Eisai's breast cancer drug Halaven has failed to hit targets in a Phase III trial pitting its performance against Xeloda to gage its potential as a second-line treatment for the disease.
Halaven (eribulin) has received approval in the US, Europe and other countries as a third-line treatment for patients with locally advanced or metastatic breast cancer who have previously received at least two chemotherapeutic regimens.
The company was assessing whether the drug could be used earlier in the treatment pathway, but initial results from the trial have diminished hopes of expanding its scope to a second-line therapy.
According to preliminary data from the global 1,102-patient trial, Halaven did not show a stastically-significant benefit compared to Xeloda in terms of progression free survival (PFS) or overall survival (OS) in women with breast cancer who have had up to two cycles of chemotherapy for advanced disease.
The company noted that the study did show a trend towards improved OS for patients taking Halaven compared with those on Xeloda, but the improvement was not statistically significant, and there was no difference in terms of PFS.
"There are important trends here that will need further analysis," said Kenichi Nomoto, President, Oncology Product Creation Unit at Eisai, and the firm said it would present further study results at forthcoming international medical meetings.
France says yes
In better news for Eisai on the drug, health authorities in France have agreed reimbursement for treatment with Halaven within its licensed indication as a third-line treatment for breast cancer.
Breast cancer is the most common cancer amongst women in France, accounting for 35.5% and the highest death rate of all cancers in France, so "it is really encouraging to see that the French health authorities recognise the innovative drug status and clinical value eribulin may offer to women with locally advanced or metastatic breast cancer," said Evelyne Lepetit, Oncology Business Unit Head for France, Eisai Europe.
"Patients who are eligible may now benefit from a novel treatment that may extend their lives, a notion that had until now been deemed unrealistic,” she added.
The news will be especially sweet given that cost regulators in the UK have not backed the drug for National Health Service use.