– NCCN Guidelines Include QINLOCK as a
Preferred Regimen for Second-Line GIST Patients Intolerant to
Sunitinib –
– Breakthrough Therapy Designation is Based on
Results from ctDNA Analysis of INTRIGUE Phase 3 Clinical Study
Demonstrating Substantial Clinical Benefit of QINLOCK in
Second-Line GIST Patients with Mutations in KIT Exon 11 and 17/18
–
– Company Plans to Initiate the INSIGHT Pivotal
Phase 3 Study of QINLOCK Versus Sunitinib in Second-Line GIST
Patients with Mutations in KIT Exon 11 and 17/18 in the Second Half
of 2023–
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
biopharmaceutical company focused on discovering, developing, and
commercializing important new medicines to improve the lives of
people with cancer, today announced that QINLOCK® (ripretinib) has
been included in the latest National Comprehensive Cancer Network®
(NCCN®) Clinical Practice Guidelines in Oncology as a preferred
regimen for second-line gastrointestinal stromal tumor (GIST)
patients intolerant to sunitinib.
The Company also announced that the U.S. Food and Drug
Administration (FDA) has granted Breakthrough Therapy Designation
(BTD) for QINLOCK for the treatment of adult patients with
unresectable or metastatic GIST who received prior treatment with
imatinib, and who harbor a KIT exon 11 mutation and co-occurring
KIT exon 17 and/or 18 mutations (KIT exon 11+17/18 mutations).
QINLOCK is Deciphera’s switch-control inhibitor currently approved
in 12 territories around the world, including major markets of the
United States, Europe, and China for the treatment of fourth-line
GIST.
“The Breakthrough Therapy Designation reflects the substantial
clinical benefit of QINLOCK in second-line GIST patients harboring
mutations in KIT exon 11 and 17/18 that we observed in the ctDNA
analysis from the INTRIGUE Phase 3 study. If approved, we believe
QINLOCK has the potential to become the standard-of-care for this
group of second-line GIST patients around the world. GIST key
opinion leaders and physicians have long been proponents of
clinical drug development targeted at specific molecular subtypes
of GIST, and we are pleased with the FDA’s recognition that the
ctDNA data indicates QINLOCK may demonstrate substantial
improvement over the current standard-of-care in this population,”
said Steve Hoerter, President and Chief Executive Officer of
Deciphera Pharmaceuticals. “Further, the inclusion of QINLOCK in
the latest NCCN clinical practice guidelines underscores both the
need for additional treatment options for GIST patients in the
post-imatinib setting and the significance of the results from the
INTRIGUE study, which demonstrated that QINLOCK is an active and
well-tolerated agent.”
The update to the NCCN GIST Guidelines is based on the primary
analysis of the INTRIGUE Phase 3 study as published in the Journal
of Clinical Oncology (Bauer S, Jones RL, Blay JY, et al. Ripretinib
versus sunitinib in patients with advanced gastrointestinal stromal
tumor after treatment with imatinib (INTRIGUE): A randomized,
open-label, phase III trial. J Clin Oncol 2022; 40: 3918-3928). Key
study results include:
- In the intention-to-treat (ITT) population (n=453), QINLOCK
demonstrated a median PFS (mPFS) of 8.0 months compared to 8.3
months for the sunitinib arm (Hazard Ratio [HR] 1.05, nominal p
value=0.72).
- Ripretinib was generally well tolerated. Fewer patients in the
QINLOCK 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 QINLOCK
(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 QINLOCK (10.0% vs. 1.3%).
- Patient reported outcome measures also showed a more favorable
tolerability profile for patients receiving QINLOCK compared to
patients receiving sunitinib. Patients receiving QINLOCK
experienced less deterioration in their ability to engage in either
work or leisure activities during treatment, and fewer patients
receiving QINLOCK experienced moderate to extremely large impact on
their lives due to skin toxicity across treatment cycles compared
to patients receiving sunitinib.
The updated NCCN Guidelines are available online at
www.nccn.org.
The FDA’s BTD is intended to expedite the development and review
of a medicine aiming to treat a serious or life-threatening disease
with preliminary clinical evidence that indicates the drug may
demonstrate substantial improvement over existing therapies. This
is the second BTD granted to QINLOCK. The BTD is supported by an
exploratory analysis from the INTRIGUE Phase 3 study in GIST
patients previously treated with imatinib to evaluate anti-tumor
efficacy of QINLOCK according to baseline KIT primary and secondary
mutation status using circulating tumor DNA (ctDNA). Patients with
mutations in KIT exon 11 and exon 17/18 only (n=52) derived
substantially improved clinical benefit with QINLOCK versus
sunitinib. Key results of the ctDNA analysis in the KIT exon 11 and
17/18 subgroup include:
- QINLOCK demonstrated an mPFS of 14.2 months compared to 1.5
months for the sunitinib arm (HR 0.22, nominal p value
<0.0001).
- QINLOCK demonstrated a confirmed objective response rate (ORR)
of 44.4% (n=12 of 27) compared to 0% for sunitinib (nominal p value
0.0001).
- OS for the QINLOCK arm has not reached a median, while patients
randomized to the sunitinib arm had a median OS (mOS) of 17.5
months (HR 0.34, nominal p value 0.0061).
- The subgroup safety profiles were consistent with the primary
analysis.
Based on the results of the ctDNA analysis and discussions with
the FDA, the Company plans to initiate the INSIGHT pivotal Phase 3
clinical study of QINLOCK versus sunitinib in second-line GIST
patients with mutations in KIT exon 11 and 17/18 in the second half
of 2023.
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 GIST.
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.
About the INSIGHT Study
The planned INSIGHT 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 with mutations in KIT exon 11 and
17 and/or 18 and the absence of mutations in KIT exon 9, 13, and/or
14 (also referred to as patients with mutations in KIT exon 11 and
17/18). In the study, 54 patients will be randomized 2:1 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 PFS as determined by independent radiologic review using
modified RECIST 1.1 criteria. Secondary endpoints include ORR as
determined by independent radiologic review using modified RECIST
1.1 criteria and OS.
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. As
previously reported, the study did not achieve the primary efficacy
endpoint of PFS as determined by independent radiologic review
using modified RECIST 1.1 criteria.
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, Israel, Macau, New Zealand, 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
and timing regarding our planned Phase 3 INSIGHT study of QINLOCK
versus sunitinib in second-line GIST patients with mutations in KIT
exon 11 and 17/18, the potential for QINLOCK to become the
standard-of-care for second-line GIST patients with mutations in
KIT exon 11 and 17/18, the ability for QINLOCK to offer substantial
improvement over the current standard-of-care in this patient
population, and plans to initiate the INSIGHT study in the second
half of 2023; the potential benefits of QINLOCK in second-line GIST
patients intolerant to sunitinib and the extent to which the NCCN
Clinical Practice Guidelines are recognized and followed by the
medical community. 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, our ability to successfully
demonstrate the efficacy and safety of our drug or drug candidates
and in additional indications for our existing drug, the
preclinical or clinical results for our drug candidates, which may
not support further development of such drug 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 Annual Report on Form 10-K for the year ended December 31,
2022, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230314006032/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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