– Exploratory Analysis of the INVICTUS Phase 3
Study Showed QINLOCK Dose Escalation After Disease Progression
Provided Substantial Clinical Benefit in Advanced GIST –
– Rebastinib in Combination with Paclitaxel in
a Phase 1b/2 Study Demonstrated Median Progression Free Survival of
6.2 Months in Heavily Pretreated Patients with Endometrial Cancer
–
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
commercial-stage biopharmaceutical company developing innovative
medicines to improve the lives of people with cancer, today
announced two e-poster presentations at the 2021 ASCO Annual
Meeting. The presentations include intra-patient dose escalation
(IPDE) data from the INVICTUS Phase 3 study of QINLOCK in patients
with advanced gastrointestinal stromal tumor (GIST), as well as
preliminary results from the Company’s ongoing Phase 1b/2 study of
rebastinib in combination with paclitaxel in patients with
endometrial cancer.
Both e-poster presentations are now available on-demand via the
ASCO Meeting Library and on the Company’s website at
www.deciphera.com/presentations-publications.
“We are committed to understanding the full benefit QINLOCK may
provide to patients with GIST and the data presented at ASCO
further demonstrate the important clinical benefits QINLOCK can
provide in this population,” said Matthew L. Sherman, MD, Executive
Vice President and Chief Medical Officer of Deciphera.
“Importantly, consistent with our Phase 1 data, these exploratory
results from the Phase 3 study show that dose escalation to QINLOCK
150 mg BID after disease progression on QINLOCK 150 mg QD can offer
substantial additional clinical benefit with a tolerable safety
profile. As the body of data supporting QINLOCK’s efficacy and
safety continues to grow, we are pleased with QINLOCK’s potential
to offer clinically meaningful benefit for GIST patients in
multiple settings of the disease.”
Dr. Sherman continued, “Results presented today from the
endometrial cancer cohort of the Phase 1b/2 study of rebastinib,
our selective TIE2 inhibitor, in combination with paclitaxel
continue to demonstrate rebastinib’s anti-tumor activity as well as
its evolving safety profile. We look forward to sharing updated
data from the platinum-resistant ovarian cancer cohort of this
study in the third quarter of 2021 and finalizing the pivotal
development plan for rebastinib in combination with paclitaxel in
the second half of 2021.”
INVICTUS Dose Escalation
Data
The INVICTUS Phase 3 clinical study is a randomized (2:1),
double-blind, placebo-controlled, international, multicenter study
to evaluate the safety, tolerability, and efficacy of QINLOCK
compared to placebo in patients with advanced GIST whose previous
therapies have included at least imatinib, sunitinib, and
regorafenib. The Company previously reported primary results from
the randomized portion of the INVICTUS study, in which QINLOCK
significantly improved PFS and showed a clinically meaningful
overall survival (OS) benefit. An exploratory analysis was
conducted to assess the safety and efficacy of QINLOCK dose
escalation to 150 mg BID among patients randomized to QINLOCK 150
mg QD in the INVICTUS study.
As of an August 10, 2020 cutoff date, of the 85 patients
randomized to QINLOCK 150 mg QD in the INVICTUS study, 43 dose
escalated to 150 mg BID after disease progression by blinded
independent central review using modified RECIST version 1.1.
- Among the 43 patients in the QINLOCK arm who dose escalated,
initial median PFS, or mPFS1, was 4.6 months (95% CI 2.7–6.4) and
the subsequent median PFS, or mPFS2, from the day of dose
escalation to second disease progression or death was 3.7 months
(95% CI 3.1–5.3). The ratio of mPFS2/mPFS1 was 80%.
- Median OS was 18.4 months in patients randomized to QINLOCK 150
mg QD with progressive disease and who dose escalated to 150 mg BID
(n=43) and 14.2 months in those randomized to QINLOCK 150 mg QD
with progressive disease and not dose escalating (n=22) (HR 0.74,
95% CI 0.37–1.49).
- QINLOCK 150 mg BID was well tolerated with a similar safety
profile to QINLOCK 150 mg QD, with new or worsening Grade 3–4 TEAEs
of anemia in 6 (14%) and abdominal pain in 3 (7%) patients.
Updated Preliminary Data from the
Ongoing Phase 1b/2 Study of Rebastinib in Combination with
Paclitaxel in Endometrial Cancer
The Phase 1b/2 study of rebastinib in combination with
paclitaxel is a two-part, open-label, multicenter study assessing
the safety, tolerability, anti-tumor activity, and pharmacokinetics
of rebastinib in patients with advanced or metastatic solid tumors.
As previously announced, both the endometrial and
platinum-resistant ovarian cancer cohorts in Part 2 of the study
advanced into the second stage of the Simon two-stage design based
on demonstrating at least five responses in each cohort.
As of a March 19, 2021 cutoff date, 38 patients with endometrial
cancer initiated treatment with rebastinib in combination with
weekly paclitaxel 80 mg/m2. All 38 patients received prior taxane,
with 44% of patients having received four or more prior anti-cancer
regimens, with a median of three prior therapies across all
patients. 16 patients were treated with rebastinib at a starting
dose of 100 mg BID (11 reduced to 50 mg BID) and 22 patients were
treated with a starting dose of 50 mg BID. Of the 38 patients with
endometrial cancer who initiated treatment with rebastinib, the
median duration of treatment was 3.7 months.
Of the 33 patients in the modified intent-to-treat (mITT)
population:
- There were 11 partial responses (8 confirmed) and 12 patients
with stable disease for an objective response rate of 33%
(unconfirmed and confirmed) and 24% (confirmed only) with a median
duration of response of 7.4 months,
- The median progression-free survival (PFS) was 6.2 months.
- The majority of the common (≥15%) treatment-emergent adverse
events (TEAEs) were Grade 2 or lower.
- Nine patients experienced SAEs at least possibly related to
rebastinib including muscular weakness (n=3), nausea (n=2), acute
myocardial infarction (n=1), atrial flutter (n=1), dehydration
(n=1), noninfective encephalitis (n=1), peritonsillitis (n=1), and
stress cardiomyopathy (n=1).
The Company expects to present updated data from the ongoing
Phase 1b/2 study of rebastinib in combination with paclitaxel in
the platinum-resistant ovarian cancer cohort in the third quarter
of 2021 and finalize the pivotal development plan for rebastinib in
combination with paclitaxel in the second half of 2021, subject to
favorable data and discussions with regulators.
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
FDA-approved switch-control kinase inhibitor for the treatment of
fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also
approved for fourth-line GIST in Canada, Australia, China, and Hong
Kong. 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 the potential benefit of QINLOCK, including, without
limitation, on dose escalation and in multiple settings of GIST,
presenting updated data from the Phase 1b/2 study of rebastinib in
combination with paclitaxel for patients with platinum-resistant
ovarian cancer and finalizing the pivotal study plan for the
rebastinib/paclitaxel combination, subject to favorable data and
discussions with regulators. 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 March 31, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210604005122/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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