– MOTION Phase 3 Data Demonstrate Robust
Efficacy, Clinically Meaningful Improvements in Quality-of-Life
Measures, and Well-Tolerated Safety Profile, Positioning
Vimseltinib as Potential New TGCT Treatment –
– Company Expects to Submit a New Drug
Application (NDA) in the Second Quarter of 2024 and Marketing
Authorisation Application (MAA) in the Third Quarter of 2024 –
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 that results from the Company’s
MOTION pivotal Phase 3 study of vimseltinib in patients with TGCT
are being highlighted in an oral presentation at the 2024 American
Society of Clinical Oncology (ASCO) Annual Meeting, being held in
Chicago, Illinois, and have been published in The Lancet.
The article titled “Vimseltinib versus placebo for tenosynovial
giant cell tumour (MOTION): a randomised phase 3 trial” is now
available online and will be published in a future print issue of
The Lancet.
“The results from the MOTION pivotal Phase 3 study provide
compelling evidence that vimseltinib can address the unmet medical
need in TGCT for an effective and well-tolerated therapy without
cholestatic hepatotoxicity,” said Hans Gelderblom, M.D., Ph.D.,
Chair of the Department of Medical Oncology at Leiden University
Medical Center and senior author of the manuscript. “In addition to
its robust antitumor activity and tolerability, vimseltinib also
demonstrated clinically significant functional and symptomatic
improvements in key quality-of-life measures, which can provide
long-term, meaningful benefits to TGCT patients.”
“Building upon the strong efficacy results disclosed previously
at topline, we are excited to share details on the statistically
significant and clinically meaningful improvements that vimseltinib
offered TGCT patients across all six key secondary endpoints, along
with its favorable safety profile,” said Matthew L. Sherman, M.D.,
Executive Vice President and Chief Medical Officer of Deciphera.
“We remain on track to submit an NDA for vimseltinib in the second
quarter of 2024, and an MAA in the third quarter of 2024, and look
forward to bringing this important new therapy to TGCT patients
globally.”
In addition to the results from the MOTION pivotal Phase 3
study, the Company will also be presenting a trial-in-progress
poster for the ongoing Phase 1/2 study of DCC-3116 in combination
with ripretinib at the 2024 ASCO Annual Meeting.
Both presentations are available on the Company’s website at
www.deciphera.com/presentations-publications. Presentation details
are as follows:
Abstract Number: 11500 Title: Efficacy, safety,
and patient-reported outcomes of vimseltinib in patients with
tenosynovial giant cell tumor: Results from the phase 3 MOTION
trial. Presenter: William D. Tap, M.D., FASCO, Memorial
Sloan Kettering Cancer Center Presentation Date: Monday,
June 3, 2024 Presentation Time: 3:00 – 3:12 PM CT Key
Highlights:
- Study Design: The MOTION pivotal
Phase 3 study is a two-part, randomized, double-blind,
placebo-controlled study to assess the efficacy and safety of
vimseltinib in patients with TGCT not amenable to surgery with no
prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or
nilotinib allowed).
- In Part 1, patients (n=123) were randomized two-to-one to
receive either 30 mg twice weekly of vimseltinib (n=83) or placebo
(n=40) for 24 weeks. The results for Part 1 of the study are based
on a data cutoff date of August 22, 2023.
- The open-label Part 2 portion of MOTION, in which patients from
both the vimseltinib and placebo arms receive treatment with
vimseltinib, remains ongoing.
- ORR: The primary endpoint of the
study is ORR at Week 25 as measured by Response Evaluation Criteria
in Solid Tumors (RECIST) version 1.1 by blinded independent
radiologic review (IRR).
- The study met its primary endpoint in the intent-to-treat (ITT)
population demonstrating statistically significant and clinically
meaningful improvement versus placebo in ORR at Week 25 based on
IRR per RECIST v1.1.
- In the ITT population, the ORR at Week 25 was 40% (95% CI: 29%,
51%) for the vimseltinib arm and 0% (95% CI: 0%, 9%) for the
placebo arm resulting in a response difference (vimseltinib versus
placebo) of 40% (95% CI: 29%, 51%) (p<0.0001).
- Secondary Endpoints: In addition
to meeting the primary endpoint, the study also achieved
statistically significant and clinically meaningful improvements
versus placebo in all six key secondary endpoints assessed at Week
25 including ORR by tumor volume score (TVS), active range of
motion (ROM), physical function, stiffness, quality of life, and
pain.
- ORR by TVS: The ORR at Week 25
based on IRR per TVS was 67% (95% CI: 56%, 77%) for the vimseltinib
arm and 0% (95% CI: 0%, 9%) for the placebo arm (p<0.0001).
- Active ROM: Treatment with
vimseltinib demonstrated an improvement in mean change from
baseline in active ROM at Week 25 of 18.4% versus a 3.8%
improvement for placebo (p=0.0077).
