Eisai Co., Ltd., engaged in manufacturing and selling pharmaceutical products worldwide, has submitted applications to regulatory authorities in Japan, the United States and Europe (MHLW, FDA and EMA respectively) seeking an additional indication for its in-house developed anticancer agent Halaven (eribulin mesylate) as a treatment for soft tissue sarcoma.
Halaven is the first and only single agent systemic therapy to demonstrate an improvement in overall survival (OS) in people previously treated for soft tissue sarcomas in a randomized controlled trial to date. In a phase III clinical study (Study 309) which examined the efficacy and safety of Halaven versus dacarbazine in patients with locally advanced or recurrent and metastatic soft tissue sarcoma (one of two subtypes: leiomyosarcoma or adipocytic sarcoma) who had disease progression following standard therapies (including an anthracycline and at least one other additional regimen), Halaven demonstrated a statistically significant extension in the study's primary endpoint of OS over the comparator treatment dacarbazine (Halaven median OS: 13.5 months vs dacarbazine median OS: 11.5 months, Hazard Ratio (HR) 0.768 [95 per cent CI=0.618-0.954], p=0.017). In this study, the most common treatment-emergent adverse events observed in the Halaven arm were fatigue or asthenia, neutropenia, nausea, alopecia, and peripheral neuropathy, which was consistent with the known side-effect profile of Halaven.
These data were presented at an oral session at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2015.
Soft tissue sarcoma is a collective term for a diverse group of malignant tumours that occur throughout the soft tissue (fat, muscle, nerves, fibrous tissues and blood vessels) in the body. While treatment of soft tissue sarcoma is focused on curative surgery, if the degree of malignancy is high, treatment then becomes a combination of chemotherapy and radiation therapy. As outcomes are poor for patients with advanced disease, it remains a disease with significant unmet medical needs. Approximately 12,000 patients in the United States and 29,000 patients in Europe are diagnosed with soft tissue sarcoma each year. According to a patient survey conducted by the MHLW, there are approximately 4,000 patients with soft tissue sarcoma in Japan. Meanwhile, Halaven has been designated as an orphan drug for the treatment of soft tissue sarcoma in the United States and Japan.
Halaven is a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action. It belongs to a class of antineoplastic agents, the halichondrins, which are natural products isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequestering tubulin into nonproductive aggregates. It was first approved for the treatment of metastatic breast cancer in the United States in November 2010, and is currently approved in approximately 60 countries including Japan and countries in Europe, the Americas and Asia.
Eisai remains committed to providing further clinical evidence for Halaven aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.