ASCO25: Merck KGaA Seeks Approval for TGCT Drug After Phase III Success

Merck KGaA is pursuing global approval for pimicotinib, a CSF-1R inhibitor, after positive Phase III results in tenosynovial giant cell tumor (TGCT) patients. The MANEUVER study reported a 61.9% overall response rate (ORR) by tumor volume score (TVS) after 25 weeks, outperforming placebo (3.2%) and Daiichi Sankyo’s Turalio (56%). Pimicotinib showed improved quality of life with better range of motion, less stiffness, and reduced pain.

All patients experienced adverse events, though serious ones were rare (4.8%). No liver toxicity was observed.

Merck acquired global rights to pimicotinib from Abbisko Therapeutics in March 2025 and has filed for approval in China, with FDA submission planned by year-end. Data will be presented at ASCO 2025 in Chicago.

03-06-2025