SHANGHAI, China — Abbisko Therapeutics Co., Ltd. announced the completion of patient enrollment for its pivotal Phase III trial, MANEUVER (ABSK021-301) STUDY, for evaluating the efficacy and safety of pimicotinib in patients with tenosynovial giant cell tumor (TGCT). A total of 94 patients were enrolled and exceeded the original target of 90 patients. The study is being conducted across more than 30 investigational sites worldwide, with European and North American patients accounted for more than half of the total enrollment. This study is a Phase III, randomized, double-blind, placebo-controlled, multicenter trial, which is the first global Phase III trial of TGCT simultaneously conducted in China, the U.S., Canada and Europe. The approval to conduct this Phase III trial was received by the China NMPA in October 2022, the U.S. FDA in March 2023, and the EMA in September 2023.
Pimicotinib is a novel, orally available, highly selective, and highly potent small molecule inhibitor of CSF-1R independently discovered and developed by Abbisko Therapeutics. It has obtained the Breakthrough Therapy Designation (BTD) from China NMPA and the U.S. FDA, as well as the PRIME designation from EMA. Furthermore, the U.S. FDA granted Fast Track Designation (FTD), and Orphan Drug Designation (ODD) granted by EMA in January 2024, for the treatment of TGCT patients who are not amenable to surgery. The designations are poised to accelerate the global development and commercialization of pimicotinib.
In early December 2023, Abbisko Therapeutics entered into a license agreement with Merck. Under the terms of the agreement, Abbisko Therapeutics has granted Merck an exclusive license to commercialize products comprising or containing pimicotinib in the Chinese mainland, Hong Kong, Macau and Taiwan, and an exclusive option for global commercial rights of pimicotinib.
TGCT, a locally aggressive neoplasm which affects synovial joints, mucous sacs, and tendon membranes, resulting in swelling, pain, stiffness, and decreased activity of the affected joints which seriously affect patient’s quality of life. Currently, there is no systemic therapy approved in China and Europe, and only one in the U.S. There are unmet medical needs of TGCT patients in the regions of China, the U.S. and Europe.
In addition to TGCT, Abbisko is actively exploring the potential of pimicotinib in treating other indications. The company has obtained approval from China NMPA to conduct Phase II clinical studies in chronic graft-versus-host disease (cGVHD) and advanced pancreatic cancer.
PHASE III MANEUVER (ABSK021-301) STUDY
The Phase III MANEUVER (ABSK021-301) study is a randomized, double-blind, placebo-controlled, multi-centered clinical trial designed to evaluate the safety and efficacy of pimicotinib in patients with TGCT. This study consists of two parts. Part 1 is a double-blinded phase, in which eligible patients were randomized to the pimicotinib treatment group or matching placebo group and receive 50mg QD of pimicotinib or matching placebo (28 days/cycle) until completion of 24 weeks of dosing (Part 1). Patients who complete Part 1 were eligible to continue in Part 2 of the study. Part 2 is an open-label treatment phase, and all patients entering this phase received 50mg QD of open-label pimicotinib until 24 weeks of dosing or withdrawal from the study. Approximately 90 patients were planned to be enrolled, and the primary endpoint is 25-Week ORR by the Blinded Independent Review Committee(IRC).
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