Xyotax Trial Shows Reduced Side Effects of Paclitaxel, Equivalent Efficacy

Cell Therapeutics has announced that while a Phase III study of Xyotax in combination with carboplatin, known as STELLAR 3, missed its primary endpoint, it met statistical significance for noninferiority of survival compared to paclitaxel in combination with carboplatin.

Patients who received the Xyotax/carboplatin regimen had significantly less hair loss and a reduction in other side effects, including muscle and joint pain, cardiac symptoms, and an overall reduction in neurologic toxicities compared to patients who received the standard paclitaxel/carboplatin regimen.

The Xyotax regimen was given in a convenient 10-minute infusion without the requirement for steroids and other premedications. Hypersensitivity reactions were rare on the Xyotax/carboplatin arm of the study despite the lack of premedications. Complete research findings from this trial are expected to be presented at the American Society of Clinical Oncology meeting in mid-May.