DAIICHI SANKYO COMPANY, LIMITED

ETNA-AF-Europe Registry Data on LIXIANA®▼(edoxaban) Published in a Leading Cardiology Journal Highlights Important Clinical Considerations for Treating Ageing Patients with Atrial Fibrillation

Retrieved on: 
Thursday, August 20, 2020
Clinical research, Health, Design of experiments, Articles, Medical research, Clinical pharmacology, Clinical trial, Pharmaceutical industry, Randomized controlled trial

[1]

Key Points: 
  • [1]
    "Findings noted in ETNA-AF-Europe now complement the outcomes reported in other observational data sets on DOACs.
  • Advancing age, accumulation of comorbidities and frailty are believed to increase thromboembolic and bleeding risks in patients with AF.
  • [1],[3]The wider global ETNA-AF programme has so far collected data from 24,962 patients in 2,242 sites in Japan, Korea/Taiwan and Europe.
  • The study is part of the Edoxaban Clinical Research Programme, which includes more than 10 randomised, controlled trials, registries and non-randomised clinical studies.

Large Real-World Data Confirm Safety and Effectiveness of LIXIANA®▼ (edoxaban) in Routine Clinical Practice for Elderly AF Patients with Comorbidities

Retrieved on: 
Wednesday, December 18, 2019
RTT, Anticoagulants, Hematology, Medical specialties, Medicine, Clinical medicine, Atrial fibrillation, Cardiac arrhythmia, Chloroarenes, Embolism, Stroke, Edoxaban

In addition, primary (composite) bleeding outcomes requiring hospitalisation were approximately 50% lower than observed in ENGAGE AF-TIMI 48.1 The real-world findings reinforce LIXIANA's efficacy and safety profile in elderly AF patients in routine clinical practice.1

Key Points: 
  • In addition, primary (composite) bleeding outcomes requiring hospitalisation were approximately 50% lower than observed in ENGAGE AF-TIMI 48.1 The real-world findings reinforce LIXIANA's efficacy and safety profile in elderly AF patients in routine clinical practice.1
    Commenting on the study, lead author, Assoc.
  • The primary effectiveness endpoint of thromboembolism, comprised of a composite outcome of stroke and systemic embolism, occurred 41 times.
  • [1]
    The safety outcomes, comprised of a composite of all bleedings, including intracranial, gastrointestinal and major bleeding in other anatomic sites, occurred 89 times.
  • Effectiveness and safety of edoxaban in patients with atrial fibrillation: data from the Danish nationwide cohort.

Daiichi Sankyo Presents Positive Results of the ENTRUST-AF PCI Study of LIXIANA®▼ (edoxaban) in Patients with Atrial Fibrillation

Retrieved on: 
Wednesday, September 4, 2019
Companies, Daiichi Sankyo, Chloroarenes, Stroke, Anticoagulants, Edoxaban, Intracranial hemorrhage, Economy of Japan

The ENTRUST-AF PCI study enrolled 1,506 patients with AF following successful stent placement for ACS (51.6%) or stable CAD (48.4%).

Key Points: 
  • The ENTRUST-AF PCI study enrolled 1,506 patients with AF following successful stent placement for ACS (51.6%) or stable CAD (48.4%).
  • We are encouraged by these results which represent an important advancement in our understanding of how to best manage AF patients post-PCI."
  • [2]Intracranial hemorrhage occurred in four (0.58% per year) of edoxaban-treated patients and nine (1.32% per year) VKA-treated patients.
  • Edoxaban is currently marketed by Daiichi Sankyo and its partners in more than 30 countries and regions around the world.

ETNA-AF Registry Data Provide Real-world Evidence of the Efficacy and Safety Profile of LIXIANA®▼ (edoxaban) in Elderly NVAF Patients

Retrieved on: 
Monday, September 2, 2019
Clinical research

A new analysis, which reported the outcomes of 24,962 edoxaban-treated patients with NVAF at one year follow up supports the treatment's safety and efficacy profile in elderly and very elderly AF patients.

Key Points: 
  • A new analysis, which reported the outcomes of 24,962 edoxaban-treated patients with NVAF at one year follow up supports the treatment's safety and efficacy profile in elderly and very elderly AF patients.
  • ICH occurred in 0.2% patients aged
  • Ishaemic stroke occurred in 0.6% of patients aged
  • The data from this set of unselected patients support edoxaban's growing evidence of safety profile and its use as an effective treatment for elderly, and very elderly, AF patients in regular clinical care.

Updated Clinical Results and New Translational Research Data for Daiichi Sankyo's ADCs U3-1402 and DS-1062 to be Presented at the 2019 World Conference on Lung Cancer

Retrieved on: 
Thursday, August 22, 2019
Companies, Clinical medicine, Daiichi Sankyo, Medicine, Metastatic breast cancer, Cancer, Monoclonal antibodies, Cancer treatments

Translational research findings from both studies, including biomarker expression and genomic alterations, will be presented alongside patient response data.

