Deciphera to Present Comprehensive Pipeline Data at the 2025 Connective Tissue Oncology Society (CTOS) Annual Meeting
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) and its subsidiary Deciphera Pharmaceuticals, Inc. today announced that new and updated data from multiple ongoing clinical and preclinical programs will be featured in oral and poster presentations at the Connective Tissue Oncology Society (CTOS) Annual Meeting 2025, taking place November 12–15 in Boca Raton, Florida.
The presentations highlight Deciphera’s commitment to advancing precision oncology through the development of innovative kinase inhibitors designed to address difficult-to-treat cancers such as tenosynovial giant cell tumor (TGCT) and gastrointestinal stromal tumor (GIST). The company’s participation at CTOS 2025 underscores its ongoing leadership in the field of targeted oncology and translational medicine.
Showcasing Pipeline Strength and Clinical Progress
During CTOS 2025, Deciphera will present a diverse portfolio of studies, including long-term efficacy and safety data from the Phase 3 MOTION trial evaluating vimseltinib in patients with TGCT for whom surgical resection is not a viable option. The company will also share updates from its Phase 1 study of DCC-3009, a next-generation investigational therapy for GIST designed to overcome known mechanisms of drug resistance.
We are excited about the breadth of data we’re presenting at CTOS this year, which underscores the strong progress we continue to sustain across our clinical pipeline,” said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. “We look forward to sharing encore data from our Phase 3 MOTION study of vimseltinib and providing new insights from our DCC-3009 Phase 1 program. These data collectively demonstrate our ability to expand GIST treatment options by targeting both primary and secondary drug-resistant mutations across multiple KIT exons.”
The presentations will provide new perspectives on Deciphera’s drug development strategy and reinforce its scientific and clinical expertise in kinase inhibition—a therapeutic approach that has proven transformative in multiple cancer types.
Details of Oral and Poster Presentations
1. Long-Term Efficacy and Safety of Vimseltinib in Patients with TGCT
Study Title: Long-Term Efficacy and Safety of Vimseltinib in Patients (Pts) with Tenosynovial Giant Cell Tumor (TGCT): Results from the MOTION Phase 3 Trial
Presenter: Silvia Stacchiotti, M.D., Fondazione IRCCS Istituto Nazionale Dei Tumori
Session: Session 8: TGCT & Desmoid Tumor
Date & Time: Friday, November 14, 2025 | 2:30 – 3:30 PM ET
This oral presentation will highlight the sustained efficacy and safety profile of vimseltinib over extended treatment durations. The Phase 3 MOTION trial demonstrated that vimseltinib, an oral colony-stimulating factor 1 receptor (CSF1R) inhibitor, offers durable clinical benefits and improved quality of life for TGCT patients with limited or no surgical options.
2. Impact of Expert-Led Education Programs on Healthcare Provider Knowledge of GIST
Study Title: Impact of Expert-Led Education Programs on Health Care Provider (HCP) Knowledge of Gastrointestinal Stromal Tumor (GIST)
Presenter: Mark Agulnik, M.D., USC Norris Comprehensive Cancer Center, University of Southern California
Poster Session: Thursday, November 13, 2025 | 5:30 – 6:30 PM ET
This poster examines how structured, expert-driven educational initiatives can improve awareness, diagnostic accuracy, and clinical decision-making among healthcare providers treating GIST. Enhanced medical education has proven essential in ensuring that novel therapies like ripretinib and other targeted agents are optimally utilized in clinical practice.
3. Vimseltinib in TGCT Patients Previously Treated with CSF1 Inhibitors
Study Title: Efficacy with Vimseltinib in Patients (Pts) with Tenosynovial Giant Cell Tumor (TGCT) and Prior Colony-Stimulating Factor 1 (CSF1) Inhibitor Therapy: A Phase 2 Case Series
Presenter: Andrew J. Wagner, M.D., Ph.D., Harvard Medical School, Dana-Farber Cancer Institute
Poster Session: Thursday, November 13, 2025 | 5:30 – 6:30 PM ET
This Phase 2 case series provides insights into vimseltinib’s performance in TGCT patients previously treated with other CSF1 inhibitors. The findings may help guide future sequencing strategies and highlight vimseltinib’s ability to achieve tumor control even in heavily pretreated or resistant cases.
