Strong Phase III results for pimicotinib in patients with TGCT

German life sciences company Merck KGaA (MRK: DE) today announced that the Phase III MANEUVER trial of pimicotinib met its primary endpoint, demonstrating significant improvement in objective response rate (ORR) in patients with tenosynovial giant cell tumor (TGCT). The ORR for pimicotinib at week 25 was 54.0% compared with 3.2% for placebo (p<0.0001).

Notably, said Merck, the study also showed that treatment with pimicotinib provided statistically significant and clinically meaningful improvements in secondary endpoints associated with important patient outcomes in TGCT, including stiffness by Numeric Rating Scale (NRS; -3.00 mean change from baseline versus -0.57 for placebo, p<0.0001) and pain by Brief Pain Inventory (BPI; -2.32 versus 0.23 mean change from baseline, p<0.0001). Further efficacy and safety data from the MANEUEVER study will be presented at an upcoming medical conference.

Drug licensed from Abbisko