Regorafenib

CARsgen Announces Formation of its Clinical Advisory Board

Retrieved on: 
Monday, November 20, 2023
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SHANGHAI, Nov. 20, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the formation of its Clinical Advisory Board.

Key Points: 
  • SHANGHAI, Nov. 20, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the formation of its Clinical Advisory Board.
  • This highly regarded panel of experts will provide invaluable guidance and insights for the global clinical development of company's innovative product candidates.
  • "As we embark on this exciting journey to advance our differentiated CAR T-cell therapies, I am delighted to welcome our esteemed Clinical Advisory Board members.
  • The formation of this Clinical Advisory Board marks a significant step forward for CARsgen as it continues to pioneer CAR T-cell therapies with the potential to transform cancer treatment.

ESMO GI Data: Agenus' Botensilimab/Balstilimab Combination Achieves Unprecedented Survival in Advanced Colorectal Cancer

Retrieved on: 
Friday, June 30, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, Pancreatic cancer, Gastrointestinal cancer, Liver disease, ESMO, Survival, RECIST, NSCLC, Immunotherapy, Assistant, Harvard Medical School, Patient, Standard of care, Colorectal cancer, Melanoma, Cancer, Metastasis, Liver, MOS, Recurrence, Fast track (FDA), Safety, Regorafenib, Pharmaceutical industry, Medical imaging, Medicinal plants, Agenus

The new data show substantial survival benefits and long-lasting responses for patients with non-MSI-H (microsatellite stable or non-microsatellite instability-high) metastatic colorectal cancer previously resistant to chemotherapy and/or immunotherapy.

Key Points: 
  • The new data show substantial survival benefits and long-lasting responses for patients with non-MSI-H (microsatellite stable or non-microsatellite instability-high) metastatic colorectal cancer previously resistant to chemotherapy and/or immunotherapy.
  • Agenus is planning to submit its first Biologics License Application to the U.S. Food & Drug Administration (FDA) for patients with non-MSI-H metastatic colorectal cancer.
  • Additionally, global randomized Phase 2 trials for the botensilimab/balstilimab combination in melanoma and botensilimab/chemotherapy in pancreatic cancer are underway, with plans to initiate Phase 3 studies in colorectal and non-small cell lung cancer (NSCLC).
  • "Prognostic value of liver metastases in colorectal cancer treated by systemic therapy: An ARCAD pooled analysis."

Gritstone bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Updates

Retrieved on: 
Thursday, March 9, 2023
SIV, Vaccine, Cancer, HIV, Neoplasm, Trifluridine/tipiracil, United States Patent and Trademark Office, MOS, Clinical trial, NCI, 1836 U.S. Patent Office fire, KRAS, ESMO, Fungal infection, Infection, CRC, National Cancer Institute, Simian immunodeficiency virus, Conference, Collaboration, CROI, Research, NIAID, Patient, FDA, DNA, Circulating tumor DNA, RECIST, Patent, Gilead Sciences, OS, MRR, Regorafenib, Progression-free survival, Therapy, ChAdOx1, NSCLC, Messenger, Immunotherapy, CORAL, SLATE, Pharmaceutical industry, Cryptocurrency, Nature Medicine, Gritstone

-- Gritstone to host conference call today at 4:30pm ET --

Key Points: 
  • -- In August 2022, interim results from the Phase 1/2 trial of GRANITE, Gritstone’s individualized neoantigen vaccine for solid tumor cancers, were published in Nature Medicine ( here ).
  • -- In August 2022, Gritstone reported 6-month neutralizing antibody data from the first two cohorts of its CORAL-BOOST trial.
  • -- In October 2022, Gritstone shared interim positive results from the ongoing Phase 1 CORAL-BOOST and CORAL-CEPI studies at a Company-sponsored webinar .
  • Collaboration, license, and grant revenues were $19.9 million for the year ended December 31, 2022, compared to $48.2 million for the prior year.

Global Coalition for Adaptive Research Announces That Regorafenib Has Completed Follow-up in the GBM AGILE Trial for Patients With Glioblastoma

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Wednesday, September 21, 2022
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Global Coalition for Adaptive Research (GCAR), Sponsor of GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) master protocol, announced that regorafenib has completed enrollment and follow-up in GBM AGILE.

Key Points: 
  • Global Coalition for Adaptive Research (GCAR), Sponsor of GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) master protocol, announced that regorafenib has completed enrollment and follow-up in GBM AGILE.
  • Regorafenib was being evaluated in GBM AGILE for efficacy in patients with recurrent glioblastoma and in patients with newly diagnosed MGMT unmethylated glioblastoma.
  • GBM AGILE is an international, innovative platform trial designed to identify effective therapies more rapidly for patients with glioblastoma through response adaptive randomization and a seamless phase 2/3 design.
  • GCAR is the sponsor of GBM AGILE, an adaptive platform trial for patients with GBM the most common and deadliest of malignant primary brain tumors.

Global Glioblastoma Multiforme Drug Forecast and Market Analysis to 2030 - ResearchAndMarkets.com

Retrieved on: 
Friday, February 4, 2022
Biotechnology, Pharmaceutical, Health, Oncology, Growth, Diagnosis, Traffic barrier, Temozolomide, Patient, III, IDH, OS, Astrocyte, Cancer, Tyrosine kinase inhibitor, Epidemiology, R, Human, BBB, Patent, Northwest Biotherapeutics, Astrocytoma, Research, GBM, CAGR, WHO, Disease, Method, MGMT, Investment, Industry, Therapy, Compound annual growth rate, Regorafenib, Review, Oil, Pharmaceutical industry, Fine chemical, Marketing, Medical device, Retail, Glioblastoma, Bevacizumab

Topline Glioblastoma Multiforme market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.

