- Data from Phase 1 Study Supports Ongoing
INTRIGUE Phase 3 Clinical Study in Patients with Second-line GIST
–
- Median Progression Free Survival (mPFS)
Sustained across All Cohorts -
- Additional Phase 1 Results Expected to be
Presented at Upcoming Medical Meeting -
- Company to Host Conference Call Today at 8:00
AM ET -
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage
biopharmaceutical company focused on addressing key mechanisms of
tumor drug resistance, today reported updated data from its ongoing
Phase 1 clinical study of ripretinib, a broad-spectrum KIT and
PDGFRα inhibitor, in patients with second-line through fourth-line
plus gastrointestinal stromal tumors (GIST).
In a separate press release issued today, Deciphera announced
positive top-line results from its INVICTUS pivotal Phase 3
clinical study supporting a potential new drug application (NDA)
submission to the U.S. Food and Drug Administration (FDA) for
ripretinib for the treatment of patients with advanced GIST who
have received prior treatment with imatinib, sunitinib and
regorafenib. In addition to the INVICTUS data, Deciphera will also
be submitting in its NDA supportive data from the ongoing Phase 1
clinical study, which will include the updated data from GIST
patients at doses of >100mg of
ripretinib. Additional results from the Phase 1 clinical study in
these patients are expected to be presented at an upcoming medical
meeting.
“We believe the updated data from our ongoing Phase 1 clinical
study, with the additional six months of maturity from our last
Phase 1 data cut-off, continue to support ripretinib’s potential
across the broad range of KIT and PDGFRα mutations known to occur
in patients with GIST following therapy with imatinib,” said Steve
Hoerter, President and Chief Executive Officer of Deciphera. “In
the updated data from the second-line cohort, we believe ripretinib
has demonstrated encouraging clinical benefit based on the
objective response rate, disease control rate and median
progression free survival rates observed. These results strengthen
our confidence in the INTRIGUE pivotal Phase 3 clinical study
comparing ripretinib to sunitinib, the standard of care for
patients receiving second-line treatment for GIST.”
Updated Phase 1 Data
Updated data from 178 GIST patients receiving ripretinib at
doses of >100mg daily are noted in
the table below as of March 1, 2019. The table includes
investigator-assessed objective response rate (ORR) by best
response, disease control rate (DCR) and median progression free
survival (mPFS), all of which were determined by Response
Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Line of Therapy(1)
Objective Response Rate by
Best Response
Includes Unconfirmed
(Confirmed Only)
Disease Control Rate
at 3 Months
Median Progression Free
Survival (mPFS)
Censored Patients for
mPFS
Mean Treatment
Duration(2)(3)
Second-Line (n=37)
30% (22%)
81%
42 weeks
38%
43 weeks
Third-Line (n=31)
23% (13%)
80%
40 weeks
32%
48 weeks
Fourth-Line (n=60)
15% (8%)
73%
30 weeks
30%
49 weeks
≥Fourth-Line (n=110)(4)
11% (7%)
66%
24 weeks
22%
41 weeks
(1) Overall number of patients (n=178) remains the same as prior
data presented at ESMO 2018; based on additional data cleaning, one
patient from each of 2nd line and 4th/≥4th line were reclassified
as 3rd line patients; (2) Median treatment durations were: 2nd line
= 44 weeks, 3rd line = 48 weeks, 4th line = 46 weeks and ≥4th line
= 29 weeks; (3) Includes 60 patients who elected for intra-patient
dose escalation from 150 mg QD to 150 mg BID; (4) Number of
patients includes 60 patients from 4th line.
Ripretinib was generally well tolerated and the updated adverse
events were consistent with previously presented Phase 1 data in
patients with GIST. Grade 3 or 4 treatment-emergent adverse events
(TEAEs) in >5% of patients were lipase increased (18%; n=33),
anemia (11%; n=20), hypertension (7%; n=13) and abdominal pain (6%;
n=11). 13% of patients (n=24) experienced TEAEs leading to study
treatment discontinuation, 17% of patients (n=31) experienced TEAEs
leading to dose reduction and 49% of patients (n=88) had TEAEs
leading to study drug interruption.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss
this announcement, as well as results from the INVICTUS Phase 3
clinical study, today, August 13, 2019 at 8:00 AM ET. To access the
live call by phone please dial 866-930-5479 (domestic) or
409-216-0603 (international); the conference ID is 8859018. A live
audio webcast of the event and accompanying slides may also be
accessed through the “Investors” section of Deciphera’s website at
www.deciphera.com. A replay of the webcast will be available for 30
days following the event.
About GIST
Gastrointestinal stromal tumor (GIST) is a cancer affecting the
digestive tract or nearby structures within the abdomen, most often
presenting in the stomach or small intestine. GIST is the most
common sarcoma of the gastrointestinal tract, with approximately
4,000 to 6,000 new GIST cases each year in the United States and a
similar incidence rate in European and other countries. Most cases
of GIST are driven by a spectrum of mutations. The most common
primary mutations are in KIT kinase, representing approximately 75%
to 80% of cases, or in PDGFRα kinase, representing approximately 5%
to 10% of cases. Current therapies are unable to inhibit the full
spectrum of primary and secondary mutations, which drives
resistance and disease progression. Estimates for 5-year survival
range from 48% to 90%, depending on the stage of the disease at
diagnosis.
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 the INTRIGUE Phase 3 Study
The INTRIGUE Phase 3 clinical study is an interventional,
randomized, global, multicenter, open-label study to evaluate the
safety, tolerability and efficacy of ripretinib compared to
sunitinib in patients with GIST previously treated with imatinib.
This study was designed to provide evidence of clinical benefit to
support regulatory approvals in second-line GIST patients in the
United States, Europe and other major markets. Patients will be
randomized 1:1 to either 150 mg of ripretinib once daily or 50 mg
of sunitinib once daily for four weeks followed by two weeks
without sunitinib. The primary efficacy endpoint is median
progression-free survival (mPFS) 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) and Overall Survival (OS). See
www.clinicaltrials.gov for further information (NCT03673501).
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.
Availability of Other Information About Deciphera
Pharmaceuticals
Investors and others should note that Deciphera Pharmaceuticals
communicates with its investors and the public using its company
website (www.deciphera.com), including but not limited to investor
presentations and scientific presentations, Securities and Exchange
Commission filings, press releases, public conference calls and
webcasts. The information that Deciphera Pharmaceuticals posts on
these channels and websites could be deemed to be material
information. As a result, Deciphera Pharmaceuticals encourages
investors, the media and others interested in Deciphera
Pharmaceuticals to review the information that it posts on these
channels, including Deciphera Pharmaceuticals’ investor relations
website, on a regular basis. This list of channels may be updated
from time to time on Deciphera Pharmaceuticals' investor relations
website and may include other social media channels than the ones
described above. The contents of Deciphera Pharmaceuticals' website
or these channels, or any other website that may be accessed from
its website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933, as
amended.
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 Phase 1 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, our
plans for and the data to be included in a NDA submission for
ripretinib, the potential for ripretinib (DCC-2618) 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, the prospects for and initiation of
and enrollment for our INTRIGUE pivotal Phase 3 study and our
confidence in such trial, preparations for and timing of a possible
NDA submission, and potential commercial launch of ripretinib in
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/20190813005236/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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