– European Commission Decision Anticipated by
the Fourth Quarter of 2021 –
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 European Medicines Agency’s (EMA) Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion recommending the approval of 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 imatinib.
The positive CHMP opinion is a scientific recommendation for
marketing authorization and one of the final steps before the
European Commission (EC), which has the authority to approve
medicines in the European Union (EU), issues a decision on
Deciphera's marketing authorization application (MAA) for
ripretinib.
“The majority of GIST patients who initially respond to
traditional tyrosine kinase inhibitors eventually develop tumor
progression due to secondary mutations, rendering this a disease
area where novel treatment options are crucially needed,” said
Prof. Peter Reichardt, HELIOS Privatklinik Berlin-Buch, Germany.
“In the Phase 3 INVICTUS study, ripretinib demonstrated significant
clinical benefit in progression-free and meaningful overall
survival.”
"We are delighted that the CHMP has adopted a positive opinion
for QINLOCK, which could lead to Deciphera's regulatory approval in
the European Union," said Steve Hoerter, President and Chief
Executive Officer of Deciphera Pharmaceuticals. "This positive
opinion highlights the CHMP's recognition of the potential for
QINLOCK to help GIST patients who have received three prior
therapies. If approved by the EC, ripretinib will be commercialized
under the brand name QINLOCK®.”
The MAA is supported by efficacy results from 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, ripretinib 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). In addition, ripretinib
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) 1.
About QINLOCK (ripretinib)
Ripretinib 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. Ripretinib 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. Ripretinib
also inhibits primary PDGFRA mutations in exons 12, 14, and 18,
including the exon 18 D842V mutation, involved in a subset of GIST
2.
Ripretinib is approved by the U.S. FDA for the treatment of
adult patients with advanced GIST who have received prior treatment
with three or more kinase inhibitors, including imatinib. It is
also approved by Health Canada for the treatment of adult patients
with advanced GIST who have received prior treatment with imatinib,
sunitinib, and regorafenib; by the Australian Therapeutic Goods
Administration for the treatment of adult patients with advanced
GIST who have received prior treatment with three or more kinase
inhibitors, including imatinib; and by the China National Medical
Products Administration for the treatment of adult patients with
GIST who have received prior treatment with three or more kinase
inhibitors, including imatinib3,4,5,6.
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, ripretinib is Deciphera’s
FDA-approved switch-control kinase inhibitor for the treatment of
fourth-line gastrointestinal stromal tumor (GIST)3. Ripretinib is
also approved for fourth-line GIST in Australia4, Canada5, China6,
Hong Kong7, and Taiwan8.
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 European Commission decision on marketing
approval for QINLOCK in fourth-line GIST and the potential for
QINLOCK to help fourth-line GIST patients. 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.
QINLOCK and the QINLOCK logo are registered trademarks, and
Deciphera and the Deciphera logo are trademarks, of Deciphera
Pharmaceuticals, LLC.
References
- 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.
- Sch�ffski P, Bauer S, Heinrich M, et al. Ripretinib
demonstrated activity across all KIT/PDGFRA mutations in patients
with fourth-line advanced gastrointestinal stromal tumor: analysis
from the phase 3 INVICTUS study. Presented at: 2020 CTOS Virtual
Meeting; November 18-21, 2020; Virtual.
https://www.deciphera.com/sites/default/files/publication-files/CTOS-2020-Poster-INVICTUS-MutEfficacy.pdf.
- 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].
- 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: 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: 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].
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version on businesswire.com: https://www.businesswire.com/news/home/20210917005259/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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