– Median Progression-Free Survival for QINLOCK®
of 14.2 Months Versus 1.5 Months for Sunitinib –
– Objective Response Rate of 44.4% for QINLOCK
Versus 0% for Sunitinib –
– Median Overall Survival for QINLOCK was Not
Estimable Versus 17.5 Months for Sunitinib –
– Results Support Ongoing Pivotal Phase 3
INSIGHT Study –
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 Nature Medicine has
published results from a circulating tumor DNA (ctDNA) analysis of
the INTRIGUE Phase 3 study of QINLOCK (ripretinib) in GIST patients
with mutations in KIT exon 11 and 17/18 only previously treated
with imatinib.
The article, titled “Ripretinib versus sunitinib in
gastrointestinal stromal tumor: ctDNA biomarker analysis of the
phase 3 INTRIGUE trial” is now available online and will be
published in a future print issue of Nature Medicine.
“The results published in Nature Medicine provide compelling
evidence that QINLOCK may provide progression-free and overall
survival benefit to second-line (2L) GIST patients in whom a liquid
biopsy reveals primary KIT exon 11 mutations plus secondary
mutations restricted to KIT exons 17 and 18. It is the first test
that measures heterogeneity of resistance and may allow for a more
optimized and targeted treatment plan for people living with this
disease,” said Sebastian Bauer, M.D., Medical Oncologist at the
West German Cancer Center in Essen and senior author of the
manuscript. “This analysis is leading us to consider a new approach
in GIST treatment using sensitive and minimally invasive blood
tests to identify the specific secondary mutational profile for
individual patients in order to tailor their therapy based on the
differential activity of QINLOCK and sunitinib seen in the INTRIGUE
subgroup analysis.”
“In second-line GIST patients with KIT exon 11 + 17/18 mutations
only, treatment with QINLOCK resulted in a 78% reduction in the
risk of disease progression and a 66% reduction in the risk of
death compared to sunitinib, representing a substantial clinical
benefit for these patients,” said Matthew L. Sherman, M.D., Chief
Medical Officer of Deciphera. “Our ongoing INSIGHT pivotal Phase 3
study is designed to confirm the exceptional efficacy we observed
in this exploratory analysis from INTRIGUE. The INSIGHT study is
now open at multiple sites and we are committed to enrolling the
study as quickly as possible.”
INTRIGUE is an international, multi-center study conducted in
122 active sites across 22 countries, where 453 patients in the all
patient intent-to-treat population (AP-ITT) with second-line GIST
were randomized to receive ripretinib (n=226) or sunitinib
(n=227).
In the AP-ITT population, QINLOCK demonstrated similar efficacy
with a median progression-free survival (PFS) of 8.0 months versus
8.3 months for sunitinib (HR 1.05, nominal p=0.72). There were
fewer patients with Grade 3-4 drug-related treatment emergent
adverse events (TEAE) with QINLOCK (26.5%) compared with sunitinib
(55.2%). Based on the primary results from the INTRIGUE study,
QINLOCK was included in the National Comprehensive Cancer Network
Clinical Practice Guidelines in Oncology (version 1.2023) as the
preferred second-line regimen for patients with advanced GIST who
are intolerant to sunitinib.
A prespecified exploratory objective in INTRIGUE was to evaluate
anti-tumor efficacy of QINLOCK according to baseline KIT primary
and secondary mutation status. Baseline peripheral whole blood was
analyzed by Guardant360, a 74-gene ctDNA next-generation sequencing
liquid biopsy assay in patients for whom evaluable samples were
available (n=362) out of whom 280 patients had detectable ctDNA. In
patients with a detectable KIT exon 11 primary mutation (n=157), 52
patients also had mutations in KIT exon 17/18 only and 41 had
mutations in KIT exon 13/14 only.
Patients with mutations in KIT exon 11 and 17/18 only had
improved progression-free survival (PFS), objective response rate
(ORR), and overall survival (OS) with QINLOCK versus sunitinib
while patients with mutations in KIT exon 11 and 13/14 only had
improved PFS, ORR, and OS with sunitinib compared to QINLOCK.
Summary of INTRIGUE Efficacy Results of ctDNA Analysis for
Patients with Mutations in KIT Exon 11 and 17/18 Only
Ripretinib
(n=27)
Sunitinib
(n=25)
Hazard Ratio/Response
Difference (95% CI)
Median Progression-Free Survival
(1)
14.2 months
1.5 months
0.22 (0.11, 0.44), nominal p
value <0.0001
Objective Response Rate (1)
44.4%
0%
44.4% (23.0%, 62.7%)
nominal p value = 0.0001
Overall Survival (2)
Not Estimable
17.5 months
0.34 (0.15, 0.76), nominal p
value = 0.0061
Notes: (1) Data cutoff as of September 1, 2021; (2) Data cutoff
as of September 1, 2022.
