– Study Did Not Achieve Primary Efficacy
Endpoint of Improved Progression-Free Survival Versus Standard of
Care Sunitinib in Patients with Second-line GIST –
– Conference Call to be Held Today at 8:00 AM
ET –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
commercial-stage biopharmaceutical company developing innovative
medicines to improve the lives of people with cancer, today
announced top-line results from the INTRIGUE Phase 3 clinical study
of QINLOCK in patients with gastrointestinal stromal tumor (GIST)
previously treated with imatinib. The study did not meet the
primary endpoint of improved progression-free survival (PFS)
compared with the standard of care sunitinib.
“While we are disappointed with these results, which we learned
yesterday, we believe this was a robust, well-designed, and
well-executed study. The full results from the INTRIGUE Phase 3
clinical study are expected to be presented at an upcoming medical
meeting,” said Steve Hoerter, President and Chief Executive Officer
of Deciphera. “On behalf of the entire Deciphera team, I would like
to thank the patients, their caregivers, and the healthcare
professionals who participated in the INTRIGUE study. QINLOCK
remains the standard of care and only approved therapy in patients
with fourth-line GIST, and we are committed to ensuring that
patients around the world in the fourth-line GIST treatment setting
have access to QINLOCK.”
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.
The study did not achieve the primary efficacy endpoint of
progression-free survival (PFS) as determined by independent
radiologic review using modified Response Evaluation Criteria in
Solid Tumors (RECIST). 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) population. In patients with a KIT exon 11
primary mutation, (n=327), QINLOCK demonstrated a median PFS (mPFS)
of 8.3 months compared to 7.0 months for the sunitinib arm (Hazard
Ratio [HR] 0.88, p=0.360). Although not formally tested due to the
rules of the hierarchical testing sequence, in the AP population
QINLOCK demonstrated a mPFS of 8.0 months compared to 8.3 months
for the sunitinib arm (HR 1.05, nominal p=0.715).
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss
this announcement today, November 5, 2021 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 3072405. A
live audio webcast of the event 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 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. The
primary endpoint is progression-free survival (PFS) as determined
by independent radiologic review using modified Response Evaluation
Criteria in Solid Tumors (RECIST) in the pre-specified subgroup of
patients with a KIT exon 11 mutation (exon 11) and then in the all
patient intent-to-treat (AP) population. Secondary endpoints
include Objective Response Rate (ORR) as determined by independent
radiologic review using modified RECIST and Overall Survival (OS)
in both the exon 11 and AP groups. The study is being conducted at
122 investigational sites in 22 countries.
About QINLOCK (ripretinib)
QINLOCK is a switch-control tyrosine kinase inhibitor that was
engineered to broadly inhibit KIT mutated kinases by using a dual
mechanism of action that regulates the kinase switch pocket and
activation loop1,2.
Important Safety Information
There are no contraindications for QINLOCK.
Palmar-plantar erythrodysesthesia syndrome (PPES): In INVICTUS,
Grade 1-2 PPES occurred in 21% of the 85 patients who received
QINLOCK. PPES led to dose discontinuation in 1.2% of patients, dose
interruption in 2.4% of patients, and dose reduction in 1.2% of
patients. Based on severity, withhold QINLOCK and then resume at
same or reduced dose.
New Primary Cutaneous Malignancies: In INVICTUS, cutaneous
squamous cell carcinoma (cuSCC) occurred in 4.7% of the 85 patients
who received QINLOCK with a median time to event of 4.6 months
(range 3.8 to 6 months). In the pooled safety population, cuSCC and
keratoacanthoma occurred in 7% and 1.9% of 351 patients,
respectively. In INVICTUS, melanoma occurred in 2.4% of the 85
patients who received QINLOCK. In the pooled safety population,
melanoma occurred in 0.9% of 351 patients. Perform dermatologic
evaluations when initiating QINLOCK and routinely during treatment.
