Merck KGaA (MKGAF) Files for Global Approval of Pimicotinib After Positive Phase III TGCT Results

Merck KGaA (OTC:MKGAF) is seeking worldwide regulatory approval for its CSF-1R inhibitor pimicotinib following robust Phase III results in tenosynovial giant cell tumour (TGCT). The MANEUVER trial, conducted with Abbisko Therapeutics, showed a 61.9% overall response rate (ORR) by tumour volume score (TVS) after 25 weeks, far surpassing placebo (3.2%). This efficacy outperformed Daiichi Sankyo’s Turalio (56% ORR) and was just behind Ono Pharmaceutical’s Romvimza (67% ORR), which received FDA approval in February 2025.

Quality of life improvements were notable, with significant gains in range of movement, stiffness, and pain reduction. Importantly, pimicotinib demonstrated a favorable safety profile: while all patients experienced some adverse events, only 4.8% were serious, and there were no signs of liver toxicity, a key differentiator from other therapies.

TGCT, a rare non-cancerous joint tumour, often recurs after surgery, making effective drug options crucial. Merck KGaA (OTC:MKGAF), having secured global rights from Abbisko in March 2025, is planning to file for approval in China and plans an FDA submission by year-end. Full results will be presented at ASCO 2025 in Chicago.

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