveza izinzuzo zekhwalithi yokuphila (ii-QoL) ezihlolwe nge-EQ-5D-5L visual analog scale (i-VAS). Iziguli ezithola ukwelashwa kwe-pimicotinib zibonise ukuthuthuka okumaphakathi kwe-QoL okungu-7.4% kusukela ekuqaleni kweviki lama-25, okwakhula kakhulu kwaya ku-13.1% ngeviki lama-73.
Ngaphezu kwalokho, iziguli ezaqala ngokuzenzakalelayo zasebenzisa i-placebo engalweni ku-Ingxenye 1 futhi kamuva zashintshela ku-pimicotinib ku-Ingxenye 2 nazo zithole izinzuzo zomtholampilo, zathola i-ORR engu-64.5% ekulandeleni okuphakathi kwezinyanga ezingu-8.5, kanye nentuthuko ephawulekayo kuma-COA.
Ngokuphathelene nokuphepha, ukuqina komthamo omaphakathi kwahlala kuphezulu ku-88.2% ngesikhathi sokwelashwa. Iningi lezehlakalo ezimbi ezivele ngokushesha (ama-TEAE) zaziyibanga 1-2. Azikho izimpawu ezintsha zokuphepha ezibonwe, futhi akukho bufakazi bokuthi isibindi sinobuthi, ukulimala kwesibindi okubangelwa izidakamizwa, noma ukuncipha kombala wezinwele/isikhumba.
Kuyaphawuleka ukuthi eNgqungqutheleni ye-European Society for Medical Oncology (ESMO) ka-2025 ebibanjwe ngo-Okthoba kulo nyaka, uSolwazi Xiaohui Niu waseBeijing Jishuitan Hospital, umphenyi oyinhloko ohamba phambili (PI) wesifundo se-MANEUVER, wethule le miphumela ebalulekile yocwaningo ekwethulweni ngomlomo.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
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Isikhathi sokuthunyelwe: Novemba-18-2025