Abbisko Cayman Limited (2256) announced that Abbisko Therapeutics, its subsidiary, presented longer-term efficacy, safety, and patient-reported outcomes from the global Phase III MANEUVER study of pimicotinib (ABSK021) in tenosynovial giant cell tumour (TGCT) at the Connective Tissue Oncology Society 2025 Annual Meeting. According to the announcement, sustained treatment with pimicotinib showed continued enhancements in tumor response and quality of life measures, while maintaining an acceptable safety profile.

The first part of the MANEUVER study demonstrated that pimicotinib led to a statistically significant higher objective response rate (ORR) at Week 25 compared to placebo (54.0% vs. 3.2%), as verified by a blind independent review committee per RECIST v1.1. In the longer-term analysis at a median follow-up of 14.3 months, the ORR further increased to 76.2%, with several patients achieving complete response. Those initially receiving placebo and subsequently switched to pimicotinib also showed clinical benefit, reaching a 64.5% ORR after a median follow-up of 8.5 months.

Clinical outcome assessments related to pain, stiffness, and physical function continued to improve over time. Quality of life improvements increased from 7.4% at Week 25 to 13.1% at Week 73. No new safety signals were observed, and most adverse events were Grade 1–2. There was no evidence of cholestatic hepatotoxicity, drug-induced liver injury, or hair/skin hypopigmentation, with the median dose intensity remaining at 88.2%.

Pimicotinib is a novel, oral, highly selective, and potent small-molecule CSF-1R inhibitor independently developed by Abbisko Therapeutics. It has been granted breakthrough therapy designation by the China National Medical Products Administration and the US Food and Drug Administration, and it holds PRIME Designation from the European Medicines Agency. Abbisko Therapeutics has partnered with Merck KGaA, Darmstadt, Germany, for the global commercialization of pimicotinib.