77.4% ORR! Abbisko to present the updated clinical phase Ib data of Pimicotinib … – Press Release


SHANGHAI, May 28, 2023 /PRNewswire/ — Abbisko Therapeutics Co., Ltd. (“Abbisko Therapeutics” hereafter) today announced that the updated results of Phase Ib study of its CSF-1R inhibitor Pimicotinib (ABSK021) in treating patients with advanced tenosynovial giant cell tumor (“TGCT”), will be released at the 2023 American Society of Clinical Oncology (“ASCO”) annual meeting to be held in Chicago, USA from June 2 to June 6, 2023.

The data demonstrates the excellent antitumor efficacy and the safety profile of Pimicotinib in the treatment of patients with advanced TGCT and will be presented with the title of “EFFICACY AND SAFETY PROFILE OF PIMICOTINIB (ABSK021) IN TENOSYNOVIAL GIANT CELL TUMOR (TGCT): PHASE 1B UPDATE” in a poster presentation with the poster Bd# of “493”.

Among the data released by Abbisko, the most remarkable result is the objective response rate (ORR) of the 50 mg QD dose group of Pimicotinib (ABSK021), which reached 77.4% (24/31), including two complete responses (CR) and 22 partial responses (PR). Additionally, 87.5% (21/24) of patients with objective response were observed within the first 25 weeks.

In addition, Pimicotinib (ABSK021) also presented apparent advantages in terms of safety profile.

Currently Pexidartinib developed by Daiichi Sankyo is the only drug approved for the treatment of TGCT (tenosynovial giant cell tumor) in the global market. However, it has been given a “black box warning” by the FDA due to the potential risk of fatal liver damage, and its objective response (ORR) is only 38%. Nevertheless, Daiichi Sankyo achieved sales of approximately US$40 million in the global market with Pexidartinib. CICC predicts that the global market of TGCT could amount to around 1 billion US dollars. Compared with Pexidartinib of Daiichi Sankyo, Abbisko’s Pimicotinib shows better efficacy and safety in the treatment of TGCT. Thus, it is expected to become a best-in-class drug. Assuming that Pimicotinib could be approved for the indication of…