Deciphera Pharmaceuticals Announces Completion of Enrollment for Pivotal Phase 3 MOTION Study of Vimseltinib in TGCT
Deciphera Pharmaceuticals has announced the completion of enrollment in its pivotal Phase 3 MOTION study for vimseltinib, targeting patients with tenosynovial giant cell tumor (TGCT) not suitable for surgery. The company expects to release top-line results in Q4 2023.
Prior Phase 1/2 data indicated vimseltinib's promising clinical activity, with objective response rates at 69% in Phase 1 and 53% in Phase 2 Cohort A. The drug was well-tolerated, showing significant improvements in patient-reported pain and stiffness.
The MOTION study aims to validate vimseltinib's efficacy and safety as a potential best-in-class treatment for TGCT.
- Completion of enrollment in the pivotal Phase 3 MOTION study.
- Top-line results from the study expected in Q4 2023.
- Phase 1/2 study demonstrated objective response rates of 69% and 53%.
- Clinical benefit rate of 100% in Phase 1/2 patients.
- Vimseltinib showed favorable safety and tolerability.
- None.
– Top-line Results Expected in the Fourth Quarter of 2023 –
– Phase 1/2 Data Demonstrated Vimseltinib’s Best-in-Class Potential for the Treatment of TGCT –
“The rapid enrollment of the pivotal Phase 3 MOTION study underscores both the substantial unmet medical need for a highly effective and well-tolerated drug for patients with TGCT and the best-in-class therapeutic potential of vimseltinib,” said
In
Phase 3 MOTION Study
The ongoing pivotal Phase 3 MOTION study of vimseltinib for the treatment of TGCT, which has completed enrollment, is a two-part, randomized, double-blind, placebo-controlled study of vimseltinib to assess the efficacy and safety in patients with TGCT not amenable to surgery. The primary endpoint of the study is objective response rate at week 25 as measured by RECIST version 1.1 by blinded independent radiologic review. For more information about the clinical trial design, please visit https://www.clinicaltrials.gov/ct2/show/NCT05059262.
About Vimseltinib
Vimseltinib is an investigational, orally administered, potent and highly selective switch-control kinase inhibitor of CSF1R. It was discovered using Deciphera’s proprietary drug discovery platform and was designed to selectively bind to the CSF1R switch pocket. Vimseltinib has demonstrated encouraging preliminary efficacy and safety data in patients with TGCT and is currently being evaluated in a Phase 1/2 clinical study. Phase 1 is the dose escalation portion of the study, Cohort A includes TGCT patients with no prior anti-CSF1/CSF1R therapy (previous therapy with imatinib or nilotinib is allowed) and Cohort B includes patients with prior anti-CSF1/CSF1R therapy. The Phase 3 MOTION study is a two-part, randomized, double-blind, placebo-controlled study of vimseltinib to assess the efficacy and safety in patients with symptomatic TGCT who are not amenable to surgery, and has completed enrollment.
About
Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera’s switch-control inhibitor for the treatment of fourth-line GIST. QINLOCK is approved in
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, our expectations and timing regarding the potential for vimseltinib to be a best-in-class treatment, if approved, and the topline readout for the pivotal Phase 3 MOTION study. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, our ability to successfully demonstrate the efficacy and safety of our drug or drug candidates, the preclinical or clinical results for our product candidates, which may not support further development of such product candidates, comments, feedback and actions of regulatory agencies, our ability to commercialize QINLOCK and execute on our marketing plans for any drugs or indications that may be approved in the future, the inherent uncertainty in estimates of patient populations, competition from other products, our ability to obtain and maintain reimbursement for any approved product and the extent to which patient assistance programs are utilized and other risks identified in our
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are registered trademarks of
View source version on businesswire.com: https://www.businesswire.com/news/home/20230301005309/en/
Investor Relations:
Deciphera@argotpartners.com
212-600-1902
Media:
david.rosen@argotpartners.com
212-600-1902
Source:
FAQ
What are the top-line results expected for vimseltinib in Q4 2023?
What was the response rate in the Phase 1/2 study of vimseltinib?
What is vimseltinib being tested for?
What is the design of the Phase 3 MOTION study for vimseltinib?
What is the significance of vimseltinib's safety profile?
