– 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 –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
biopharmaceutical company focused on discovering, developing, and
commercializing important new medicines to improve the lives of
people with cancer, today announced the completion of enrollment in
the pivotal Phase 3 MOTION study of vimseltinib in patients with
tenosynovial giant cell tumor (TGCT) not amenable to surgery.
Deciphera expects to report top-line results in the fourth quarter
of 2023.
“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 Matthew
L. Sherman, M.D., Chief Medical Officer of Deciphera. “Results from
the Phase 1/2 study of vimseltinib have demonstrated not only its
compelling clinical activity, but also the favorable safety and
tolerability profile essential for TGCT patients. We look forward
to reporting top-line results from the MOTION study later this
year.”
In September 2022, Deciphera presented updated results from the
ongoing Phase 1/2 study of vimseltinib in TGCT at the European
Society for Medical Oncology (ESMO) Congress. The results showed
objective response rates of 69% in Phase 1, 53% in Phase 2 Cohort
A, and 46% in Phase 2 Cohort B, with a demonstrated clinical
benefit rate of 100% across all Phase 1/2 patients. Preliminary
patient-reported outcome data in the Phase 2 portion demonstrated
clinically meaningful improvements in pain and stiffness at week 25
compared to baseline. Treatment with vimseltinib across all Phase
1/2 patients was well-tolerated. The full Phase 1/2 data for
vimseltinib in TGCT presented at ESMO can be accessed here:
https://investors.deciphera.com/news-releases/news-release-details/deciphera-pharmaceuticals-inc-presents-updated-phase-12-data.
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 Pharmaceuticals
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 Australia, Canada, China, the European
Union, Hong Kong, Israel, Macau, New Zealand, Switzerland, Taiwan,
the United Kingdom, and the United States. For more information,
visit www.deciphera.com and follow us on LinkedIn and Twitter
(@Deciphera).
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 Securities and Exchange
Commission (SEC) filings, including our Annual Report on Form 10-K
for the year ended December 31, 2022, and subsequent filings with
the SEC. We caution you not to place undue reliance on any
forward-looking statements, which speak only as of the date they
are made. We disclaim any obligation to publicly update or revise
any such statements to reflect any change in expectations or in
events, conditions or circumstances on which any such statements
may be based, or that may affect the likelihood that actual results
will differ from those set forth in the forward-looking
statements.
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are
registered trademarks of Deciphera Pharmaceuticals, LLC.
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version on businesswire.com: https://www.businesswire.com/news/home/20230301005309/en/
Investor Relations: Maghan Meyers Argot Partners
Deciphera@argotpartners.com 212-600-1902
Media: David Rosen Argot Partners
david.rosen@argotpartners.com 212-600-1902
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