- Preliminary Anti-tumor Activity Observed in
Initial Diffuse-type TGCT Patients Treated with DCC-3014 in Ongoing
Phase 1 Study -
- DCC-3014 was Generally Well Tolerated with No
Reported Grade 3 or Higher TEAEs in Initial Diffuse-Type TGCT
Patients -
- Encore Presentation of Results from the
INVICTUS Pivotal Phase 3 Study of Ripretinib in Advanced GIST to be
Featured in Oral Presentation Session -
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced
preliminary data from the ongoing Phase 1 study of DCC-3014, an
oral inhibitor of CSF1R, including initial data in diffuse-type
tenosynovial giant cell tumor (TGCT) patients as well as an encore
presentation of the INVICTUS pivotal Phase 3 study of ripretinib, a
broad-spectrum KIT and PDGFRα inhibitor, in patients with advanced
gastrointestinal stromal tumors (GIST). Results from these programs
will be presented at the Connective Tissue Oncology Society (CTOS)
2019 Annual Meeting being held November 13-16 in Tokyo, Japan.
“We are excited to share preliminary data from the initial TGCT
patients enrolled in the ongoing Phase 1 study of DCC-3014. While
this program in TGCT is in its early stages, we are encouraged by
the preliminary evidence of anti-tumor activity and emerging
tolerability profile,” said Matthew L. Sherman, M.D., Executive
Vice President and Chief Medical Officer of Deciphera. “We plan to
continue to enroll TGCT patients to further explore the potential
of DCC-3014, with the goal of making a meaningful impact on disease
progression and, importantly, quality of life for patients with
TGCT.”
Preliminary Data from DCC-3014 in
Initial TGCT Patients
The Company’s Phase 1 study of DCC-3014 was designed to evaluate
the safety, pharmacokinetics, and pharmacodynamics of multiple
doses of DCC-3014 in patients with advanced solid tumors and TGCT.
Tumor reductions from baseline were determined by investigator
assessment by Response Evaluation Criteria in Solid Tumors (RECIST)
version 1.1. The CTOS presentation highlights preliminary results
from the initial three TGCT patients enrolled in the
dose-escalation portion of the Phase 1 study. Safety,
pharmacokinetic, and pharmacodynamic data were analyzed as of
September 10, 2019, with additional anti-tumor activity data
reported as of November 8, 2019.
- All three patients with diffuse-type TGCT treated as of the
data analyses dates showed preliminary anti-tumor activity.
- As of their first tumor assessment at Cycle 3 Day 1, tumor
reductions from baseline of 48%, 25% and 24%, respectively, were
observed.
- One patient had a confirmed partial response, which has been
sustained for nine months and is ongoing as of the most recent
investigator report, with a tumor reduction from baseline of 84% as
of Cycle 10 Day 1.
- Symptomatic improvements in mobility and reduced pain, as
reported by the investigator, were observed.
- These patients were enrolled in Cohort 5 (30 mg loading dose
daily for 5 days followed by a maintenance dose of 30 mg twice a
week).
- DCC-3014 was generally well-tolerated, with no grade 3 or
higher treatment-emergent adverse events (TEAEs) observed.
- Two patients remained on study as of the November data analyses
date. One patient discontinued in Cycle 4 due to relocation outside
of the U.S.
- Dose-escalation evaluation is ongoing to determine the
recommended Phase 2 dose for advanced solid tumors and diffuse-type
TGCT.
Results from the INVICTUS Pivotal Phase
3 Study of Ripretinib
An encore presentation of results from the INVICTUS pivotal
Phase 3 study of ripretinib in advanced GIST will be featured
during an oral presentation session. INVICTUS is a randomized
(2:1), double-blind, placebo-controlled, international, multicenter
study to evaluate the safety, tolerability, and efficacy of
ripretinib compared to placebo in 129 patients with advanced GIST
whose previous therapies have included at least imatinib,
sunitinib, and regorafenib. As previously reported, the study
achieved the primary endpoint of improved progression free survival
(PFS) compared to placebo in patients with fourth-line and
fourth-line plus GIST, as determined by blinded independent central
radiologic review using modified RECIST version 1.1.
Based on the positive INVICTUS data, the Company expects to
submit an NDA to the U.S. Food and Drug Administration (FDA) for
ripretinib for the treatment of patients with advanced GIST who
have prior treatment with imatinib, sunitinib and regorafenib in
the first quarter of 2020.