Key Points: 
  • Translational research findings from both studies, including biomarker expression and genomic alterations, will be presented alongside patient response data.
  • U3-1402 also is being evaluated in a phase 1/2 trial in patients with HER3 positive metastatic breast cancer.
  • 14:30 16:00 CEST)
    "First-in-Human Phase 1 Study of DS-1062a (TROP2 Antibody Drug Conjugate) in Patients with Advanced Non-Small Cell Lung Cancer" (Abstract #3854.
  • The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer.

Updated Clinical Results and New Translational Research Data for Daiichi Sankyo's ADCs U3-1402 and DS-1062 to be Presented at the 2019 World Conference on Lung Cancer

Retrieved on: 
Wednesday, August 21, 2019
Companies, Clinical medicine, Daiichi Sankyo, Medicine, Metastatic breast cancer, Cancer, Monoclonal antibodies, Cancer treatments

Translational research findings from both studies, including biomarker expression and genomic alterations, will be presented alongside patient response data.

Key Points: 
  • Translational research findings from both studies, including biomarker expression and genomic alterations, will be presented alongside patient response data.
  • U3-1402 also is being evaluated in a phase 1/2 trial in patients with HER3 positive metastatic breast cancer.
  • 14:30 16:00 CEST)
    "First-in-Human Phase 1 Study of DS-1062a (TROP2 Antibody Drug Conjugate) in Patients with Advanced Non-Small Cell Lung Cancer" (Abstract #3854.
  • The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer.

FDA Approves Daiichi Sankyo's TURALIO™ (pexidartinib) for the Treatment of Select Patients with TGCT, a Rare and Debilitating Tumor

Retrieved on: 
Monday, August 5, 2019
Medical specialties, Medicine, Hepatology, Hepatotoxicity, Toxicology, Risk Evaluation and Mitigation Strategies, Liver, Hy's law

"We now have a new oral treatment option that can have a meaningful clinical benefit in select patients, including a reduction in tumor size."

Key Points: 
  • "We now have a new oral treatment option that can have a meaningful clinical benefit in select patients, including a reduction in tumor size."
  • TURALIO is approved with a Boxed Warning for hepatotoxicity due to the risk of serious and potentially fatal liver injury.
  • Across 768 patients who received TURALIO in clinical trials, there were two irreversible cases of cholestatic liver injury.
  • Because of the risk of hepatotoxicity, TURALIO will be available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program.

FDA Approves Daiichi Sankyo's TURALIO™ (pexidartinib) for the Treatment of Select Patients with TGCT, a Rare and Debilitating Tumor

Retrieved on: 
Saturday, August 3, 2019
Medical specialties, Medicine, Hepatology, Hepatotoxicity, Toxicology, Risk Evaluation and Mitigation Strategies, Liver, Hy's law

"We now have a new oral treatment option that can have a meaningful clinical benefit in select patients, including a reduction in tumor size."

Key Points: 
  • "We now have a new oral treatment option that can have a meaningful clinical benefit in select patients, including a reduction in tumor size."
  • TURALIO is approved with a Boxed Warning for hepatotoxicity due to the risk of serious and potentially fatal liver injury.
  • Across 768 patients who received TURALIO in clinical trials, there were two irreversible cases of cholestatic liver injury.
  • Because of the risk of hepatotoxicity, TURALIO will be available only through a restricted program called the TURALIO Risk Evaluation and Mitigation Strategy (REMS) Program.

Daiichi Sankyo Presents Preliminary Phase 1 Data for TROP2 Targeting ADC DS-1062 in Patients with Non-Small Cell Lung Cancer at 2019 ASCO Annual Meeting

Retrieved on: 
Sunday, June 2, 2019
Medicine, Clinical medicine, Cancer, Cancer treatments, Antineoplastic drugs, Lung cancer, Non-small-cell lung carcinoma, Daiichi Sankyo, Chemotherapy

"These early results are encouraging as we have seen increased activity with higher doses of DS-1062 including several partial responses.

Key Points: 
  • "These early results are encouraging as we have seen increased activity with higher doses of DS-1062 including several partial responses.
  • Additional study is warranted to further determine the potential for targeting TROP2 with DS-1062 in these patients with advanced NSCLC."
  • DS-1062 was designed to target and deliver chemotherapy inside cancer cells that express TROP2 as a cell surface antigen.
  • Part of the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise, DS-1062 is an investigational TROP2 targeting ADC.

Daiichi Sankyo Presents Preliminary Phase 1 Data for TROP2 Targeting ADC DS-1062 in Patients with Non-Small Cell Lung Cancer at 2019 ASCO Annual Meeting

Retrieved on: 
Sunday, June 2, 2019
Medicine, Clinical medicine, Cancer, Cancer treatments, Antineoplastic drugs, Lung cancer, Non-small-cell lung carcinoma, Daiichi Sankyo, Chemotherapy

"These early results are encouraging as we have seen increased activity with higher doses of DS-1062 including several partial responses.

Key Points: 
  • "These early results are encouraging as we have seen increased activity with higher doses of DS-1062 including several partial responses.
  • Additional study is warranted to further determine the potential for targeting TROP2 with DS-1062 in these patients with advanced NSCLC."
  • DS-1062 was designed to target and deliver chemotherapy inside cancer cells that express TROP2 as a cell surface antigen.
  • Part of the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise, DS-1062 is an investigational TROP2 targeting ADC.