Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it will present data from two clinical studies on its next-generation CSF-1R inhibitor, ABSK021 (pimicotinib), at the Connective Tissue Oncology Society (CTOS) annual meeting. The presentations will highlight significant findings from the Phase Ib clinical study and the ongoing Phase III MANEUVER study, showcasing the potential of pimicotinib in the treatment of giant cell tumors of the tendon sheath (TGCT).
Phase Ib Clinical Study Results
The Phase Ib clinical study for pimicotinib in TGCT demonstrated continuous improvement in efficacy, with an objective response rate (ORR) of 87.5% in the 50mg QD cohort and 66.7% in the 25mg QD cohort. The median duration of remission (DOR) has not been achieved, indicating sustained effects. Pimicotinib was well tolerated, with a median treatment duration of 12.2 months and a maximum of 17.5 months, highlighting its potential as a safe and effective therapy for TGCT.
Phase III MANEUVER Study
The Phase III MANEUVER study is currently recruiting patients for a global trial expected to be conducted across approximately 40 centers. The study is divided into two parts: the first part involves a double-blind treatment with 50 mg QD of pimicotinib or a matched placebo, followed by an open-label treatment stage in the second part, where all subjects receive 50 mg QD of pimicotinib until 24 weeks of administration or withdrawal from the study.
Pimicotinib’s Profile and TGCT Context
Pimicotinib is an orally administered, potent, and selective small-molecule inhibitor of CSF-1R, with breakthrough therapy designation (BTD) and priority review awards in China, the US, and Europe. TGCT is a locally invasive tumor that significantly impacts patients’ quality of life due to swelling, pain, stiffness, and limited mobility of the affected joints. Currently, no targeted therapy exists in China for TGCT, although Daiichi-Sankyo’s pexidartinib has been approved for use outside of the country.-Fineline Info & Tech
