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Nov 13, 2024, Abbisko Therapeutics (HKEX: 02256)  presented model-informed dose selection results for its self-discovered, orally available, highly selective, and potent small-molecule CSF-1R inhibitor, pimicotinib (ABSK021)，for the treatment of Tenosynovial Giant Cell Tumor (TGCT) at the American Conference on Pharmacometrics (ACoP) 2024. The study integrated drug pharmacokinetics, safety, and efficacy data to guide model-informed dose selection. These results support 50 mg QD as the recommended dose of pimicotinib for the global development and treatment of TGCT.

Key data points from the poster presented by Abbisko at this ACoP 2024 meeting include:

Poster number：M-082

Title： Integration of Pharmacokinetics, safety, and Efficacy into model-informed Dose Selection for Pimicotinib

Objectives:

Pimicotinib, an oral, highly potent and selective small-molecule antagonist of CSF-1R with minimum inhibition of c-Kit and PDGFR, is currently being developed for patients with Tenosynovial Giant Cell Tumor (TGCT), a rare type of locally aggressive neoplasm primarily caused by the overexpression of the CSF-1 gene^[1]. The objective of this analysis was to develop a population PK (popPK) model and concurrently identify intrinsic/extrinsic factors that significantly influence pimicotinib’s PK profile. Additionally, an exposure-response (E-R) analysis was performed to depict the relationship between pimicotinib exposure and efficacy/safety endpoints to support the selection of appropriate doses in subsequent clinical development in patients with TGCT.

Conclusions:

The study characterized pimicotinib popPK and E-R relationships and their association with efficacy and safety. These models were used to identify optimal dose selection for pimicotinib, supporting 50 mg QD as the recommended dose of pimicotinib for the global development and treatment of TGCT.

Reference：

1. Cannarile MA, et al. J Immunother Cancer. 2017; 5(1):53.