Xyotax Produces Equivalent Survival, Reduces Side Effects in Lung Cancer
Cell Therapeutics announced the results of its Phase III clinical studies of Xyotax in non-small cell lung cancer (NSCLC), known as STELLAR 2 and 4.
The studies were designed to determine if Xyotax could increase the overall survival of patients while reducing serious side effects associated with the treatment of first-line or second-line NSCLC. Both trials demonstrated equivalent survival with significant reductions in serious side effects when compared to either docetaxel or gemcitabine/vinorelbine; although they missed their primary endpoints of superior overall survival.
Xyotax was administered in a convenient 10-minute infusion without the requirement for steroids and other premedications. STELLAR 4, a Phase III clinical trial of Xyotax versus either gemcitabine or vinorelbine for the first-line treatment of poor performance status patients with NSCLC, resulted in a median survival of 7.3 months and two-year survival of 15 percent for patients on the Xyotax arm compared to 6.6 months and 10 percent for the control arm.
Significantly more patients completed a full six courses of therapy on the Xyotax arm compared to the control arm. Side effects were comparable on both arms, except for a significant reduction in all cardiac toxicities, gastrointestinal side effects, nausea and vomiting. Xyotax patients also had a significant reduction in severe hematologic toxicities including anemia, neutropenia and thrombocytopenia. Hair loss was uncommon on both arms. Grade 3/4 neuropathy was observed more frequently on the Xyotax arm.