By Fineline Cube 
Abbisko Therapeutics Co., Ltd. (HKG: 2256) released long‑term efficacy, safety and patient‑reported outcome data from its global Phase 3 MANEUVER study, evaluating the oral CSF‑1R inhibitor pimicotinib (ABSK021) in patients with tenosynovial giant cell tumour (TGCT).
Study Highlights
| Metric | Result |
|---|---|
| Primary Endpoints (Week 25) | ORR: 54.0 % vs 3.2 % placebo (P < 0.0001) |
| Long‑Term ORR (Median Follow‑up 14.3 months) | 76.2 % (95 % CI: 63.8‑86.0) |
| Complete Responses | 4 patients (including 2 early‑switchers) |
| Placebo‑to‑Pimicotinib Switch Cohort (Median 8.5 months) | ORR: 64.5 % |
| Median Dose Intensity | 88.2 % |
| Safety Profile | Predominantly Grade 1‑2 TEAEs; no new safety signals |
The data underscore pimicotinib’s potency and confirm the drug’s ability to produce robust, durable tumour regression over a 14‑month median follow‑up, with a progressive rise in objective response rate (ORR) from 54 % at week 25 to 76.2 %.
Pimicotinib – Product Overview
- Mechanism – Highly selective, potent inhibition of the colony‑stimulating factor‑1 receptor (CSF‑1R), the key driver of macrophage‑mediated tumour growth in TGCT.
- Administration – Once‑daily oral capsule, enabling systemic therapy for patients who would otherwise rely on surgical excision.
- Regulatory Status – Granted priority review and breakthrough therapy designation (BTD) by the National Medical Products Administration (NMPA) in China in December 2023.
Commercial Outlook
In December 2023, Abbisko entered a global commercialization partnership with Merck KGaA (Merck), transferring worldwide marketing rights for pimicotinib. The agreement positions Merck to launch the drug across key markets, including the United States, Europe, and Japan, after Abbisko’s NMPA breakthrough designation gives regulatory momentum in China.
Forward‑Looking Statements
The information herein contains forward‑looking statements regarding clinical data, regulatory decisions and commercialization prospects. Actual outcomes may differ materially.-Fineline Info & Tech