– QINLOCK Significantly Reduced the Risk of
Disease Progression or Death by 85% and Showed Clinically
Meaningful Overall Survival in the INVICTUS Phase 3 Study –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
commercial-stage biopharmaceutical company developing innovative
medicines to improve the lives of people with cancer, today
announced that the United Kingdom (UK) Medicines and Healthcare
products Regulatory Agency (MHRA) has granted marketing
authorization for QINLOCK® (ripretinib) in the UK for the treatment
of adult patients with advanced gastrointestinal stromal tumor
(GIST) who have received prior treatment with three or more kinase
inhibitors, including imatinib1.
“The approval of QINLOCK in the UK is an important milestone for
patients with advanced GIST who have been waiting for a new
treatment option,” said Steve Hoerter, President and Chief
Executive Officer of Deciphera. “The results from the INVICTUS
study underscore the potential for QINLOCK to transform the
treatment of advanced GIST and establish a new standard of care in
the UK for fourth-line GIST.”
The QINLOCK approval was supported by efficacy results from the
primary analysis of the pivotal Phase 3 INVICTUS study in patients
with advanced GIST as well as combined safety results from INVICTUS
and the Phase 1 study of QINLOCK. In INVICTUS, QINLOCK demonstrated
a median progression-free survival of 6.3 months compared to 1.0
month in the placebo arm and significantly reduced the risk of
disease progression or death by 85% (hazard ratio of 0.15,
p<0.0001)2. Secondary endpoints include Objective Response Rate
(ORR) as determined by independent radiologic review using modified
RECIST and Overall Survival (OS). QINLOCK demonstrated an ORR of
9.4% compared with 0% for placebo (p =0.0504)2 In addition, QINLOCK
demonstrated a median overall survival of 15.1 months compared to
6.6 months in the placebo arm and reduced the risk of death by 64%
(hazard ratio of 0.36)2.
The most frequently observed adverse drug reactions (≥25%) in a
pooled safety population (n=392) treated with QINLOCK were fatigue,
alopecia, nausea, myalgia, constipation, diarrhea, palmar-plantar
erythrodysesthesia syndrome (PPES), weight decreased, and
vomiting1,2.
In the INVICTUS study, adverse reactions resulting in permanent
discontinuation occurred in 8% of patients, dosage interruptions
due to an adverse reaction occurred in 24% of patients and dose
reductions due to an adverse reaction occurred in 7% of patients
who received QINLOCK2.
About QINLOCK (ripretinib)
QINLOCK is a switch-control tyrosine kinase inhibitor that was
engineered to broadly inhibit KIT and PDGFRA mutated kinases by
using a dual mechanism of action that regulates the kinase switch
pocket and activation loop. QINLOCK inhibits primary and secondary
KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST,
as well as the primary exon 17 D816V mutation3,4. QINLOCK also
inhibits primary PDGFRA mutations in exons 12, 14, and 18,
including the exon 18 D842V mutation, involved in a subset of
GIST3,4.
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 Australia5, Canada6, China7, European
Union8, Hong Kong7 Switzerland10, Taiwan9, and the United States11.
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 the potential for QINLOCK the transform the
treatment of advanced GIST and establish a new standard of care in
the UK for fourth-line GIST. 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 our ability to provide access to QINLOCK
in European countries other than Germany and France through other
channels, 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 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,
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, 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, 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.
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are
registered trademarks of Deciphera Pharmaceuticals, LLC.
References
- QINLOCK Summary of Product Characteristics. December 2021.
- Blay JY, Serrano C, Heinrich MC et al. Ripretinib in patients
with advanced gastrointestinal stromal tumours (INVICTUS): A
double-blind, randomised, placebo-controlled, phase 3 trial. Lancet
Oncol 2020; 21:923–934.
- Smith B et al., Ripretinib (DCC-2618) is a switch control
kinase inhibitor of a broad spectrum of oncogenic and
drug-resistant KIT and PDGFRA variants. Cancer Cell 2019;
35:738–751.
- Bauer S, Heinrich M, et al. Clinical activity of ripretinib in
patients with advanced gastrointestinal stromal tumor harboring
heterogenous KIT/PDGFRA mutations in the phase 3 INVICTUS study.
Clinical Cancer Research 2021; 27:6333-6342.
- 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: December 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: December 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: December 2021].
- Deciphera Press Release: Deciphera Receives European Commission
Approval of QINLOCK® for the Treatment of Fourth-Line
Gastrointestinal Stromal Tumor [online] November 22, 2021.
Available from:
https://investors.deciphera.com/news-releases/news-release-details/deciphera-receives-european-commission-approval-qinlockr
[Last accessed: December 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: December 2021].
- Deciphera Press Release: Deciphera Announces Approval of
QINLOCK® in Switzerland for the Treatment of Fourth-Line
Gastrointestinal Stromal Tumor [online] October 12, 2020. Available
from:
https://investors.deciphera.com/news-releases/news-release-details/deciphera-announces-approval-qinlockr-switzerland-treatment
[Last accessed: December 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: December 2021].
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211221005446/en/
Investor Relations: Maghan Meyers Argot Partners
Deciphera@argotpartners.com +1 212-600-1902
Media: David Rosen Argot Partners
David.Rosen@argotpartners.com +1 212-600-1902
Deciphera Pharmaceuticals (NASDAQ:DCPH)
Historical Stock Chart
From Jun 2024 to Jul 2024
Deciphera Pharmaceuticals (NASDAQ:DCPH)
Historical Stock Chart
From Jul 2023 to Jul 2024