– Efficacy Observed with QINLOCK® was
Comparable to Sunitinib with a More Favorable Safety and
Tolerability Profile in GIST Patients Previously Treated with
Imatinib –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
commercial-stage biopharmaceutical company developing innovative
medicines to improve the lives of people with cancer, announced the
presentation of results from the INTRIGUE Phase 3 study of QINLOCK
(ripretinib) in patients with gastrointestinal stromal tumor (GIST)
previously treated with imatinib at the American Society of
Clinical Oncology (ASCO) Plenary Series Session. The presentation,
which follows the announcement in November 2021 of the top-line
results, is titled “INTRIGUE: A phase III, randomized, open-label
study to evaluate the efficacy and safety of ripretinib vs
sunitinib in patients with advanced gastrointestinal stromal tumor
previously treated with imatinib” and is available on the Company’s
website at www.deciphera.com/presentations-publications.
ASCO will be hosting a livestream event on Tuesday, January 25,
2022 at 3:00 PM ET featuring presentation of the abstract by
Michael Heinrich, M.D., FACP, Professor of Medicine at Oregon
Health & Science University followed by a discussion of the
abstract by George D. Demetri, M.D., FASCO, FACP, Dana-Farber
Cancer Institute, as well as a panel discussion with Drs. Heinrich
and Demetri and Vicki Keedy, M.D., MSCI, Vanderbilt University
Medical Center. To participate in the free and open session
participants may register and login at
https://www.asco.org/meetings-education/monthly-plenary-series/program.
“Patients with GIST in the post-imatinib setting are in need of
additional treatment options for their disease, and the results
from INTRIGUE demonstrate that ripretinib is an active and
well-tolerated agent. Although the INTRIGUE study did not meet its
primary endpoint of superiority in progression-free survival versus
sunitinib, the efficacy of ripretinib appears comparable to
sunitinib in 2nd line patients. In addition, ripretinib had a more
favorable safety profile than sunitinib with fewer Grade 3/4
adverse events and patients reported less deterioration in role
functioning and several other key patient-reported outcome measures
of tolerability,” said Dr. Heinrich. “It is important to provide
the detailed results of this study to the oncology community to
help treating physicians make well-informed decisions on the best
treatment options for their patients with advanced GIST.”
In patients with GIST who progressed on or were intolerant to
imatinib, the efficacy of QINLOCK and sunitinib were comparable,
although progression-free survival (PFS) of QINLOCK as determined
by independent radiologic review using modified Response Evaluation
Criteria in Solid Tumors (RECIST) did not meet the study’s primary
endpoint of superiority compared to sunitinib. The statistical
analysis plan included a hierarchical testing sequence that
included evaluation of patients with a KIT exon 11 primary mutation
(Exon 11) and then of the all patient (AP) population. Key
highlights from the study presented today include the
following:
- An international, multicenter study conducted in 122 active
sites across 22 countries, 453 patients were randomized to
ripretinib (n = 226; Exon 11, n = 163) or sunitinib (n = 227; Exon
11, n = 164).
- In patients with a KIT exon 11 primary mutation, ripretinib
demonstrated a median PFS (mPFS) of 8.3 months compared to 7.0
months for the sunitinib arm (Hazard Ratio [HR] 0.88, p=0.36). In
the AP population (n=453), ripretinib demonstrated an mPFS of 8.0
months compared to 8.3 months for the sunitinib arm (HR 1.05,
nominal p value=0.72).
- In patients with a KIT exon 11 primary mutation, ripretinib
demonstrated an objective response rate (ORR) of 23.9% (n=39 of
163) compared to 14.6% (n=24 of 164) for sunitinib (nominal p
value=0.03). In the AP population ripretinib demonstrated an ORR
21.7% (n=49 of 226) compared to 17.6% (n=40 of 227) for sunitinib
(nominal p value=0.27).
- Ripretinib was generally well tolerated. Fewer patients in the
ripretinib arm experienced Grade 3-4 treatment-emergent adverse
events compared to sunitinib (41.3% vs 65.6%).
- Patients receiving sunitinib were three times more likely to
develop Grade 3 hypertension compared to patients receiving
ripretinib (26.7% vs. 8.5%) and patients receiving sunitinib were
seven times more likely to develop Grade 3 palmar-plantar
erythrodysesthesia compared to patients receiving ripretinib (10.0%
vs. 1.3%).
- Patient reported outcome measures also showed a more favorable
tolerability profile for patients receiving ripretinib compared to
patients receiving sunitinib. Patients receiving ripretinib
experienced less deterioration in their ability to engage in either
work or leisure activities during treatment and fewer patients
receiving ripretinib experienced moderate to extremely large impact
on their lives due to skin toxicity across treatment cycles
compared to patients receiving sunitinib.
QINLOCK is approved by the U.S. Food and Drug Administration
(FDA) for the treatment of adult patients with advanced GIST who
have received prior treatment with three or more kinase inhibitors,
including imatinib. The new drug application (NDA) for QINLOCK was
based on positive results from the Phase 3 INVICTUS trial in
patients with fourth-line and fourth-line plus GIST1. QINLOCK is
also approved for the treatment of fourth-line GIST in Australia,
Canada, China, the European Union, Hong Kong, Switzerland, Taiwan,
and the United Kingdom.
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 mutation2,3. QINLOCK also
inhibits primary PDGFRA mutations in exons 12, 14, and 18,
including the exon 18 D842V mutation, involved in a subset of
GIST2,3.
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 Australia, Canada, China, the European
Union, Hong Kong, Switzerland, Taiwan, the United Kingdom, and the
United States. 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
regarding QINLOCK and our INTRIGUE study. 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
- 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220124005796/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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