– Median Overall Survival for QINLOCK® of 35.5
Months Versus 31.5 Months for Sunitinib in the All-Patient
Intent-to Treat-Population –
– Long-Term Safety Profile Consistent with
Primary Analysis Showing Fewer Patients with Grade 3/4
Treatment-Emergent Adverse Events (TEAEs) and Lower Rate of
Treatment Discontinuations Due to TEAEs with QINLOCK Versus
Sunitinib –
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 the presentation of new
long-term results from the INTRIGUE Phase 3 clinical study
comparing QINLOCK® (ripretinib) versus sunitinib in patients with
advanced gastrointestinal stromal tumor (GIST) previously treated
with imatinib.
The presentation titled “Overall survival and long-term safety
with ripretinib vs sunitinib in patients with advanced
gastrointestinal stromal tumor previously treated with imatinib:
final analyses from INTRIGUE” will be presented by John Zalcberg,
M.D., Ph.D., Cancer Research Program, Monash University School of
Public Health and Preventive Medicine and Department of Medical
Oncology, Alfred Health, Melbourne, Victoria, Australia at the
American Society of Clinical Oncology (ASCO) Gastrointestinal
Cancers Symposium and will be available on the Company’s website at
www.deciphera.com/presentations-publications.
“These long-term clinical results demonstrate that the overall
survival rate was similar for both QINLOCK and sunitinib, and that
treatment with QINLOCK continued to show a favorable safety profile
compared to treatment with sunitinib,” said Dr. Zalcberg. “In
addition, the data show that patient outcomes in the third-line
setting are comparable for patients that were treated with either
QINLOCK or sunitinib in the second line.”
“The final results from INTRIGUE demonstrate the strong clinical
activity of QINLOCK in the broader second-line GIST patient
population,” said Matthew L. Sherman, M.D., Chief Medical Officer
of Deciphera. “Importantly, these results also indicate that third
line treatment is not adversely impacted by treatment with QINLOCK
in the second line and that QINLOCK continues to show a favorable
safety profile compared to sunitinib.”
Results of INTRIGUE Study Long-Term Follow-Up
In INTRIGUE, 453 patients in the all-patient intent-to-treat
population (AP-ITT) with second-line GIST were randomized 1:1 to
receive QINLOCK 150 mg once daily (n=226) or sunitinib 50 mg once
daily (4 weeks on/2 weeks off) (n=227) of which 444 patients
received treatment.
In the primary analysis of the AP-ITT population based on a data
cut of September 1, 2021, while the primary endpoint was not
achieved, QINLOCK demonstrated similar efficacy with a median
progression-free survival (PFS) of 8.0 months versus 8.3 months for
sunitinib (hazard ratio [HR] 1.05, nominal p=0.72). There were
fewer patients with Grade 3/4 drug-related treatment emergent
adverse events (TEAE) with QINLOCK (26.5%) compared with sunitinib
(55.2%). Based on the primary results from the INTRIGUE study,
QINLOCK was included in the National Comprehensive Cancer Network
Clinical Practice Guidelines in Oncology for GIST (version 1.2023)
as a preferred second-line regimen for patients with advanced GIST
who are intolerant to sunitinib.
The final analysis includes 18 months of additional follow up
after the primary analysis based on a data cut of March 15, 2023.
Key highlights from the final results presented include the
following:
Overall Survival (OS)
- There were 211 OS events (46.6%) in the AP-ITT population with
median duration of follow-up in the QINLOCK and sunitinib arms of
35.1 months and 34.1 months, respectively.
- Median OS in the AP-ITT population was similar with QINLOCK
(35.5 months) versus sunitinib (31.5 months) (HR 0.86; 95% CI, 0.65
to 1.13; nominal p= 0.275).
Safety and Tolerability
- Among the 444 patients treated, 9.0% of patients remained on
treatment at the time of data cutoff including 12.6% of 223
patients treated with QINLOCK and 5.4% of 221 patients treated with
sunitinib.
- The long-term safety profile of QINLOCK was consistent with the
primary analysis.
- Fewer patients had Grade 3/4 drug-related TEAEs with QINLOCK
(27.4%) versus sunitinib (57.9%).
