Pharmaceutical Business review

Cell Thera nosedives on lung cancer trial failure

However, although the study of Xyotax in combination with carboplatin in non-small cell lung cancer (NSCLC), known as STELLAR 3, missed its primary endpoint, it did meet statistical significance for non-inferiority 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.

“We are disappointed that Xyotax in combination with carboplatin showed equal efficacy after the unprecedented blended median and one-year survival we saw on the trial,” stated Dr James Bianco, president and CEO of Cell Therapeutics. “We are encouraged by the preliminary analysis, which demonstrates a significant Xyotax treatment effect, reduction in toxicities, and increased patient convenience.”