On January 4, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that it has initiated a Phase 3 clinical study to evaluate the safety and efficacy of DCC-2618, a pan-KIT and PDGFRα inhibitor, in patients with advanced gastrointestinal stromal tumors (GIST) (Press release, Deciphera Pharmaceuticals, JAN 4, 2018, View Source [SID1234522871]).
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"We are extremely pleased to initiate the INVICTUS study with DCC-2618 in heavily pretreated GIST patients, specifically fourth-line and fourth-line plus patients," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera. "We expect to report top-line results in 2019 and, if successful, this pivotal Phase 3 study could serve as the basis for a New Drug Application (NDA), providing a much-needed therapeutic option for these patients for whom there are no approved treatments. We also plan to initiate a second Phase 3 study later this year evaluating DCC-2618 in second-line GIST patients who have progressed or are intolerant to front-line therapy with imitanib."
"While effective treatments are available for patients with early-stage GIST, in 9 out 10 patients the disease will eventually progress due to the development of secondary drug resistance mutations," said Professor Jean-Yves Blay, Medical Oncologist, General Director Centre Léon Bérard, Comprehensive cancer Centre of Lyon, France. "A therapy with the potential to provide broad coverage across the full spectrum of KIT and PDGFRα mutations would represent a much-needed improvement over currently approved treatment options for patients with later-stage GIST."
Initiation of the INVICTUS study follows results from the ongoing Phase 1 clinical trial presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2017, in which durable disease control by DCC-2618 was observed in heavily pretreated patients with GIST.
INVICTUSPhase 3 Study
The INVICTUS Phase 3 clinical study is a randomized, double-blind, placebo-controlled, international, multicenter trial to evaluate the safety, tolerability, and efficacy of DCC-2618 compared to placebo in patients with advanced GIST patients whose previous therapies have included imatinib, sunitinib, and regorafenib. The trial is expected to enroll approximately 120 patients randomized 2:1 to either 150 mg once daily of DCC-2618 or placebo. The primary efficacy endpoint is median progression free survival (PFS) as determined by independent radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints as determined by independent radiologic review using modified RECIST include Objective Response Rate (ORR); Time to Tumor Progression (TTP); and Overall Survival (OS). See www.clinicaltrials.gov for further information (NCT03353753).
About DCC-2618
DCC-2618 is a pan-KIT and PDGFRα kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, glioblastoma multiforme and systemic mastocytosis. DCC-2618 was specifically designed to improve the treatment of GIST patients by inhibiting the full spectrum of mutations in KIT and PDGFRα. DCC-2618 is a pan-KIT and pan-PDGFRα inhibitor that blocks initiating KIT mutations in exons 9, 11, 13, 14, 17, and 18, known to be present in GIST patients and the D816V exon 17 mutation known to be present in ASM patients. DCC-2618 inhibits PDGFRα mutations in exon 18, including the D842V mutation that drives a subset of GIST.