Gastrointestinal stromal tumor

Deciphera Pharmaceuticals Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 6, 2024
Biotechnology, Pharmaceutical, Health, Oncology, OS, KIT, European, Investigational New Drug, Trial of the century, DNA, Research, Patient, IND, Autophagy, ASCO, GIST, Public expenditure, FDA, EMA, MAA, Part, Food, Society, TGCT, Gastrointestinal stromal tumor, European Medicines Agency, Sunitinib, Neoplasm, Cancer, INSIGHT, Tenosynovial giant cell tumor, NDA, Nature Medicine, Pharmaceutical industry

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.
  • Expects to present updated results from the Phase 1/2 study of vimseltinib in TGCT in the second half of 2024.
  • Expects to initiate a Phase 2 proof-of-concept study of vimseltinib for the treatment of chronic graft versus host disease (cGVHD) in the fourth quarter of 2024.
  • Cost of Sales: Cost of sales were $1.8 million in the fourth quarter of 2023, which includes $0.9 million in cost of product sales, compared to cost of product sales of $0.7 million for the fourth quarter of 2022.

Deciphera Pharmaceuticals Announces Planned 2024 Corporate Milestones Supporting Evolution to a Self-Sustaining, Multi-Product Company

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Monday, January 8, 2024
Research, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Gastrointestinal stromal tumor, Food, Neoplasm, IND, INSIGHT, Autophagy, FDA, MAA, Cetuximab, European, Encorafenib, Public expenditure, KIT, NDA, Cancer, European Medicines Agency, Part, TGCT, MEK, Patient, GIST, Pharmaceutical industry

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today highlighted its strategic outlook for 2024 and planned 2024 corporate milestones, and announced preliminary unaudited fourth quarter and full year 2023 revenue.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today highlighted its strategic outlook for 2024 and planned 2024 corporate milestones, and announced preliminary unaudited fourth quarter and full year 2023 revenue.
  • Present updated data from the Phase 1/2 study of vimseltinib in TGCT in the second half of 2024.
  • Initiate a Phase 2 proof-of-concept study of vimseltinib for the treatment of cGVHD in the fourth quarter of 2024.
  • Initiate a Phase 1 study for DCC-3084, a potential best-in-class pan-RAF inhibitor, in the first half of 2024.

Deciphera Pharmaceuticals Announces Nature Medicine Publication of Results from Exploratory ctDNA Analysis from INTRIGUE Phase 3 Study Demonstrating Substantial Clinical Benefit of QINLOCK® in 2L GIST Patients with Mutations in KIT Exon 11 and 17/18

Retrieved on: 
Friday, January 5, 2024
Research, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Patient, Gastrointestinal stromal tumor, Survival, Risk, Neoplasm, INSIGHT, Progression-free survival, Disease, KIT, DNA, Cancer, Liquid biopsy, Exon, Death, Nature Medicine, Manuscript, Overalls, PFS, Sunitinib, AP, GIST, Pharmaceutical industry

“The results published in Nature Medicine provide compelling evidence that QINLOCK may provide progression-free and overall survival benefit to second-line (2L) GIST patients in whom a liquid biopsy reveals primary KIT exon 11 mutations plus secondary mutations restricted to KIT exons 17 and 18.

Key Points: 
  • “The results published in Nature Medicine provide compelling evidence that QINLOCK may provide progression-free and overall survival benefit to second-line (2L) GIST patients in whom a liquid biopsy reveals primary KIT exon 11 mutations plus secondary mutations restricted to KIT exons 17 and 18.
  • “Our ongoing INSIGHT pivotal Phase 3 study is designed to confirm the exceptional efficacy we observed in this exploratory analysis from INTRIGUE.
  • A prespecified exploratory objective in INTRIGUE was to evaluate anti-tumor efficacy of QINLOCK according to baseline KIT primary and secondary mutation status.
  • In patients with a detectable KIT exon 11 primary mutation (n=157), 52 patients also had mutations in KIT exon 17/18 only and 41 had mutations in KIT exon 13/14 only.

ESMO 2023 | Ascentage Pharma to Present Results from Two Clinical Studies, including One Oral Presentation, at 2023 ESMO Congress

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Thursday, August 3, 2023
GIST, Mini, ESMO, Cancer, Hope, TKI, CHB, BCR-ABL, Oncology, NSCLC, European Society for Medical Oncology, Congress, Poster, Patient, Notifiable disease, Gastrointestinal stromal tumor, Hepatitis, Pharmaceutical industry

As one of the most authoritative and influential congresses in oncology globally, the ESMO Congress showcases the latest results from some of the most cutting-edge research from around the world.

