Pimicotinib trial shows TGCT gains, Merck says

Merck said two-year follow-up data from a Phase 3 study of pimicotinib showed sustained symptom and joint-function improvements in patients with tenosynovial giant cell tumor.

The company said results from the MANEUVER study were being presented at the European Society for Medical Oncology Congress 2026. It said patients initially randomized to pimicotinib had improvements in pain, stiffness and range of motion that were observed as early as Week 5 and sustained through two years.

Merck said the objective response rate by blinded independent review committee under RECIST v1.1 was 76.2% at two years, unchanged from the one-year analysis. It said a tumor volume score-based response rate rose from 74.6% at one year to 77.8% at two years.

The company said median duration of response had not been reached at the March 1, 2026 data cutoff, and that 54% of patients initially randomized to pimicotinib remained on treatment at two years.

Merck said pimicotinib was approved in China in December 2025 and in Canada in June 2026 for adult patients with symptomatic TGCT. It said a regulatory application is under review by the US Food and Drug Administration and other agencies.