Eisai’s breast cancer drug impresses at ASCO

pharmafile | June 9, 2010 | News story | Research and Development ASCO, Eisai, Xeloda, eribulin 

A new cancer drug developed by Japanese pharma company Eisai has shown promise in increasing overall survival rates in heavily pre-treated breast cancer patients.

The phase III data, presented at the ASCO oncology conference in Chicago, shows that Eribulin met its primary endpoint by increasing overall survival of 13.25 months over 10.65 months – a median of 2.5 months.

Eribulin has been trialed on female metastatic breast cancer (MBC) patients as a monotherapy who have had between two and a maximum of five chemotherapy or cancer treatments to which the patient remains refractory.

Lead Investigator and professor of clinical cancer pharmacology and oncology from the University of Leeds Dr Chris Twelves told Pharmafocus: “Unlike [Roche’s blockbuster cancer drugs] Herceptin and Avastin, Eribulin is highly active as a single agent.

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“The prolonged survival we saw has not been seen previously in such heavily pre-treated patients with any other cancer drug (including Herceptin and Avastin). In the future, Eribulin may be combined with either Herceptin or Avastin.”

The drug is derived from Halichondrin B, an extract from a marine sponge, and acts on microtubules that are the scaffold the cell uses when dividing. Other cancer drugs such as taxanes also target this area, but Eribulin binds in a unique way that helps ‘kill’ cancer cells in a way other microtubule drugs cannot.

The EMBRACE trial was an open-label, randomised, multi-centre study of 762 patients with locally or recurrent metastatic breast cancer. Eribulin’s side effects were similar to other chemotherapy drugs but caused less damage to the nerves than other microtubule-targeted drugs.

The results of the trial showed that women with HER2 negative or positive, and ER positive or negative and triple negative MBC could all benefit from Eribulin at a late stage in the disease.

Dr Twelves told Pharmafocus that he hoped Eribulin could be used as an earlier stage of treatment in the future as a “second, large trial has already completed recruitment comparing Eribulin to capecitabine (Roche’s MBC drug Xeloda) in women with less heavily treated breast cancer.

“Colleagues are already discussing how and when we can evaluate Eribulin earlier in the course of the disease.”

Eribulin’s performance has already prompted Eisai to submit simultaneous regulatory applications for the drug to agencies in Japan, the US and the EU, and last month US regulator the FDA granted it priority review status.

Ben Adams

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