Presentation Details
Poster Presentation:
Poster Title: Phase 1 study of DCC-3014 to assess the
safety, tolerability, pharmacokinetics, and pharmacodynamics, in
patients with malignant solid and diffuse-type tenosynovial giant
cell tumor Author: Breelyn Wilky, M.D., Associate Professor,
Department of Medicine, Division of Medical Oncology, University of
Colorado Cancer Center, University of Colorado School of Medicine
Poster Viewing Reception Date and Time: Thursday, November
14, 2019, 5:30 – 6:30 PM JST Location: 3rd Floor, Hilton
Tokyo Hotel Abstract Number: 3241734
Oral Presentation:
Poster Title: INVICTUS: A Phase 3, interventional,
double-blind, placebo-controlled study to assess the safety and
efficacy of ripretinib (DCC-2618) in patients with advanced
gastrointestinal stromal tumors (GIST) who have received treatment
with prior anticancer therapies (NCT03353753) Session Title:
GIST Author: Jean-Yves Blay, M.D., General Director, Centre
Léon Bérard and Université Claude Bernard Lyon 1, Lyon, France
Presentation Date and Time: Friday, November 15, 2019, 1:00-
1:12 PM JST Location: Kiku Ballroom, Hilton Tokyo Hotel
Abstract Number: 3254072
A copy of each presentation is available at
www.deciphera.com/science/presentation-publications/.
About DCC-3014
DCC-3014 is an investigational, orally administered, potent and
highly selective inhibitor of CSF1R. DCC-3014 was designed using
the Company’s proprietary switch control kinase inhibitor platform
to selectively bind to the CSF1R switch pocket. DCC-3014 has
greater than 100-fold selectivity for CSF1R over other closely
related kinases and has an even greater selectivity for CSF1R over
approximately 300 other human kinases. CSF1R controls the
differentiation and function of macrophages including
tumor-associated macrophages (TAMs) whose density within certain
tumors including cancers of the breast, cervix, pancreas, bladder
and brain, as well as tenosynovial giant cell tumors (TGCT),
correlates with poor prognosis. Tumors induce TAMs to suppress a
natural immune response mediated by cytotoxic T-cells, a type of
lymphocyte that would otherwise eradicate the tumor; a process
known as macrophage checkpoints. Through inhibition of CSF1R,
DCC-3014 has in preclinical studies demonstrated potent macrophage
checkpoint inhibition as both a single agent and in combination
with PD1 inhibitors. DCC-3014 is currently being evaluated in a
Phase 1 clinical study. For more information about the clinical
trial design please visit www.clinicaltrials.gov (NCT03069469).
About Ripretinib
Ripretinib is an investigational tyrosine kinase switch control
inhibitor that was engineered to broadly inhibit KIT and PDGFRα
mutated kinases by using a unique dual mechanism of action that
regulates the kinase switch pocket and activation loop. Ripretinib
is currently 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 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. In October
2019, FDA granted Breakthrough Therapy Designation (BTD) for
ripretinib for the treatment of patients with advanced GIST who
have received prior treatment with imatinib, sunitinib and
regorafenib. For more information about the Company’s clinical
trials with ripretinib, please visit www.clinicaltrials.gov.
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
addressing key mechanisms of drug resistance that limit the rate
and/or durability of response to existing cancer therapies. Our
small molecule product 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, and
agents designed to inhibit reprogramming of cancer cell metabolism.
We have used our platform to develop a diverse pipeline of
tumor-targeted, immuno-targeted, and metabolism-targeted product
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 our ongoing Phase 1 study of
DCC-3014, our plans to continue to enroll TGCT patients in this
study, the potential benefits of DCC-3014 in patients with TGCT and
other cancers, our planned potential NDA submission with FDA for
ripretinib for patients with advanced GIST and the timing of such
filing, the breakthrough therapy designation of ripretinib for
patients with advanced GIST, and the potential of our pipeline
product candidates to improve the lives of patients with cancer.
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
product candidates, including ripretinib, our ability to
successfully demonstrate the efficacy and safety of our product
candidates including in later-stage studies, the preclinical and
clinical results for our product candidates, which may not support
further development of such product candidates, the possibility
that results experienced in early, preliminary, top-line or initial
data, including preliminary data from initial TGCT patients in our
Phase 1 study of DCC-3014, may not be indicative of the results
experienced in final data, our ability to timely complete and
prepare the information required for and file an NDA for
ripretinib, the fact that receipt of a breakthrough therapy
designation for a product candidate, such as ripretinib, may not
result in us receiving any of the benefits of such designation, our
ability to manage and our reliance on third parties such as our
third party drug substance and drug product contract manufacturers,
actions of regulatory agencies, any or all of which may affect the
initiation, timing and progress of clinical studies and the timing
of and our ability to obtain regulatory approval, if at all, and
make our investigational drugs available to patients, and other
risks identified in our SEC filings, including our Quarterly Report
on Form 10-Q for the quarter ended September 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/20191113005738/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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