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Eribulin (Halaven) Improves Survival in Sarcoma Study

Treatment trumps dacarbazine in late-stage trial

Eribulin (Halaven, Eisai Inc.) has demonstrated a statistically significant improvement in overall survival (OS) compared with dacarbazine in patients with advanced soft-tissue sarcoma –– the primary endpoint in a new phase III trial.

This is the second late-stage study in which eribulin, as a single agent, provided an overall survival benefit in distinct solid-tumor types (metastatic breast cancer and soft-tissue sarcomas) after two prior treatment regimens in the advanced setting.

Eribulin is indicated for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens, which should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. The drug is not currently FDA-approved for the treatment of soft-tissue sarcoma.

Approximately 12,000 cases soft-tissue sarcoma will be diagnosed in the U.S. in 2015, and 4,700 Americans are expected to die of the disease. While many patients with soft-tissue sarcoma are diagnosed early in their disease and are curable with surgery, outcomes for patients with advanced or metastatic disease are poor, and median survival is around 1 year or less.

In the new randomized, open-label trial, eribulin mesylate 1.4 mg/m2 was administered intravenously (IV) on days 1 and 8 of a 21-day cycle, compared with dacarbazine IV on day 1 every 21 days (dose range: 850 mg/m2 to 1,200 mg/m2), in 452 patients with locally advanced or recurrent and/or metastatic adipocytic sarcoma or leiomyosarcoma who had disease progression following two standard therapies, which must have included an anthracycline and at least one additional regimen after anthracycline failure. The study’s primary endpoint was a comparison of OS between the two treatment arms.

The most common adverse events observed in the eribulin arm included neutropenia, fatigue, nausea, alopecia, and constipation.

Based on the results of this study, a new drug application is expected to be submitted to the FDA during fiscal year 2015 seeking an expansion of the indication for eribulin to include soft-tissue sarcoma.

Soft-tissue sarcomas are cancers that develop from cells in the soft, supporting tissues of the body, such as fat, muscle, nerves, fibrous tissues, and blood vessels. These tumors are mostly diagnosed in early-stage or localized disease, and many patients are amenable to complete surgical removal. Relapse rates, however, can be as high as 50%, and outcomes for patients with advanced disease are poor, with a median survival period of approximately 1 year or less. Because of the rarity of these tumors, the evidence for prognostic factors is weak and is not well understood.

Eribulin is a synthetic analog of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor with a distinct binding profile. Based on in vitro studies, eribulin exerts its effect via a tubulin-based antimitotic mechanism, ultimately leading to apoptosis after prolonged and irreversible mitotic blockage.

Source: Eisai; February 25, 2015.

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