Manage suspicious skin lesions with excision and dermatopathologic
evaluation. Continue QINLOCK at the same dose.
Hypertension: In INVICTUS, Grade 1-3 hypertension occurred in
14% of the 85 patients who received QINLOCK, including Grade 3
hypertension in 7% of patients. Do not initiate QINLOCK in patients
with uncontrolled hypertension. Monitor blood pressure as
clinically indicated. Based on severity, withhold QINLOCK and then
resume at same or reduced dose or permanently discontinue.
Cardiac Dysfunction: In INVICTUS, cardiac failure occurred in
1.2% of the 85 patients who received QINLOCK. In the pooled safety
population, cardiac dysfunction (including cardiac failure, acute
left ventricular failure, diastolic dysfunction, and ventricular
hypertrophy) occurred in 1.7% of 351 patients, including Grade 3
adverse reactions in 1.1% of patients.
In INVICTUS, Grade 3 decreased ejection fraction occurred in
2.6% of the 77 patients who received QINLOCK and who had a baseline
and at least one post-baseline echocardiogram. Grade 3 decreased
ejection fraction occurred in 3.4% of the 263 patients in the
pooled safety population who received QINLOCK and who had a
baseline and at least one post-baseline echocardiogram.
In INVICTUS, cardiac dysfunction led to dose discontinuation in
1.2% of the 85 patients who received QINLOCK. The safety of QINLOCK
has not been assessed in patients with a baseline ejection fraction
below 50%. Assess ejection fraction by echocardiogram or MUGA scan
prior to initiating QINLOCK and during treatment, as clinically
indicated. Permanently discontinue QINLOCK for Grade 3 or 4 left
ventricular systolic dysfunction.
Risk of Impaired Wound Healing: QINLOCK has the potential to
adversely affect wound healing. Withhold QINLOCK for at least 1
week prior to elective surgery. Do not administer for at least 2
weeks following major surgery and until adequate wound healing. The
safety of resumption of QINLOCK after resolution of wound healing
complications has not been established.
Embryo-Fetal Toxicity: QINLOCK can cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential
and males with female partners of reproductive potential to use
effective contraception during treatment and for at least 1 week
after the final dose. Because of the potential for serious adverse
reactions in the breastfed child, advise women not to breastfeed
during treatment and for at least 1 week after the final dose.
QINLOCK may impair fertility in males of reproductive
potential.
Adverse Reactions: The most common adverse reactions (≥20%) were
alopecia, fatigue, nausea, abdominal pain, constipation, myalgia,
diarrhea, decreased appetite, PPES, and vomiting. The most common
Grade 3 or 4 laboratory abnormalities (≥4%) were increased lipase
and decreased phosphate.
The safety and effectiveness of QINLOCK in pediatric patients
have not been established.
Administer strong CYP3A inhibitors with caution. Monitor
patients who are administered strong CYP3A inhibitors more
frequently for adverse reactions. Avoid concomitant use with strong
CYP3A inducers.
Please click here to see the full Prescribing Information
for QINLOCK.
To report SUSPECTED ADVERSE REACTIONS, contact Deciphera
Pharmaceuticals, LLC, at 1-888-724-3274 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
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 inhibitor for the treatment of fourth-line GIST.