- Dose interruptions and reductions as well as treatment
discontinuations due to TEAEs were lower with QINLOCK versus
sunitinib. Fewer patients discontinued treatment due to any TEAE
for QINLOCK (4.9%) versus sunitinib (9.0%).
- The most common TEAEs in the QINLOCK arm were alopecia,
fatigue, and myalgia. The most common TEAEs in patients treated
with sunitinib were palmar-plantar erythrodysesthesia syndrome,
diarrhea, and hypertension.
Exploratory Analysis: Efficacy of Next-Line Therapy
- Median PFS on the next line of therapy after protocol treatment
was similar for QINLOCK (7.7 months) versus sunitinib (7.4 months)
in the AP-ITT population (HR 1.03; 95% CI, 0.78 to 1.35).
- Following study treatment discontinuation, the most common
third-line therapy was sunitinib for patients in the QINLOCK arm
(59.7%) and regorafenib for patients in the sunitinib arm
(42.7%).
- Patients in the QINLOCK arm who received third-line sunitinib
had a median PFS on next line of therapy of 8.5 months compared
with 6.3 months for patients in the sunitinib arm who received
third-line regorafenib (HR 0.90; 95% CI, 0.66 to 1.24).
Details of the poster presentation are as follows:
Title: Overall survival and long-term safety with
ripretinib vs sunitinib in patients with advanced gastrointestinal
stromal tumor previously treated with imatinib: final analyses from
INTRIGUE Author: John Zalcberg, M.D., Ph.D., Monash
University School of Public Health and Preventive Medicine
Session: A: Cancers of the Esophagus and Stomach and Other
GI Cancers Abstract #: 748 Date and Time: Thursday
January 18, 2024 11:45 AM – 1:15 PM PT
In January 2024, Nature Medicine published the results of the
exploratory ctDNA analysis from INTRIGUE showing substantial
clinical benefit of QINLOCK compared to sunitinib in second-line
GIST patients with mutations in KIT exon 11 and 17/18 only.
Patients with mutations in KIT exon 11 and 17/18 had improved
progression-free survival, objective response rate, and overall
survival with QINLOCK versus sunitinib.
Based on the results of this prespecified exploratory objective
in INTRIGUE, the Company is enrolling the INSIGHT pivotal Phase 3
clinical study of QINLOCK in second-line GIST patients with
mutations in KIT exon 11 and 17/18 only.
About the INSIGHT Study
The 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 17/18
(excluding patients with mutations in KIT exons 9, 13, or 14). 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. The statistical analysis plan
included a hierarchical testing sequence that included testing in
patients with a KIT exon 11 primary mutation and then in the AP-ITT
population. In patients with a KIT exon 11 primary mutation
(n=327), QINLOCK demonstrated a median PFS of 8.3 months compared
to 7.0 months for the sunitinib arm (HR 0.88, p=0.360). Although
not formally tested due to the rules of the hierarchical testing
sequence, in the AP-ITT population QINLOCK demonstrated a median
PFS of 8.0 months compared to 8.3 months for the sunitinib arm (HR
1.05, nominal p=0.72). QINLOCK 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%). Similarly, there were fewer patients with Grade 3/4
drug-related TEAEs with QINLOCK (26.5%) compared with sunitinib
(55.2%).
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, Iceland, Israel, Liechtenstein, Macau, New
Zealand, Norway, Singapore, Switzerland, Taiwan, The United
Kingdom, and the United States. For more information, visit
www.deciphera.com and follow us on LinkedIn and X (@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 our preclinical and/or
clinical stage pipeline assets to be first-in-class and/or
best-in-class treatments, our Phase 3 INSIGHT clinical study of
QINLOCK versus sunitinib in second-line GIST patients with
mutations in KIT exon 11 and 17/18 and plans to enroll the INSIGHT
study as quickly as possible. 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 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, 2023, 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.
The Deciphera logo and the QINLOCK® word mark and logo are
registered trademarks and the Deciphera word mark is a trademark of
Deciphera Pharmaceuticals, LLC.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240117482266/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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