English | 简体中文 | 繁體中文 | 한국어 | 日本語
Friday, 18 September 2020, 11:29 JST
Share:
    

Source: Eisai
Eisai Presents Latest Data of Phase I Clinical Trial on Liposomal Formulation of Anti-Cancer Agent Halaven (Eribulin) at ESMO Virtual Congress 2020

TOKYO, Sept 18, 2020 - (JCN Newswire) - Eisai Co., Ltd. has announced that the latest results from the cohort targeting patients with HER2-negative breast cancer in phase I clinical trial for the new liposomal formulation (E7389-LF) of the in-house discovered anti-cancer treatment Halaven (generic name: eribulin mesylate, "eribulin") were presented (abstract number: 346P) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

E7389-LF is a new formulation using liposomes made of a lipid bilayer to encapsulate the halichondrin-class microtubule dynamics inhibitor eribulin. In tumor tissue, gaps exist among vascular endothelial cells due to incomplete vasculature, which is thought to allow for penetration by macromolecules. This condition, in addition to incomplete lymphatic function, is predicted to enable high-molecular-weight drugs including liposomal formulations to be respectively delivered and retained in greater amounts in tumors as compared to in normal tissue, through Enhanced Permeability and Retention (EPR) effects. Thus E7389-LF is expected to improve the concentration of eribulin in tumor tissues.

This presentation reported efficacy and safety results of E7389-LF in a cohort enrolling 28 patients with recurrent (HER2-negative) breast cancer (hormone receptor-positive: 21, triple negative: 7) who had previously undergone treatment with anthracycline or taxane class treatments and had no prior treatment with eribulin (data cutoff: January 24, 2020, progression free survival and overall survival cutoff: April 17, 2020), as part of the open-label, phase I clinical trial (Study 114) on patients with select solid tumors who had previously undergone treatment. Patients were treated with E7389-LF 2.0 mg/m2 body surface area (as free eribulin) intravenously once every three weeks, and demonstrated an overall response rate (ORR) of 35.7% (95% confidence interval (CI): 18.6-55.9) in the HER2-negative breast cancer cohort as a whole. Within the cohort, hormone receptor positive patients demonstrated an ORR of 42.9% (95% CI: 21.8-66.6) and triple negative patients demonstrated an ORR of 14.3% (95% CI: 0.4-57.9). The disease control rate combining stable disease rate, partial response rate, and complete response rate was 89.3% (95% CI: 71.8-97.7). Additionally, progression-free survival (PFS) was a median of 5.7 months (95% CI: 3.9-8.3), and the median overall survival (OS) was not reached (95% CI: 10.3 - not reached). Adverse events of grade 3 or above (top 5) were neutropenia (67.9%), leukopenia (42.9%), thrombocytopenia (32.1%), febrile neutropenia (25.0%), and increased alanine aminotransferase (21.4%), which were consistent with the safety profile of eribulin to date. Additionally, preventive treatment with the G-CSF (granulocyte colony stimulating factor) pegfilgrastim demonstrated a decrease in the ratio of febrile neutropenia occurrence (with treatment: 10.0%, without treatment: 33.3%).

Eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.

For more information, visit https://www.eisai.com/news/2020/news202056.html.

Contact:
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120


Topic: Press release summary
Source: Eisai

Sectors: BioTech
https://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

 

Eisai Related News
Wednesday, 15 May 2024, 11:19 JST
Eisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI (lecanemab-irmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status
Monday, 13 May 2024, 17:06 JST
Eisai's Antiepileptic Drug Fycompa Approved in China for Adjunctive Treatment of Primary Generalized Tonic-Clonic Seizures
Thursday, 18 April 2024, 10:53 JST
Eisai: Research on Treatments for Alzheimer's Disease Based on Its Pathological Mechanisms Recieves Award for Science and Technology (Research Category)
Wednesday, 17 April 2024, 16:17 JST
Eisai's Antiepileptic Drug Fycompa Injection Formulation Launched In Japan
2024年4月17日 10時00分 JST
エーザイ、抗てんかん剤「フィコンパ(R)」の注射剤を新発売
More news >>
Copyright © 2024 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Cookies Policy | Privacy Policy | Disclaimer | Terms of Use | RSS
US: +1 214 890 4418 | China: +86 181 2376 3721 | Hong Kong: +852 8192 4922 | Singapore: +65 6549 7068 | Tokyo: +81 3 6859 8575