QINLOCK is approved in Australia1, Canada2, China3, Hong Kong4,
Switzerland5, Taiwan6, and the United States7. For more
information, visit www.deciphera.com and follow us on LinkedIn and
Twitter (@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 presenting the full results from the INTRIGUE
Phase 3 clinical study and our commitment to ensuring patients
around the world in the fourth-line GIST treatment setting have
access to QINLOCK. 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, risks and uncertainties related to
the severity and duration of the impact of COVID-19 on our business
and operations, our ability to successfully demonstrate the
efficacy and safety of our drug candidates including in additional
indications for our existing drug such as second-line GIST patients
in our INTRIGUE Phase 3 study, the preclinical or clinical results
for our product candidates, which may not support further
development of such product candidates, our ability to manage our
reliance on sole-source third parties such as our third party drug
substance and drug product contract manufacturers, comments,
feedback and actions of regulatory agencies, our ability to
commercialize QINLOCK and execute on our marketing plans for any
drugs or indications that may be approved in the future, our
ability to build and scale our operations to support growth in
additional geographies, the inherent uncertainty in estimates of
patient populations, 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, our
ability to comply with healthcare regulations and laws, our ability
to obtain, maintain and enforce our intellectual property rights,
any or all of which may affect the initiation, timing and progress
of clinical studies and the timing of and our ability to obtain
additional regulatory approvals, 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,
2021, 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 our views
as of any subsequent date. We explicitly disclaim any obligation to
update any forward-looking statements.
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are
registered trademarks of Deciphera Pharmaceuticals, LLC.
References
- Deciphera Press Release: Deciphera Announces Australian
Therapeutic Goods Administration’s Approval of QINLOCK™
(ripretinib) for the Treatment of Fourth-Line Gastrointestinal
Stromal Tumor [online] July 14, 2020. Available from:
https://investors.deciphera.com/news-releases/news-release-details/deciphera-announces-australian-therapeutic-goods-administrations
[Last accessed: November 2021].
- Deciphera Press Release: Deciphera Announces Health Canada’s
Authorization of QINLOCK™ (ripretinib) for the Treatment of
Fourth-Line Gastrointestinal Stromal Tumor [online] June 22, 2020.
Available from:
https://investors.deciphera.com/news-releases/news-release-details/deciphera-announces-health-canadas-authorization-qinlocktm
[Last accessed: November 2021].
- Zai Lab Press Release: China NMPA Approves QINLOCK®
(Ripretinib) for Treatment of Advanced Gastrointestinal Stromal
Tumors (GIST) [online] March 31, 2021. Available from:
https://zailab.gcs-web.com/news-releases/news-release-details/china-nmpa-approves-qinlockr-ripretinib-treatment-advanced
[Last accessed: November 2021].
- Zai Lab Press Release: Zai Lab Announces Financial Results for
Second-half and Full-year 2020 [online] March 1, 2021. Available
from:
https://zailab.gcs-web.com/news-releases/news-release-details/zai-lab-announces-financial-results-second-half-and-full-year
[Last accessed: November 2021].
- Deciphera Press Release: Deciphera Announces Approval of
QINLOCK® in Switzerland for the Treatment of Fourth-Line
Gastrointestinal Stromal Tumor [online] October 12, 2021. Available
from:
https://investors.deciphera.com/news-releases/news-release-details/deciphera-announces-approval-qinlockr-switzerland-treatment
[Last accessed: November 2021].
- Zai Lab Press Release: QINLOCK® (Ripretinib) Approved in Taiwan
for Treatment of Advanced Gastrointestinal Stromal Tumors (GIST)
[online] September 1, 2021. Available from:
https://zailab.gcs-web.com/news-releases/news-release-details/qinlockr-ripretinib-approved-taiwan-treatment-advanced
[Last accessed: November 2021].
- Deciphera Press Release: FDA Grants Full Approval of Deciphera
Pharmaceuticals’ QINLOCK™ (ripretinib) for the Treatment of
Fourth-Line Gastrointestinal Stromal Tumor [online] May 15, 2020.
Available from:
https://investors.deciphera.com/news-releases/news-release-details/fda-grants-full-approval-deciphera-pharmaceuticals-qinlocktm
[Last accessed: November 2021].
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version on businesswire.com: https://www.businesswire.com/news/home/20211105005311/en/
Investor Relations: Maghan Meyers Argot Partners
Deciphera@argotpartners.com 646-367-2769
Media: David Rosen Argot Partners
David.Rosen@argotpartners.com 212-600-1902
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