A ranar 17 ga Nuwamba, 2025, Abbisko ya sanar da gabatar da sakamakon dogon lokaci na inganci, aminci da kuma sakamakon da marasa lafiya suka ruwaito daga binciken duniya na Phase III MENUVER na pimicotinib (ABSK021) na marasa lafiya da ke fama da ciwon tarin ƙwayoyin cuta na tenosynovial (TGCT) a taron shekara-shekara na Connective Tissue Oncology Society (CTOS) na 2025.
Pimicotinib wani sabon magani ne mai hana ƙwayoyin cuta na CSF-1R, wanda aka yi ta hanyar baki, mai zaɓe sosai, kuma mai ƙarfi wanda Abbisko Therapeutics suka samar da shi daban-daban. Binciken MANEUVER gwaji ne na asibiti na mataki na uku na duniya, mai cibiya da yawa, bazuwar, makafi biyu, wanda aka sarrafa shi ta hanyar placebo, wanda ya ƙunshi sassa uku, wanda aka tsara don kimanta inganci da amincin pimicotinib ga marasa lafiya da TGCT. An cimma babban magani da duk manyan maki na biyu a cikin Sashe na 1 a mako na 25, kuma an gabatar da sakamakon da ya dace a Taron Shekara-shekara na Ƙungiyar Kula da Cututtukan Cututtuka ta Amurka (ASCO) na 2025. Babban magani shine ƙimar amsawa ta haƙiƙa (ORR) a ƙarshen Sashe na 1, kamar yadda kwamitin bita mai zaman kansa na makafi (BIRC) ya tantance ta kowace RECIST v1.1. A Mako na 25, pimicotinib ya nuna ci gaba mai mahimmanci a cikin ORR idan aka kwatanta da placebo a Mako na 25 (54.0% vs 3.2%, P＜0.0001).
Sakamakon da aka gabatar a taron shekara-shekara na CTOS 2025 sune bayanai na tsawon lokaci da inganci da aminci daga kammala Sashe na 2 na binciken MENUEVER. Tare da matsakaicin bin diddigin watanni 14.3, marasa lafiya da suka karɓi pimicotinib tun daga farkon binciken sun nuna ƙarfin amsawar ƙari mai ɗorewa. ORR ta kwamitin bita mai zaman kansa (BIRC) ga kowane RECIST v1.1 ya ƙaru daga 54% a mako na 25 zuwa 76.2% (95% CI: 63.8, 86.0), tare da marasa lafiya huɗu sun sami cikakken amsawa.
A halin yanzu, binciken ya kuma nuna ci gaba da ci gaba da samun ci gaba mai ma'ana a fannin kimanta sakamakon asibiti (COAs) da suka shafi ingancin rayuwar marasa lafiya ta TGCT, gami da kewayon motsi, tauri, ciwo, da aikin jiki. Fosta ɗin ya kuma gabatar da fa'idodin ingancin rayuwa (QoL) da aka kimanta ta hanyar sikelin analog na gani na EQ-5D-5L (VAS). Marasa lafiya da suka karɓi maganin pimicotinib sun nuna matsakaicin ci gaban QoL na 7.4% daga farkon Mako na 25, wanda ya ƙara ƙaruwa zuwa 13.1% a Mako na 73.
Bugu da ƙari, marasa lafiya waɗanda aka fara bazuwa zuwa ga hannun placebo a Sashe na 1 kuma daga baya suka canza zuwa pimicotinib a Sashe na 2 suma sun sami fa'idar asibiti, inda suka sami ORR na 64.5% a matsakaicin bin diddigin watanni 8.5, tare da ci gaba mai mahimmanci a cikin COAs.
Dangane da aminci, matsakaicin ƙarfin maganin ya kasance mai girma a kashi 88.2% yayin jiyya. Yawancin abubuwan da suka faru na rashin lafiya da suka faru a lokacin jiyya (TEAEs) sun kasance aji na 1-2. Ba a lura da sabbin alamun aminci ba, kuma babu wata shaida ta gubar hanta ta cholestatic, raunin hanta da miyagun ƙwayoyi suka haifar, ko kuma rashin haske a fata/fata.
Abin lura ne cewa a taron Ƙungiyar Kula da Lafiya ta Turai (ESMO) na 2025 da aka gudanar a watan Oktoban wannan shekarar, Farfesa Xiaohui Niu daga Asibitin Jishuitan na Beijing, babban mai bincike (PI) na binciken MENUEVER, ya gabatar da waɗannan muhimman binciken a cikin gabatarwa ta baki.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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