Abbisko Therapeutics Ikupereka Zotsatira Zachitetezo ndi Kugwira Ntchito Kwa Nthawi Yaitali Kuchokera ku Kafukufuku wa Gawo Lachitatu la MANEUVER wa Pimicotinib pa Msonkhano Wapachaka wa CTOS 2025

Pa 17 Novembala, 2025, Abbisko adalengeza za chiwonetsero cha nthawi yayitali cha mphamvu, chitetezo ndi zotsatira zomwe odwala adazipeza kuchokera ku kafukufuku wapadziko lonse wa Phase III MANEUVER wa pimicotinib (ABSK021) mwa odwala omwe ali ndi tenosynovial giant cell tumor (TGCT) pa Msonkhano Wapachaka wa Connective Tissue Oncology Society (CTOS) 2025.

Pimicotinib ndi mankhwala atsopano, omwa, osankha kwambiri, komanso amphamvu a CSF-1R oletsa mamolekyulu ang'onoang'ono omwe adapangidwa paokha ndi Abbisko Therapeutics. Kafukufuku wa MANEUVER ndi mayeso azachipatala apadziko lonse lapansi, apakati, osasankhidwa, akhungu awiri, olamulidwa ndi placebo Phase III omwe ali ndi magawo atatu, opangidwa kuti awone momwe pimicotinib imagwirira ntchito komanso chitetezo cha odwala omwe ali ndi TGCT. Mapeto oyamba ndi mapeto onse ofunikira achiwiri adakwaniritsidwa mu Gawo 1 pa sabata 25, ndipo zotsatira zofananazo zidaperekedwa pa Msonkhano Wapachaka wa 2025 wa American Society of Clinical Oncology (ASCO). Mapeto oyamba ndi ofunikira poyankha (ORR) kumapeto kwa Gawo 1, monga momwe adawunikira ndi komiti yowunikira yodziyimira payokha (BIRC) pa RECIST v1.1. Pa Sabata 25, pimicotinib idawonetsa kusintha kwakukulu mu ORR poyerekeza ndi placebo pa Sabata 25 (54.0% vs 3.2%, P<0.0001).

Zotsatira zomwe zinaperekedwa pa Msonkhano Wapachaka wa CTOS 2025 zinali deta ya nthawi yayitali yogwira ntchito bwino komanso chitetezo kuyambira pomwe Gawo Lachiwiri la kafukufuku wa MANEUVER linamalizidwa. Ndi kutsatiridwa kwapakati kwa miyezi 14.3, odwala omwe adalandira pimicotinib kuyambira pachiyambi cha kafukufukuyu adawonetsa mayankho olimba komanso okhazikika a chotupa. ORR ndi komiti yowunikira yodziyimira payokha (BIRC) pa RECIST v1.1 idakwera kuchoka pa 54% pa sabata la 25 kufika pa 76.2% (95% CI: 63.8, 86.0), pomwe odwala anayi adalandira yankho lathunthu.

Pakadali pano, kafukufukuyu adawonetsanso kusintha kwapadera kwachipatala mu mayeso azachipatala (COAs) okhudzana ndi moyo wa odwala a TGCT, kuphatikizapo kuyenda, kuuma, kupweteka, ndi magwiridwe antchito amthupi. Chithunzicho chidawonetsanso maubwino a moyo (QoL) omwe adayesedwa ndi EQ-5D-5L visual analog scale (VAS). Odwala omwe amalandira chithandizo cha pimicotinib adawonetsa kusintha kwapakati pa QoL kwa 7.4% kuchokera pa chiyambi pa Sabata 25, komwe kudakweranso kufika pa 13.1% pa Sabata 73.

Kuphatikiza apo, odwala omwe poyamba adapatsidwa mankhwala a placebo mwachisawawa mu Gawo 1 kenako nkusintha kupita ku pimicotinib mu Gawo 2 adapezanso phindu lachipatala, zomwe zidapeza ORR ya 64.5% pakuwunika kwapakati kwa miyezi 8.5, komanso kusintha kwakukulu kwa COAs.

Ponena za chitetezo, mphamvu yapakati ya mlingo inalibe yokwera pa 88.2% panthawi ya chithandizo. Zochitika zambiri zoyipa zomwe zimachitika mwadzidzidzi (TEAEs) zinali za Giredi 1-2. Palibe zizindikiro zatsopano zachitetezo zomwe zinawonedwa, ndipo panalibe umboni wa poizoni wa chiwindi, kuvulala kwa chiwindi chifukwa cha mankhwala, kapena kuchepa kwa pigmentation ya tsitsi/khungu.

N'zochititsa chidwi kuti pa msonkhano wa European Society for Medical Oncology (ESMO) Congress 2025 womwe unachitika mu Okutobala chaka chino, Pulofesa Xiaohui Niu wochokera ku Beijing Jishuitan Hospital, wofufuza wamkulu (PI) wa kafukufuku wa MANEUVER, adapereka zomwe zapezeka pa kafukufukuyu pakamwa.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

Nambala ya Foni: 4008803716

Chizindikiro cha WeChat: 17801183037

Email ①：myimmnet@163.com

Email ②：100085_010@163.com