和誉-B 于 2025 年 ESMO 会议展示匹米替尼临床 III 期 MANEUVER 研究长期疗效和安全性数据

According to the Zhitong Finance APP, HeYu-B (02256) announced that its subsidiary Shanghai HeYu Biopharmaceutical Technology Co., Ltd. (HeYu Pharmaceuticals) has presented the long-term efficacy and safety data of its global Phase III MANEUVER study of pimicotinib (pimicotinib/ABSK021) for the treatment of patients with tenosynovial giant cell tumor (TGCT) in an oral presentation at the 2025 European Society for Medical Oncology (ESMO) annual meeting. This long-term analysis shows that the objective response rate (ORR) assessed by the blinded independent review committee (BIRC) according to RECIST v1.1 criteria and tumor volume score (TVS) confirms that pimicotinib demonstrates strong and durable tumor response efficacy, with clinical outcome assessments (including joint mobility, stiffness, pain, and physical function) showing clinically meaningful sustained improvements, and safety consistent with previous analyses, validating the feasibility of long-term treatment.

TGCT is a rare locally aggressive mesenchymal tumor primarily affecting joints, tendon sheaths, and bursae, which can lead to severe local lesions and functional impairment. Its mechanism of occurrence is the overexpression of colony-stimulating factor 1 (CSF-1) in tumor synovial cells, leading to the accumulation of inflammatory cells expressing colony-stimulating factor 1 receptor (CSF-1R) in the tumor.

Pimicotinib is a novel, orally administered, highly selective, and effective small molecule CSF-1R inhibitor independently developed by HeYu Pharmaceuticals. The global Phase III MANEUVER study consists of three parts and aims to evaluate the efficacy and safety of pimicotinib in patients with TGCT. The results of the first part of the MANEUVER study, announced at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, showed that pimicotinib provided significant efficacy benefits for patients: at week 25, the ORR in the pimicotinib treatment group assessed by BIRC according to RECIST v1.1 criteria reached 54%, while the placebo control group was only 3.2%.

At the 2025 ESMO meeting, the principal investigator (PI) of the MANEUVER study, Professor Niu Xiaohui from Beijing Jishuitan Hospital, reported the long-term efficacy and safety data: at a median follow-up of 14.3 months, the ORR in patients randomly assigned to receive pimicotinib in the first part, assessed by BIRC according to RECIST v1.1 criteria, increased to 76.2% (95% CI: 63.8, 86.0), with the median duration of response (mDOR) not yet reached (range: 0.03-19.81 months); at the end of the second part (week 49), clinical outcome assessments continued to improve and safety was good, with pimicotinib showing a relative improvement in joint mobility of 23.9% compared to baseline by week 73. Patients who were randomly assigned to receive placebo in the first part also benefited after switching to pimicotinib in the second part, with ORR assessed by BIRC according to RECIST v1.1 criteria and TVS both reaching 64.5%, and clinical outcome assessments also showed improvement.

As more data confirms the efficacy, safety, and tolerability of pimicotinib in the long-term treatment of TGCT, its potential and commercial value as a best-in-class treatment option will gradually be realized Pimicotinib is a new, oral, highly selective, and efficient small molecule CSF-1R inhibitor independently developed by ABBISKO. Its positive top-line results for TGCT in the global Phase III MANEUVER study were published in November 2024. Currently, Pimicotinib has been included in priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for adult patients with TGCT requiring systemic treatment. Pimicotinib has also received Breakthrough Therapy Designation (BTD) from the NMPA. In December 2023, ABBISKO reached an agreement with Merck & Co. for the commercialization rights of Pimicotinib, with Merck responsible for its global commercialization.

In overseas regions, Pimicotinib has also received BTD from the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA)