Eisai Announces Real-World Data Demonstrating Strong Efficacy of HALAVEN® (Eribulin Mesylate) in Metastatic Breast Cancer, Now Available in China

May 19, 2021 /BioonBIOON/ -- Eisai recently announced the evaluation of the innovator anticancer drug Halaven (Chinese brand name: Hailewei, generic name: eribulin mesylate) for the treatment of metastaticBreast cancerData from a real-world study in (mBC). The study evaluated the treatment patterns and clinical outcomes of Halaven as a third-line or later-line therapy in patients with mBC, including the triple-negative breast cancer (TNBC) subtype. The study data were recently published in the international medical journal 《Advances in Therapy》, with the article titled:Effectiveness of Eribulin in Metastatic Breast Cancer: 10 Years of Real-World Clinical Experience in the United States。

In November 2010, Halaven was by the United StatesFDAApproved for the treatment of patients with metastatic breast cancer (mBC) who have previously received at least two chemotherapy regimens for metastatic disease. Prior therapy should include an anthracycline and a taxane in either the adjuvant or metastatic setting.

In China, Halaven was approved by the National Medical Products Administration (NMPA) in July 2019 for the treatment of patients with locally recurrent or metastatic breast cancer who have previously received at least two chemotherapy regimens (including anthracyclines and taxanes).In January 2020, Halaven was launched in China.

This study is a retrospective, multicenter medical record review study conducted in the United StatesTumorConducted in clinical practice, the study enrolled mBC patients (n=513) who initiated treatment with Halaven according to the U.S. Prescribing Information between 2011 and 2017. Data were extracted by prescribing physicians from patients' electronic health records and collected via electronic case report forms. All patient data were de-identified prior to analysis. Evaluated clinical endpoints included provider-reported objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), and overall survival (OS), assessed in both the overall mBC population and the TNBC subtype subgroup.

The median age of these patients at the initiation of Havalen treatment was 59 years, with 61% of patients from the Eastern United States# TumorEastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Within the overall mBC cohort, 50% (n=256) had TNBC. Compared with the overall patient cohort (78%), a higher proportion of TNBC patients received Havalen in the third-line setting (87.9%), with the remainder receiving Havalen in the fourth-line or later lines of therapy. At the data cutoff, 96.9% (n=497) of the overall patient cohort and 96.9% (n=248) of the TNBC subgroup had discontinued Havalen treatment. Among patients who discontinued Havalen, disease progression was the primary reason for discontinuation in 78.1% of the overall cohort and 84.3% of the TNBC subgroup, respectively.

ORR, PFS, and OS Data

In the overall mBC cohort, the median PFS was 6.1 months (95% CI: 5.8–6.6). In the TNBC subgroup, the median PFS was 5.8 months (95% CI: 5.1–6.4). The median OS was 10.6 months (95% CI: 9.9–11.7) in the mBC group and 9.8 months (95% CI: 8.6–11.0) in the TNBC group. In the overall mBC cohort, the ORR was 54.4% (95% CI: 50.1–58.7), and 55.1% (95% CI: 49.0–61.2) in the TNBC subgroup. In the overall mBC cohort, the CBR was 56.7% (95% CI: 52.4–61.0), and 57.4% (95% CI: 51.4–63.5) in the TNBC subgroup.

One limitation of this study was that detailed safety data were not collected. Furthermore, the treatment patterns reflected in the study may only represent the practices of physicians who agreed to participate. If patients transferred their treatment to other medical institutions or centers, they may have been lost to follow-up during the study period.

Dr. Takashi Owa, Vice President of Eisai's Oncology Business Group, Chief Drug Creation Officer and Chief Discovery Officer, stated: "ForTumorFor oncologists and patients with metastatic breast cancer, these data provide insights into real-world practice with Havalen. We remain committed to continuously providing data for Havalen, both in real-world settings and in translational research related to mBC, to drive our ongoing innovation in refractory diseases such as mBC.”

The active pharmaceutical ingredient of Halaven is eribulin, a synthetic analog of halichondrin B discovered and developed by Eisai. Halichondrin B is a natural product isolated from the sponge Halichondria okadai.

Eribulin is the first halichondrin-class microtubule dynamics inhibitor., with a novel mechanism of action. Eribulin is believed to exert its effects primarily through a tubulin-based mechanism, which induces prolonged and irreversible mitotic arrest, ultimately leading to apoptotic cell death.

Additionally, in preclinical studies of human breast cancer, eribulin exhibited complex effects on the tumor biology of surviving cancer cells, including reduced tumor hypoxia resulting from increased vascular perfusion, andTumorGene expression alterations associated with phenotypic changes in the specimens promote the epithelial phenotype and suppress the mesenchymal phenotype. Eribulin has also been shown to reduce the migration and invasiveness of human breast cancer cells.

To date, Halaven has been approved in multiple countries across Europe, the Americas, and Asia for the treatment of breast cancer. Additionally, in some countries, Halaven has also been approved for the treatment of soft tissue sarcoma. (Bioon.com)

Source: Eisai Announces Real-World Data on the Effectiveness of HALAVEN® (eribulin mesylate) for the Treatment of Patients with Metastatic Breast Cancer (mBC) Published in Advances in Therapy