WALTHAM, Mass.--(BUSINESS WIRE)--Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced that it has initiated a Phase 3 clinical study to evaluate the safety and efficacy of DCC-2618, a pan-KIT and PDGFRα inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST).
“We are extremely pleased to initiate the INVICTUS study with DCC-2618 in heavily pretreated GIST patients, specifically fourth-line and fourth-line plus patients,” said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. “We expect to report top-line results in 2019 and, if successful, this pivotal Phase 3 study could serve as the basis for a New Drug Application (NDA), providing a much-needed therapeutic option for these patients for whom there are no approved treatments. We also plan to initiate a second Phase 3 study later this year evaluating DCC-2618 in second-line GIST patients who have progressed or are intolerant to front-line therapy with imitanib.”
“While effective treatments are available for patients with early-stage GIST, in 9 out 10 patients the disease will eventually progress due to the development of secondary drug resistance mutations,” said Professor Jean-Yves Blay, Medical Oncologist, General Director Centre Léon Bérard, Comprehensive cancer Centre of Lyon, France. “A therapy with the potential to provide broad coverage across the full spectrum of KIT and PDGFRα mutations would represent a much-needed improvement over currently approved treatment options for patients with later-stage GIST.”
Initiation of the INVICTUS study follows results from the ongoing Phase 1 clinical trial presented at the European Society for Medical Oncology (ESMO) Congress in September 2017, in which durable disease control by DCC-2618 was observed in heavily pretreated patients with GIST.
INVICTUS Phase 3 Study
The INVICTUS Phase 3 clinical
study is a randomized, double-blind, placebo-controlled, international,
multicenter trial to evaluate the safety, tolerability, and efficacy of
DCC-2618 compared to placebo in patients with advanced GIST patients
whose previous therapies have included imatinib, sunitinib, and
regorafenib. The trial is expected to enroll approximately 120 patients
randomized 2:1 to either 150 mg once daily of DCC-2618 or placebo. The
primary efficacy endpoint is median progression free survival (PFS) as
determined by independent radiologic review using modified Response
Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints as
determined by independent radiologic review using modified RECIST
include Objective Response Rate (ORR); Time to Tumor Progression (TTP);
and Overall Survival (OS). See www.clinicaltrials.gov
for further information (NCT03353753).
About DCC-2618
DCC-2618 is a pan-KIT and PDGFRα kinase
switch control inhibitor in clinical development for the treatment of
KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal
tumors, glioblastoma multiforme and systemic mastocytosis. DCC-2618 was
specifically designed to improve the treatment of GIST patients by
inhibiting the full spectrum of mutations in KIT and PDGFRα. DCC-2618 is
a pan-KIT and pan-PDGFRα inhibitor that blocks initiating KIT mutations
in exons 9, 11, 13, 14, 17, and 18, known to be present in GIST patients
and the D816V exon 17 mutation known to be present in ASM patients.
DCC-2618 inhibits PDGFRα mutations in exon 18, including the D842V
mutation that drives a subset of GIST.
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.
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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 the potential for
DCC-2618 to treat GIST; statements regarding the potential benefits to
patients of DCC-2618; statements regarding plans and timelines for the
clinical development of DCC-2618; and Deciphera Pharmaceuticals’
strategy, business plans and focus. 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, statements regarding the
potential for DCC-2618 to treat GIST; statements regarding the potential
benefits to patients of DCC-2618; statements regarding plans and
timelines for the clinical development of DCC-2618; and Deciphera
Pharmaceuticals’ strategy, business plans and focus. These and other
risks and uncertainties are described in greater detail in the section
entitled "Risk Factors" in Deciphera Pharmaceuticals’ most recent
quarterly report on Form 10-Q, and other filings that Deciphera
Pharmaceuticals may make with the SEC in the future. Any forward-looking
statements contained in this press release represent Deciphera
Pharmaceuticals' views only as of the date hereof and should not be
relied upon as representing its views as of any subsequent date.
Deciphera Pharmaceuticals explicitly disclaims any obligation to update
any forward-looking statements.
