Abbisko Therapeutics has reported updated results from a Phase Ib study of Pimicotinib (ABSK021) for the treatment of advanced tenosynovial giant cell tumour (TGCT).
Pimicotinib is an orally available, highly selective and potent small molecule CSF-1R inhibitor.
Various studies have also shown that blocking the CSF-1R signaling pathway can modulate and change macrophage functions as well as treat many macrophage-dependent human diseases.
The data demonstrated Pimicotinib’s antitumour efficacy and safety profile to treat patients with advanced TGCT.
Objective response rate of 77.4% (24/31) including two complete responses and 22 partial responses were demonstrated at 50 mg QD dose group of Pimicotinib.
In addition, 87.5% (21/24) of patients with objective response were observed within the first 25 weeks.
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Furthermore, Pimicotinib showed apparent advantages in terms of safety profile.
First patient dosing of ABSK021 in a placebo-controlled, randomised, double-blind, multicentre Phase III study was completed in Beijing Jishuitan Hospital.
This study is said to be the first global Phase III study of TGCT to be carried out simultaneously in the US and China.
Around 100 participants are planned to be enrolled in nearly 50 centres globally including 30 centres in China.
Developed by Daiichi Sankyo, Pexidartinib is the only drug that received approval to treat TGCT in the markets globally.
Pimicotinib showed better efficacy and safety in the treatment of TGCT compared to Pexidartinib.