Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that its Category 1 drug ABSK021 (pimicotinib) has received Priority Medicine (PRIME) status from the European Medicines Agency (EMA) for the treatment of inoperable tenosynovial giant cell tumor (TGCT). This decision comes on the heels of positive results from an ongoing Phase Ib study focusing on the TGCT cohort. The latest data, showcased at the 2023 American Society of Clinical Oncology (ASCO) annual meeting, demonstrated an objective response rate (ORR) of 77.4% (24/31) for the 50mg QD dose group of pimicotinib, including 2 complete responses and 22 partial responses, with 87.5% of patients showing an objective response within the first 25 weeks.
Pimicotinib: A Potent Inhibitor of CSF-1R
ABSK021 is an orally administrated, highly potent, and selective small-molecule inhibitor of CSF-1R. Currently, there is no drug approved for the treatment of inoperable TGCT in China. Pexidartinib, the only TGCT drug developed by Daiichi Sankyo and available worldwide, has been issued a black box warning in the US due to the potential risk of lethal liver damage, with an ORR of 38%.
Global Phase III Study for Pimicotinib in TGCT
Previously, Abbisko initiated a global Phase III study for pimicotinib in TGCT in China, aiming to enroll 100 subjects across 30 centers in China and an additional 50 worldwide. The PRIME designation by the EMA highlights the potential of pimicotinib to address a significant unmet medical need and underscores Abbisko’s commitment to advancing treatments for patients with TGCT.-Fineline Info & Tech
