Merck KGaA, Darmstadt, Germany, has reported sustained improvements in symptoms, physical function and tumour control with pimicotinib in patients with tenosynovial giant cell tumour (TGCT), with benefits maintained over two years in the Phase 3 MANEUVER study.

 

The latest follow-up findings, being presented at the European Society for Medical Oncology (ESMO) Congress 2026, show that patients initially randomized to pimicotinib experienced improvements in symptoms and joint function as early as Week 5, with gains sustained through two years and continuing to improve over time. 

 

Tumour responses remained robust and durable, while the drug’s safety profile was consistent with previous analyses.

 

"For people living with TGCT, the impact of the disease is often felt through persistent limitations in mobility, physical function and the ability to carry out everyday activities," said Vinod Ravi, an investigator on the MANEUVER trial. 

 

"What is encouraging about these two-year findings is the consistency of improvements, not only in the durability of tumor response, but across the symptoms and functional outcomes that matter to patients. Together with the observed safety profile, these results provide important insight into the potential for pimicotinib to deliver meaningful benefit over time."

 

At Week 97, patients initially randomized to pimicotinib showed a mean improvement of 19.6% in range of motion from baseline. Stiffness scores fell by 3.9 points on the Worst Stiffness Numeric Scale Rating, while worst pain scores dropped by 3.1 points on the Brief Pain Inventory. Physical function also improved, with a 7.4-point increase on the patient-reported PROMIS-PF scale.

 

The results suggest that the benefits of treatment extended beyond tumor control, with improvements across several measures of daily functioning and symptom burden sustained over the long term.

 

Tumor response rates remained strong at the two-year mark. Based on blinded independent review committee (BICR) assessment using RECIST v1.1 criteria, the objective response rate (ORR) was 76.2% unchanged from the one-year analysis.

 

Using tumor volume score (TVS), the ORR rose from 74.6% at one year to 77.8% at two years. Median duration of response had not been reached at the time of analysis.

 

At the March 1, 2026, data cutoff, median treatment duration was 22.6 months, with a range of 1.8 to 33.6 months. More than half of patients — 54% of those initially randomized to pimicotinib — remained on treatment at two years.

 

"These two-year findings add to the growing body of evidence from the MANEUVER study demonstrating the potential for pimicotinib to meaningfully address some of the burden of TGCT," said David Weinreich, Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck KGaA, Darmstadt, Germany. 

 

“The sustained improvements observed across symptoms, physical function and tumor control reinforce the potential of pimicotinib to address aspects of TGCT that can affect patients every day. These results add to our evolving understanding of the long-term benefit that pimicotinib may provide for people living with this debilitating rare tumour."