DelveInsight’s “Gastrointestinal Stromal Tumor Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Gastrointestinal Stromal Tumor, historical and forecasted epidemiology as well as the Gastrointestinal Stromal Tumor market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.
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Key Takeaways from Gastrointestinal Stromal Tumor Market Report
- In December 2024:- Deciphera Pharmaceuticals- The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.
- In December 2024:- Cogent Biosciences Inc.- This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 442 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating the potential for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs.
- In the assessment done by DelveInsight, the estimated total incident cases of GIST in the 7MM were nearly 16 thousand in 2023.
- The highest incident cases of GIST were accounted by the US in 2023 (approximately 7k cases), which are expected to show a steep rise soon due to the improvement in diagnostic testing and advancements in genetic testing and accounts for 43% of the total cases in the 7MM.
- In 2023, the age-specific incident cases of GIST accounted highest in the age group 66-80 years with nearly 6 thousand cases in the 7MM, followed by age group 51-65 years with around 5 thousand cases. While the least number of cases were seen in the age group 0-17 years.
- Among the European countries, Germany had the highest incident population of GIST with nearly 2 thousand cases, followed by Italy, which had incident population of over 1k in 2023. On the other hand, Spain had the lowest incident population.
- Japan had more than 2,500 incident cases for GIST in 2023, accounting for approximately 16% of total incident cases in the 7MM.
- In 2023, our estimations indicate that within the 7MM, a higher percentage of males (52%) were affected by Gastrointestinal Stromal Tumor (GIST) compared to females (48%). The reason for this gender difference could be attributed to various factors, including potential differences in genetic susceptibility, hormonal influences, occupational exposures, lifestyle habits, and healthcare-seeking behaviors.
- The leading Gastrointestinal Stromal Tumor Companies such as Jiangsu Hengrui Medicine, Daiichi Sankyo Company, Cogent Biosciences, Advenchen Laboratories, AB Science, Immunicum AB, Novartis, Bristol-Myers Squibb, Hanmi Pharmaceutical Company Limited, Ascentage Pharma, Array BioPharma, Plexxikon, Arog Pharmaceuticals, Xencor, Inc., DNAtrix, Inc., Onyx Pharmaceuticals, Exelixis, Allarity Therapeutics, Theseus Pharmaceuticals, IDRx, Inc., Allarity Therapeutics, and others.
- Promising Gastrointestinal Stromal Tumor Therapies such as TAS-116, Bezuclastinib, Iclusig, Cabozantinib, THE-630, Famitinib, PLX9486, Nilotinib, HQP1351, DS 6157, IDRX-42, and others
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Gastrointestinal Stromal Tumor Epidemiology Segmentation in the 7MM
- Total Prevalence of Gastrointestinal Stromal Tumor
- Prevalent Cases of Gastrointestinal Stromal Tumor by severity
- Gender-specific Prevalence of Gastrointestinal Stromal Tumor
- Diagnosed Cases of Episodic and Chronic Gastrointestinal Stromal Tumor
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Gastrointestinal Stromal Tumor Marketed Therapies
- Ayvakit (Avapritinib): Blueprint Medicines Corporation
Ayvakit is a kinase inhibitor indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations and Advanced Systemic Mastocytosis (AdvSM). The FDA granted full approval to Ayvakit based on efficacy results from the Phase I NAVIGATOR clinical trial, as well as combined safety results from multiple clinical trials for avapritinib.
- STIVARGA (Regorafenib): Bayer
Stivarga (BAY 73-4506) is the brand name for the generic chemotherapy agent regorafenib, an oral anticancer medication approved by the FDA for individuals with locally advanced, unresectable, or metastatic GIST who have previously received imatinib mesylate and sunitinib malate. In September 2021, Bayer presented study results indicating close proximity to the prespecified activity threshold, possibly influenced by a low recruitment rate. The notable frequency of undetected mutant GIST by Sanger sequencing underscores the importance of next-generation sequencing (NGS) in presumed KIT/PDGFR wild-type GIST.
Gastrointestinal Stromal Tumor Emerging Therapies
- Crenolanib: Arog Pharmaceuticals
Crenolanib, an investigational small molecule drug, is currently undergoing Phase III clinical trials to assess its safety and efficacy in treating acute myeloid leukemia (AML) and gastrointestinal stromal tumor (GIST). Acting as a potent inhibitor of both wild-type and mutant forms of FLT3 (FMS-like Tyrosine Kinase 3) and PDGFRα/β (Platelet-derived Growth Factor Receptor), Crenolanib holds promise as a potential additional treatment option for patients with advanced or metastatic GIST harboring a D842V mutation in the PDGFRA gene, offering hope for improved outcomes in this specific subgroup.
- Bezuclastinib (CGT9486/PLX9486): Cogent Biosciences, Inc. / Plexxikon Inc.
