Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025
Shots:
- Part 1 of P-III (MANEUVER) trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment; trial also incl. an open-label Part 2 (data expected in mid-2025) & an OLE phase (Part 3)
- Trial met its 1EP of improved ORR (54.0% vs 3.2%) at 25wks., with 41.3% of objective response by 13wks.; 92.1% had tumor shrinkage, incl. 1 CR & 33 PRs, plus 61.9% vs 3.2% observed ≥50% tumor volume reduction. mDoR was not reached at the data cutoff
- Trial also depicted improvement across all five 2EPs, incl. range of motion & physical function (PROMIS-PF scale), plus reductions in worst stiffness & pain, regardless of an objective tumor response
Ref: Businesswire | Image: Merck Kga| Press Release
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