Press Release Details
Deciphera Pharmaceuticals Reports Positive Updated Phase 1 Data for Ripretinib in Gastrointestinal Stromal Tumors
- Data from Phase 1 Study Supports Ongoing INTRIGUE Phase 3 Clinical Study in Patients with Second-line GIST –
- Median Progression Free Survival (mPFS) Sustained across All Cohorts -
- Additional Phase 1 Results Expected to be Presented at Upcoming Medical Meeting -
- Company to Host Conference Call Today at
In a separate press release issued today, Deciphera announced positive top-line results from its INVICTUS pivotal Phase 3 clinical study supporting a potential new drug application (NDA) submission to the
“We believe the updated data from our ongoing Phase 1 clinical study, with the additional six months of maturity from our last Phase 1 data cut-off, continue to support ripretinib’s potential across the broad range of KIT and PDGFRα mutations known to occur in patients with GIST following therapy with imatinib,” said
Updated Phase 1 Data
Updated data from 178 GIST patients receiving ripretinib at doses of >100mg daily are noted in the table below as of
Line of Therapy(1) |
Objective Response Rate by Best Response Includes Unconfirmed (Confirmed Only) |
Disease Control Rate at 3 Months |
Median Progression Free Survival (mPFS) |
Censored Patients for mPFS |
Mean Treatment Duration(2)(3) |
Second-Line (n=37) |
30% (22%) |
81% |
42 weeks |
38% |
43 weeks |
Third-Line (n=31) |
23% (13%) |
80% |
40 weeks |
32% |
48 weeks |
Fourth-Line (n=60) |
15% (8%) |
73% |
30 weeks |
30% |
49 weeks |
≥Fourth-Line (n=110)(4) |
11% (7%) |
66% |
24 weeks |
22% |
41 weeks |
(1) Overall number of patients (n=178) remains the same as prior data presented at
Ripretinib was generally well tolerated and the updated adverse events were consistent with previously presented Phase 1 data in patients with GIST. Grade 3 or 4 treatment-emergent adverse events (TEAEs) in >5% of patients were lipase increased (18%; n=33), anemia (11%; n=20), hypertension (7%; n=13) and abdominal pain (6%; n=11). 13% of patients (n=24) experienced TEAEs leading to study treatment discontinuation, 17% of patients (n=31) experienced TEAEs leading to dose reduction and 49% of patients (n=88) had TEAEs leading to study drug interruption.
Conference Call and Webcast
Deciphera will host a conference call and webcast to discuss this announcement, as well as results from the INVICTUS Phase 3 clinical study, today,
About GIST
Gastrointestinal stromal tumor (GIST) is a cancer affecting the digestive tract or nearby structures within the abdomen, most often presenting in the stomach or small intestine. GIST is the most common sarcoma of the gastrointestinal tract, with approximately 4,000 to 6,000 new GIST cases each year in
About Ripretinib
Ripretinib is an investigational KIT and PDGFRα kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, or GIST, systemic mastocytosis, or SM, and other cancers. Ripretinib was specifically designed to improve the treatment of patients with GIST by inhibiting a broad spectrum of mutations in KIT and PDGFRα. Ripretinib is a KIT and PDGFRα inhibitor that inhibits initiating and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST, as well as the primary D816V exon 17 mutation involved in SM. Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14 and 18, including the exon 18 D842V mutation, involved in a subset of GIST. In
About the INTRIGUE Phase 3 Study
The INTRIGUE Phase 3 clinical study is an interventional, randomized, global, multicenter, open-label study to evaluate the safety, tolerability and efficacy of ripretinib compared to sunitinib in patients with GIST previously treated with imatinib. This study was designed to provide evidence of clinical benefit to support regulatory approvals in second-line GIST patients in
About
Availability of
Investors and others should note that
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, statements regarding our expectations regarding reporting additional data from our Phase 1 study of ripretinib in GIST patients at an upcoming medical meeting, the potential for the results of our INVICTUS pivotal Phase 3 clinical study to support a NDA submission, our plans for and the data to be included in a NDA submission for ripretinib, the potential for ripretinib (DCC-2618) and our other drug candidates based on our kinase switch control inhibitor platform to provide clinical benefit and treat cancers such as GIST and other possible indications, the prospects for and initiation of and enrollment for our INTRIGUE pivotal Phase 3 study and our confidence in such trial, preparations for and timing of a possible NDA submission, and potential commercial launch of ripretinib in fourth-line and fourth-line plus GIST, if approved. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “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 delay of any current or planned clinical studies or the development of our drug candidates, including ripretinib, our ability to successfully demonstrate the efficacy and safety of our drug candidates including in later-stage studies, the preclinical and clinical results for our drug candidates, which may not support further development of such drug candidates, actions of regulatory agencies, any or all of which may affect the initiation, timing and progress of clinical studies and regulatory development and other risks identified in our
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Source:
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