Abbisko Presents Long-Term Phase III TGCT Data for CSF-1R Inhibitor

China's Abbisko Therapeutics has reported extended follow-up data from the Phase III MANEUVER trial, showing 76.2% objective response rate (ORR) at median 14.3 months for CSF-1R inhibitor pimicotinib in tenosynovial giant cell tumour (TGCT), with median duration of response not reached. The oral small molecule demonstrated sustained clinical outcome assessment improvements including 23.9% joint range of motion enhancement at 73 weeks, with a safety profile consistent with previous analyses and supporting long-term treatment feasibility. Cross-over patients achieving 64.5% response rate after switching from placebo further validated the therapeutic benefit in this rare proliferative disorder affecting synovial joints and tendon sheaths.

Pimicotinib holds breakthrough therapy designation (BTD) in the US and priority medicines status from the European Medicines Agency, with China National Medical Products Administration (NMPA) priority review underway for systemic treatment of tenosynovial giant cell tumour. Abbisko partnered global commercialisation rights with Merck in December 2023 following a positive top-line results announcement. The CSF-1R inhibitor addresses pathological CSF-1 overexpression driving inflammatory cell accumulation, representing a first-in-class mechanism for non-malignant tumour management with potential applications in oncology and inflammatory diseases.

According to PharmCube's NextBiopharm® database, pimicotinib ranks second globally in terms of development among CSF-1R inhibitors. Click here to request a free trial for NextBiopharm®.

Daily News
Capricor Shares Soar 371% on Positive Phase III Results for DMD Cell Therapy
2025-12-05
Pfizer Files Third-Generation Migraine Nasal Spray in China
2025-12-05
Proviva Secures Over USD 30m in Series A+ Financing
2025-12-04
Rhegen Advances mRNA Shingles Vaccine into Phase II
2025-12-04
Qilu Initiates World's First Phase III Trial for Tezepelumab Biosimilar
2025-12-03
Latest Report
China's Innovative Phamaceutical Industry in a Global Perspective - 10-year Review and Outlook
Details