Key Points: 
  • Topline Glioblastoma Multiforme market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
  • Analysis of the current and future market competition in the global Glioblastoma Multiforme therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Glioblastoma Multiforme market in the future.
  • Track drug sales in the global Glioblastoma Multiforme therapeutics market from 2020-2030.

Arcus Biosciences Presents Updated Data for Etrumadenant in Third-Line Metastatic Colorectal Cancer and New Data on its HIF-2α Program at the AACR 2021 Annual Meeting

Retrieved on: 
Saturday, April 10, 2021
Biotechnology, Hospitals, Health, Pharmaceutical, Oncology, Organic compounds, Chemical compounds, Chemistry, Chloroarenes, Pyridines, Regorafenib, Ureas, Tipiracil, Progression-free survival, Cancer, Etrumadenant, Arcus Biosciences

Efficacy Results (n=22 efficacy-evaluable 3L+ patients as of the DCO of Feb. 26, 2021)

Key Points: 
  • Efficacy Results (n=22 efficacy-evaluable 3L+ patients as of the DCO of Feb. 26, 2021)
    Median progression-free survival (PFS) of 4.2 months.
  • Reported data for current standard-of-care (SOC) therapies have shown a median PFS of 2.0 and 1.9 months for trifluridine-tipiracil and regorafenib, respectively3,4.
  • Reported data for trifluridine-tipiracil and regorafenib have shown a median OS of 7.1 and 6.4 months, respectively3,4.
  • Few options exist today to treat third-line colorectal cancer, and these therapies are associated with significant toxicity and limited efficacy.

Ipsen Announces Publication of First Matching-Adjusted Indirect Comparison of Cabometyx® (cabozantinib) Versus regorafenib in Advanced Hepatocellular Carcinoma in Advances in Therapy

Retrieved on: 
Tuesday, May 19, 2020
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Aromatic compounds, Chloroarenes, Pyridines, Ureas, Cancer treatments, Regorafenib, Tyrosine kinase inhibitors, Sorafenib, Hepatocellular carcinoma, Cabozantinib

CABOMETYX (cabozantinib) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Key Points: 
  • CABOMETYX (cabozantinib) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • Matching-adjusted indirect comparison of cabozantinib versus regorafenib in advanced hepatocellular carcinoma.
  • Cost of treatment-related adverse events (TRAES) in second-line (2l) advanced hepatocellular carcinoma (AHCC): match adjusted indirect comparison (MAIC) of nivolumab and regorafenib.
  • Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomized, double-blind, placebo-controlled, phase 3 trial.

Tiziana Lifesciences Announces Online Publication of Two Abstracts at the American Society of Clinical Oncology (ASCO) Reporting Clinical Activity and Safety of Milciclib in Patients with Advanced Hepatocellular Carcinoma

Retrieved on: 
Thursday, May 14, 2020
Chemical compounds, Organic compounds, Aromatic compounds, Chloroarenes, Pyridines, Ureas, Cancer treatments, Hepatology, Sorafenib, Regorafenib, Hepatocellular carcinoma, Protein kinase inhibitor

Abstract #298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients.

Key Points: 
  • Abstract #298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients.
  • Positive demonstrated clinical activity included:
    50% (14 out of 28) evaluable patients completed 6-month duration of the trial.
  • Abstract #307309: Safety and Clinical Activity of Combination Treatment with Regorafenib and Milciclib in Liver Transplant Patients with Hepatocellular Carcinoma Recurrence.
  • The American Society of Clinical Oncology (ASCO) was established in 1964 with the sole purpose of improving the care of people with cancer.

Blueprint Medicines Announces Top-line Results from Phase 3 VOYAGER Trial of Avapritinib versus Regorafenib in Patients with Advanced Gastrointestinal Stromal Tumor

Retrieved on: 
Tuesday, April 28, 2020
Creative works, Chemical compounds, Organic compounds, Chloroarenes, Pyridines, Regorafenib, Ureas, Clinical endpoint, Progression-free survival, Star Trek: Voyager

The VOYAGER trial did not meet the primary endpoint of an improvement in progression-free survival (PFS) for avapritinib versus regorafenib.

Key Points: 
  • The VOYAGER trial did not meet the primary endpoint of an improvement in progression-free survival (PFS) for avapritinib versus regorafenib.
  • The VOYAGER trial evaluated the efficacy and safety of avapritinib (N=240) versus regorafenib (N=236) in patients with third- or fourth-line GIST.
  • Additional analyses of the VOYAGER trial results are ongoing, and Blueprint Medicines plans to present the data at a future medical meeting.
  • VOYAGER was a global, open-label, randomized, Phase 3 trial designed to evaluate the efficacy and safety of avapritinib versus regorafenib in patients with third- or fourth-line GIST.

Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors

Retrieved on: 
Wednesday, February 12, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Chemical compounds, Health, Organic compounds, Pyridines, Cancer treatments, Indoles, Pyrroles, Sunitinib, Gastrointestinal stromal tumor, Imatinib, Regorafenib, Prescription Drug User Fee Act

Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its New Drug Application (NDA) seeking approval for ripretinib, the Companys investigational broad-spectrum KIT and PDGFR inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST).

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its New Drug Application (NDA) seeking approval for ripretinib, the Companys investigational broad-spectrum KIT and PDGFR inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST).
  • Under the PDUFA, a Priority Review targets a review time of six months compared to a standard review time of ten months.
  • The FDA previously granted Breakthrough Therapy Designation (BTD) for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib, and regorafenib.
  • In addition, the Company has submitted additional marketing applications in Canada and Australia for ripretinib in advanced GIST.