Global Phase 3 MANEUVER study of pimicotinib in tenosynovial giant cell tumor (TGCT) met the primary endpoint, demonstrating objective response rate at week 25 of 54.0% versus 3.2% for placebo (p<0.0001)

全球三期MANEUVER研究中，pimicotinib在腱鞘巨细胞瘤（TGCT）的治疗中达到了主要终点，显示出第25周时客观缓解率为54.0%，而安慰剂组为3.2%（p<0.0001）。

MANEUVER met all five key secondary endpoints, with statistically significant and clinically meaningful improvements in pain, stiffness, range of motion, physical function, and decrease in tumor volume

MANEUVER达到了所有五个关键的次要终点，在疼痛、僵硬、运动范围、身体功能方面均有统计学显著性和临床意义的改善，并且肿瘤体积减少。

Treatment was well-tolerated, with low incidence of treatment discontinuation and dose reductions

治疗耐受性良好，治疗中断和剂量减少的发生率较低。

Merck, a leading science and technology company, today announced the presentation of detailed positive results from Part 1 of the global Phase 3 MANEUVER trial evaluating pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., in the treatment of patients with tenosynovial giant cell tumor (.

默克公司，一家领先的科学和技术公司，今天宣布了全球三期MANEUVER试验第一部分的详细积极结果，该试验评估了由上海和誉生物医药科技有限公司开发的潜在同类最佳的集落刺激因子-1受体（CSF-1R）抑制剂pimicotinib，在治疗腱鞘巨细胞瘤患者中的效果。

TGCT). Once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo (p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT.

TGCT）。每日一次的匹米科替尼在第25周时，由盲态独立审查委员会（BIRC）评估的主要终点客观缓解率（ORR）方面显示出具有统计学意义的改善，相较于安慰剂组（54.0%对比3.2%，p<0.0001）。该研究还显示，在与TGCT相关的关键患者报告的所有次要终点上，均取得了具有统计学意义和临床意义的改善。

These findings will be presented Sunday, June 1 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #11500)..

这些研究结果将于 2025 年 6 月 1 日（周日）在 2025 年美国临床肿瘤学会 (ASCO) 年会上以口头报告形式公布（摘要编号：#11500）。

“The impact that TGCT has on patients goes far beyond the physical presence of the tumor. It affects their ability to work, to move freely, and to engage in everyday activities,' said Prof. Niu Xiaohui, Director of the Bone and Soft Tissue Tumour Diagnosis and Research Centre at Beijing Jishuitan Hospital.

北京积水潭医院骨与软组织肿瘤诊治研究中心主任牛晓辉教授表示：“TGCT对患者的影响远远超出了肿瘤的物理存在。它影响了他们的工作能力、自由活动能力以及参与日常活动的能力。”

“In MANEUVER, we observed the highest ORR seen to date with a systemic therapy, together with statistically significant improvements in measures of pain, stiffness, and range of motion. These improvements in outcomes that matter to patients with TGCT and the physicians who care for them show the potential of pimicotinib to allow patients to go about their daily lives with fewer negative effects of their disease.”.

“在MANEUVER研究中，我们观察到迄今为止全身治疗中最高的客观缓解率（ORR），同时在疼痛、僵硬和活动范围的指标上也取得了统计学显著改善。这些对腱鞘巨细胞瘤（TGCT）患者及其主治医生至关重要的结果表明，pimicotinib有潜力让患者在日常生活中受到更少的疾病负面影响。”

In MANEUVER, which enrolled patients from China, Europe and North America, the effect of pimicotinib had an early onset, with 41.3 % (26 of 63) of patients experiencing objective response to therapy after 13 weeks. By the data cutoff for primary analysis, nearly all patients in the pimicotinib group (58 of 63 patients; 92.1%) had a decrease in tumor size per BIRC based on RECIST v1.1; one patient achieved a complete response and 33 patients achieved a partial response.

在MANEUVER研究中，该研究纳入了来自中国、欧洲和北美的患者，结果显示pimicotinib的疗效起效较早，在治疗13周后，41.3%（63名患者中的26人）出现客观缓解。截至主要分析的数据截止日期，根据RECIST v1.1标准，pimicotinib组几乎所有患者（63名患者中的58人；92.1%）基于BIRC评估显示肿瘤体积缩小；其中一名患者达到完全缓解，33名患者达到部分缓解。

The median duration of response was not reached by the data cutoff. The analysis of tumor volume score (TVS, an endpoint designed specifically for TGCT) showed that nearly two-thirds of patients treated with pimicotinib experienced a reduction in tumor volume of at least 50% (61.9% vs. 3.2% for placebo, p<0.0001)..

数据截止时未达到反应持续时间的中位数。对肿瘤体积评分（TVS，专门为TGCT设计的终点）的分析显示，近三分之二接受pimicotinib治疗的患者肿瘤体积减少了至少50%（61.9% vs. 安慰剂组3.2%，p<0.0001）。

Pimicotinib also demonstrated statistically significant and clinically meaningful improvement across all additional secondary endpoints relevant to patients’ daily lives, and these improvements were seen regardless of achieving objective tumor response to pimicotinib. Pimicotinib improved active range of motion (p=0.0003) and physical function measured by PROMIS-PF scale (p=0.0074).

Pimicotinib还在所有与患者日常生活相关的其他次要终点上显示出具有统计学意义和临床意义的改善，无论是否对pimicotinib产生客观肿瘤反应，均能观察到这些改善。Pimicotinib改善了活动范围（p=0.0003）以及由PROMIS-PF量表测量的身体功能（p=0.0074）。

Pimicotinib also reduced worst stiffness (p<0.0001) and worst pain (p<0.0001)..

