Pimicotinib versus placebo for tenosynovial giant cell tumour (MANEUVER): an international, randomised, placebo-controlled, phase 3 trial - PubMed

4 days ago

Pimicotinib versus placebo for tenosynovial giant cell tumour (TGCT) was evaluated in the MANEUVER trial.
The study was a phase 3, international, randomised, placebo-controlled trial involving 94 patients across 40 hospitals.
Patients received either pimicotinib (50 mg once daily) or placebo for 24 weeks in part 1, with an option to continue in open-label parts.
Primary endpoint was objective response rate (ORR) at week 25, with pimicotinib showing 54% ORR vs. 3% for placebo (p<0.0001).
Pimicotinib had a manageable safety profile, with mild adverse events like pruritus, facial edema, and fatigue.
No severe hepatotoxicity or drug-induced liver injury was reported.
The study highlights pimicotinib as a promising treatment for TGCT with robust antitumour activity and symptom improvement.

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