Pimicotinib Demonstrates Deep and Durable Tumor Responses in TGCT Patients: Long-Term Follow-Up Results from Global Phase 3 MANEUVER Trial Announced

Source: Global Times

On October 18, Merck announced the release of long-term follow-up results from the global Phase III MANEUVER study. The study aims to evaluate the long-term efficacy of Pimicotinib (a Colony Stimulating Factor-1 Receptor (CSF-1R) inhibitor developed by Abbisko Therapeutics) in treating patients with Tenosynovial Giant Cell Tumor (TGCT).

Latest analysis shows that at a median follow-up of 14.3 months, according to the blinded independent review committee (BICR) assessment using RECIST v1.1 criteria, the objective response rate (ORR) of patients treated with Pimicotinib from the start of the study significantly increased from 54% at week 25 to 76.2% (95% CI: 63.8, 86.0). The study also demonstrated sustained, clinically meaningful improvements in key secondary endpoints related to patient prognosis, such as pain and physical function, with a safety profile consistent with previously reported data. These findings were presented in the mini oral session on sarcoma at the 2025 European Society for Medical Oncology (ESMO) Congress (Abstract ID: 7692).

"The preliminary results of the global MANEUVER study announced at this year's ASCO meeting show that Pimicotinib has achieved the highest objective response rate ever recorded in Phase III clinical trials for systemic treatment of tenosynovial giant cell tumors." Professor Niu Xiaohui, Director of the Bone and Soft Tissue Tumor Diagnosis and Treatment Center at Beijing Jishuitan Hospital, stated, "The latest research findings further confirm, on top of previous data, that the tumor response efficacy of Pimicotinib is not only sustained but also continues to improve over time. More importantly, after more than a year of follow-up, patient-reported symptoms and functional outcomes are still continuously improving — these indicators directly relate to the patients' ability to perform daily activities. Overall, the study results suggest that Pimicotinib has the potential to become the 'best-in-class' systemic treatment option for patients with tenosynovial giant cell tumors."

"Tenosynovial giant cell tumor can cause patients pain, joint stiffness, and restricted mobility, impacting their daily living abilities and even preventing them from participating normally in family and social activities, creating a dual burden on patients' physical and mental health," noted Dr. Sydney Stern of the Life Raft Group's tenosynovial giant cell tumor patient support program. "Patients are in urgent need of more treatment options that can alleviate symptoms and reduce tumor size. More importantly, effectively improving symptoms can help patients return to roles as parents, partners, or caregivers, allowing them to live life as they desire without constantly worrying about when the disease might take control of their lives again."

"Long-term data fully demonstrates the potential of Pimicotinib to transform the treatment landscape for tenosynovial giant cell tumors — as a systemic treatment, Pimicotinib not only effectively reduces tumor burden but also helps restore physical function and alleviate pain, offering patients clinically meaningful and lasting benefits," said Dr. Victoria Zazulina, Head of Oncology Development at Merck's Healthcare business. "Based on the data from this global study covering North America, Europe, and China, we will work closely with regulatory authorities to ensure this treatment can benefit patients worldwide as soon as possible."

It is reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China has accepted the marketing authorization application for Pimicotinib as a Class 1 innovative drug for the treatment of adult patients with tenosynovial giant cell tumor. Marketing authorization applications in the United States and other global markets are also in planning.