TOKYO, Sep 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.
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Eisai Co., Ltd. defines our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through working with key stakeholders to improve access to medicines in developing and emerging countries.
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