Pimicotinib还减轻了最严重的僵硬（p<0.0001）和最严重的疼痛（p<0.0001）。

“TGCT, although rare, has a significant impact on the daily lives of the primarily working-age adults who live with the disease, due to swelling, pain, stiffness, and limited mobility caused by the growth of these tumors in and around the joints,” said Danny Bar-Zohar, appointed CEO Healthcare and current Global Head of R&D and Chief Medical Officer.

“TGCT虽然罕见，但因肿瘤在关节内部及周围生长，会引起肿胀、疼痛、僵硬和活动受限，对主要处于工作年龄的成年患者日常生活造成显著影响，”指定为医疗保健首席执行官兼现任全球研发主管和首席医学官的丹尼·巴尔-佐哈尔表示。

“The landmark global Phase 3 MANEUVER study data will help redefine how TGCT is treated, and we plan regulatory submissions to start this year.”.

“具有里程碑意义的全球三期MANEUVER研究数据将有助于重新定义TGCT的治疗方法，我们计划在今年开始提交监管文件。”

Pimicotinib was well-tolerated, and the safety profile was consistent with previously reported data, with no evidence of cholestatic hepatotoxicity or hair/skin hypopigmentation. Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation occurred in one patient (1.6%) treated with pimicotinib; TEAEs leading to dose reduction occurred in 7.9% (n=5) of pimicotinib-treated patients..

Pimicotinib 耐受性良好，其安全性特征与之前报告的数据一致，未发现胆汁淤积性肝毒性和毛发/皮肤低色素沉着的现象。在使用 Pimicotinib 的患者中，有一名患者（1.6%）因治疗期间出现的不良事件（TEAEs）而停止治疗；在使用 Pimicotinib 的患者中有 7.9%（n=5）因 TEAEs 而减少剂量。

About MANEUVER

关于机动

The pivotal Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who require systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy. The study is being conducted by Abbisko Therapeutics in China (n=45), Europe (n=28), and the US and Canada (n=21)..

关键的 III 期 MANEUVER 研究是一项分为三部分、随机、双盲、安慰剂对照的研究，旨在评估 pimicotinib 在需要系统治疗且未接受过抗 CSF-1/CSF-1R 治疗的 TGCT 患者中的疗效和安全性。该研究由 Abbisko Therapeutics 在中国（n=45）、欧洲（n=28）以及美国和加拿大（n=21）进行。

In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. The primary endpoint is objective response rate (ORR) at week 25, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review in the intent-to-treat (ITT) population.

在双盲的第一部分中，94名患者被随机分配为2:1的比例，接受每日一次50毫克的匹米替尼（n=63）或安慰剂（n=31），持续24周。主要终点是由独立中心评审委员会根据实体瘤疗效评价标准（RECIST）1.1版评估的第25周客观缓解率（ORR），针对意向治疗（ITT）人群进行评估。

Secondary endpoints include tumor volume score, active range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS)..

次要终点包括肿瘤体积评分、活动范围、数字评分量表（NRS）评估的僵硬程度、简要疼痛量表（BPI）评估的疼痛，以及患者报告结果测量信息系统（PROMIS）评估的身体功能。

After the double-blind Part 1, eligible patients could continue to the open-label Part 2 for up to 24 weeks of dosing, results of which are expected in mid-2025. Patients who complete Part 2 may then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up.

在双盲的第一部分之后，符合条件的患者可以继续进入开放标签的第二部分，进行最长24周的给药，其结果预计在2025年年中公布。完成第二部分的患者随后可进入开放标签扩展阶段（第三部分），以获得延长的治疗和安全性随访。

About Pimicotinib (ABSK021)

关于Pimicotinib (ABSK021)

Pimicotinib (ABSK021), which is being developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib was recently granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with tenosynovial giant cell tumor (TGCT) who require systemic therapy.

和誉医药开发的Pimicotinib（ABSK021）是一种新型的、口服的、高选择性和强效的小分子CSF-1R抑制剂。Pimicotinib最近被中国国家药品监督管理局（NMPA）药品审评中心（CDE）授予优先审评资格，用于治疗需要系统性疗法的腱鞘巨细胞瘤（TGCT）患者。

Pimicotinib has been granted breakthrough therapy designation (BTD) for the treatment of unresectable TGCT by China National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds .

Pimicotinib 已被中国国家药品监督管理局 (NMPA) 和美国食品药品监督管理局 (FDA) 授予用于治疗无法切除的腱鞘巨细胞瘤 (TGCT) 的突破性疗法认定 (BTD)，并获得欧洲药品管理局 (EMA) 的优先药物 (PRIME) 认定。默克持有该药权益。

worldwide commercialization rights for pimicotinib

pimicotinib的全球商业化权利

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Advancing the Future of Cancer Care

推进癌症护理的未来

At Merck, we strive every day to improve the futures of people living with cancer. Building on our 350-year global heritage as pharma pioneers, we are focusing our most promising science to target cancer’s deepest vulnerabilities, pursuing differentiated molecules to strike cancer at its core. By developing new therapies that can help advance cancer care, we are determined to create a world where more cancer patients will become cancer survivors.

在默克，我们每天都在努力改善癌症患者的生活前景。基于我们作为制药先驱350年的全球传承，我们正集中最有前景的科学力量，瞄准癌症最深层的脆弱点，追索差异化分子以直击癌症核心。通过开发能够促进癌症治疗的新疗法，我们决心创造一个让更多的癌症患者成为癌症幸存者的世界。

Learn more at .

了解更多，请访问。

www.merckgroup.com.

www.merckgroup.com.