Key Points: 
  • As one of the most authoritative and influential congresses in oncology globally, the ESMO Congress showcases the latest results from some of the most cutting-edge research from around the world.
  • This year, the ESMO Congress will take place on October 20 to October 24, local time, in Madrid, Spain.
  • "These presentations highlight Ascentage Pharma's robust capabilities in clinical development and global innovation, as well as our strong potential in solid tumors.
  • These two clinical studies to be presented at the ESMO Congress this year are as follows:

Ascentage Pharma's Novel Drug Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug

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Wednesday, May 31, 2023
TKI, GIST, E pluribus unum, Priority review, Science, Malignancy, Drug development, Gastrointestinal tract, CML, New Drug Application, American Society of Clinical Oncology, Succinate dehydrogenase, NDA, Cancer, Quality of life, SDH, Mutation, CHB, BTD, BCR-ABL, Prognosis, Research, John-Ross Rizzo, Multimedia, CBR, Bangladesh Technical Education Board, ASCO, KIT, Patient, PDGFRA, Douglas BTD Destroyer, Annual general meeting, National Medical Products Administration, CDE, EFS, Center for Drug Evaluation and Research, Notifiable disease, Gastrointestinal stromal tumor, Society, NMPA, Hepatitis, Pharmaceutical industry, Silviculture

To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.

Key Points: 
  • To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.
  • Drugs that have been granted BTDs are prioritized by the CDE in communications and exchange, and in receiving guidance to advance the drug development progress.
  • Furthermore, BTD-designated drugs will be eligible for Priority Review status and conditional approvals upon submission of a New Drug Application (NDA).
  • Antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor (TKI)–resistant succinate dehydrogenase (SDH)–deficient gastrointestinal stromal tumor (GIST).

Deciphera Pharmaceuticals to Present Data from INTRIGUE Phase 3 Study of QINLOCK® (ripretinib) and Trial-in-Progress Poster for INSIGHT Pivotal Phase 3 Study of QINLOCK® at the 2023 American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Thursday, May 25, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, GIST, DNA, University, Diarrhea, Progression-free survival, Sunitinib, Survival, OS, Cancer, AP, Toxicity, Associate, PFS, Mutation, Teaching hospital, QD, ASCO, KIT, Hypertension, Hair, Myalgia, American Society of Clinical Oncology, HIV disease progression rates, Patient, Clinical research, Annual general meeting, German Cancer Research Center, University of Duisburg-Essen, Neoplasm, ITT, Gastrointestinal stromal tumor, Society, Alvin J. Siteman Cancer Center, Clinical, ORR, IRR, Safety, Fatigue, Pharmaceutical industry, Medical imaging, Typesetting, Jet fuel, Bookkeeping

“As we prepare to initiate our INSIGHT pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with KIT exon 11 and 17/18 mutations, we are excited to share details on the study design and additional supporting data from the INTRIGUE study.

Key Points: 
  • “As we prepare to initiate our INSIGHT pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with KIT exon 11 and 17/18 mutations, we are excited to share details on the study design and additional supporting data from the INTRIGUE study.
  • In the all-patient intent-to-treat population, overall survival was 35.5 months in the QINLOCK arm and 30.9 months in the sunitinib arm.
  • The favorable safety profile was consistent with our primary analysis, with fewer patients on QINLOCK experiencing Grade 3/4 treatment-emergent adverse events compared to sunitinib.
  • Presentation details are as follows:
    Title: Overall survival and long-term safety in patients with advanced gastrointestinal stromal tumor previously treated with imatinib: Updated analyses from INTRIGUE.

Powered by Its Industry-Leading Comprehensive Multi-Omic Database, Caris Life Sciences to Showcase Extensive Research at ASCO 2023

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Tuesday, May 23, 2023
Consensus, DSCR1, Pancreatic cancer, PDAC, Database, GIST, Abstract, ICIS, TMB, Genomics, Glioma, Neoplasm, FACP, Aggression, MSS, Cancer, Intelligence, MYB, Prognosis, MBA, Research, NSCLC, Biomarker, Lung cancer, Cetuximab, ASCO, American Society of Clinical Oncology, POA, Patient, Machine learning, Colorectal cancer, Medicine, Annual general meeting, Diagnosis, MSI-H, Health, Gastrointestinal stromal tumor, Society, Pharmaceutical industry, Medical imaging, Nursing

IRVING, Texas, May 23, 2023 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, today announced that the company and collaborators within the Caris Precision Oncology Alliance™ (POA) will collectively present 42 studies across more than 30 solid tumor types at the 2023 American Society of Clinical Oncology (ASCO®) Annual Meeting from June 2-6, 2023 (Booth #13081). The findings demonstrate the power of Caris' comprehensive clinico-genomic database that enable novel insights into cancer that could have profound effects on a patient's diagnosis, prognosis, care plan, and response to treatment.

