Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) announced the presentation of preliminary Phase II study results for pimicotinib (ABSK021) in patients with chronic Graft-versus-Host Disease (cGvHD) at the 66th American Society of Hematology (ASH) annual meeting. The study focused on patientszhe who have either progressed or not responded to one or more prior lines of therapy.
Pimicotinib Achieves 64% ORR in Preliminary cGvHD Study
Preliminary data from the subset of patients receiving 20mg of pimicotinib once daily (QD) indicates that the drug achieved an Objective Response Rate (ORR) of 64%. It is important to note that most enrolled patients have not yet completed the 6-month treatment cycle required for cGvHD response evaluation, making these results a promising early indicator of the drug’s potential efficacy.
Pimicotinib’s Profile and Regulatory Designations
Pimicotinib is an orally administrated, highly potent, and selective small-molecule inhibitor of CSF-1R. The molecule has received Breakthrough Therapy Designations (BTDs) from China’s Center for Drug Evaluation (CDE) and the US Food and Drug Administration (FDA), as well as Priority Medicines (PRIME) status in the European Union. These designations are all for the treatment of tendon sheath giant cell tumor (TGCT), highlighting the drug’s potential in addressing significant unmet medical needs.-Fineline Info & Tech
