Abbisko Therapeutics Co., Ltd. is developing pimicotinib (previously known as ABSK-021) to treat TGCT by targeting a protein that drives the growth of the tumor, known as the colony stimulating factor 1 (CSF1). pimicotinib is an oral (50mg) daily medication that is designed to block CSF1. As an investigational drug, pimicotinib has not been approved by the United States Food and Drug Administration (FDA) or any other regulatory agencies for sale or use by the public.
The purpose of their upcoming Phase 3 study is to test the effectiveness and long-term safety of an investigational drug, pimicotinib, as a potential new treatment for TGCT.
As of June 01, 2022, 32 Chinese TGCT patients have received pimicotinib. Majority of side effects have been mild-to-moderate. At 13 weeks, TGCT patients showed improvement in range of motion, pain, and stiffness. It is reported that 35% of patients had TGCT shrinkage. Due to the limited number of patients, there may be other side effects that are unknown, and the potential side effects listed below may change with the increase of patients enrolled to the study.
Their Phase 3 trial has not started recruiting. The only trial listed as recruiting is their Phase 1 trial that evaluates the safety and tolerability of pimicotinib (ABSK021) in patients with TGCT, as well as other advanced solid tumors.
For more information on the trial and the locations, visit the Phase 1 ABSK-021 trialor ask your healthcare provider.