Pimicotinib demonstrates best-in-class potential in TGCT

Germany’s Merck KGaA (MRK: DE) today announced the presentation of detailed positive results from Part 1 of the global Phase III MANEUVER trial evaluating pimicotinib, a potentially best-in-class investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics (HKEX: 02256), in the treatment of patients with tenosynovial giant cell tumor (TGCT).

Merck recently exercised its option with China’s Abbisko for commercialization of pimicotinib in the USA and rest of world. As a result, Merck paid Abbisko an option fee of $85 million.

Once-daily pimicotinib demonstrated a statistically-significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% versus 3.2% for placebo (p<0.0001). The study also demonstrated statistically-significant and clinically-meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT. These findings will be presented Sunday, June 1 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #11500).