Key Points: 
  • "The findings of these studies illustrate the power of comprehensive molecular profiling to identify molecular changes that may affect tumor behavior and patient outcomes.
  • The research further illustrates the emerging role of artificial intelligence in informing patient care.
  • (Abstract: 3535; Poster Board: 235)
    Poster and abstract summaries highlighting this research will be available onsite at Caris' booth 13081.
  • The full abstracts will be available on May 25, 2023, at 5 PM EDT through the ASCO website .

Syndax Pharmaceuticals Announces Appointment of Neil Gallagher, M.D., Ph.D. as President, Head of Research and Development

Retrieved on: 
Thursday, March 30, 2023
SNDX, Inflammation, Amgen, Trinity College, Oncology, Partnership, Drug development, University, Head, Astex Pharmaceuticals, Acute leukemia, Cancer, AstraZeneca, Research and development, University of Birmingham, Novartis, Patient, AbbVie, Hematology, R, Therapy, Gastrointestinal stromal tumor, Pharmaceutical industry, Development

WALTHAM, Mass., March 30, 2023 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced the appointment of Neil Gallagher, M.D., Ph.D., to the role of President, Head of Research and Development (R&D), effective April 10, 2023. Dr. Gallagher brings to Syndax over 20 years of industry experience, most recently serving as Chief Medical Officer, Vice President, Head of Development at AbbVie, where he led multiple development programs through approval globally and oversaw asset strategy and portfolio management across several therapeutic areas, including oncology.

Key Points: 
  • Prior to joining AbbVie, he served as Head of Development for Oncology and Inflammation at Amgen.
  • Dr. Gallagher previously spent a decade at Novartis, where he led several development and clinical programs across the portfolio.
  • Earlier in his career, he was a Senior Medical Director at AstraZeneca and later Director of Clinical Development at Astex Therapeutics.
  • Revumenib and axatilimab have the potential to become the standard of care in their respective disease areas," said Dr. Gallagher.

Deciphera Pharmaceuticals Announces Eight Presentations Highlighting Discovery Research Programs at the American Association for Cancer Research (AACR) Annual Meeting 2023

Retrieved on: 
Tuesday, March 14, 2023
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, ULK, Cancer, Research, Integrated stress response, AACR, Abstract, Encorafenib, Cetuximab, BRAF, Gastrointestinal stromal tumor, Autophagy, III, Exon, Growth, GIST, Colorectal cancer, RAF, KIT, Preclinical SPECT, GCN2, Investigational New Drug, II, IND, Pharmaceutical industry, Vaccine, Medical imaging

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced the presentation of eight posters at the upcoming AACR Annual Meeting 2023, taking place in Orlando, Florida on April 14-19, 2023.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced the presentation of eight posters at the upcoming AACR Annual Meeting 2023, taking place in Orlando, Florida on April 14-19, 2023.
  • The Company will also host a virtual investor event on Tuesday, April 18 at 6:30 PM ET.
  • A webcast of the event will be available in the “Events and Presentations” page in the “Investors” section of the Company’s website at https://investors.deciphera.com/events-presentations .
  • The archived webcast will be available on the Company’s website within 24 hours after the event and will be available for 30 days following the event.

Deciphera Pharmaceuticals Presents Results from ctDNA Analysis of INTRIGUE Phase 3 Clinical Study at the American Society of Clinical Oncology Plenary Series Session

Retrieved on: 
Tuesday, January 24, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, DNA, German Cancer Research Center, American Society of Clinical Oncology, Trial of the century, GIST, KIT, Neoplasm, Patient, ITT, University, Gastrointestinal stromal tumor, University of Duisburg-Essen, Disease, Society, PFS, Cancer, Circulating tumor DNA, Teaching hospital, ASCO, Pharmaceutical industry

Baseline peripheral whole blood was analyzed by Guardant360, a 74-gene ctDNA next-generation sequencing liquid biopsy assay.

Key Points: 
  • Baseline peripheral whole blood was analyzed by Guardant360, a 74-gene ctDNA next-generation sequencing liquid biopsy assay.
  • Patients with mutations in KIT exon 11 and exon 17/18 only derived substantially improved clinical benefit with QINLOCK versus sunitinib.
  • Patients with mutations in KIT exon 11 and 13/14 only derived substantially improved clinical benefit with sunitinib versus QINLOCK.
  • QINLOCK was generally well-tolerated and the safety profiles were consistent with the primary analysis of the INTRIGUE study.