November 17, 2025,Abbisko announced the poster presentation of longer-term efficacy, safety and patient-reported outcomes from the global Phase III MANEUVER study of pimicotinib (ABSK021) in patients with tenosynovial giant cell tumour (TGCT) at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting.
Pimicotinib is a novel, oral, highly selective, and potent small-molecule CSF-1R inhibitor independently developed by Abbisko Therapeutics.The MANEUVER study is a global, multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial consisting of three parts, designed to evaluate the efficacy and safety of pimicotinib in patients with TGCT. The primary endpoint and all key secondary endpoints were met in Part 1 at week 25, and the corresponding results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The primary endpoint is the objective response rate (ORR) at the end of Part 1, as assessed by blind independent review committee (BIRC) per RECIST v1.1. At Week 25, pimicotinib demonstrated a statistically significant improvement in ORR compared with placebo at Week 25 (54.0% vs 3.2%, P＜0.0001).
The outcomes presented at the CTOS 2025 Annual Meeting were the longer-term efficacy and safety data from the completion of Part 2 of the MANEUVER study. With a median follow-up of 14.3 months, patients who had received pimicotinib from the beginning of the study demonstrated robust and durable tumor responses. The ORR by blinded independent review committee (BIRC) per RECIST v1.1 increased from 54% at week 25 to 76.2% (95% CI: 63.8, 86.0), with four patients achieving complete response.
Meanwhile, the study also showed continued clinically meaningful improvements in clinical outcome assessments (COAs) related to TGCT patients’ quality of life, including range of motion, stiffness, pain, and physical function. The poster also presented quality of life (QoL) benefits assessed by the EQ-5D-5L visual analog scale (VAS). Patients receiving pimicotinib treatment showed a mean QoL improvement of 7.4% from baseline at Week 25, which further increased to 13.1% at Week 73.
In addition, patients who were initially randomized to the placebo arm in Part 1 and subsequently switched to pimicotinib in Part 2 also derived clinical benefit, achieving an ORR of 64.5% at a median follow-up of 8.5 months, along with notable improvements in COAs.
In terms of safety, the median dose intensity remained high at 88.2% during treatment. Most treatment-emergent adverse events (TEAEs) were Grade 1–2. No new safety signals were observed, and there was no evidence of cholestatic hepatotoxicity, drug-induced liver injury, or hair/skin hypopigmentation.
It is noteworthy that at the European Society for Medical Oncology (ESMO) Congress 2025 held in October this year, Professor Xiaohui Niu from Beijing Jishuitan Hospital, the leading principal investigator (PI) of MANEUVER study, presented these significant research findings in an oral presentation.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
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Post time: Nov-18-2025