Long-term efficacy, clinical outcomes, and safety of vimseltinib in patients with tenosynovial giant cell tumor: results from the MOTION phase 3 trial
Abstract
Background: Tenosynovial giant cell tumor (TGCT) is a locally aggressive neoplasm caused by colony-stimulating factor 1 (CSF1) gene dysregulation. Vimseltinib is an oral, switch-control tyrosine kinase inhibitor of the CSF1 receptor. In part 1 of the MOTION phase 3 trial, vimseltinib demonstrated statistically significant and clinically meaningful improvements in antitumor activity and clinical outcome assessments (COAs). Here, we report long-term results from MOTION in patients with >2 years of follow-up on study.
Methods: MOTION is a randomized, double-blind, placebo-controlled, phase 3 trial with double-blind (part 1; to week 25), open-label (part 2; weeks 25-49), and extension periods (NCT05059262). Eligible adult patients with histologically confirmed TGCT not amenable to surgery received vimseltinib 30 mg twice weekly. Efficacy was assessed by objective response rate (ORR) on study evaluated by independent radiological review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and Tumor Volume Score. COAs and safety were assessed.
Results: In total, 118 patients received vimseltinib during MOTION (randomized to vimseltinib, n = 83; crossover, n = 35), with 51% (60/118) remaining on treatment. ORR on study per RECIST v1.1 was 48% (40/83) for patients randomized to vimseltinib and 54% (19/35) for crossover. Patients in both groups experienced long-term improvements in COAs. The safety profile was consistent with prior reports, with no evidence of cholestatic hepatotoxicity or drug-induced liver injury.
Conclusion: Vimseltinib continued to provide robust and durable antitumor activity and demonstrated long-term improvements in COAs, with manageable safety for the treatment of patients with TGCT not amenable to surgery.
Related
- Safety and efficacy of lacnotuzumab, a colony-stimulating factor 1 antibody for the treatment of tenosynovial giant cell tumors: a randomized phase II trial
- Short-term clinical efficacy and recorded adverse events of semaglutide combined with dapagliflozin in patients with type 2 diabetes mellitus and chronic kidney disease
- Evaluation of the efficacy of duloxetine and venlafaxine in chemotherapy-induced neuropathy in cancer patients: a double-blind multicenter randomized clinical trial
- Evaluation of the clinical efficacy of repeated intra-articular injections of stanozolol in canine patients with spontaneous osteoarthritis
- Efficacy and safety of narlumosbart in combination with stereotactic body radiation therapy followed by first-line chemotherapy combined with immunotherapy in advanced driver gene-negative non-small cell lung cancer patients with bone metastases: a phase II, single-arm, single-centre clinical trial protocol
BibTeX
@article{bhadri2026longterm,
title = {{Long-term efficacy, clinical outcomes, and safety of vimseltinib in patients with tenosynovial giant cell tumor: results from the MOTION phase 3 trial}},
author = {Vivek Bhadri and Hans Gelderblom and Silvia Stacchiotti and Sebastian Bauer and Andrew J Wagner and Michiel van de Sande and Nicholas M Bernthal and Antonio López Pousa and Albiruni Abdul Razak and Antoine Italiano and Mahbubl Ahmed and Axel Le Cesne and Gabriel Tinoco and Kjetil Boye and Javier Martín-Broto and Emanuela Palmerini and Salvatore Tafuto and Sarah Pratap and Benjamin C Powers and Peter Reichardt and Antonio Casado Herráez and Piotr Rutkowski and Christopher Tait and Giulia Agnello and Brooke Harrow and Amanda Saunders and Maitreyi G Sharma and Matthew L Sherman and Jean-Yves Blay and William D Tap},
journal = {The Oncologist},
year = {2026},
month = oct,
doi = {10.1093/oncolo/oyag421},
url = {https://doi.org/10.1093/oncolo/oyag421},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Long-term efficacy, clinical outcomes, and safety of vimseltinib in patients with tenosynovial giant cell tumor: results from the MOTION phase 3 trial
AU - Vivek Bhadri
AU - Hans Gelderblom
AU - Silvia Stacchiotti
AU - Sebastian Bauer
AU - Andrew J Wagner
AU - Michiel van de Sande
AU - Nicholas M Bernthal
AU - Antonio López Pousa
AU - Albiruni Abdul Razak
AU - Antoine Italiano
AU - Mahbubl Ahmed
AU - Axel Le Cesne
AU - Gabriel Tinoco
AU - Kjetil Boye
AU - Javier Martín-Broto
AU - Emanuela Palmerini
AU - Salvatore Tafuto
AU - Sarah Pratap
AU - Benjamin C Powers
AU - Peter Reichardt
AU - Antonio Casado Herráez
AU - Piotr Rutkowski
AU - Christopher Tait
AU - Giulia Agnello
AU - Brooke Harrow
AU - Amanda Saunders
AU - Maitreyi G Sharma
AU - Matthew L Sherman
AU - Jean-Yves Blay
AU - William D Tap
PY - 2026
DA - 2026/10/19
JO - The Oncologist
DO - 10.1093/oncolo/oyag421
UR - https://doi.org/10.1093/oncolo/oyag421
AB - Background: Tenosynovial giant cell tumor (TGCT) is a locally aggressive neoplasm caused by colony-stimulating factor 1 (CSF1) gene dysregulation. Vimseltinib is an oral, switch-control tyrosine kinase inhibitor of the CSF1 receptor. In part 1 of the MOTION phase 3 trial, vimseltinib demonstrated statistically significant and clinically meaningful improvements in antitumor activity and clinical outcome assessments (COAs). Here, we report long-term results from MOTION in patients with >2 years of follow-up on study. Methods: MOTION is a randomized, double-blind, placebo-controlled, phase 3 trial with double-blind (part 1; to week 25), open-label (part 2; weeks 25-49), and extension periods (NCT05059262). Eligible adult patients with histologically confirmed TGCT not amenable to surgery received vimseltinib 30 mg twice weekly. Efficacy was assessed by objective response rate (ORR) on study evaluated by independent radiological review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and Tumor Volume Score. COAs and safety were assessed. Results: In total, 118 patients received vimseltinib during MOTION (randomized to vimseltinib, n = 83; crossover, n = 35), with 51% (60/118) remaining on treatment. ORR on study per RECIST v1.1 was 48% (40/83) for patients randomized to vimseltinib and 54% (19/35) for crossover. Patients in both groups experienced long-term improvements in COAs. The safety profile was consistent with prior reports, with no evidence of cholestatic hepatotoxicity or drug-induced liver injury. Conclusion: Vimseltinib continued to provide robust and durable antitumor activity and demonstrated long-term improvements in COAs, with manageable safety for the treatment of patients with TGCT not amenable to surgery.
SN - 1083-7159
SN - 1549-490X
ER -