Bezuclastinib (CGT9486) is a highly selective Type I inhibitor of KIT receptor tyrosine kinase, specifically targeting oncogenic KIT with mutations in the activation loop encoded by exons 17 and 18, including the pivotal KIT D816V mutation found in the majority of patients with systemic mastocytosis. The combination of bezuclastinib with sunitinib, a Type-II inhibitor effective against KIT ATP-binding pocket mutations, demonstrated prolonged progression-free survival in extensively treated patients with gastrointestinal stromal tumor. Cogent Biosciences, Inc. holds worldwide rights to bezuclastinib, encompassing all facets of development, manufacturing, and commercialization activities related to this promising molecule.
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Gastrointestinal Stromal Tumor Market Outlook
Knowledge about the underlying genetic alterations revealed possible targeted treatment with TKIs such as imatinib and sunitinib. Continuous research efforts helped to further elucidate molecular insights of this disease and allowed the development of new treatment options based on the underlying molecular signature. Currently, there are seven therapies approved for GIST that includes five TKIs, and two NTRK inhibitors such as GLEEVEC (Imatinib Mesylate), STIVARGA (Regorafenib), SUTENT (sunitinib malate), AYVAKIT (avapritinib), QINLOCK (Ripretinib), ROZLYTREK (Entrectinib), and VITRAKVI (Larotrectinib), approved in different lines. Along with these, there are certain therapies being used as off-label therapies in patients resistant to approved therapies.
Gastrointestinal Stromal Tumor Treatment Market Landscape
In the landscape of advanced GIST treatment, GLEEVEC (imatinib mesylate) stands as the approved first-line therapy, followed by SUTENT (sunitinib) as a second-line option for those resistant or intolerant to imatinib. In real-world scenarios, SUTENT or regorafenib may even be considered as first-line therapies in cases of intolerance or severe adverse events with imatinib. STIVARGA (regorafenib) and QINLOCK (ripretinib) are approved as third and fourth-line options, respectively. Notably, emerging therapies such as Crenolanib, Bezuclastinib, and others are being investigated for GIST and are anticipated to get approved during the forecast period (2024–2034).
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Scope of the Gastrointestinal Stromal Tumor Market Report
- Study Period: 2020–2034
- Coverage: 7MM
- Key Gastrointestinal Stromal Tumor Companies: Jiangsu Hengrui Medicine, Daiichi Sankyo Company, Cogent Biosciences, Advenchen Laboratories, AB Science, Immunicum AB, Novartis, Bristol-Myers Squibb, Hanmi Pharmaceutical Company Limited, Ascentage Pharma, Array BioPharma, Plexxikon, Arog Pharmaceuticals, Xencor, Inc., DNAtrix, Inc., Onyx Pharmaceuticals, Exelixis, Allarity Therapeutics, Theseus Pharmaceuticals, IDRx, Inc., Allarity Therapeutics and others
- Key Gastrointestinal Stromal Tumor Therapies: TAS-116, Bezuclastinib, Iclusig, Cabozantinib, THE-630, Famitinib, PLX9486, Nilotinib, HQP1351, DS 6157, IDRX-42, and others
- Gastrointestinal Stromal Tumor Therapeutic Assessment: Gastrointestinal Stromal Tumor current marketed and Gastrointestinal Stromal Tumor emerging therapies
- Gastrointestinal Stromal Tumor Market Dynamics: Gastrointestinal Stromal Tumor market drivers and Gastrointestinal Stromal Tumor market barriers
Table of Contents
1. Gastrointestinal Stromal Tumor Market Report Introduction
2. Executive Summary for Gastrointestinal Stromal Tumor
3. SWOT analysis of Gastrointestinal Stromal Tumor
4. Gastrointestinal Stromal Tumor Patient Share (%) Overview at a Glance
5. Gastrointestinal Stromal Tumor Market Overview at a Glance
6. Gastrointestinal Stromal Tumor Disease Background and Overview
7. Gastrointestinal Stromal Tumor Epidemiology and Patient Population
8. Country-Specific Patient Population of Gastrointestinal Stromal Tumor
9. Gastrointestinal Stromal Tumor Current Treatment and Medical Practices
10. Gastrointestinal Stromal Tumor Unmet Needs
11. Gastrointestinal Stromal Tumor Emerging Therapies
12. Gastrointestinal Stromal Tumor Market Outlook
13. Country-Wise Gastrointestinal Stromal Tumor Market Analysis (2020–2034)
14. Gastrointestinal Stromal Tumor Market Access and Reimbursement of Therapies
15. Gastrointestinal Stromal Tumor Market Drivers
16. Gastrointestinal Stromal Tumor Market Barriers
17. Gastrointestinal Stromal Tumor Appendix
18. Gastrointestinal Stromal Tumor Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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