The subgroup safety profile was consistent with the primary
analysis in the AP-ITT population and demonstrated a more favorable
safety profile for QINLOCK compared with sunitinib with fewer
patients experiencing Grade 3-4 drug-related TEAEs (KIT exon 11 and
17/18 only: 33.3% for QINLOCK versus 50.0% for sunitinib).
About the INSIGHT Study
The INSIGHT Phase 3 clinical study is a randomized, global,
multicenter, open-label study to evaluate the efficacy and safety
of QINLOCK compared to sunitinib in patients with GIST previously
treated with imatinib with mutations in KIT exon 11 and 17/18 only
(excluding patients with mutations in KIT exons 9, 13, or 14). In
the study, 54 patients will be randomized 2:1 to either QINLOCK 150
mg once daily or sunitinib 50 mg once daily for four weeks followed
by two weeks without sunitinib. The primary endpoint is PFS as
determined by independent radiologic review using modified RECIST
1.1 criteria. Secondary endpoints include ORR as determined by
independent radiologic review using modified RECIST 1.1 criteria
and OS.
About the INTRIGUE Study
The INTRIGUE Phase 3 clinical study is a randomized, global,
multicenter, open-label study to evaluate the efficacy and safety
of QINLOCK compared to sunitinib in patients with GIST previously
treated with imatinib. In the study, 453 patients were randomized
1:1 to either QINLOCK 150 mg once daily or sunitinib 50 mg once
daily for four weeks followed by two weeks without sunitinib. As
previously reported, the study did not achieve the primary efficacy
endpoint of PFS as determined by independent radiologic review
using modified RECIST 1.1 criteria. The statistical analysis plan
included a hierarchical testing sequence that included testing
patients with a KIT exon 11 primary mutation and then in the all
patient intent-to-treat (AP-ITT) population. In patients with a KIT
exon 11 primary mutation (n=327), QINLOCK demonstrated a median PFS
of 8.3 months compared to 7.0 months for the sunitinib arm (HR
0.88, p=0.360). Although not formally tested due to the rules of
the hierarchical testing sequence, in the AP-ITT population QINLOCK
demonstrated a median PFS of 8.0 months compared to 8.3 months for
the sunitinib arm (HR 1.05, nominal p=0.72). QINLOCK was generally
well tolerated. Fewer patients in the QINLOCK arm experienced Grade
3-4 treatment-emergent adverse events compared to sunitinib (41.3%
vs. 65.6%). Similarly, there were fewer patients with Grade 3-4
drug-related TEAEs with ripretinib (26.5%) compared with sunitinib
(55.2%).
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 kinase inhibitor for the treatment of fourth-line
GIST. QINLOCK is approved in Australia, Canada, China, the European
Union, Hong Kong, Israel, Macau, New Zealand, Singapore,
Switzerland, Taiwan, the United Kingdom, and the United States. For
more information, visit 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 potential for QINLOCK to provide a
more optimized and targeted treatment plan for people living with
GIST, the substantial clinical benefit that QINLOCK can potentially
offer second-line GIST patients with KIT exon 11+17/18 mutations
only; the exceptional efficacy in a sub-group of second-line GIST
patients observed in the exploratory analysis from INTRIGUE, and
plans to enroll the pivotal Phase 3 INSIGHT study as quickly as
possible. 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, our ability to successfully demonstrate the efficacy
and safety of our drug or drug candidates, the preclinical or
clinical results for our product candidates, which may not support
further development of such product candidates, comments, feedback
and actions of regulatory agencies, including the FDA and the EMA,
our ability to commercialize QINLOCK and execute on our marketing
plans for any drugs or indications that may be approved in the
future, the inherent uncertainty in estimates of patient
populations and total addressable markets, competition from other
products, our ability to obtain and maintain reimbursement for any
approved product and the extent to which patient assistance
programs are utilized and other risks identified in our Securities
and Exchange Commission (SEC) filings, including our Quarterly
Report on Form 10-Q for the quarter ended September 30, 2023, 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, QINLOCK, and the QINLOCK logo are registered
trademarks and Deciphera is a trademark of Deciphera
Pharmaceuticals, LLC.
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version on businesswire.com: https://www.businesswire.com/news/home/20240105634919/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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