STELLAR 3 Pivotal Trial Shows XYOTAX(TM) Reduces Side Effects of Paclitaxel With Equivalent Efficacy in the Treatment of Non-Small Cell Lung Cancer (NSCLC) Patients
Monday March 7, 7:00 am ET
- Study Misses Primary Endpoint, Meets Standard Statistical Test for Non-inferiority; STELLAR 3 Trial Demonstrates Longest Median Survival Reported in PS2 NSCLC Patients; Tolerability and Convenience Favor XYOTAX
SEATTLE, March 7 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC - News) 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 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. 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 (ASCO) meeting in mid-May.
"When one controls for validated risk factors, including weight loss, LDH (a marker of tumor aggressiveness), and calcium levels, the single most important and highly statistically significant determinant of survival in the STELLAR 3 study was whether the patient received XYOTAX instead of paclitaxel," noted Jack W. Singer, M.D., Chief Medical Officer at CTI. "This intent-to-treat analysis, using a Cox multivariate model, was pre-specified in the protocol's statistical analysis plan. It provides a strong argument for a survival benefit for XYOTAX over paclitaxel that is not apparent in the primary analysis."
The multi-center, randomized, controlled phase III study compared XYOTAX (210mg/m2) in combination with carboplatin (AUC 6) to paclitaxel (225mg/m2) in combination with carboplatin (AUC 6) every three weeks for up to six cycles of therapy in 400 poor performance status (PS2) NSCLC patients.
"We are disappointed that XYOTAX in combination with carboplatin showed equal efficacy after the unprecedented blended median and 1-year survival we saw on the trial. We are encouraged by the preliminary analysis, which demonstrates a significant XYOTAX treatment effect, reduction in toxicities, and increased patient convenience," stated James A. Bianco, M.D., President and CEO of CTI. "We look forward to our upcoming discussion with FDA regarding our STELLAR 2 amendment and the preliminary results of STELLAR 3, as well as having results from STELLAR 2 in April, with STELLAR 4 results coming in shortly thereafter." |
