DECIPHERA PHARMACEUTICALS, INC. Item 7.01 Regulation FD Disclosure.
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The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Exchange Act"), except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
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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.
The study did not achieve the primary efficacy endpoint of median progression-free survival (mPFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). The statistical analysis plan included a hierarchical testing structure that included testing patients with a KIT exon 11 primary mutation and in the all patient intent-to-treat (AP) population. In patients with a KIT exon 11 primary mutation, (n=327), QINLOCK demonstrated a mPFS of 8.3 months compared to 7.0 months for the sunitinib arm (HR of 0.88, p=0.360). Although not formally tested due to the rules of the hierarchical testing sequence, in the AP population QINLOCK demonstrated a mPFS of 8.0 months compared to 8.3 months for the sunitinib arm (HR of 1.05, nominal p=0.715).
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K 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 presenting
the full results from the INTRIGUE Phase 3 clinical study and our commitment to
ensuring patients around the world in the fourth-line GIST treatment setting
have access to QINLOCK. 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 report 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 report,
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 including in additional indications for our existing drug such as
second-line GIST patients in our INTRIGUE Phase 3 study, 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
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Press Release issued byDeciphera Pharmaceuticals, Inc. onNovember 5, 2021 , furnished herewith 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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