Deciphera Pharmaceuticals Announces Late-Breaking Oral Presentation of Pivotal Phase 3 INVICTUS Data at the European Society ...
September 05 2019 - 7:00AM
Business Wire
Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage
biopharmaceutical company focused on addressing key mechanisms of
tumor drug resistance, today announced that data from the Company’s
INVICTUS pivotal Phase 3 study of ripretinib in patients with
fourth-line and fourth-line plus gastrointestinal stromal tumors
(GIST) has been selected as an oral presentation at the European
Society for Medical Oncology (ESMO) 2019 Congress to be held
September 27 – October 1, in Barcelona, Spain.
“We look forward to the first presentation of the INVICTUS Phase
3 data in an oral session at ESMO later this month,” said Steve
Hoerter, President and Chief Executive Officer of Deciphera. “The
INVICTUS data have given us confidence that ripretinib has the
potential to fundamentally transform the treatment paradigm for
patients with advanced GIST who have no approved treatment options.
We expect that these data will serve as the basis for our first
NDA, which we plan to submit in the first quarter of 2020.”
Presentation information is as follows:
Session Type: Late-Breaking Abstract, Proffered Paper
Session Session Title: Proffered Paper - Sarcoma (ID 249)
Title: INVICTUS: A Phase 3, INterVentional, Double-Blind,
Placebo-Controlled Study to Assess the Safety and Efficacy of
Ripretinib as ≥4th-Line Therapy In Patients With AdvanCed
Gastrointestinal Stromal TUmorS (GIST) Who have Received Treatment
With Prior Anticancer Therapies (NCT03353753) (ID 4794)
Presentation Number: LBA87 Date and Time: Monday,
September 30, 2:45 – 2:57 PM CET Location: Malaga Auditorium
(Hall 5) Speaker: Margaret von Mehren, MD, Department of
Medical Oncology, Fox Chase Cancer Center, Philadelphia,
Pennsylvania
About Ripretinib
Ripretinib is an investigational KIT and PDGFRα kinase switch
control inhibitor in clinical development for the treatment of KIT
and/or PDGFRα-driven cancers, including gastrointestinal stromal
tumors, or GIST, systemic mastocytosis, or SM, and other cancers.
Ripretinib was specifically designed to improve the treatment of
patients with GIST by inhibiting a broad spectrum of mutations in
KIT and PDGFRα. Ripretinib is a KIT and PDGFRα inhibitor that
inhibits initiating and secondary KIT mutations in exons 9, 11, 13,
14, 17, and 18, involved in GIST, as well as the primary D816V exon
17 mutation involved in SM. Ripretinib also inhibits primary PDGFRα
mutations in exons 12, 14 and 18, including the exon 18 D842V
mutation, involved in a subset of GIST. In June 2019, the U.S. FDA
granted Fast Track Designation to ripretinib for the treatment of
patients with advanced GIST who have received prior treatment with
imatinib, sunitinib and regorafenib.
Deciphera Pharmaceuticals has an exclusive license agreement
with Zai Lab (Shanghai) Co., Ltd. for the development and
commercialization of ripretinib in Greater China (Mainland China,
Hong Kong, Macau and Taiwan). Deciphera Pharmaceuticals retains
development and commercial rights for ripretinib in the rest of the
world.
About Deciphera Pharmaceuticals
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical
company focused on improving the lives of cancer patients by
tackling key mechanisms of drug resistance that limit the rate
and/or durability of response to existing cancer therapies. Our
small molecule drug candidates are directed against an important
family of enzymes called kinases, known to be directly involved in
the growth and spread of many cancers. We use our deep
understanding of kinase biology together with a proprietary
chemistry library to purposefully design compounds that maintain
kinases in a “switched off” or inactivated conformation. These
investigational therapies comprise tumor-targeted agents designed
to address therapeutic resistance causing mutations and
immuno-targeted agents designed to control the activation of
immunokinases that suppress critical immune system regulators, such
as macrophages. We have used our platform to develop a diverse
pipeline of tumor-targeted and immuno-targeted drug candidates
designed to improve outcomes for patients with cancer by improving
the quality, rate and/or durability of their responses to
treatment.
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, statements
regarding our expectations regarding reporting additional data from
our INVICTUS pivotal Phase 3 study of ripretinib in GIST patients
at an upcoming medical meeting, the potential for the results of
our INVICTUS pivotal Phase 3 clinical study to support a NDA
submission, the timing of our planned NDA submission for fourth and
fourth-line plus GIST, the potential for ripretinib and our other
drug candidates based on our kinase switch control inhibitor
platform to provide clinical benefit and treat cancers such as GIST
and other possible indications, and preparations for seeking
regulatory approval for and making ripretinib available to patients
with fourth-line and fourth-line plus GIST, if approved,. The words
“may,” “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “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, risks and uncertainties related to the delay of any
current or planned clinical studies or the development of our drug
candidates, including ripretinib, our ability to successfully
demonstrate the efficacy and safety of our drug candidates
including in later-stage studies, the preclinical and clinical
results for our drug candidates, which may not support further
development of such drug candidates, actions of regulatory
agencies, any or all of which may affect the initiation, timing and
progress of clinical studies and regulatory development and other
risks identified in our SEC filings, including our Quarterly Report
on Form 10-Q for the quarter ended June 30, 2019, 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.
Any forward-looking statements contained in this press release
represent our views only as of the date hereof and should not be
relied upon as representing its views as of any subsequent date. We
explicitly disclaim any obligation to update any forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20190905005301/en/
Investor Relations: Jen Robinson Deciphera Pharmaceuticals, Inc.
jrobinson@deciphera.com 781-906-1112 Media: David
Rosen Argot Partners David.Rosen@argotpartners.com
212-600-1902
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