Ono Pharmaceutical Announces Two-Year Results from Phase 3 MOTION Study of Vimseltinib in TGCT at ESMO 2025
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) today announced that two-year efficacy and safety results from the Phase 3 MOTION study of vimseltinib in patients with tenosynovial giant cell tumor (TGCT) for whom surgical resection is not an option will be presented as a poster at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17–21 in Berlin, Germany.
“These long-term Phase 3 MOTION results add to the growing body of evidence supporting vimseltinib as a best-in-class treatment for TGCT,” said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. “TGCT can cause significant pain, stiffness, and reduced mobility. These findings highlight the durable clinical benefit vimseltinib offers to patients.”
Study Overview
The global Phase 3 MOTION trial (NCT05059262) evaluated the efficacy and safety of vimseltinib in TGCT patients who were not candidates for surgery.
The study included two parts:
- Part 1: Participants were randomized to receive vimseltinib or placebo for 24 weeks.
- Part 2: All participants received open-label vimseltinib (30 mg twice weekly). Those initially on placebo could cross over to vimseltinib.
Efficacy was assessed by independent radiologic review using RECIST v1.1 and Tumor Volume Score (TVS). Duration of response (DOR) and safety were also evaluated.
Efficacy Results
At the data cutoff (February 22, 2025), 118 patients had received vimseltinib; 51% (60/118) remained on treatment. The results demonstrated durable and robust antitumor activity consistent with prior reports.
- Patients randomized to vimseltinib in Part 1 (n=83):
- 73 continued treatment in Part 2
- Median treatment duration: 23.6 months (range: 2–36)
- ORR per RECIST v1.1: 48% (40/83)
- ORR per TVS: 81% (67/83)
- Patients who crossed over from placebo (n=35):
- Median treatment duration: 19.1 months (range: 1–30)
- ORR per RECIST v1.1: 54% (19/35)
- ORR per TVS: 71% (25/35)
Median DOR by both RECIST v1.1 and TVS was not yet reached.
Safety Results
Vimseltinib maintained a manageable and consistent safety profile, with no new safety signals observed.
- Most treatment-emergent adverse events (TEAEs) were Grade 1/2; Grade 3/4 TEAEs were comparable between treatment groups.
- No new TEAEs occurred in ≥15% of patients, and no new serious adverse events were reported in more than one patient.
- Serum enzyme elevations were consistent with CSF1R inhibition, with no evidence of cholestatic hepatotoxicity or drug-induced liver injury.
About Vimseltinib (ROMVIMZA™)
Vimseltinib is an oral, highly selective inhibitor of CSF1R designed to target the underlying cause of TGCT, a rare, locally aggressive tumor of the joint or tendon sheath that can cause pain, swelling, and impaired mobility.
