An independent data safety monitoring board advised the company to stop the trial based on an interim analysis of 351 events, indicating that the trial was highly unlikely to reach a pre-specified survival benefit.
YM BioSciences said that the trial was not stopped due to safety concerns relating to the product. The company plans to submit data from this trial to a medical meeting after it completes its review.
The phase III trial compared the survival of patients treated with tesmilifene combined with epirubicin/cyclophosphamide to epirubicin/cyclophosphamide alone in women with rapidly progressing metastatic and/or recurrent breast cancer.
“We are very disappointed by this outcome and will be evaluating the data to understand why tesmilifene did not add a clinical benefit in this trial,” said David Allan, chairman and CEO of YM BioSciences.
“Upon completing the review of the phase III data, the company will consider its options relating to tesmilifene.”