On September 11, 2017 Deciphera Pharmaceuticals, a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the presentation of updated data from its ongoing Phase 1 clinical trial of DCC-2618, the Company’s pan-KIT and PDGFRα inhibitor, in patients with gastrointestinal stromal tumors (GIST) (Press release, Deciphera Pharmaceuticals, SEP 11, 2017, View Source [SID1234520498]). The data were presented in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress on September 9, 2017, in Madrid, Spain. This expands upon data from the same trial presented at the ASCO (Free ASCO Whitepaper) meeting in June 2017, providing further validation of the clinical benefit of DCC-2618 with more patients continuing on therapy out to 12 and 24 weeks. The data showed that in heavily pretreated patients with GIST, treatment with DCC-2618 at >100 mg daily resulted in disease control rates of 76% at 12 weeks and 57% at 24 weeks.

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"The clinical activity observed to date, which includes durable responses in patients who were resistant to other kinase inhibitors, supports the planned evaluation of DCC-2618 in a placebo-controlled randomized, pivotal Phase 3 trial in patients with GIST who have previously received approved therapies," said Michael D. Taylor, Ph.D., President and Chief Executive Officer of Deciphera Pharmaceuticals. "In addition to this initial Phase 3 trial in fourth-line GIST patients, where there are no approved therapies, we plan to initiate a second pivotal Phase 3 trial in second-line GIST patients comparing DCC-2618 to sunitinib."

"DCC-2618 continues to demonstrate good tolerability and clinical activity in heavily pretreated patients with GIST," said Oliver Rosen, M.D., Chief Medical Officer of Deciphera Pharmaceuticals. "The extensive reductions in KIT mutant allele frequencies observed across the spectrum of exons 9, 11, 13, 14, 17 and 18 mutations supports the pan-KIT activity of DCC-2618 in these patients."

In an oral presentation, titled "Encouraging activity of novel pan-KIT and PDGFRα inhibitor DCC-2618 in patients (pts) with gastrointestinal stromal tumor (GIST)," Filip Janku, M.D., Ph.D., The University of Texas MD Anderson Cancer Center, presented data from 57 heavily pretreated GIST patients. As of July 28, 2017, data showed:

At daily doses of 100 mg or greater, GIST patients with KIT or PDGFRα driven disease on DCC-2618 showed a disease control rate (DCR) of 76% at 12 weeks (n=25) and a DCR of 57% at 24 weeks (n=21). DCR is defined as patients with stable disease, partial response or complete response as assessed by Response Evaluation Criteria in Solid Tumors, or RECIST.
Treatment with DCC-2618 resulted in reductions in cfDNA KIT mutant allele frequencies (MAF) compared to baseline values (n=19), suggesting pan-KIT activity across the spectrum of exons 9, 11, 13, 14, 17 and 18 mutations.
DCC-2618 was generally well-tolerated at all dose levels studied, and a dose of 150 mg once per day was selected for the expansion cohorts and planned Phase 3 pivotal trials.

Details for the presentation are as follows:

Title: Encouraging activity of novel pan-KIT and PDGFRα inhibitor DCC-2618 in patients (pts) with gastrointestinal stromal tumor (GIST).
Author: Filip Janku, M.D., Ph.D., The University of Texas MD Anderson Cancer Center
Session: Sarcoma: Proffered Paper Sarcoma Session
Chair: Sebastian Bauer, M.D., West German Cancer Center, University of Essen
Abstract #: 14730
Date and Time: Saturday, September 9, 2017, 11:00 AM – 12:30 PM (CEST)

About DCC-2618
DCC-2618 is currently in a first-in-human Phase 1 clinical trial. 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.