October
24, 2003 Following safety analysis by an independent Data Monitoring Committee of its three pivotal trials for Xyotax in non-small cell lung cancer (NSCLC), Cell Therapeutics (NASDAQ: CTIC) has amended the STELLAR 4 Xyotax dosing schedule from 235mg/m2 to 175mg/m2. A “small percentage” of participants apparently developed early (first- or second-cycle) neutropenic-related toxicities. All patients currently enrolled will receive 175mg/m2, while the comparator arm dosages will continue according to the protocol.
Xyotax investigation to date has demonstrated that the 175mg/m2 dose level is associated with a reassuring tolerability and adverse effect profile. Clinically relevant median survival has been achieved with this dose in the poor performance status (PS2) population. Three phase III trials will determine whether the magnitude of survival benefit merits Xyotax approval for the treatment of NSCLC. The single-agent dose of Xyotax 175mg/m2 will be standardized across all PS2 patients.
STELLAR 4 compares Xyotax to either gemcitabine or vinorelbine in the first-line management of PS2 NSCLC. Cell Therapeutics expects study enrollment to be complete by “the end of the first quarter, 2004.” STELLAR 2 compares Xyotax to docetaxel for the second-line treatment of NSCLC, and STELLAR 3 studies the clinical merits of carboplatin in combination with either Xyotax or paclitaxel in the first-line treatment of PS2 patients with NSCLC. STELLAR 3 is slated to complete its enrollment this quarter.
Xyotax has a fast track designation from the FDA for the management of advanced, PS2 NSCLC. The drug is a polyglutamated, long-acting formulation of the well-established chemotherapeutic paclitaxel. Cell Therapeutics hopes to submit the relevant NDA by the end of 2004. Evolving surrogate endpoint data have suggested that solid tumor Xyotax-response rates, especially for NSCLC and ovarian cancer, will translate into quality of life and/or survival advantages, at least in some populations. Data presented at American Society of Clinical Oncology (ASCO) identified NSCLC patients with poor performance status as among the populations most likely to derive clear benefit from Xyotax administration.
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