- Physical Function by PROMIS-PF:
Treatment with vimseltinib demonstrated an improvement in mean
change from baseline in PROMIS-PF at Week 25 of 4.6 versus 1.3 for
placebo (p=0.0007).
- Worst Stiffness Numeric Rating Scale
(NRS): Patients treated with vimseltinib reported a decrease
of 2.1 versus 0.3 for placebo in worst stiffness
(p<0.0001).
- Quality of Life by EuroQol Visual
Analogue Scale (EQ-VAS): The mean change from baseline for
EQ-VAS was significantly higher with 13.5 in the vimseltinib arm
versus 6.1 in the placebo arm (p=0.016).
- Brief Pain Inventory (BPI) Worst Pain
Response Rate: The BPI worst pain response rate was 48% for
patients receiving vimseltinib versus 23% for placebo
(p=0.0056).
- Safety and Tolerability:
- Vimseltinib was well tolerated with most treatment-emergent
adverse events (TEAEs) were grade 1 or 2.
- There was no evidence of cholestatic hepatotoxicity,
drug-induced liver injury, or hair hypopigmentation.
- Serum enzyme elevations were consistent with the known
mechanism of action of CSF1R inhibitors.
- TEAEs leading to treatment discontinuation was 6% in the
vimseltinib arm.
- If approved, vimseltinib offers an effective systemic treatment
to patients with TGCT and provides proven functional health and
symptomatic benefit to a population living with substantial
morbidity and limited treatment options.
Abstract Number: TPS11587 Title: DCC-3116 in
combination with ripretinib for patients with advanced
gastrointestinal stromal tumor: A phase 1/2 study.
Presenter: Sreenivasa Chandana, M.D., Ph.D., START Midwest,
The Cancer & Hematology Centers Session Date: Saturday,
June 1, 2024 Session Time: 1:30 – 4:30 PM CT Key
Highlights:
- This is a phase 1/2, multicenter study designed to evaluate the
safety, tolerability, and efficacy of DCC-3116 in combination with
ripretinib.
- In Part 1, eligible patients will receive escalating oral doses
of DCC-3116 combined with ripretinib 150 mg once daily (QD); the
safety will be evaluated and the recommended phase 2 dose (RP2D)
will be determined.
- In Part 2, eligible patients will receive the RP2D of DCC-3116
in combination with ripretinib 150 mg QD; antitumor activity will
be evaluated.
- The trial is currently enrolling in the phase 1 dose escalation
portion.
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, Iceland, Israel, Liechtenstein, Macau, New
Zealand, Norway, Singapore, Switzerland, Taiwan, The United
Kingdom, and the United States. For more information, visit
https://www.deciphera.com/ and follow us on LinkedIn and X
(@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 our preclinical and/or
clinical stage pipeline assets to be first-in-class and/or
best-in-class treatments, the timing of our NDA and MAA submissions
for vimseltinib, and plans to present trial-in-progress poster for
the ongoing Phase 1/2 study of DCC-3116 in combination with
ripretinib at the 2024 ASCO Annual Meeting. 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: (i) risks associated
with the timing of the closing of the proposed transaction,
including the risks that a condition to closing would not be
satisfied within the expected timeframe or at all or that the
closing of the proposed transaction will not occur; (ii)
uncertainties as to how many of Deciphera’s stockholders will
tender their shares in the offer; (iii) the possibility that a
governmental entity may prohibit, delay or refuse to grant approval
for the consummation of the transaction; (iv) the possibility that
competing offers will be made; (v) the outcome of any legal
proceedings that may be instituted against the parties and others
related to the merger agreement; (vi) unanticipated difficulties or
expenditures relating to the proposed transaction, the response of
business partners and competitors to the announcement of the
proposed transaction, and/or potential difficulties in employee
retention as a result of the announcement and pendency of the
proposed transaction; (vii) Deciphera’s ability to successfully
demonstrate the efficacy and safety of its drug or drug candidates,
and the preclinical or clinical results for its product candidates,
which may not support further development of such product
candidates; (viii) comments, feedback and actions of regulatory
agencies; (ix) Deciphera’s ability to commercialize QINLOCK® and
execute on its marketing plans for any drugs or indications that
may be approved in the future; (x) the inherent uncertainty in
estimates of patient populations, competition from other products,
Deciphera’s ability to obtain and maintain reimbursement for any
approved product and the extent to which patient assistance
programs are utilized; and (xi) other risks identified in our
Securities and Exchange Commission (SEC) filings, including our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2024,
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.
The Deciphera logo and the QINLOCK® word mark and logo are
registered trademarks and the Deciphera word mark is a trademark of
Deciphera Pharmaceuticals, LLC.
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version on businesswire.com: https://www.businesswire.com/news/home/20240603284422/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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