– Seventh Approval Worldwide for QINLOCK and
First European Approval –
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 Swiss Agency for Therapeutic Products
(Swissmedic) has granted approval for QINLOCK (ripretinib) 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.
“We are committed to delivering this much-needed medicine to
patients globally, and are thrilled that we have received approval
in Switzerland, which is our seventh approval worldwide and the
first in Europe,” said Steve Hoerter, President and Chief Executive
Officer of Deciphera. “Following a positive opinion earlier this
month from the European Medicines Agency’s (EMA) Committee for
Medicinal Products for Human Use (CHMP), we look forward to a
potential approval from the European Commission (EC) for QINLOCK in
the fourth quarter of this year, and to ensuring that GIST patients
across the EU have access to this treatment option designed
specifically for their disease.”
The application for QINLOCK approval was supported by efficacy
results from the primary analysis of the pivotal Phase 3 INVICTUS
study of QINLOCK 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). Secondary endpoints as
determined by independent radiologic review using modified RECIST
include Objective Response Rate (ORR) 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 (≥20%) in
patients treated with QINLOCK were fatigue, alopecia, nausea,
myalgia, constipation, diarrhea, palmar-plantar erythrodysesthesia
syndrome (PPES), weight decreased, vomiting, lipase increased,
muscle spasms, arthralgia, headache and dyspnoea1,2.
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 QINLOCK 1,2.
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 mutation. 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, Hong Kong8,
Switzerland1, Taiwan8, and the United States9. 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 potential European Commission decision on
marketing approval for QINLOCK in fourth-line GIST and ensuring
QINLOCK access for GIST patients in the European Union. 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 and in additional indications for our existing
drug, 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 June 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
- Swiss medicinal product information.
- 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 [online] September 9, 2021. Available
from:
https://clincancerres.aacrjournals.org/content/early/2021/09/08/1078-0432.CCR-21-1864
[Last accessed: September 2021].
- 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: September 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: September 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: September 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: September 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: September 2021].
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version on businesswire.com: https://www.businesswire.com/news/home/20211012005254/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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