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SHANGHAI, May 28, 2023 ~ Abbisko Therapeutics Co., Ltd. has announced that the updated results of their Phase Ib study of their 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 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".
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. Furthermore, Pimicotinib also presented apparent advantages in terms of safety profile.
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Currently, Pexidartinib developed by Daiichi Sankyo is the only drug approved for the treatment of TGCT in the global market. However, it has been given a "black box warning" by the FDA due to potential risk of fatal liver damage and its objective response rate is only 38%. Despite this, Daiichi Sankyo achieved sales of approximately US$40 million in the global market with Pexidartinib. CICC predicts that the global market for TGCT could amount to around 1 billion US dollars.
In comparison to Pexidartinib from Daiichi Sankyo, Abbisko's Pimicotinib shows better efficacy and safety in treating TGCT and is expected to become a best-in-class drug. If approved for use on TGCT in 2025 with a market penetration rate of 20%, its peak sales are estimated to reach 3.14 billion yuan (after risk adjustment) with listing price reference to Pexidartinib at $250,000 per year.
The data demonstrates the excellent antitumor efficacy and 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".
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. Furthermore, Pimicotinib also presented apparent advantages in terms of safety profile.
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Currently, Pexidartinib developed by Daiichi Sankyo is the only drug approved for the treatment of TGCT in the global market. However, it has been given a "black box warning" by the FDA due to potential risk of fatal liver damage and its objective response rate is only 38%. Despite this, Daiichi Sankyo achieved sales of approximately US$40 million in the global market with Pexidartinib. CICC predicts that the global market for TGCT could amount to around 1 billion US dollars.
In comparison to Pexidartinib from Daiichi Sankyo, Abbisko's Pimicotinib shows better efficacy and safety in treating TGCT and is expected to become a best-in-class drug. If approved for use on TGCT in 2025 with a market penetration rate of 20%, its peak sales are estimated to reach 3.14 billion yuan (after risk adjustment) with listing price reference to Pexidartinib at $250,000 per year.
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