Xyotax STELLAR 3 Trial in NSCLC Reaches Required Number of Events

Cell Therapeutics is on track to report results in late March or early April from the Xyotax pivotal trial in non-small cell lung cancer (NSCLC), known as STELLAR 3.

Due to prolonged survival rates in this blinded trial, the company had to delay the data analysis from the date anticipated when the trial was initiated in November 2002.

The company also has updated its progress on the two other ongoing pivotal trials in NSCLC, STELLAR 4 and STELLAR 2. In STELLAR 4, approximately 250 of the 313 required events (deaths) have been reached, and in STELLAR 2, 578 out of the 635 required events have been reached. The company expects results from STELLAR 4 in the second quarter of this year and results from STELLAR 2 in the third quarter.

STELLAR, which stands for "Selective Targeted Efficacy in Lung cancer, Lower Adverse Reactions," are the largest randomized trials to date in either second-line lung cancer or front-line poor performance status lung cancer patients, according to the company. STELLAR 2 is a Phase III clinical trial of Xyotax versus docetaxel for the potential second-line treatment of NSCL cancer patients. STELLAR 3 is a Phase III clinical trial of carboplatin in combination with either Xyotax or paclitaxel for the potential front-line treatment of poor performance status patients with NSCL cancer. STELLAR 4 is a Phase III clinical trial of Xyotax versus either gemcitabine or vinorelbine for the potential front-line treatment of poor performance status patients with NSCL cancer.