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Business Wire 25-May-2023 5:00 PM
– Company Presents Poster on Overall Survival and Long-Term Safety Results from INTRIGUE Study; Second Poster Presents Analysis from INTRIGUE Patients without Detectable ctDNA at Baseline –
– Encore Oral Presentation of Results of ctDNA Analysis of INTRIGUE Phase 3 Study in Second-Line GIST Patients with Mutations in KIT Exon 11 and 17/18 Which Demonstrated Substantial Clinical Benefit from QINLOCK but Not Sunitinib –
– Trial-in-Progress Poster Outlines Planned INSIGHT Pivotal Phase 3 Study of QINLOCK Versus Sunitinib in Second-Line GIST Patients with KIT Exon 11 and 17/18 Mutations, Expected to Initiate 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 four poster presentations at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, Illinois on June 2-6, 2023.
"As we prepare to initiate our INSIGHT pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with KIT exon 11 and 17/18 mutations, we are excited to share details on the study design and additional supporting data from the INTRIGUE study. Our exploratory analysis from INTRIGUE using baseline circulating tumor DNA (ctDNA) showed that QINLOCK provided clinically meaningful benefit in patients with co-occurring KIT exon 11 and 17/18 mutations, with a median progression-free survival of 14.2 months compared to 1.5 months for sunitinib," said Matthew L. Sherman, M.D., Executive Vice President and Chief Medical Officer of Deciphera. "QINLOCK has the clear potential to become the standard-of-care for these second-line GIST patients and provide exceptional clinical benefit compared to the current standard of care."
Dr. Sherman continued, "We are also pleased to report overall survival and long-term safety data for our INTRIGUE Phase 3 study. In the all-patient intent-to-treat population, overall survival was 35.5 months in the QINLOCK arm and 30.9 months in the sunitinib arm. The favorable safety profile was consistent with our primary analysis, with fewer patients on QINLOCK experiencing Grade 3/4 treatment-emergent adverse events compared to sunitinib. Separately, our analysis from the INTRIGUE study showed better clinical outcomes for patients without detectable ctDNA at baseline, and among these patients without baseline ctDNA, ripretinib showed a median PFS of 16.6 months compared to 11.0 months for patients in the sunitinib arm."
Copies of the posters are currently available on the Company's website at www.deciphera.com/presentations-publications. Presentation details are as follows:
Abstract Number: 11524 Title: Overall survival and long-term safety in patients with advanced gastrointestinal stromal tumor previously treated with imatinib: Updated analyses from INTRIGUE. Presenter: Robin L. Jones, M.D., Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research Session Date: Saturday, June 3 Session Time: 1:15 – 4:15 PM CT Poster Discussion Session: 4:30 – 6:00 PM CT Key Highlights:
Abstract Number: 11536 Title: Outcomes in patients with advanced gastrointestinal stromal tumor who did not have baseline ctDNA detected in the INTRIGUE study Presenter: Jonathan Trent, M.D., Ph.D., Associate Director for Clinical Research, Sylvester Comprehensive Cancer Center, University of Miami Health System Session Date: Saturday, June 3 Session Time: 1:15 – 4:15 PM CT Key Highlights:
Abstract Number: TPS11582 Title: INSIGHT: A phase 3, randomized, multicenter, open-label study of ripretinib vs sunitinib in patients with advanced gastrointestinal stromal tumor previously treated with imatinib harboring KIT exon 11 + 17 and/or 18 mutations. Presenter: Suzanne George, M.D., Associate Division Chief, Sarcoma Center, Dana-Farber Cancer Institute Session Date: Saturday, June 3 Session Time: 1:15 – 4:15 PM CT Key Highlights:
Abstract Number: 397784* Title: Mutational heterogeneity of imatinib resistance and efficacy of ripretinib vs sunitinib in patients with gastrointestinal stromal tumor: ctDNA analysis from INTRIGUE Presenter: Sebastian Bauer, M.D., Head of Sarcoma Center and Translational Sarcoma Research at the West German Cancer Center, University Hospital Essen, University Duisburg-Essen and German Cancer Consortium Session Date: Saturday, June 3 Presentation Time: 1:54 – 2:00 PM CT Key Highlights:
* ASCO Plenary Series: Rapid Abstract Update
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 17/18 only (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 patients with a KIT exon 11 primary mutation and then in the all patient intent-to-treat (AP) population. In patients with a KIT exon 11 primary mutation (n=327), QINLOCK demonstrated an mPFS 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 population QINLOCK demonstrated a mPFS of 8.0 months compared to 8.3 months for the sunitinib arm (HR 1.05, nominal p=0.715). 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%).
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, plans to initiate the INSIGHT study in the second half of 2023, our ability to offer clinically meaningful benefit for second-line GIST patients based on mutational drivers of their disease, and 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 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, 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 March 31, 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, QINLOCK, and the QINLOCK logo are registered trademarks and Deciphera is a trademark of Deciphera Pharmaceuticals, LLC.
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