4. Pharmacokinetic Studies of Vimseltinib
Two complementary pharmacokinetic (PK) analyses will be presented by Chengyue Zhang, Ph.D., Deciphera Pharmaceuticals, evaluating how food intake and drug interactions affect vimseltinib’s absorption and metabolism in healthy participants.
a. Effect of a High-Fat Meal on the Pharmacokinetics of Vimseltinib
Title: Effect of a High-Fat Meal on the Pharmacokinetics (PK) of Vimseltinib, an Oral Inhibitor of the Colony-Stimulating Factor 1 Receptor (CSF1), in Healthy Participants
Session: Thursday, November 13, 2025 | 5:30 – 6:30 PM ET
This study investigates how dietary fat influences vimseltinib’s pharmacokinetic profile, a crucial consideration for dosing recommendations and patient counseling.
b. Effect of Itraconazole and Rabeprazole on the Pharmacokinetics of Vimseltinib
Title: Effect of Itraconazole (ITX) and Rabeprazole (RBP) on the Pharmacokinetics (PK) of Vimseltinib, an Oral Inhibitor of the Colony-Stimulating Factor 1 Receptor (CSF1), in Healthy Participants
Session: Thursday, November 13, 2025 | 5:30 – 6:30 PM ET
This analysis explores potential drug-drug interactions involving vimseltinib and common co-administered medications such as itraconazole (an antifungal) and rabeprazole (a proton pump inhibitor). Findings from these studies are expected to guide clinical management and ensure patient safety in real-world settings.
5. Early Clinical Data for DCC-3009 in Advanced GIST
Study Title: An Open-Label Phase 1/2 Study of DCC-3009 Monotherapy in Patients (Pts) with Advanced Gastrointestinal Stromal Tumor (GIST)
Presenter: Suzanne George, M.D., Division of Sarcoma, Dana-Farber Cancer Institute – Sarcoma Center
Poster Session: Thursday, November 13, 2025 | 5:30 – 6:30 PM ET
This study represents one of the first opportunities to evaluate Deciphera’s next-generation KIT inhibitor, DCC-3009, in patients with advanced or resistant GIST. DCC-3009 is designed to inhibit a wide range of primary and secondary KIT mutations, potentially addressing limitations of current therapies and expanding treatment possibilities for patients who have exhausted standard options.
About Vimseltinib (ROMVIMZA™)
Vimseltinib (ROMVIMZA™) is a highly selective, oral small-molecule inhibitor of the colony-stimulating factor 1 receptor (CSF1R), developed using Deciphera’s proprietary switch-control kinase inhibitor platform. The therapy is designed to modulate macrophage activity by blocking CSF1R signaling, thereby reducing the tumor-promoting environment characteristic of TGCT.
Vimseltinib is approved in the United States for the treatment of adult patients with symptomatic TGCT for whom surgical resection is likely to cause worsening functional limitation or severe morbidity. In the European Union, it is approved for adult patients with TGCT associated with clinically relevant functional impairment and for whom surgical options have been exhausted or would cause unacceptable morbidity or disability.
The MOTION Phase 3 trial demonstrated significant and durable improvements in tumor response rate, pain reduction, and mobility, reinforcing vimseltinib’s role as a standard of care for TGCT patients lacking viable surgical options.
About DCC-3009
DCC-3009 is a potent, next-generation KIT inhibitor currently under clinical investigation for the treatment of advanced GIST. Unlike existing therapies that primarily target early mutations, DCC-3009 has been rationally designed to address both primary and secondary drug-resistant mutations across multiple KIT exons, including those that drive resistance to approved kinase inhibitors.
By employing Deciphera’s advanced switch-control technology, DCC-3009 aims to provide durable disease control and improved outcomes for patients with GIST who have relapsed or progressed on standard therapies such as imatinib, sunitinib, and ripretinib.
Commitment to Innovation in Oncology
Deciphera’s presentations at CTOS 2025 reflect the company’s continuous commitment to expanding the scientific understanding of tumor biology and improving therapeutic outcomes for patients with rare and difficult-to-treat cancers. Through its expanding clinical pipeline and strategic integration with Ono Pharmaceutical, Deciphera is advancing next-generation oncology programs rooted in deep kinase biology expertise.
The data being presented at CTOS this year are a testament to the strength of our discovery engine and our dedication to improving the lives of patients with serious cancers,” Dr. Sherman added. “Our long-term focus is on translating groundbreaking science into meaningful therapeutic advances that address both current and emerging challenges in oncology.”
About Deciphera Pharmaceuticals, Inc.
Deciphera Pharmaceuticals, a subsidiary of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company dedicated to discovering, developing, and commercializing transformative medicines that bring hope to patients with cancer, neurologic, and autoimmune diseases.
Leveraging its proprietary switch-control kinase inhibitor platform, Deciphera designs highly selective molecules that precisely target dysregulated kinase pathways implicated in tumor growth, drug resistance, and immune evasion.
In addition to advancing a rich pipeline of novel compounds, Deciphera has successfully developed and commercialized QINLOCK® (ripretinib)—a switch-control kinase inhibitor approved in multiple countries, including the United States and European Union, for the treatment of adult patients with advanced GIST who have received prior treatment with three or more kinase inhibitors, including imatinib.
The company’s growing oncology portfolio now includes both approved therapies (QINLOCK®, ROMVIMZA™) and investigational candidates (DCC-3009 and others) in early- and late-stage clinical development. For more information, visit www.deciphera.com and follow the company on LinkedIn and X (@Deciphera).
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